SlideShare ist ein Scribd-Unternehmen logo
1 von 58
Downloaden Sie, um offline zu lesen
Shaping the Future: Clinicians and
Faculty Define Strategies for the
Next Era of HCV Therapy
This program is supported by educational grants from
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Program Director
Mark S. Sulkowski, MD
Professor of Medicine
Medical Director, Viral Hepatitis Center
Divisions of Infectious Diseases and Gastroenterology/Hepatology
Johns Hopkins University School of Medicine
Baltimore, Maryland
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Faculty
Jordan J. Feld, MD, MPH
Assistant Professor of Medicine
University of Toronto
Hepatologist
Toronto Western Hospital Liver Centre
McLaughlin-Rotman Centre for Global
Health
Toronto, Ontario, Canada
Graham R. Foster, FRCP, PhD
Professor of Hepatology
The Liver Unit
Consultant Hepatologist
Queen Marys University of London
London, United Kingdom
Michael W. Fried, MD
Professor of Medicine
Director, UNC Liver Center
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
Alessandra Mangia, MD
Liver Unit Hospital ‘Casa Sollievo della
Sofferenza’
Istituto di Ricovero e Cura a Carattere
Scientifico
San Giovanni Rotondo, Italy
Fred Poordad, MD
Vice President, Academic and Clinical
Affairs
The Texas Liver Institute
Professor of Medicine
University of Texas Health Science Center
San Antonio, Texas
Stefan Zeuzem, MD
Professor of Medicine
Chief, Department of Medicine I
JW Goethe University Hospital
Frankfurt, Germany
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
New Standard of Care for HCV in
2013/2014
Standard
Interferon
Interferon +
Ribavirin
Peginterferon/
Ribavirin
1991 1998 2001
2005
Boceprevir or
Telaprevir +
P/R
GT1
GT2/3
2011 2013
2013
Simeprevir or
Sofosbuvir +
P/R
Sofosbuvir +
Ribavirin
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Key Questions That Define the Future of
Hepatitis C Virus Therapy
 How do we determine the best regimen for genotype 1 going forward?
Jordan J. Feld, MD, MPH
 Why does genotype 3 do poorly and how can we do better?
Stefan Zeuzem, MD
 Is one-size-fits-all treatment a possibility and how would that change
management?
Alessandra Mangia, MD
 How will we manage patients who fail direct-acting antiviral therapies?
Graham R. Foster, FRCP, PhD
 Why do cirrhotics do poorly and how can we do better?
Fred Poordad, MD
 How will high-risk patients be managed going forward?
Michael W. Fried, MD
Jordan J. Feld, MD, MPH
Assistant Professor of Medicine
University of Toronto
Hepatologist
Toronto Western Hospital
Liver Centre
McLaughlin-Rotman Centre for Global
Health
Toronto, Ontario, Canada
How Do We Determine the Best
Regimen for Genotype 1 Going
Forward?
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Summary of New Agents for GT1 in 2013
 Sofosbuvir + P/R
– Sofosbuvir is oral, once daily
– 12 wks with P/R
– SVR rate 89% in naives
– Low impact of baseline factors
 Simeprevir + P/R
– Simeprevir is oral, once daily
– 12 wks with P/R + 12-36 wks with P/R
– SVR rate 80% in naives
– Q80K testing will be needed in GT 1a
Baseline Factor SVR12, % (n/N)
Black
Non-Black
86 (43/50)
90 (218/242)
Genotype 1a
Genotype 1b
92 (206/225)
82 (54/66)
Cirrhosis*
No cirrhosis*
80 (43/54)
92 (252/273)
*Represents GT 1/4/5/6.
Sofosbuvir FDA hearing. October 25, 2013. Simeprevir FDA hearing. October 24, 2013.
Baseline Factor SVR12, % (n/N)
Black
Non-Black
67 (29/43)
81 (378/464)
GT1a with Q80K
GT 1a, no Q80K
GT 1b
58 (49/84)
84 (138/165)
85 (228/267)
F3-F4*
F0-F2*
68 (89/130)
84 (317/378)
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Priorities
 SVR trumps all
 But SVR is a necessity—assuming SVR > 90%, what is next?
 Considerations
– Several new P/R-based regimens completing phase III
– Faldaprevir + P/R
– Daclatasvir + P/R
– But with 89% SVR with 12-wk SOF + P/R, will there be a clinical role for
longer-duration P/R-based regimens?
– An all-oral future for GT1: multiple studies of 12- to 16-wk regimens
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Over-
treatment
of some
Tailored
regimen
for each
population
Priorities
Cost
Fewest
drugs
Shortest
duration
Simplicity
One size
fits all
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
2/12
One Size Fits All or Simpler Regimen for
Genotype 1b Only?
 Genotype 1, naive
 10% had cirrhosis
Dufour J-F, et al. AASLD 2013. Abstract 1102.
16-Wk Regimen: Faldaprevir (PI) 120 mg QD
+ Deleobuvir (NNI) 600 mg BID + RBV
(N = 32)
Simple regimen for genotype 1b only?
What if it were very cheap?
EOT SVR12
UndetectableHCV
RNA(IU/mL)
100
80
60
40
20
0
58
100
17
95
7/12 20/20 19/20
Genotype 1a,
IL28B CC
Genotype 1b
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
One Size Fits All or Simpler Regimen for
GT1b? Various Ways to Look at the Same Data
82
0
20
40
60
80
100
SVR12(%)
100 100 100 100 100
79
100
29 12
85
100
52 27
83
96
52 25
96 100
54 25
81
100
26 18
89
100
28 17
Observed data
(above bar)
ITT (within bar)
n =
81
98
8888
100
89
1a 1b 1a 1b 1a 1b 1a 1b 1a 1b 1a 1b
ABT-450
ABT-333
RBV
ABT-450
ABT-267
RBV
ABT-450
ABT-267
ABT-333
ABT-450
ABT-267
ABT-333
RBV
ABT-450
ABT-267
RBV
ABT-450
ABT-267
ABT-333
RBV
Treatment-Naive Patients Null Responders
Kowdley KV, et al. AASLD 2012. Abstract LB-1.
ABT-450/RTV (PI) ± ABT-333 (NNI) +
ABT-267 (NS5A) ± RBV x 12 Wks
One size fits all OR “simpler regimen” for GT1b?
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
What Is the Role of Ribavirin for
Genotype 1 Going Forward?
 Still an enigma
 Prevents/delays resistance
– Important for genotype 1a
– Important with NNI, PI, and NS5A
– Not relevant with NI-based combination
 Reduces relapse
– May be relevant with shorter durations
– Limited data to date but does not look critical for most
NI-based combination regimens
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Same Duration for All or Shorter for Naive,
Longer for Previous Failures?
12 wks for all or 8 for naive and 12 for failures?
What about RBV? A third DAA for 6 wks?
SVR12(%)
0
20
40
60
80
100
19/
20
SOF
LDV
SOF
LDV
RBV
SOF
LDV
95
100
21/
21
95
18/
19
95
SOF
LDV
100
18/
19
21/
21
8 Wks 12 Wks 12 Wks
SOF
LDV
RBV
Naive
PI failure
n/N =
Lawitz E, et al. AASLD 2013. Abstract 215.
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Are We Moving to Primary Care?
Project ECHO
One size fits all may be critical
Project ECHO Web site.
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Conclusions
 Research continues for GT1 HCV
– More tailored approach in the near future
– Longer duration or additional agents for difficult-to-treat
populations?
 One-size-fits-all approach ideal for inexperienced
providers
 Rising demand for treatment anticipated
– Increased screening
– Availability of IFN-free regimens
Stefan Zeuzem, MD
Professor of Medicine
Chief, Department of Medicine
JW Goethe University Hospital
Frankfurt, Germany
Why Does Genotype 3 Do Poorly
and How Can We Do Better?
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Standard Treatment for GT2/3 HCV
Before treatment
(HCV RNA
quantification)
16 wks
therapy
HCV RNA
< 12-15
IU/mL
Pre-tx
< 8 x 105
IU/mL*
48 wks
therapy‡
HCV RNA
≥ 2 log
decline†
Wk 4
HCV RNA quantification
Wk 12
HCV RNA
quantification
24 wks
therapy
HCV RNA
< 12-15
IU/mL
*No treatment shortening in patients with advanced fibrosis, cirrhosis, metabolic syndrome, insulin resistance, HIV/HCV
coinfection, etc. No data for patients with persistently normal ALT levels. †
Detectable HCV RNA at Wk 24: discontinuation
of treatment.‡
Treatment duration of 36, 48, 72 wks in slow responders is currently investigated in prospective trials.
Tx
discontinued
< 2 log decline
EASL Practice Guidelines.
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
FISSION: Poorer Response to SOF/RBV in
GT3 vs GT2 Naives, Especially Cirrhotics
Lawitz E, et al. N Engl J Med. 2013;368:1878-1887.
SVR12(%)
All Patients Patients With Cirrhosis
n/N =
10/
11
13/
38
8/
13
11/
37
100
80
60
40
20
0
97
56
78
63
91
34
62
30
68/
70
52/
67
102/
183
110/
176
GT2 GT3
SOF/RBV 12 Wks
PegIFN/RBV 24 Wks
GT2 GT3
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
FUSION: Impact of Cirrhosis and Duration
on SVR Rates
Jacobson IM, et al. N Engl J Med. 2013;368:1867-1877.
6/10 5/26
SVR12(%)
25/26 7/923/23 14/38 14/2325/40
No Cirrhosis
Sofosbuvir + RBV 12 wks Sofosbuvir + RBV 16 wks
No CirrhosisCirrhosis Cirrhosis
Genotype 2 Genotype 3
19
6163
37
n/N =
100
80
60
40
20
0
96
100
60
78
100
80
60
40
20
0
SVR12(%)
n/N =
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Wk 0 Wk 24 SVR4,
SVR12,
SVR24
Placebo*
(n = 85)
Sofosbuvir + Ribavirin
(n = 84)*
*Protocol amended to eliminate placebo arm. 12-wk arm predominantly GT2 patients
(N = 73); 11 GT3 patients completed 12 wks of SOF + RBV prior to amendment to extend
treatment duration.
Zeuzem S, et al. AASLD 2013. Abstract 1085.
VALENCE: Evaluating Impact of Duration
on SVR With SOF/RBV
Wk 12
Tx-naive or
-experienced
GT2 or GT3 pts
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Overall Treatment Naive Treatment Experienced
SVR4(%)
n/N =
2/
2
30/
33
12/
13
87/
100
100
80
60
40
20
0
93
97
85
94
100
9192
87
68/
73
212/
250
29/
30
86/
92
No Cirrhosis Cirrhosis
7/
8
27/
45
88
60
No Cirrhosis CirrhosisOverall
12 wks of SOF + RBV in GT2
24 wks of SOF + RBV in GT3
Zeuzem S, et al. AASLD 2013. Abstract 1085. Jacobson IM, et al. N Engl J Med. 2013;368:1867-1877.
Lawitz E, et al. N Engl J Med. 2013;368:1878-1887.
VALENCE Efficacy Summary: SVR12
 Phase III GT3 SVR12 data summary:
– TN noncirrhotics, 12 wks: 61% (FISSION)
– TN cirrhotics, 12 wks: 34% (FISSION)
– TE noncirrhotics, 16 wks: 63% (FUSION)
– TE cirrhotics, 16 wks: 61% (FUSION)
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Conclusions
 Most GT3 patients will be able to be treated with 24 wks of
SOF/RBV
 GT3, treatment-experienced, cirrhotic patients most
challenging group to treat with all-oral regimens
– Experts recommend 12 wks of SOF + pegIFN/RBV in short
term
Alessandra Mangia, MD
Liver Unit Hospital 'Casa Sollievo della
Sofferenza'
Istituto di Ricovero e Cura a Carattere
Scientifico
San Giovanni Rotondo, Italy
Is One-Size-Fits-All Treatment a
Possibility and How Would That
Change Management?
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
How Far Are We?
One Size . . . . . . Fits All?
Same treatment regardless of
fibrosis level, previous treatment
experience, or HCV genotype?
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
AVIATOR: Less Impact of Traditional
Negative Predictors on SVR Rates
 Comparable high SVR rates among 247 patients administered 12 or 24 wks of
treatment
 All enrolled patients were noncirrhotic
Kowdley KV, et al. EASL 2013. Abstract 3.
Treatment Naive Null Responders
100
80
60
40
20
0
M
aleFem
ale
1a
1b
≥
7log
F0-F1
<
7
log
F2-F3Non-CC
CC
SVR24(%)
SVR24(%)
n =
92 94 91
98
89
94 94 91
95
89
78 81 108 50 35 124 113 42 115 44
100
80
60
40
20
0
M
aleFem
ale
1a
1b
≥
7
log
F0-F1
<
7
log
F2-F3Non-CC
CC
n =
93
97 93 97
91
96 95 93 94
100
55 33 55 33 22 66 41 45 85 3
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
GT1 HCV Tx Naive: SVR Rates With
12 Wks of IFN-Free Tx in Phase II Studies
 Few or no cirrhotic patients included in above studies
 Corresponding rates for 24-wk regimens showed SVR12/24 of 52% (QUANTUM[1]
), 95%
to 100% (AI-444040[6]
), 93% (AVIATOR[5]
), 94% (A1443-014[8]
)
1. Lalezari LP, et al. EASL 2013. Abstract 845. 2. Gane E, et al. EASL 2013. Abstract 14. 3. Lawitz E, et al. AASLD 2013.
Abstract 215. 4. Sulkowski MS, et al. AASLD 2012. Abstract LB-2. 5. Kowdley K, et al. EASL 2013. Abstract 3. 6. Everson G,
et al. AASLD 2013. Abstract LB-1. 7. Lawitz E, et al. AASLD 2013. Abstract 76. 8. Sulkowski M, et al. EASL 2013. Abstract
1423.
Regimen N Study SVR 4/12, %
SOF (NS5B) + RBV 25 QUANTUM[1]
56
SOF (NS5B) + RBV 25 ELECTRON[2]
84
SOF (NS5B) + LDV (NS5A) 19 LONESTAR[3]
95
SOF (NS5B) + DCV (NS5A) ± RBV 82 AI-444040[4]
98-100
ABT-450 (PI) + ABT-267 (NS5A) + ABT-333
(NS5B) ± RBV
158 AVIATOR[5]
94
DCV (NS5A) + ASV (PI) + BMS-791325 (NS5B) 161 A1443-014[6]
92
MK-5172 (PI) + MK-8742 (NS5A) ± RBV 65 C-WORTHY[7]
96-100
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Phase III Studies of Sofosbuvir (Nuc) +
Ledipasvir (NS5A) ± RBV in GT1 HCV
ION-1*: GT1 Tx-Naive Pts
(16% Cirrhotic): SOF/LDV
FDC ± RBV for 12 Wks
Press release. These data are available in press release format only, have not been peer reviewed, may be incomplete,
and we await presentation or publication in a peer-reviewed format before conclusions should be made from these data.
*24-wk arms not yet reported.
ION-3: GT1 Tx-Naive Pts:
SOF/LDV FDC ± RBV
for 8 or 12 Wks
SOF/LDV FDC
SOF/LDV FDC +
RBV
n/N =
209/
214
211/
217
SVR12(%)
12 Wks
98 97100
90
60
40
20
0
8 Wks 12 Wks
202/
215
206/
216
201/
216
94 93 95
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
12-Wk Treatment in Previous Null
Responders?
ABT-450/RTV + ABT-267 +
ABT-333 + RBV
12 Wks
SVR12(%)
Naive
n/N =
42/
45
F0-F2 fibrosis
SVR4/12(%)
n/N =
SMV + SOF
+ RBV
12 Wks
SMV + SOF
12 Wks
*No F4
COSMOS[1,2]
Caveat: small numbers,
few patients with cirrhosis
1. Jacobson IM, et al. AASLD 2013. Abstract LB-3. 2. Lawitz E, et al. CROI 2013. Abstract 155LB.
3. Kowdley K, et al. EASL 2013. Abstract 3.
26/
27
13/
14
96 93
76/
79
14/
15
7/
7
93
100
F3/4 fibrosis
96 93
AVIATOR[3]
100
80
60
40
20
0
Null*
100
80
60
40
20
0
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
SAPPHIRE Phase III Studies: PI Backbone
+ 2 Other DAAs
SAPPHIRE-1: GT1 Tx-Naive
Noncirrhotic Pts:
ABT-450/RTV/ABT-267 FDC
+ ABT-333 + RBV for 12 Wks
Press release. These data are available in press release format only, have not been peer reviewed, may be incomplete,
and we await presentation or publication in a peer-reviewed format before conclusions should be made from these data.
n/N =
455/
473
307/
322
148/
151
SAPPHIRE-2: GT1 Tx-Experienced
Noncirrhotic Pts (49% Null Responders):
ABT-450/RTV/ABT-267 FDC
+ ABT-333 + RBV for 12 Wks
100
80
60
40
20
0
SVR12(%)
96 95 98
Overall GT1a GT1b
n/N =
286/
297
166/
173
119/
123
100
80
60
40
20
0
SVR12(%)
96 96 97
Overall GT1a GT1b
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
SOF-Based IFN-Free DAA Treatment in
GT1 Treatment-Experienced Patients
SOF + LDV + RBV x 12 wks
(prior null, noncirrhotic)
100
80
60
40
20
0
SVR4/12(%)
100[1]
2 DAAs + RBV
SOF + LDV x 12 wks (prior
PI failures, 50% cirrhotic)
2 DAAs, No RBV
7/10
70[2]
9/9
100[2]
SOF + LDV + RBV x 12 wks
(TE with cirrhosis)
SOF + LDV x 12 wks
(TE with cirrhosis)
95[3]
1. Gane EJ, et al. CROI 2013. Abstract 41LB. 2. Gane EJ, et al. AASLD 2013. Abstract 73. 3. Lawitz E, et
al. AASLD 2013. Abstract 215.
18/199/9n/N =
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Phase III Studies of Sofosbuvir (Nuc) +
Ledipasvir (NS5A) ± RBV in GT1 HCV
Press release. These data are available in press release format only, have not been peer reviewed, may be incomplete, and we
await presentation or publication in a peer-reviewed format before conclusions should be made from these data.
SOF/LDV FDC SOF/LDV FDC + RBV
ION-2: GT1 Treatment-Experienced Pts (20% Cirrhotic):
SOF/LDV FDC ± RBV for 12 or 24 Wks
n/N =
SVR12(%)
100
90
60
40
20
0
12 Wks 24 Wks
102/
109
107/
111
108/
109
110/
111
94 96 99 99
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Challenging Patient Groups
 Patients with cirrhosis
 HCV genotype 3 infection
 Patients nonresponsive to DAA regimens
 HIV coinfection
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Conclusions
 Future role for specialists in HCV
– Treating more complex cases
– Determining indication for starting treatment
– Surveillance of cirrhotic patients following successful therapy
Graham R. Foster, FRCP, PhD
Professor of Hepatology
The Liver Unit
Consultant Hepatologist
Queen Marys University of London
London, United Kingdom
How Will We Manage Patients Who
Fail Direct-Acting Antiviral
Therapies?
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
DAA Failures: The Principles
 In other viral infections, “failure” can be resolved by
complementary drugs
– eg, in HBV, lamivudine failures respond to adefovir or
tenofovir
 Will the same hold true for HCV?
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
High SVR Rates With 24 Wks of All-Oral
Therapy in GT1 Patients With PI Failure
Sulkowski MS, et al. EASL 2013. Abstract 1417.
*1 patient in daclatasvir/sofosbuvir/RBV arm had missing data at Wk 12 posttreatment; this patient had
undetectable HCV RNA at Wk 4 and Wk 24 posttreatment.
SVR4 SVR12
24 wks of daclatasvir
+ sofosbuvir
24 wks of daclatasvir
+ sofosbuvir + RBV
100 100 100
95*100
80
60
40
20
0
Patients(%)
n/N =
21/
21
20/
20
21/
21
19/
20
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
LONESTAR: High SVR Rates With 12 Wks
of Therapy in GT1 Patients With PI Failure
Lawitz E, et al. AASLD 2013. Abstract 215.
12 wks of SOF/LDV FDC
12 wks of SOF/LDV FDC + RBV
95
100
100
80
60
40
20
0
SVR12(%)
n/N =
18/
19
21/
21
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Complementary Regimens:
Drug Classes for the Future
 Nucleotide polymerase inhibitors (eg, sofosbuvir)
 NS5A inhibitors (eg, daclatasvir, ledipasvir)
 Protease inhibitors (eg, simeprevir, faldaprevir)
 Non-nucleotide polymerase inhibitors (3 different classes)
 Host-targeting drugs (cyclophilins, microRNAs RIG-I
activators)
 Which will work best together?
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Conclusions
 Second-line therapy and beyond
– New challenges with increased treatment options
– Continued treatment failures anticipated with more difficult-
to-treat populations
 Managing treatment failures
– Determine cause
– Risk factors – modifiable?
– Adherence with all-oral regimens
– Patient education and adherence management key
Fred Poordad, MD
Vice President
Academic and Clinical Affairs
The Texas Liver Institute
Professor of Medicine
University of Texas Health Science Center
San Antonio, Texas
Why Do Cirrhotics Do Poorly and
How Can We Do Better?
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
CUPIC: Telaprevir or Boceprevir + P/R
in GT1 Treatment-Experienced Cirrhotics
Fontaine H, et al. EASL 2013. Abstract 60. Hezode C, et al. J Hepatol. 2013;59:434-441.
n/N =
118/
295
79/
190
61/
116
43/
85
43/
135
32/
80
8/
28 1/9
100
80
60
40
20
0
SVR12(%)
Overall Relapsers PRs NRs
40 41
53 51
32
40
29
11
Telaprevir + P/R
Boceprevir + P/R
Risk of Death or Severe
Complications, % (n/N)
Platelet Count
> 100,000 cells/mm3
Platelet Count
≤ 100,000 cells/mm3
Albumin ≥ 35 g/L 3.4 (10/298) 4.3 (3/69)
Albumin < 35 g/L 7.1 (2/28) 44.1 (15/34)
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Impact of Cirrhosis on SVR12 With
Next-Generation PI + P/R
Jacobson I, et al. EASL 2013. Abstract 1425. Ferenci P, et al. EASL 2013. Abstract 1416.
18/
31n/N =
5/
17
188/
229
60/
113
82
53
58
29
Simeprevir + P/R
P/R
100
80
60
40
20
0
SVR12(%)
No Cirrhosis Cirrhosis
QUEST-1:
Simeprevir + P/R
Treatment-Naive GT1
172/
212
30/
45
9/
16
100
80
60
40
20
0
81
67
56
< F3 ≥ F3 F4
STARTVerso1:
Faldaprevir + P/R
Treatment-Naive GT1
Faldaprevir + P/R
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Impact of Cirrhosis on SVR12 With
Sofosbuvir-Based Therapy in Tx-Naive Pts
Lawitz E, et al. EASL 2013. Abstract 1411. Zeuzem S, et al. AASLD 2013. Abstract 1085.
SVR12(%)
92
80
252/
273 43/54
NEUTRINO:
12 Wks of SOF +
P/R
GT1/4/5/6
Genotype 2 Genotype 3
58/59 10/11 89/145 13/38
100
80
60
40
20
0
n/N =
98
91
61
34
FISSION:
12 Wks of SOF + RBV
GT2/3
CirrhoticNoncirrhotic
94
86/92 12/13
92
VALENCE:
24 Wks of SOF +
RBV
GT3
Genotype 1/4/5/6 Genotype 3
100
80
60
40
20
0
100
80
60
40
20
0
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
100
80
60
40
20
0
37
63
87
19
61 60
No Cirrhosis Cirrhosis
Impact of Duration, Addition of PegIFN on
Efficacy of SOF in Tx-Experienced GT2/3
FUSION: 12 wks of SOF/RBV
FUSION: 16 wks of SOF/RBV
VALENCE: 24 wks of SOF/RBV
LONESTAR-2:
12 Wks of SOF + PegIFN/RBV
Sofosbuvir FDA hearing. October 25, 2013. Lawitz E, et al. AASLD 2013.
SVR12(%)
14/
38
25/
40
87/
100
5/
26
14/
23
27/
45
Genotype 3
100
80
60
40
20
0
96 93
100
83 83 83
Genotype 2 Genotype 3
SVR12(%)
Overall Cirrhotic Noncirrhotic
n/N =
22/
23
13/
14
9/
9
20/
24
10/
12
10/
12
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Efficacy of IFN-Free DAA Combinations in
Tx-Naive and Tx-Experienced Cirrhotics
COSMOS:
12-Wk Regimens in GT1 HCV Cirrhotic
Tx-Naive or Previous Null Responders
SVR4/12(%)
Jacobson IM, et al. AASLD 2013. Abstract LB-3. Lawitz E, et al. AASLD 2013. Abstract 215. Everson GT,
et al. AASLD 2013. Abstract LB-1.
LONESTAR:
12-Wk Regimens in GT1 HCV
PI Failures (55% Cirrhotic)
AI443-014:
12-Wk Regimen in GT1
Tx-Naive Cirrhotics
100
80
60
40
20
0
91
100
10/11 7/7
Simeprevir + sofosbuvir + RBV
Simeprevir + sofosbuvir
100
80
60
40
20
0
18/19 21/21
95
100
Sofosbuvir/ledipasvir
Sofosbuvir/ledipasvir + RBV
100
80
60
40
20
0
87
Daclatasvir + asunaprevir
+ BMS-791325
13/15n/N =
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Conclusions
 Eradication of HCV optimal before progression to cirrhosis
 Poorer response of cirrhotic patients likely multifactorial
– Poor prior IFN response and GT3 most challenging
 Treatment approaches
– GT3 experienced, cirrhotic: 12 wks of SOF + pegIFN/RBV
– GT3 naive, cirrhotic: 24 wks of SOF + RBV
 Further improvements anticipated with DAA combinations
Michael W. Fried, MD
Professor of Medicine
Director, UNC Liver Center
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
How Will High-Risk Patients Be
Managed Going Forward?
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Goals of Antiviral Therapy
 Decompensated cirrhosis
– Eradicate HCV to prevent further deterioration
– Eradicate HCV to prevent reinfection of graft
– Improve hepatic functional status
– Delay or obviate the need for transplantation
 Posttransplantation
– Treat acute complications of HCV reinfection
– Prevent/arrest progression to cirrhosis
– Improve morbidity and mortality
– Liver related
– Extrahepatic effects on cardiovascular disease
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
HCV Management Issues Unique to
Pre- and Posttransplantation Patients
 Pretransplantation
– Intolerance to peginterferon regimens
– Impaired hepatic metabolism
– Renal insufficiency
 Posttransplantation
– High HCV RNA/impact of immunosuppression
– Fibrosing cholestatic hepatitis
– Drug–drug interactions
– Renal insufficiency
– Other medical comorbidities
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
PegIFN/RBV Before Transplantation to
Minimize HCV Recurrence Post-LT
Everson GT, et al. Hepatology. 2013;57:1752-1762.
P = .6011
TreatedLTPatients(%)
100
80
60
40
20
0
Overall
(n = 44)
GT1/4/6
(n = 23)
GT2/3
(n = 44)
59
25
52
22
67
29
HCV RNA negative at LT
HCV RNA negative 12 wks of post-LT
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Characteristic SOF + RBV
(N = 61)
Median age, yrs (range) 59 (46-73)
HCV genotype, %
 1a 39
 1b 34
 2 13
 3a 12
 4 2
Non-CC IL28B genotype, % 78
CTP score, %
 5-7 96
 8 5
Previous HCV treatment, % 75
Pretransplant Sofosbuvir + RBV to
Prevent Posttransplant HCV Recurrence
 Study 025: single-arm, open-label,
phase II study from 16 LT sites
– Listed for LT due to HCC meeting
Milan criteria
– MELD exception for HCC
– CTP score ≤ 7
 Excluded decompensated cirrhosis,
renal impairment, living donor LT
 Pre-LT therapy: SOF 400 mg/day +
RBV 1000-1200 mg/day for 48 wks
or until time of LT
– Post-LT immunosuppression:
≥ 12 wks of tacrolimus +
prednisone + MMF
Curry MP, et al. AASLD 2013. Abstract 213.
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Duration of Undetectable HCV RNA Before
Transplant Predicted Lack of Recurrence
 64% of pts HCV RNA negative 12 wks
post-LT (93% at LT)
 Continuous days TND pre-LT only
factor predicting HCV recurrence in
multivariate analysis
– Only 1/24 pts with > 30 days TND
experienced recurrence
Curry MP, et al. AASLD 2013. Abstract 213.
3300 30 60 90 120 150 180 210 240 270 300
Days With HCV RNA Continuously TND Prior to LT
> 30 days TND
No recurrence (n = 28)
Recurrence (n = 10)
Median days TND (P < .001)
No recurrence: 95
Recurrence: 5.5
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
CRUSH C: PI + PegIFN/RBV in Liver
Transplantation Recipients
 112 patients: 30 were F4 or FCH
 Treatment: TVR 88% or BOC 12%
– P/R lead-in 96%
Verna EC, et al. EASL 2013. Abstract 23.
HCVRNA<LOD(%)
100
80
60
40
20
0
EOTR SVR4
67 65
n = 43
Adverse Effect All Patients
(N = 112)
AE requiring treatment d/c, % 11
Dose reduction, %
PegIFN/RBV 34/80
Transfusion, % 46
Erythropoietin, % 79
G-CSF 41
Hospitalization, %* 21
Renal function
Cr increase > 0.5 mg/dL, %
Max ↑ in Cr, mg/dL (range)
34
0.4 (0-2.5)
Rejection, %†
4
Death, % 6
*Significantly differed between groups (P = .02).
†
Any treated rejection during or after TT.
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Daclatasvir 60 mg/day +
Sofosbuvir 400 mg/day
Case Report: Sofosbuvir + Daclatasvir in
Post-LT Fibrosing Cholestatic Hepatitis
Fontana RJ, et al. Am J Transplant. 2013;13:1601-1605.
8
7
6
5
4
3
2
1
0
LogHCVRNA(IU/mL)
Treatment Wk
400
350
300
250
200
150
100
50
0
ALT(IU/L)
AlkPhos(IU/L)
0 1 2 3 4 6 8 1012 14 1618 20 222425 2848 56 60
ALT
Alk Phos
HCV RNA
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Sofosbuvir + RBV for Treatment of
Post-LT HCV Recurrence
 Ongoing prospective,
multicenter, single-arm,
open-label pilot study
– Median time since LT: 4.3 yrs
(range: 1.02-10.6)
– CTP ≤ 7 and MELD ≤ 17
– 83% GT1, 33% IL28B CC, 40%
with comp’d cirrhosis
 SOF 400 mg/day + RBV
400-1200 mg/day for ≤ 24 wks
– RBV started at 400 mg/day and
increased based on hemoglobin
levels
Charlton MR, et al. AASLD 2013. Abstract LB-2. Reproduced with permission.
Virologic Response Rates
*1 patient still on treatment.
†
4 patients had not reached SVR4 visit.
Wk 4 EOT* SVR4
Response(%)
100
80
60
40
20
0
100 100
77
40/40 39/39 27/35†
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Other Studies Recruiting
 Sofosbuvir/ledipasvir FDC + RBV for 12 or 24 wks in
patients with advanced liver disease or posttransplantation
recurrence[1]
 Simeprevir + daclatasvir + RBV for 24 wks in genotype 1b
patients with posttransplantation recurrence[2]
 ABT-450/RTV/ABT-267 FDC + ABT-333 + RBV for 24 wks
in liver transplantation recipients[3]
1. ClinicalTrials.gov. NCT01938430. 2. ClinicalTrials.gov. NCT01938625. 3. ClinicalTrials.gov.
NCT01782495.
clinicaloptions.com/hepatitis
Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy
Conclusions
 Pre- and post-LT patients greatest challenge to eradication
of HCV
– Recent data encouraging
– Significant challenges remain
Go Online for More
From This Program!
CME-certified module that goes in-depth on each of the key questions
addressed in this slideset
clinicaloptions.com/shaping

Weitere ähnliche Inhalte

Was ist angesagt?

Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бу...
Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бу...Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бу...
Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бу...hivlifeinfo
 
Современное лечение ВИЧ.Обобщённые данные с конференции CROI 2020 / Contempor...
Современное лечение ВИЧ.Обобщённые данные с конференции CROI 2020 / Contempor...Современное лечение ВИЧ.Обобщённые данные с конференции CROI 2020 / Contempor...
Современное лечение ВИЧ.Обобщённые данные с конференции CROI 2020 / Contempor...hivlifeinfo
 
Challenges in HCV Management
Challenges in HCV Management Challenges in HCV Management
Challenges in HCV Management drnkhokhar
 
The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014
The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014
The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014Hivlife Info
 
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...hivlifeinfo
 
HCV management, guidelines 2016
HCV management, guidelines 2016HCV management, guidelines 2016
HCV management, guidelines 2016Usama Ragab
 
Современное лечение ВИЧ: новые парадигмы в АРТ / Contemporary Management of H...
Современное лечение ВИЧ: новые парадигмы в АРТ / Contemporary Management of H...Современное лечение ВИЧ: новые парадигмы в АРТ / Contemporary Management of H...
Современное лечение ВИЧ: новые парадигмы в АРТ / Contemporary Management of H...hivlifeinfo
 
Expert Insights in Selecting a Switch Regimen for Virologically Suppressed HI...
Expert Insights in Selecting a Switch Regimen for Virologically Suppressed HI...Expert Insights in Selecting a Switch Regimen for Virologically Suppressed HI...
Expert Insights in Selecting a Switch Regimen for Virologically Suppressed HI...hivlifeinfo
 
HIV Alert :Updating Your Practice Based on New Guideline Recommendations.2016
HIV Alert :Updating Your Practice Based on New Guideline Recommendations.2016HIV Alert :Updating Your Practice Based on New Guideline Recommendations.2016
HIV Alert :Updating Your Practice Based on New Guideline Recommendations.2016hivlifeinfo
 
Современное лечение ВИЧ: лечение многократно леченных пациентов с резистентно...
Современное лечение ВИЧ: лечение многократно леченных пациентов с резистентно...Современное лечение ВИЧ: лечение многократно леченных пациентов с резистентно...
Современное лечение ВИЧ: лечение многократно леченных пациентов с резистентно...hivlifeinfo
 
Современное лечение ВИЧ: индивидуализация стартовой АРТ /Contemporary Manage...
Современное лечение ВИЧ:  индивидуализация стартовой АРТ /Contemporary Manage...Современное лечение ВИЧ:  индивидуализация стартовой АРТ /Contemporary Manage...
Современное лечение ВИЧ: индивидуализация стартовой АРТ /Contemporary Manage...hivlifeinfo
 
Choosing Among Current Antiretroviral Regimens.The Relevance of Drug–Drug Int...
Choosing Among Current Antiretroviral Regimens.The Relevance of Drug–Drug Int...Choosing Among Current Antiretroviral Regimens.The Relevance of Drug–Drug Int...
Choosing Among Current Antiretroviral Regimens.The Relevance of Drug–Drug Int...hivlifeinfo
 
Антиретровирусные средства и хроническая болезнь почек.Exposure to antiretrov...
Антиретровирусные средства и хроническая болезнь почек.Exposure to antiretrov...Антиретровирусные средства и хроническая болезнь почек.Exposure to antiretrov...
Антиретровирусные средства и хроническая болезнь почек.Exposure to antiretrov...hivlifeinfo
 
Incorporating New ART Options Into First-line and Switch Strategies for HIV C...
Incorporating New ART Options Into First-line and Switch Strategies for HIV C...Incorporating New ART Options Into First-line and Switch Strategies for HIV C...
Incorporating New ART Options Into First-line and Switch Strategies for HIV C...hivlifeinfo
 
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и ...
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и ...Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и ...
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и ...hivlifeinfo
 
Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...
Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...
Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...hivlifeinfo
 
Ключевые решения в лечении ВИЧ: оптимизация стратегии лечения для пациентов с...
Ключевые решения в лечении ВИЧ: оптимизация стратегии лечения для пациентов с...Ключевые решения в лечении ВИЧ: оптимизация стратегии лечения для пациентов с...
Ключевые решения в лечении ВИЧ: оптимизация стратегии лечения для пациентов с...hivlifeinfo
 
Слайдсет о новом в лечении ВИЧ.Key Slides on What’s Hot in HIV Treatment.2020
Слайдсет о новом в лечении ВИЧ.Key Slides on What’s Hot in HIV Treatment.2020 Слайдсет о новом в лечении ВИЧ.Key Slides on What’s Hot in HIV Treatment.2020
Слайдсет о новом в лечении ВИЧ.Key Slides on What’s Hot in HIV Treatment.2020 hivlifeinfo
 
HIV Alert:ART Considerations for Aging Patients.2018
HIV Alert:ART Considerations for Aging Patients.2018HIV Alert:ART Considerations for Aging Patients.2018
HIV Alert:ART Considerations for Aging Patients.2018hivlifeinfo
 
Revision of treatment protocols for hcv genotype 4 infection 2016
Revision of treatment protocols for hcv genotype 4 infection 2016Revision of treatment protocols for hcv genotype 4 infection 2016
Revision of treatment protocols for hcv genotype 4 infection 2016Monkez M Yousif
 

Was ist angesagt? (20)

Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бу...
Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бу...Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бу...
Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бу...
 
Современное лечение ВИЧ.Обобщённые данные с конференции CROI 2020 / Contempor...
Современное лечение ВИЧ.Обобщённые данные с конференции CROI 2020 / Contempor...Современное лечение ВИЧ.Обобщённые данные с конференции CROI 2020 / Contempor...
Современное лечение ВИЧ.Обобщённые данные с конференции CROI 2020 / Contempor...
 
Challenges in HCV Management
Challenges in HCV Management Challenges in HCV Management
Challenges in HCV Management
 
The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014
The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014
The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014
 
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...
 
HCV management, guidelines 2016
HCV management, guidelines 2016HCV management, guidelines 2016
HCV management, guidelines 2016
 
Современное лечение ВИЧ: новые парадигмы в АРТ / Contemporary Management of H...
Современное лечение ВИЧ: новые парадигмы в АРТ / Contemporary Management of H...Современное лечение ВИЧ: новые парадигмы в АРТ / Contemporary Management of H...
Современное лечение ВИЧ: новые парадигмы в АРТ / Contemporary Management of H...
 
Expert Insights in Selecting a Switch Regimen for Virologically Suppressed HI...
Expert Insights in Selecting a Switch Regimen for Virologically Suppressed HI...Expert Insights in Selecting a Switch Regimen for Virologically Suppressed HI...
Expert Insights in Selecting a Switch Regimen for Virologically Suppressed HI...
 
HIV Alert :Updating Your Practice Based on New Guideline Recommendations.2016
HIV Alert :Updating Your Practice Based on New Guideline Recommendations.2016HIV Alert :Updating Your Practice Based on New Guideline Recommendations.2016
HIV Alert :Updating Your Practice Based on New Guideline Recommendations.2016
 
Современное лечение ВИЧ: лечение многократно леченных пациентов с резистентно...
Современное лечение ВИЧ: лечение многократно леченных пациентов с резистентно...Современное лечение ВИЧ: лечение многократно леченных пациентов с резистентно...
Современное лечение ВИЧ: лечение многократно леченных пациентов с резистентно...
 
Современное лечение ВИЧ: индивидуализация стартовой АРТ /Contemporary Manage...
Современное лечение ВИЧ:  индивидуализация стартовой АРТ /Contemporary Manage...Современное лечение ВИЧ:  индивидуализация стартовой АРТ /Contemporary Manage...
Современное лечение ВИЧ: индивидуализация стартовой АРТ /Contemporary Manage...
 
Choosing Among Current Antiretroviral Regimens.The Relevance of Drug–Drug Int...
Choosing Among Current Antiretroviral Regimens.The Relevance of Drug–Drug Int...Choosing Among Current Antiretroviral Regimens.The Relevance of Drug–Drug Int...
Choosing Among Current Antiretroviral Regimens.The Relevance of Drug–Drug Int...
 
Антиретровирусные средства и хроническая болезнь почек.Exposure to antiretrov...
Антиретровирусные средства и хроническая болезнь почек.Exposure to antiretrov...Антиретровирусные средства и хроническая болезнь почек.Exposure to antiretrov...
Антиретровирусные средства и хроническая болезнь почек.Exposure to antiretrov...
 
Incorporating New ART Options Into First-line and Switch Strategies for HIV C...
Incorporating New ART Options Into First-line and Switch Strategies for HIV C...Incorporating New ART Options Into First-line and Switch Strategies for HIV C...
Incorporating New ART Options Into First-line and Switch Strategies for HIV C...
 
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и ...
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и ...Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и ...
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и ...
 
Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...
Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...
Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...
 
Ключевые решения в лечении ВИЧ: оптимизация стратегии лечения для пациентов с...
Ключевые решения в лечении ВИЧ: оптимизация стратегии лечения для пациентов с...Ключевые решения в лечении ВИЧ: оптимизация стратегии лечения для пациентов с...
Ключевые решения в лечении ВИЧ: оптимизация стратегии лечения для пациентов с...
 
Слайдсет о новом в лечении ВИЧ.Key Slides on What’s Hot in HIV Treatment.2020
Слайдсет о новом в лечении ВИЧ.Key Slides on What’s Hot in HIV Treatment.2020 Слайдсет о новом в лечении ВИЧ.Key Slides on What’s Hot in HIV Treatment.2020
Слайдсет о новом в лечении ВИЧ.Key Slides on What’s Hot in HIV Treatment.2020
 
HIV Alert:ART Considerations for Aging Patients.2018
HIV Alert:ART Considerations for Aging Patients.2018HIV Alert:ART Considerations for Aging Patients.2018
HIV Alert:ART Considerations for Aging Patients.2018
 
Revision of treatment protocols for hcv genotype 4 infection 2016
Revision of treatment protocols for hcv genotype 4 infection 2016Revision of treatment protocols for hcv genotype 4 infection 2016
Revision of treatment protocols for hcv genotype 4 infection 2016
 

Ähnlich wie Shaping the Future.Clinicians and Faculty Define: Strategies for the Next Era of HCV Therapy.2014

Managing cirrhotic HCV patients. Whom to treat, how to treat.2014
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014Managing cirrhotic HCV patients. Whom to treat, how to treat.2014
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014hivlifeinfo
 
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014Managing cirrhotic HCV patients. Whom to treat, how to treat.2014
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014Hivlife Info
 
ESSENCE OF SOFOSBUVIR 400mg.
ESSENCE OF SOFOSBUVIR 400mg.ESSENCE OF SOFOSBUVIR 400mg.
ESSENCE OF SOFOSBUVIR 400mg.Tajammul Siddiq
 
New Data on Resistance to DAAs and Implications for Therapy.2015
New Data on Resistance to DAAs and Implications for Therapy.2015New Data on Resistance to DAAs and Implications for Therapy.2015
New Data on Resistance to DAAs and Implications for Therapy.2015hivlifeinfo
 
Moscow summit 2020 : seeking for the cure of primary and secondary liver mali...
Moscow summit 2020 : seeking for the cure of primary and secondary liver mali...Moscow summit 2020 : seeking for the cure of primary and secondary liver mali...
Moscow summit 2020 : seeking for the cure of primary and secondary liver mali...Prof. Eric Raymond Oncologie Medicale
 
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015Hivlife Info
 
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015hivlifeinfo
 
METASTATC COLORECTAL CANCER IN 2017
METASTATC COLORECTAL CANCER IN 2017METASTATC COLORECTAL CANCER IN 2017
METASTATC COLORECTAL CANCER IN 2017Mohamed Abdulla
 
Aidsrounds121412morris 121214115641-phpapp01
Aidsrounds121412morris 121214115641-phpapp01Aidsrounds121412morris 121214115641-phpapp01
Aidsrounds121412morris 121214115641-phpapp01Lucas Brown
 
Crimson Publishers: Interferon-Free Therapy for Hepatits C in Brazil and Sust...
Crimson Publishers: Interferon-Free Therapy for Hepatits C in Brazil and Sust...Crimson Publishers: Interferon-Free Therapy for Hepatits C in Brazil and Sust...
Crimson Publishers: Interferon-Free Therapy for Hepatits C in Brazil and Sust...CrimsonGastroenterology
 
Новые данные с конференции по ВИЧ-инфекции CROI 2017/Clinical Impact of New D...
Новые данные с конференции по ВИЧ-инфекции CROI 2017/Clinical Impact of New D...Новые данные с конференции по ВИЧ-инфекции CROI 2017/Clinical Impact of New D...
Новые данные с конференции по ВИЧ-инфекции CROI 2017/Clinical Impact of New D...hivlifeinfo
 
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUS C MẠN NĂM 2017
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUS C MẠN NĂM 2017 CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUS C MẠN NĂM 2017
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUS C MẠN NĂM 2017 bientap2
 
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUT MAN NĂM 2017
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUT MAN NĂM 2017CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUT MAN NĂM 2017
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUT MAN NĂM 2017Great Doctor
 
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...JohnJulie1
 
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...daranisaha
 
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...EditorSara
 
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...semualkaira
 
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...semualkaira
 

Ähnlich wie Shaping the Future.Clinicians and Faculty Define: Strategies for the Next Era of HCV Therapy.2014 (20)

Managing cirrhotic HCV patients. Whom to treat, how to treat.2014
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014Managing cirrhotic HCV patients. Whom to treat, how to treat.2014
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014
 
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014Managing cirrhotic HCV patients. Whom to treat, how to treat.2014
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014
 
ESSENCE OF SOFOSBUVIR 400mg.
ESSENCE OF SOFOSBUVIR 400mg.ESSENCE OF SOFOSBUVIR 400mg.
ESSENCE OF SOFOSBUVIR 400mg.
 
New Data on Resistance to DAAs and Implications for Therapy.2015
New Data on Resistance to DAAs and Implications for Therapy.2015New Data on Resistance to DAAs and Implications for Therapy.2015
New Data on Resistance to DAAs and Implications for Therapy.2015
 
Chronic Liver Disease Conference 2015
Chronic Liver Disease Conference 2015Chronic Liver Disease Conference 2015
Chronic Liver Disease Conference 2015
 
Moscow summit 2020 : seeking for the cure of primary and secondary liver mali...
Moscow summit 2020 : seeking for the cure of primary and secondary liver mali...Moscow summit 2020 : seeking for the cure of primary and secondary liver mali...
Moscow summit 2020 : seeking for the cure of primary and secondary liver mali...
 
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015
 
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015
HCV Alerts- Rapid Response to Practice-Changing Advances From EASL 2015
 
METASTATC COLORECTAL CANCER IN 2017
METASTATC COLORECTAL CANCER IN 2017METASTATC COLORECTAL CANCER IN 2017
METASTATC COLORECTAL CANCER IN 2017
 
HCV Story ---by Mohammed Hussien
HCV Story ---by Mohammed HussienHCV Story ---by Mohammed Hussien
HCV Story ---by Mohammed Hussien
 
Aidsrounds121412morris 121214115641-phpapp01
Aidsrounds121412morris 121214115641-phpapp01Aidsrounds121412morris 121214115641-phpapp01
Aidsrounds121412morris 121214115641-phpapp01
 
Crimson Publishers: Interferon-Free Therapy for Hepatits C in Brazil and Sust...
Crimson Publishers: Interferon-Free Therapy for Hepatits C in Brazil and Sust...Crimson Publishers: Interferon-Free Therapy for Hepatits C in Brazil and Sust...
Crimson Publishers: Interferon-Free Therapy for Hepatits C in Brazil and Sust...
 
Новые данные с конференции по ВИЧ-инфекции CROI 2017/Clinical Impact of New D...
Новые данные с конференции по ВИЧ-инфекции CROI 2017/Clinical Impact of New D...Новые данные с конференции по ВИЧ-инфекции CROI 2017/Clinical Impact of New D...
Новые данные с конференции по ВИЧ-инфекции CROI 2017/Clinical Impact of New D...
 
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUS C MẠN NĂM 2017
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUS C MẠN NĂM 2017 CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUS C MẠN NĂM 2017
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUS C MẠN NĂM 2017
 
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUT MAN NĂM 2017
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUT MAN NĂM 2017CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUT MAN NĂM 2017
CẬP NHẬT ĐIỀU TRỊ VIÊM GAN VIRUT MAN NĂM 2017
 
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
 
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
 
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
 
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
 
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
Multimodal Prehabilitation in Radioactive Iodine-Refractory Differentiated Th...
 

Mehr von Hivlife Info

HIV and Cardiovascular Disease.How Worried Should We Be ? 2015
HIV and Cardiovascular Disease.How Worried Should We Be ? 2015HIV and Cardiovascular Disease.How Worried Should We Be ? 2015
HIV and Cardiovascular Disease.How Worried Should We Be ? 2015Hivlife Info
 
Cardiovascular Disease in HIV-Infected Patients.Predict It and Prevent It.2015
Cardiovascular Disease in HIV-Infected Patients.Predict It and Prevent It.2015Cardiovascular Disease in HIV-Infected Patients.Predict It and Prevent It.2015
Cardiovascular Disease in HIV-Infected Patients.Predict It and Prevent It.2015Hivlife Info
 
“Тяжелые” категории пациентов с хроническим гепатитом C- возможности терапии....
“Тяжелые” категории пациентов с хроническим гепатитом C- возможности терапии....“Тяжелые” категории пациентов с хроническим гепатитом C- возможности терапии....
“Тяжелые” категории пациентов с хроническим гепатитом C- возможности терапии....Hivlife Info
 
Рекомендации EASL по лечению гепатита С. Краткая версия.2015. RUS
Рекомендации EASL по лечению гепатита С. Краткая версия.2015. RUSРекомендации EASL по лечению гепатита С. Краткая версия.2015. RUS
Рекомендации EASL по лечению гепатита С. Краткая версия.2015. RUSHivlife Info
 
Эпидемиологическая ситуации по ВИЧ-инфекции в России. 2015.Покровский В.В. Фе...
Эпидемиологическая ситуации по ВИЧ-инфекции в России. 2015.Покровский В.В. Фе...Эпидемиологическая ситуации по ВИЧ-инфекции в России. 2015.Покровский В.В. Фе...
Эпидемиологическая ситуации по ВИЧ-инфекции в России. 2015.Покровский В.В. Фе...Hivlife Info
 
Достижения, несбывшиеся надежды и парадоксы профилактической кардиологии. Р....
Достижения, несбывшиеся надежды и  парадоксы профилактической кардиологии. Р....Достижения, несбывшиеся надежды и  парадоксы профилактической кардиологии. Р....
Достижения, несбывшиеся надежды и парадоксы профилактической кардиологии. Р....Hivlife Info
 
Integrating Recent Data When Selecting First-line Antiretroviral Therapy.2015...
Integrating Recent Data When Selecting First-line Antiretroviral Therapy.2015...Integrating Recent Data When Selecting First-line Antiretroviral Therapy.2015...
Integrating Recent Data When Selecting First-line Antiretroviral Therapy.2015...Hivlife Info
 
EASL 2015. HCV Investigational Agents
EASL 2015. HCV Investigational AgentsEASL 2015. HCV Investigational Agents
EASL 2015. HCV Investigational AgentsHivlife Info
 
Clinical Impact of Data From the CROI 2015,Seattle
Clinical Impact of Data From the CROI 2015,SeattleClinical Impact of Data From the CROI 2015,Seattle
Clinical Impact of Data From the CROI 2015,SeattleHivlife Info
 
Химиопрофилактика туберкулеза у ВИЧ-позитивных пациентов.СпбНИИФ 2012
Химиопрофилактика туберкулеза у ВИЧ-позитивных  пациентов.СпбНИИФ 2012Химиопрофилактика туберкулеза у ВИЧ-позитивных  пациентов.СпбНИИФ 2012
Химиопрофилактика туберкулеза у ВИЧ-позитивных пациентов.СпбНИИФ 2012Hivlife Info
 
Grinspoon S.Сердечно-сосудистые заболевания у пациентов с ВИЧ- парадигма и пр...
Grinspoon S.Сердечно-сосудистые заболевания у пациентов с ВИЧ- парадигма и пр...Grinspoon S.Сердечно-сосудистые заболевания у пациентов с ВИЧ- парадигма и пр...
Grinspoon S.Сердечно-сосудистые заболевания у пациентов с ВИЧ- парадигма и пр...Hivlife Info
 
Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...
Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...
Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...Hivlife Info
 
Longenecker CT et al. (McComsey G presenting) Rosuvastatin arrests progressio...
Longenecker CT et al. (McComsey G presenting) Rosuvastatin arrests progressio...Longenecker CT et al. (McComsey G presenting) Rosuvastatin arrests progressio...
Longenecker CT et al. (McComsey G presenting) Rosuvastatin arrests progressio...Hivlife Info
 
Lo J et al. Statin therapy reduces coronary noncalcified plaque volume in HIV...
Lo J et al. Statin therapy reduces coronary noncalcified plaque volume in HIV...Lo J et al. Statin therapy reduces coronary noncalcified plaque volume in HIV...
Lo J et al. Statin therapy reduces coronary noncalcified plaque volume in HIV...Hivlife Info
 
Should Integrase Inhibitors Be Your First Choice When Starting HIV Therapy- E...
Should Integrase Inhibitors Be Your First Choice When Starting HIV Therapy- E...Should Integrase Inhibitors Be Your First Choice When Starting HIV Therapy- E...
Should Integrase Inhibitors Be Your First Choice When Starting HIV Therapy- E...Hivlife Info
 
Факторы риска развития дисплазии и рака шейки матки у ВИЧ-инфицированных жен...
Факторы риска развития дисплазии и  рака шейки матки у ВИЧ-инфицированных жен...Факторы риска развития дисплазии и  рака шейки матки у ВИЧ-инфицированных жен...
Факторы риска развития дисплазии и рака шейки матки у ВИЧ-инфицированных жен...Hivlife Info
 
Лечение зависимости от табакокурения. [Всё необходимое,чтобы бросить курить.]
Лечение зависимости от табакокурения. [Всё необходимое,чтобы бросить курить.]Лечение зависимости от табакокурения. [Всё необходимое,чтобы бросить курить.]
Лечение зависимости от табакокурения. [Всё необходимое,чтобы бросить курить.]Hivlife Info
 
С.Н.Кижло.Нежелательные явления на фоне противовирусной терапии ХВГС и способ...
С.Н.Кижло.Нежелательные явления на фоне противовирусной терапии ХВГС и способ...С.Н.Кижло.Нежелательные явления на фоне противовирусной терапии ХВГС и способ...
С.Н.Кижло.Нежелательные явления на фоне противовирусной терапии ХВГС и способ...Hivlife Info
 
Современный взгляд на АГ и ХСН. Спорные и нерешенные вопросы. Новые возможнос...
Современный взгляд на АГ и ХСН. Спорные и нерешенные вопросы. Новые возможнос...Современный взгляд на АГ и ХСН. Спорные и нерешенные вопросы. Новые возможнос...
Современный взгляд на АГ и ХСН. Спорные и нерешенные вопросы. Новые возможнос...Hivlife Info
 

Mehr von Hivlife Info (20)

HIV and Cardiovascular Disease.How Worried Should We Be ? 2015
HIV and Cardiovascular Disease.How Worried Should We Be ? 2015HIV and Cardiovascular Disease.How Worried Should We Be ? 2015
HIV and Cardiovascular Disease.How Worried Should We Be ? 2015
 
ART Update 2015
ART Update 2015ART Update 2015
ART Update 2015
 
Cardiovascular Disease in HIV-Infected Patients.Predict It and Prevent It.2015
Cardiovascular Disease in HIV-Infected Patients.Predict It and Prevent It.2015Cardiovascular Disease in HIV-Infected Patients.Predict It and Prevent It.2015
Cardiovascular Disease in HIV-Infected Patients.Predict It and Prevent It.2015
 
“Тяжелые” категории пациентов с хроническим гепатитом C- возможности терапии....
“Тяжелые” категории пациентов с хроническим гепатитом C- возможности терапии....“Тяжелые” категории пациентов с хроническим гепатитом C- возможности терапии....
“Тяжелые” категории пациентов с хроническим гепатитом C- возможности терапии....
 
Рекомендации EASL по лечению гепатита С. Краткая версия.2015. RUS
Рекомендации EASL по лечению гепатита С. Краткая версия.2015. RUSРекомендации EASL по лечению гепатита С. Краткая версия.2015. RUS
Рекомендации EASL по лечению гепатита С. Краткая версия.2015. RUS
 
Эпидемиологическая ситуации по ВИЧ-инфекции в России. 2015.Покровский В.В. Фе...
Эпидемиологическая ситуации по ВИЧ-инфекции в России. 2015.Покровский В.В. Фе...Эпидемиологическая ситуации по ВИЧ-инфекции в России. 2015.Покровский В.В. Фе...
Эпидемиологическая ситуации по ВИЧ-инфекции в России. 2015.Покровский В.В. Фе...
 
Достижения, несбывшиеся надежды и парадоксы профилактической кардиологии. Р....
Достижения, несбывшиеся надежды и  парадоксы профилактической кардиологии. Р....Достижения, несбывшиеся надежды и  парадоксы профилактической кардиологии. Р....
Достижения, несбывшиеся надежды и парадоксы профилактической кардиологии. Р....
 
Integrating Recent Data When Selecting First-line Antiretroviral Therapy.2015...
Integrating Recent Data When Selecting First-line Antiretroviral Therapy.2015...Integrating Recent Data When Selecting First-line Antiretroviral Therapy.2015...
Integrating Recent Data When Selecting First-line Antiretroviral Therapy.2015...
 
EASL 2015. HCV Investigational Agents
EASL 2015. HCV Investigational AgentsEASL 2015. HCV Investigational Agents
EASL 2015. HCV Investigational Agents
 
Clinical Impact of Data From the CROI 2015,Seattle
Clinical Impact of Data From the CROI 2015,SeattleClinical Impact of Data From the CROI 2015,Seattle
Clinical Impact of Data From the CROI 2015,Seattle
 
Химиопрофилактика туберкулеза у ВИЧ-позитивных пациентов.СпбНИИФ 2012
Химиопрофилактика туберкулеза у ВИЧ-позитивных  пациентов.СпбНИИФ 2012Химиопрофилактика туберкулеза у ВИЧ-позитивных  пациентов.СпбНИИФ 2012
Химиопрофилактика туберкулеза у ВИЧ-позитивных пациентов.СпбНИИФ 2012
 
Grinspoon S.Сердечно-сосудистые заболевания у пациентов с ВИЧ- парадигма и пр...
Grinspoon S.Сердечно-сосудистые заболевания у пациентов с ВИЧ- парадигма и пр...Grinspoon S.Сердечно-сосудистые заболевания у пациентов с ВИЧ- парадигма и пр...
Grinspoon S.Сердечно-сосудистые заболевания у пациентов с ВИЧ- парадигма и пр...
 
Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...
Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...
Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...
 
Longenecker CT et al. (McComsey G presenting) Rosuvastatin arrests progressio...
Longenecker CT et al. (McComsey G presenting) Rosuvastatin arrests progressio...Longenecker CT et al. (McComsey G presenting) Rosuvastatin arrests progressio...
Longenecker CT et al. (McComsey G presenting) Rosuvastatin arrests progressio...
 
Lo J et al. Statin therapy reduces coronary noncalcified plaque volume in HIV...
Lo J et al. Statin therapy reduces coronary noncalcified plaque volume in HIV...Lo J et al. Statin therapy reduces coronary noncalcified plaque volume in HIV...
Lo J et al. Statin therapy reduces coronary noncalcified plaque volume in HIV...
 
Should Integrase Inhibitors Be Your First Choice When Starting HIV Therapy- E...
Should Integrase Inhibitors Be Your First Choice When Starting HIV Therapy- E...Should Integrase Inhibitors Be Your First Choice When Starting HIV Therapy- E...
Should Integrase Inhibitors Be Your First Choice When Starting HIV Therapy- E...
 
Факторы риска развития дисплазии и рака шейки матки у ВИЧ-инфицированных жен...
Факторы риска развития дисплазии и  рака шейки матки у ВИЧ-инфицированных жен...Факторы риска развития дисплазии и  рака шейки матки у ВИЧ-инфицированных жен...
Факторы риска развития дисплазии и рака шейки матки у ВИЧ-инфицированных жен...
 
Лечение зависимости от табакокурения. [Всё необходимое,чтобы бросить курить.]
Лечение зависимости от табакокурения. [Всё необходимое,чтобы бросить курить.]Лечение зависимости от табакокурения. [Всё необходимое,чтобы бросить курить.]
Лечение зависимости от табакокурения. [Всё необходимое,чтобы бросить курить.]
 
С.Н.Кижло.Нежелательные явления на фоне противовирусной терапии ХВГС и способ...
С.Н.Кижло.Нежелательные явления на фоне противовирусной терапии ХВГС и способ...С.Н.Кижло.Нежелательные явления на фоне противовирусной терапии ХВГС и способ...
С.Н.Кижло.Нежелательные явления на фоне противовирусной терапии ХВГС и способ...
 
Современный взгляд на АГ и ХСН. Спорные и нерешенные вопросы. Новые возможнос...
Современный взгляд на АГ и ХСН. Спорные и нерешенные вопросы. Новые возможнос...Современный взгляд на АГ и ХСН. Спорные и нерешенные вопросы. Новые возможнос...
Современный взгляд на АГ и ХСН. Спорные и нерешенные вопросы. Новые возможнос...
 

Kürzlich hochgeladen

Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D.  Bawankar.pptPharmacokinetic Models by Dr. Ram D.  Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D. Bawankar.pptRamDBawankar1
 
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdfSGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdfHongBiThi1
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE Mamatha Lakka
 
AORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectionAORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectiondrhanifmohdali
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyMedicoseAcademics
 
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdfSGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdfHongBiThi1
 
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxBreast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxNaveenkumar267201
 
ayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologypptayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologypptPradnya Wadekar
 
EXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionEXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionkrishnareddy157915
 
Unit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptUnit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptPradnya Wadekar
 
AUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsAUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsMedicoseAcademics
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfMedicoseAcademics
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondSujoy Dasgupta
 
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfCONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfDolisha Warbi
 
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdfSGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdfHongBiThi1
 
Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisSujoy Dasgupta
 
Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024EwoutSteyerberg1
 
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.aarjukhadka22
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptxWINCY THIRUMURUGAN
 

Kürzlich hochgeladen (20)

Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D.  Bawankar.pptPharmacokinetic Models by Dr. Ram D.  Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
 
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdfSGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
 
Rheumatoid arthritis Part 1, case based approach with application of the late...
Rheumatoid arthritis Part 1, case based approach with application of the late...Rheumatoid arthritis Part 1, case based approach with application of the late...
Rheumatoid arthritis Part 1, case based approach with application of the late...
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE
 
AORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectionAORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissection
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before Pregnancy
 
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdfSGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
 
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxBreast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
 
ayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologypptayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologyppt
 
EXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionEXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung function
 
Unit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptUnit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.ppt
 
AUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsAUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functions
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdf
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and Beyond
 
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfCONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
 
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdfSGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
 
Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosis
 
Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024
 
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
 

Shaping the Future.Clinicians and Faculty Define: Strategies for the Next Era of HCV Therapy.2014

  • 1. Shaping the Future: Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy This program is supported by educational grants from
  • 2. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Program Director Mark S. Sulkowski, MD Professor of Medicine Medical Director, Viral Hepatitis Center Divisions of Infectious Diseases and Gastroenterology/Hepatology Johns Hopkins University School of Medicine Baltimore, Maryland
  • 3. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Faculty Jordan J. Feld, MD, MPH Assistant Professor of Medicine University of Toronto Hepatologist Toronto Western Hospital Liver Centre McLaughlin-Rotman Centre for Global Health Toronto, Ontario, Canada Graham R. Foster, FRCP, PhD Professor of Hepatology The Liver Unit Consultant Hepatologist Queen Marys University of London London, United Kingdom Michael W. Fried, MD Professor of Medicine Director, UNC Liver Center University of North Carolina at Chapel Hill Chapel Hill, North Carolina Alessandra Mangia, MD Liver Unit Hospital ‘Casa Sollievo della Sofferenza’ Istituto di Ricovero e Cura a Carattere Scientifico San Giovanni Rotondo, Italy Fred Poordad, MD Vice President, Academic and Clinical Affairs The Texas Liver Institute Professor of Medicine University of Texas Health Science Center San Antonio, Texas Stefan Zeuzem, MD Professor of Medicine Chief, Department of Medicine I JW Goethe University Hospital Frankfurt, Germany
  • 4. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy New Standard of Care for HCV in 2013/2014 Standard Interferon Interferon + Ribavirin Peginterferon/ Ribavirin 1991 1998 2001 2005 Boceprevir or Telaprevir + P/R GT1 GT2/3 2011 2013 2013 Simeprevir or Sofosbuvir + P/R Sofosbuvir + Ribavirin
  • 5. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Key Questions That Define the Future of Hepatitis C Virus Therapy  How do we determine the best regimen for genotype 1 going forward? Jordan J. Feld, MD, MPH  Why does genotype 3 do poorly and how can we do better? Stefan Zeuzem, MD  Is one-size-fits-all treatment a possibility and how would that change management? Alessandra Mangia, MD  How will we manage patients who fail direct-acting antiviral therapies? Graham R. Foster, FRCP, PhD  Why do cirrhotics do poorly and how can we do better? Fred Poordad, MD  How will high-risk patients be managed going forward? Michael W. Fried, MD
  • 6. Jordan J. Feld, MD, MPH Assistant Professor of Medicine University of Toronto Hepatologist Toronto Western Hospital Liver Centre McLaughlin-Rotman Centre for Global Health Toronto, Ontario, Canada How Do We Determine the Best Regimen for Genotype 1 Going Forward?
  • 7. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Summary of New Agents for GT1 in 2013  Sofosbuvir + P/R – Sofosbuvir is oral, once daily – 12 wks with P/R – SVR rate 89% in naives – Low impact of baseline factors  Simeprevir + P/R – Simeprevir is oral, once daily – 12 wks with P/R + 12-36 wks with P/R – SVR rate 80% in naives – Q80K testing will be needed in GT 1a Baseline Factor SVR12, % (n/N) Black Non-Black 86 (43/50) 90 (218/242) Genotype 1a Genotype 1b 92 (206/225) 82 (54/66) Cirrhosis* No cirrhosis* 80 (43/54) 92 (252/273) *Represents GT 1/4/5/6. Sofosbuvir FDA hearing. October 25, 2013. Simeprevir FDA hearing. October 24, 2013. Baseline Factor SVR12, % (n/N) Black Non-Black 67 (29/43) 81 (378/464) GT1a with Q80K GT 1a, no Q80K GT 1b 58 (49/84) 84 (138/165) 85 (228/267) F3-F4* F0-F2* 68 (89/130) 84 (317/378)
  • 8. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Priorities  SVR trumps all  But SVR is a necessity—assuming SVR > 90%, what is next?  Considerations – Several new P/R-based regimens completing phase III – Faldaprevir + P/R – Daclatasvir + P/R – But with 89% SVR with 12-wk SOF + P/R, will there be a clinical role for longer-duration P/R-based regimens? – An all-oral future for GT1: multiple studies of 12- to 16-wk regimens
  • 9. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Over- treatment of some Tailored regimen for each population Priorities Cost Fewest drugs Shortest duration Simplicity One size fits all
  • 10. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy 2/12 One Size Fits All or Simpler Regimen for Genotype 1b Only?  Genotype 1, naive  10% had cirrhosis Dufour J-F, et al. AASLD 2013. Abstract 1102. 16-Wk Regimen: Faldaprevir (PI) 120 mg QD + Deleobuvir (NNI) 600 mg BID + RBV (N = 32) Simple regimen for genotype 1b only? What if it were very cheap? EOT SVR12 UndetectableHCV RNA(IU/mL) 100 80 60 40 20 0 58 100 17 95 7/12 20/20 19/20 Genotype 1a, IL28B CC Genotype 1b
  • 11. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy One Size Fits All or Simpler Regimen for GT1b? Various Ways to Look at the Same Data 82 0 20 40 60 80 100 SVR12(%) 100 100 100 100 100 79 100 29 12 85 100 52 27 83 96 52 25 96 100 54 25 81 100 26 18 89 100 28 17 Observed data (above bar) ITT (within bar) n = 81 98 8888 100 89 1a 1b 1a 1b 1a 1b 1a 1b 1a 1b 1a 1b ABT-450 ABT-333 RBV ABT-450 ABT-267 RBV ABT-450 ABT-267 ABT-333 ABT-450 ABT-267 ABT-333 RBV ABT-450 ABT-267 RBV ABT-450 ABT-267 ABT-333 RBV Treatment-Naive Patients Null Responders Kowdley KV, et al. AASLD 2012. Abstract LB-1. ABT-450/RTV (PI) ± ABT-333 (NNI) + ABT-267 (NS5A) ± RBV x 12 Wks One size fits all OR “simpler regimen” for GT1b?
  • 12. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy What Is the Role of Ribavirin for Genotype 1 Going Forward?  Still an enigma  Prevents/delays resistance – Important for genotype 1a – Important with NNI, PI, and NS5A – Not relevant with NI-based combination  Reduces relapse – May be relevant with shorter durations – Limited data to date but does not look critical for most NI-based combination regimens
  • 13. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Same Duration for All or Shorter for Naive, Longer for Previous Failures? 12 wks for all or 8 for naive and 12 for failures? What about RBV? A third DAA for 6 wks? SVR12(%) 0 20 40 60 80 100 19/ 20 SOF LDV SOF LDV RBV SOF LDV 95 100 21/ 21 95 18/ 19 95 SOF LDV 100 18/ 19 21/ 21 8 Wks 12 Wks 12 Wks SOF LDV RBV Naive PI failure n/N = Lawitz E, et al. AASLD 2013. Abstract 215.
  • 14. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Are We Moving to Primary Care? Project ECHO One size fits all may be critical Project ECHO Web site.
  • 15. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Conclusions  Research continues for GT1 HCV – More tailored approach in the near future – Longer duration or additional agents for difficult-to-treat populations?  One-size-fits-all approach ideal for inexperienced providers  Rising demand for treatment anticipated – Increased screening – Availability of IFN-free regimens
  • 16. Stefan Zeuzem, MD Professor of Medicine Chief, Department of Medicine JW Goethe University Hospital Frankfurt, Germany Why Does Genotype 3 Do Poorly and How Can We Do Better?
  • 17. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Standard Treatment for GT2/3 HCV Before treatment (HCV RNA quantification) 16 wks therapy HCV RNA < 12-15 IU/mL Pre-tx < 8 x 105 IU/mL* 48 wks therapy‡ HCV RNA ≥ 2 log decline† Wk 4 HCV RNA quantification Wk 12 HCV RNA quantification 24 wks therapy HCV RNA < 12-15 IU/mL *No treatment shortening in patients with advanced fibrosis, cirrhosis, metabolic syndrome, insulin resistance, HIV/HCV coinfection, etc. No data for patients with persistently normal ALT levels. † Detectable HCV RNA at Wk 24: discontinuation of treatment.‡ Treatment duration of 36, 48, 72 wks in slow responders is currently investigated in prospective trials. Tx discontinued < 2 log decline EASL Practice Guidelines.
  • 18. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy FISSION: Poorer Response to SOF/RBV in GT3 vs GT2 Naives, Especially Cirrhotics Lawitz E, et al. N Engl J Med. 2013;368:1878-1887. SVR12(%) All Patients Patients With Cirrhosis n/N = 10/ 11 13/ 38 8/ 13 11/ 37 100 80 60 40 20 0 97 56 78 63 91 34 62 30 68/ 70 52/ 67 102/ 183 110/ 176 GT2 GT3 SOF/RBV 12 Wks PegIFN/RBV 24 Wks GT2 GT3
  • 19. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy FUSION: Impact of Cirrhosis and Duration on SVR Rates Jacobson IM, et al. N Engl J Med. 2013;368:1867-1877. 6/10 5/26 SVR12(%) 25/26 7/923/23 14/38 14/2325/40 No Cirrhosis Sofosbuvir + RBV 12 wks Sofosbuvir + RBV 16 wks No CirrhosisCirrhosis Cirrhosis Genotype 2 Genotype 3 19 6163 37 n/N = 100 80 60 40 20 0 96 100 60 78 100 80 60 40 20 0 SVR12(%) n/N =
  • 20. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Wk 0 Wk 24 SVR4, SVR12, SVR24 Placebo* (n = 85) Sofosbuvir + Ribavirin (n = 84)* *Protocol amended to eliminate placebo arm. 12-wk arm predominantly GT2 patients (N = 73); 11 GT3 patients completed 12 wks of SOF + RBV prior to amendment to extend treatment duration. Zeuzem S, et al. AASLD 2013. Abstract 1085. VALENCE: Evaluating Impact of Duration on SVR With SOF/RBV Wk 12 Tx-naive or -experienced GT2 or GT3 pts
  • 21. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Overall Treatment Naive Treatment Experienced SVR4(%) n/N = 2/ 2 30/ 33 12/ 13 87/ 100 100 80 60 40 20 0 93 97 85 94 100 9192 87 68/ 73 212/ 250 29/ 30 86/ 92 No Cirrhosis Cirrhosis 7/ 8 27/ 45 88 60 No Cirrhosis CirrhosisOverall 12 wks of SOF + RBV in GT2 24 wks of SOF + RBV in GT3 Zeuzem S, et al. AASLD 2013. Abstract 1085. Jacobson IM, et al. N Engl J Med. 2013;368:1867-1877. Lawitz E, et al. N Engl J Med. 2013;368:1878-1887. VALENCE Efficacy Summary: SVR12  Phase III GT3 SVR12 data summary: – TN noncirrhotics, 12 wks: 61% (FISSION) – TN cirrhotics, 12 wks: 34% (FISSION) – TE noncirrhotics, 16 wks: 63% (FUSION) – TE cirrhotics, 16 wks: 61% (FUSION)
  • 22. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Conclusions  Most GT3 patients will be able to be treated with 24 wks of SOF/RBV  GT3, treatment-experienced, cirrhotic patients most challenging group to treat with all-oral regimens – Experts recommend 12 wks of SOF + pegIFN/RBV in short term
  • 23. Alessandra Mangia, MD Liver Unit Hospital 'Casa Sollievo della Sofferenza' Istituto di Ricovero e Cura a Carattere Scientifico San Giovanni Rotondo, Italy Is One-Size-Fits-All Treatment a Possibility and How Would That Change Management?
  • 24. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy How Far Are We? One Size . . . . . . Fits All? Same treatment regardless of fibrosis level, previous treatment experience, or HCV genotype?
  • 25. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy AVIATOR: Less Impact of Traditional Negative Predictors on SVR Rates  Comparable high SVR rates among 247 patients administered 12 or 24 wks of treatment  All enrolled patients were noncirrhotic Kowdley KV, et al. EASL 2013. Abstract 3. Treatment Naive Null Responders 100 80 60 40 20 0 M aleFem ale 1a 1b ≥ 7log F0-F1 < 7 log F2-F3Non-CC CC SVR24(%) SVR24(%) n = 92 94 91 98 89 94 94 91 95 89 78 81 108 50 35 124 113 42 115 44 100 80 60 40 20 0 M aleFem ale 1a 1b ≥ 7 log F0-F1 < 7 log F2-F3Non-CC CC n = 93 97 93 97 91 96 95 93 94 100 55 33 55 33 22 66 41 45 85 3
  • 26. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy GT1 HCV Tx Naive: SVR Rates With 12 Wks of IFN-Free Tx in Phase II Studies  Few or no cirrhotic patients included in above studies  Corresponding rates for 24-wk regimens showed SVR12/24 of 52% (QUANTUM[1] ), 95% to 100% (AI-444040[6] ), 93% (AVIATOR[5] ), 94% (A1443-014[8] ) 1. Lalezari LP, et al. EASL 2013. Abstract 845. 2. Gane E, et al. EASL 2013. Abstract 14. 3. Lawitz E, et al. AASLD 2013. Abstract 215. 4. Sulkowski MS, et al. AASLD 2012. Abstract LB-2. 5. Kowdley K, et al. EASL 2013. Abstract 3. 6. Everson G, et al. AASLD 2013. Abstract LB-1. 7. Lawitz E, et al. AASLD 2013. Abstract 76. 8. Sulkowski M, et al. EASL 2013. Abstract 1423. Regimen N Study SVR 4/12, % SOF (NS5B) + RBV 25 QUANTUM[1] 56 SOF (NS5B) + RBV 25 ELECTRON[2] 84 SOF (NS5B) + LDV (NS5A) 19 LONESTAR[3] 95 SOF (NS5B) + DCV (NS5A) ± RBV 82 AI-444040[4] 98-100 ABT-450 (PI) + ABT-267 (NS5A) + ABT-333 (NS5B) ± RBV 158 AVIATOR[5] 94 DCV (NS5A) + ASV (PI) + BMS-791325 (NS5B) 161 A1443-014[6] 92 MK-5172 (PI) + MK-8742 (NS5A) ± RBV 65 C-WORTHY[7] 96-100
  • 27. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Phase III Studies of Sofosbuvir (Nuc) + Ledipasvir (NS5A) ± RBV in GT1 HCV ION-1*: GT1 Tx-Naive Pts (16% Cirrhotic): SOF/LDV FDC ± RBV for 12 Wks Press release. These data are available in press release format only, have not been peer reviewed, may be incomplete, and we await presentation or publication in a peer-reviewed format before conclusions should be made from these data. *24-wk arms not yet reported. ION-3: GT1 Tx-Naive Pts: SOF/LDV FDC ± RBV for 8 or 12 Wks SOF/LDV FDC SOF/LDV FDC + RBV n/N = 209/ 214 211/ 217 SVR12(%) 12 Wks 98 97100 90 60 40 20 0 8 Wks 12 Wks 202/ 215 206/ 216 201/ 216 94 93 95
  • 28. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy 12-Wk Treatment in Previous Null Responders? ABT-450/RTV + ABT-267 + ABT-333 + RBV 12 Wks SVR12(%) Naive n/N = 42/ 45 F0-F2 fibrosis SVR4/12(%) n/N = SMV + SOF + RBV 12 Wks SMV + SOF 12 Wks *No F4 COSMOS[1,2] Caveat: small numbers, few patients with cirrhosis 1. Jacobson IM, et al. AASLD 2013. Abstract LB-3. 2. Lawitz E, et al. CROI 2013. Abstract 155LB. 3. Kowdley K, et al. EASL 2013. Abstract 3. 26/ 27 13/ 14 96 93 76/ 79 14/ 15 7/ 7 93 100 F3/4 fibrosis 96 93 AVIATOR[3] 100 80 60 40 20 0 Null* 100 80 60 40 20 0
  • 29. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy SAPPHIRE Phase III Studies: PI Backbone + 2 Other DAAs SAPPHIRE-1: GT1 Tx-Naive Noncirrhotic Pts: ABT-450/RTV/ABT-267 FDC + ABT-333 + RBV for 12 Wks Press release. These data are available in press release format only, have not been peer reviewed, may be incomplete, and we await presentation or publication in a peer-reviewed format before conclusions should be made from these data. n/N = 455/ 473 307/ 322 148/ 151 SAPPHIRE-2: GT1 Tx-Experienced Noncirrhotic Pts (49% Null Responders): ABT-450/RTV/ABT-267 FDC + ABT-333 + RBV for 12 Wks 100 80 60 40 20 0 SVR12(%) 96 95 98 Overall GT1a GT1b n/N = 286/ 297 166/ 173 119/ 123 100 80 60 40 20 0 SVR12(%) 96 96 97 Overall GT1a GT1b
  • 30. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy SOF-Based IFN-Free DAA Treatment in GT1 Treatment-Experienced Patients SOF + LDV + RBV x 12 wks (prior null, noncirrhotic) 100 80 60 40 20 0 SVR4/12(%) 100[1] 2 DAAs + RBV SOF + LDV x 12 wks (prior PI failures, 50% cirrhotic) 2 DAAs, No RBV 7/10 70[2] 9/9 100[2] SOF + LDV + RBV x 12 wks (TE with cirrhosis) SOF + LDV x 12 wks (TE with cirrhosis) 95[3] 1. Gane EJ, et al. CROI 2013. Abstract 41LB. 2. Gane EJ, et al. AASLD 2013. Abstract 73. 3. Lawitz E, et al. AASLD 2013. Abstract 215. 18/199/9n/N =
  • 31. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Phase III Studies of Sofosbuvir (Nuc) + Ledipasvir (NS5A) ± RBV in GT1 HCV Press release. These data are available in press release format only, have not been peer reviewed, may be incomplete, and we await presentation or publication in a peer-reviewed format before conclusions should be made from these data. SOF/LDV FDC SOF/LDV FDC + RBV ION-2: GT1 Treatment-Experienced Pts (20% Cirrhotic): SOF/LDV FDC ± RBV for 12 or 24 Wks n/N = SVR12(%) 100 90 60 40 20 0 12 Wks 24 Wks 102/ 109 107/ 111 108/ 109 110/ 111 94 96 99 99
  • 32. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Challenging Patient Groups  Patients with cirrhosis  HCV genotype 3 infection  Patients nonresponsive to DAA regimens  HIV coinfection
  • 33. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Conclusions  Future role for specialists in HCV – Treating more complex cases – Determining indication for starting treatment – Surveillance of cirrhotic patients following successful therapy
  • 34. Graham R. Foster, FRCP, PhD Professor of Hepatology The Liver Unit Consultant Hepatologist Queen Marys University of London London, United Kingdom How Will We Manage Patients Who Fail Direct-Acting Antiviral Therapies?
  • 35. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy DAA Failures: The Principles  In other viral infections, “failure” can be resolved by complementary drugs – eg, in HBV, lamivudine failures respond to adefovir or tenofovir  Will the same hold true for HCV?
  • 36. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy High SVR Rates With 24 Wks of All-Oral Therapy in GT1 Patients With PI Failure Sulkowski MS, et al. EASL 2013. Abstract 1417. *1 patient in daclatasvir/sofosbuvir/RBV arm had missing data at Wk 12 posttreatment; this patient had undetectable HCV RNA at Wk 4 and Wk 24 posttreatment. SVR4 SVR12 24 wks of daclatasvir + sofosbuvir 24 wks of daclatasvir + sofosbuvir + RBV 100 100 100 95*100 80 60 40 20 0 Patients(%) n/N = 21/ 21 20/ 20 21/ 21 19/ 20
  • 37. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy LONESTAR: High SVR Rates With 12 Wks of Therapy in GT1 Patients With PI Failure Lawitz E, et al. AASLD 2013. Abstract 215. 12 wks of SOF/LDV FDC 12 wks of SOF/LDV FDC + RBV 95 100 100 80 60 40 20 0 SVR12(%) n/N = 18/ 19 21/ 21
  • 38. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Complementary Regimens: Drug Classes for the Future  Nucleotide polymerase inhibitors (eg, sofosbuvir)  NS5A inhibitors (eg, daclatasvir, ledipasvir)  Protease inhibitors (eg, simeprevir, faldaprevir)  Non-nucleotide polymerase inhibitors (3 different classes)  Host-targeting drugs (cyclophilins, microRNAs RIG-I activators)  Which will work best together?
  • 39. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Conclusions  Second-line therapy and beyond – New challenges with increased treatment options – Continued treatment failures anticipated with more difficult- to-treat populations  Managing treatment failures – Determine cause – Risk factors – modifiable? – Adherence with all-oral regimens – Patient education and adherence management key
  • 40. Fred Poordad, MD Vice President Academic and Clinical Affairs The Texas Liver Institute Professor of Medicine University of Texas Health Science Center San Antonio, Texas Why Do Cirrhotics Do Poorly and How Can We Do Better?
  • 41. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy CUPIC: Telaprevir or Boceprevir + P/R in GT1 Treatment-Experienced Cirrhotics Fontaine H, et al. EASL 2013. Abstract 60. Hezode C, et al. J Hepatol. 2013;59:434-441. n/N = 118/ 295 79/ 190 61/ 116 43/ 85 43/ 135 32/ 80 8/ 28 1/9 100 80 60 40 20 0 SVR12(%) Overall Relapsers PRs NRs 40 41 53 51 32 40 29 11 Telaprevir + P/R Boceprevir + P/R Risk of Death or Severe Complications, % (n/N) Platelet Count > 100,000 cells/mm3 Platelet Count ≤ 100,000 cells/mm3 Albumin ≥ 35 g/L 3.4 (10/298) 4.3 (3/69) Albumin < 35 g/L 7.1 (2/28) 44.1 (15/34)
  • 42. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Impact of Cirrhosis on SVR12 With Next-Generation PI + P/R Jacobson I, et al. EASL 2013. Abstract 1425. Ferenci P, et al. EASL 2013. Abstract 1416. 18/ 31n/N = 5/ 17 188/ 229 60/ 113 82 53 58 29 Simeprevir + P/R P/R 100 80 60 40 20 0 SVR12(%) No Cirrhosis Cirrhosis QUEST-1: Simeprevir + P/R Treatment-Naive GT1 172/ 212 30/ 45 9/ 16 100 80 60 40 20 0 81 67 56 < F3 ≥ F3 F4 STARTVerso1: Faldaprevir + P/R Treatment-Naive GT1 Faldaprevir + P/R
  • 43. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Impact of Cirrhosis on SVR12 With Sofosbuvir-Based Therapy in Tx-Naive Pts Lawitz E, et al. EASL 2013. Abstract 1411. Zeuzem S, et al. AASLD 2013. Abstract 1085. SVR12(%) 92 80 252/ 273 43/54 NEUTRINO: 12 Wks of SOF + P/R GT1/4/5/6 Genotype 2 Genotype 3 58/59 10/11 89/145 13/38 100 80 60 40 20 0 n/N = 98 91 61 34 FISSION: 12 Wks of SOF + RBV GT2/3 CirrhoticNoncirrhotic 94 86/92 12/13 92 VALENCE: 24 Wks of SOF + RBV GT3 Genotype 1/4/5/6 Genotype 3 100 80 60 40 20 0 100 80 60 40 20 0
  • 44. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy 100 80 60 40 20 0 37 63 87 19 61 60 No Cirrhosis Cirrhosis Impact of Duration, Addition of PegIFN on Efficacy of SOF in Tx-Experienced GT2/3 FUSION: 12 wks of SOF/RBV FUSION: 16 wks of SOF/RBV VALENCE: 24 wks of SOF/RBV LONESTAR-2: 12 Wks of SOF + PegIFN/RBV Sofosbuvir FDA hearing. October 25, 2013. Lawitz E, et al. AASLD 2013. SVR12(%) 14/ 38 25/ 40 87/ 100 5/ 26 14/ 23 27/ 45 Genotype 3 100 80 60 40 20 0 96 93 100 83 83 83 Genotype 2 Genotype 3 SVR12(%) Overall Cirrhotic Noncirrhotic n/N = 22/ 23 13/ 14 9/ 9 20/ 24 10/ 12 10/ 12
  • 45. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Efficacy of IFN-Free DAA Combinations in Tx-Naive and Tx-Experienced Cirrhotics COSMOS: 12-Wk Regimens in GT1 HCV Cirrhotic Tx-Naive or Previous Null Responders SVR4/12(%) Jacobson IM, et al. AASLD 2013. Abstract LB-3. Lawitz E, et al. AASLD 2013. Abstract 215. Everson GT, et al. AASLD 2013. Abstract LB-1. LONESTAR: 12-Wk Regimens in GT1 HCV PI Failures (55% Cirrhotic) AI443-014: 12-Wk Regimen in GT1 Tx-Naive Cirrhotics 100 80 60 40 20 0 91 100 10/11 7/7 Simeprevir + sofosbuvir + RBV Simeprevir + sofosbuvir 100 80 60 40 20 0 18/19 21/21 95 100 Sofosbuvir/ledipasvir Sofosbuvir/ledipasvir + RBV 100 80 60 40 20 0 87 Daclatasvir + asunaprevir + BMS-791325 13/15n/N =
  • 46. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Conclusions  Eradication of HCV optimal before progression to cirrhosis  Poorer response of cirrhotic patients likely multifactorial – Poor prior IFN response and GT3 most challenging  Treatment approaches – GT3 experienced, cirrhotic: 12 wks of SOF + pegIFN/RBV – GT3 naive, cirrhotic: 24 wks of SOF + RBV  Further improvements anticipated with DAA combinations
  • 47. Michael W. Fried, MD Professor of Medicine Director, UNC Liver Center University of North Carolina at Chapel Hill Chapel Hill, North Carolina How Will High-Risk Patients Be Managed Going Forward?
  • 48. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Goals of Antiviral Therapy  Decompensated cirrhosis – Eradicate HCV to prevent further deterioration – Eradicate HCV to prevent reinfection of graft – Improve hepatic functional status – Delay or obviate the need for transplantation  Posttransplantation – Treat acute complications of HCV reinfection – Prevent/arrest progression to cirrhosis – Improve morbidity and mortality – Liver related – Extrahepatic effects on cardiovascular disease
  • 49. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy HCV Management Issues Unique to Pre- and Posttransplantation Patients  Pretransplantation – Intolerance to peginterferon regimens – Impaired hepatic metabolism – Renal insufficiency  Posttransplantation – High HCV RNA/impact of immunosuppression – Fibrosing cholestatic hepatitis – Drug–drug interactions – Renal insufficiency – Other medical comorbidities
  • 50. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy PegIFN/RBV Before Transplantation to Minimize HCV Recurrence Post-LT Everson GT, et al. Hepatology. 2013;57:1752-1762. P = .6011 TreatedLTPatients(%) 100 80 60 40 20 0 Overall (n = 44) GT1/4/6 (n = 23) GT2/3 (n = 44) 59 25 52 22 67 29 HCV RNA negative at LT HCV RNA negative 12 wks of post-LT
  • 51. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Characteristic SOF + RBV (N = 61) Median age, yrs (range) 59 (46-73) HCV genotype, %  1a 39  1b 34  2 13  3a 12  4 2 Non-CC IL28B genotype, % 78 CTP score, %  5-7 96  8 5 Previous HCV treatment, % 75 Pretransplant Sofosbuvir + RBV to Prevent Posttransplant HCV Recurrence  Study 025: single-arm, open-label, phase II study from 16 LT sites – Listed for LT due to HCC meeting Milan criteria – MELD exception for HCC – CTP score ≤ 7  Excluded decompensated cirrhosis, renal impairment, living donor LT  Pre-LT therapy: SOF 400 mg/day + RBV 1000-1200 mg/day for 48 wks or until time of LT – Post-LT immunosuppression: ≥ 12 wks of tacrolimus + prednisone + MMF Curry MP, et al. AASLD 2013. Abstract 213.
  • 52. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Duration of Undetectable HCV RNA Before Transplant Predicted Lack of Recurrence  64% of pts HCV RNA negative 12 wks post-LT (93% at LT)  Continuous days TND pre-LT only factor predicting HCV recurrence in multivariate analysis – Only 1/24 pts with > 30 days TND experienced recurrence Curry MP, et al. AASLD 2013. Abstract 213. 3300 30 60 90 120 150 180 210 240 270 300 Days With HCV RNA Continuously TND Prior to LT > 30 days TND No recurrence (n = 28) Recurrence (n = 10) Median days TND (P < .001) No recurrence: 95 Recurrence: 5.5
  • 53. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy CRUSH C: PI + PegIFN/RBV in Liver Transplantation Recipients  112 patients: 30 were F4 or FCH  Treatment: TVR 88% or BOC 12% – P/R lead-in 96% Verna EC, et al. EASL 2013. Abstract 23. HCVRNA<LOD(%) 100 80 60 40 20 0 EOTR SVR4 67 65 n = 43 Adverse Effect All Patients (N = 112) AE requiring treatment d/c, % 11 Dose reduction, % PegIFN/RBV 34/80 Transfusion, % 46 Erythropoietin, % 79 G-CSF 41 Hospitalization, %* 21 Renal function Cr increase > 0.5 mg/dL, % Max ↑ in Cr, mg/dL (range) 34 0.4 (0-2.5) Rejection, %† 4 Death, % 6 *Significantly differed between groups (P = .02). † Any treated rejection during or after TT.
  • 54. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Daclatasvir 60 mg/day + Sofosbuvir 400 mg/day Case Report: Sofosbuvir + Daclatasvir in Post-LT Fibrosing Cholestatic Hepatitis Fontana RJ, et al. Am J Transplant. 2013;13:1601-1605. 8 7 6 5 4 3 2 1 0 LogHCVRNA(IU/mL) Treatment Wk 400 350 300 250 200 150 100 50 0 ALT(IU/L) AlkPhos(IU/L) 0 1 2 3 4 6 8 1012 14 1618 20 222425 2848 56 60 ALT Alk Phos HCV RNA
  • 55. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Sofosbuvir + RBV for Treatment of Post-LT HCV Recurrence  Ongoing prospective, multicenter, single-arm, open-label pilot study – Median time since LT: 4.3 yrs (range: 1.02-10.6) – CTP ≤ 7 and MELD ≤ 17 – 83% GT1, 33% IL28B CC, 40% with comp’d cirrhosis  SOF 400 mg/day + RBV 400-1200 mg/day for ≤ 24 wks – RBV started at 400 mg/day and increased based on hemoglobin levels Charlton MR, et al. AASLD 2013. Abstract LB-2. Reproduced with permission. Virologic Response Rates *1 patient still on treatment. † 4 patients had not reached SVR4 visit. Wk 4 EOT* SVR4 Response(%) 100 80 60 40 20 0 100 100 77 40/40 39/39 27/35†
  • 56. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Other Studies Recruiting  Sofosbuvir/ledipasvir FDC + RBV for 12 or 24 wks in patients with advanced liver disease or posttransplantation recurrence[1]  Simeprevir + daclatasvir + RBV for 24 wks in genotype 1b patients with posttransplantation recurrence[2]  ABT-450/RTV/ABT-267 FDC + ABT-333 + RBV for 24 wks in liver transplantation recipients[3] 1. ClinicalTrials.gov. NCT01938430. 2. ClinicalTrials.gov. NCT01938625. 3. ClinicalTrials.gov. NCT01782495.
  • 57. clinicaloptions.com/hepatitis Clinicians and Faculty Define Strategies for the Next Era of HCV Therapy Conclusions  Pre- and post-LT patients greatest challenge to eradication of HCV – Recent data encouraging – Significant challenges remain
  • 58. Go Online for More From This Program! CME-certified module that goes in-depth on each of the key questions addressed in this slideset clinicaloptions.com/shaping

Hinweis der Redaktion

  1. GT, genotype; HCV, hepatitis C virus; P/R, peginterferon/ribavirin.
  2. GT, genotype; P/R, peginterferon/ribavirin; SVR12, sustained virologic response at 12 weeks posttreatment.
  3. GT, genotype; P/R, peginterferon/ribavirin; SOF, sofosbuvir; SVR, sustained virologic response.
  4. BID, twice daily; EOT, end of treatment; HCV, hepatitis C virus; NNI, nonnucleoside inhibitor; PI, protease inhibitor; QD, once daily; RBV, ribavirin; SVR12, sustained virologic response at 12 weeks posttreatment.
  5. GT, genotype; ITT, intent to treat; NNI, nonnucleoside inhibitor; NS5A, nonstructural protein 5A; PI, protease inhibitor; RBV, ribavirin; RTV, ritonavir; SVR12, sustained virologic response at 12 weeks posttreatment.
  6. NI, nucleos(t)ide inhibitor; NNI, nonnucleoside inhibitor; NS5A, nonstructural protein 5A; PI, protease inhibitor.
  7. DAA, direct-acting antiviral; LDV, lepidasvir; PI, protease inhibitor; RBV, ribavirin; SOF, sofosbuvir; SVR12, sustained virologic response at 12 weeks posttreatment.
  8. ECHO, Extension for Community Healthcare Outcomes.
  9. GT, genotype; HCV, hepatitis C virus; IFN, interferon.
  10. ALT, alanine aminotransferase; GT, genotype; HCV, hepatitis C virus; tx, treatment.
  11. GT, genotype; pegIFN, peginterferon; RBV, ribavirin; SOF, sofosbuvir; SVR12, sustained virologic response at 12 weeks posttreatment.
  12. RBV, ribavirin; SVR12, sustained virologic response at 12 weeks posttreatment.
  13. GT, genotype; RBV, ribavirin; SOF, sofosbuvir; SVR4, sustained virologic response at 4 weeks posttreatment; SVR12, sustained virologic response at 12 weeks posttreatment; SVR24, sustained virologic response at 24 weeks posttreatment; Tx, treatment.
  14. GT, genotype; RBV, ribavirin; SOF, sofosbuvir; SVR4, sustained virologic response at 4 weeks posttreatment; SVR12, sustained virologic response at 12 weeks posttreatment; TE, treatment experienced; TN, treatment naive.
  15. GT, genotype; pegINF, peginterferon; RBV, ribavirin; SOF, sofosbuvir.
  16. HCV, hepatitis C virus.
  17. CC, CC IL28B genotype; F, fibrosis stage; SVR4, sustained virologic response at 4 weeks posttreatment. 
  18. ASV, asunaprevir; DCV, daclatasvir; GT, genotype; HCV, hepatitis C virus; IFN, interferon; LDV, ledipasvir; NS5A, nonstructural protein 5A; NS5B, nonstructural protein 5B; PI, protease inhibitor; SOF, sofosbuvir; RBV, ribavirin; SVR4, sustained virologic response at 4 weeks posttreatment; SVR12, sustained virologic response at 12 weeks posttreatment; SVR24, sustained virologic response at 24 weeks posttreatment; Tx, treatment.
  19. FDC, fixed-dose combination; GT, genotype; HCV, hepatitis C virus; LDV, ledipasvir; Nuc, nucleotide polymerase inhibitor; NS5A, nonstructural protein 5A; RBV, ribavirin; SOF, sofosbuvir; SVR12, sustained virologic response 12 weeks posttreatment; Tx, treatment.
  20. F, fibrosis stage; RBV, ribavirin; RTV, ritonavir; SMV, simeprevir; SOF, sofosbuvir; SVR4, sustained virologic response at 4 wks posttreatment; SVR12, sustained virologic response at 12 weeks posttreatment.
  21. DAA, direct-acting antiviral; FDC, fixed-dose combination; GT, genotype; PI, protease inhibitor; RBV, ribavirin; RTV, ritonavir; SVR12, sustained virologic response 12 weeks posttreatment; Tx, treatment.
  22. DAA, direct-acting antiviral; GT, genotype; IFN, interferon; LDV, ledipasvir; PI, protease inhibitor; RBV, ribavirin; SOF, sofosbuvir; SVR4, sustained virologic response 4 weeks posttreatment; SVR12, sustained virologic response 12 weeks posttreatment; TE, treatment exposed.
  23. FDC, fixed-dose combination; GT, genotype; HCV, hepatitis C virus; LDV, ledipasvir; Nuc, nucleotide polymerase inhibitor; NS5A, nonstructural protein 5A; RBV, ribavirin; SOF, sofosbuvir; SVR12, sustained virologic response 12 weeks posttreatment.
  24. DAA, direct-acting antiviral; HCV, hepatitis C virus.
  25. HCV, hepatitis C virus.
  26. DAA, direct-acting antiviral; HBV, hepatitis B virus; HCV, hepatitis C virus.
  27. GT, genotype; HCV, hepatitis C virus; PI, protease inhibitor; RBV, ribavirin; SVR4, sustained virologic response rate at 4 weeks posttreatment; SVR12, sustained virologic response rate at 12 weeks posttreatment. For more information on this study, review the CCO Capsule Summary at: http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/Amsterdam%202013/Viral%20Hepatitis/Capsules/1417.aspx.
  28. FDC, fixed-dose combination; GT, genotype; PI, protease inhibitor; RBV, ribavirin; SOF/LDV, sofosbuvir/ledipasvir; SVR12, sustained virologic response rate at 12 weeks posttreatment.
  29. NS5A, nonstructural protein 5A; RIG-I, retinoic acid inducible gene I.
  30. GT, genotype; NRs, null responders; P/R, peginterferon/ribavirin; PRs, partial responders; SVR12, sustained virologic response at 12 weeks posttreatment.
  31. F, fibrosis stage; GT, genotype; PI, protease inhibitor; P/R, peginterferon/ribavirin; SVR12, sustained virologic response at 12 weeks posttreatment.
  32. GT, genotype; P/R, peginterferon/ribavirin; RBV, ribavirin; SOF, sofosbuvir; SVR12, sustained virologic response at 12 weeks posttreatment; Tx, treatment.
  33. GT, genotype; pegIFN/RBV, peginterferon/ribavirin; SOF, sofosbuvir; SVR12, sustained virologic response at 12 weeks posttreatment; Tx, treatment.
  34. DAA, direct-acting antiviral; GT, genotype; HCV, hepatitis C virus; IFN, interferon; PI, protease inhibitor; RBV, ribavirin; SVR4, sustained virologic response at 4 weeks posttreatment; SVR12, sustained virologic response at 12 weeks posttreatment; Tx, treatment.
  35. DAA, direct-acting antiviral; GT, genotype; HCV, hepatitis C virus; IFN, interferon; pegIFN, peginterferon; RBV, ribavirin; SOF, sofosbuvir.
  36. HCV, hepatitis C virus.
  37. HCV, hepatitis C virus.
  38. GT, genotype; HCV, hepatitis C virus; LT, liver transplantation; pegIFN, peginterferon; RBV, ribavirin.
  39. CTP, Child-Turcotte-Pugh; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; LT, liver transplantation; MELD, Model for End-Stage Liver Disease; MMF, mycophenolate mofetil; RBV, ribavirin; SOF, sofosbuvir. For more information about this study, please see the CCO Capsule Summary at: http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/AASLD%202013/Other%20Highlights/Capsules/213.aspx
  40. HCV, hepatitis C virus; LT, liver transplantation; TND, target not detected. For more information about this study, please see the CCO Capsule Summary at: http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/AASLD%202013/Other%20Highlights/Capsules/213.aspx
  41. AE, adverse effect; BOC, boceprevir; Cr, creatine; d/c, discontinuation; EOTR, end-of-treatment response; eRVR, extended rapid virologic response; F, fibrosis score; FCH, fibrosing cholestatic hepatitis; G-CSF, granulocyte-colony stimulating factor; LOD, limit of detection; peg-IFN, peginterferon; PI, protease inhibitors; P/R, peginterferon/ribavirin; RBV, ribavirin; SVR4, sustained virologic response at 4 weeks posttreatment; TT, triple therapy; TVR, telaprevir.
  42. Alk Phos, alkaline phosphatase; ALT, alanine transaminase; HCV, hepatitis C virus; LT, liver transplantation.
  43. CTP, Child-Turcotte-Pugh; EOT, end of treatment; GT, genotype; HCV, hepatitis C virus; LT, liver transplantation; MELD, Model for End-Stage Liver Disease; RBV, ribavirin; SOF, sofosbuvir; SVR4, sustained virologic response at 4 weeks posttreatment.
  44. FDC, fixed-dose combination; RBV, ribavirin; RTV, ritonavir.
  45. HCV, hepatitis C virus; LT, liver transplantation.