PPT Rizzardini "HAART, sostenibilità di un miracolo"
1.
HAART
sostenibilità
di
un
miracolo
Milano,
22
marzo
2013
Giuliano Rizzardini
Dipartimento Malattie Infettive Ospedale Luigi Sacco, Milano
School of Clinical Medicine, Faculty of Health Science,
University of the Witwatersrand, Johannesburg
6. Per-person survival gains with treatment in patients with
AIDS compared with gains associated with interventions for
other common diseases in the United States
Walensky
RP,
et
al.
J
Infect
Dis,
2006
14. CRISI DEL WELFARE STATE
IL SISTEMA SANITARIO E’
DIFFICILMENTE SOSTENIBILE
15. AL 2030
G-7 Eu (ITA, FRA, GER, UK) : +3 p.p. sul Pil
Canada: oltre +3 p.p. di Pil
Giappone: +3 p.p.
Usa: poco meno di +4,5 p.p.
AL 2050
G-7 Eu: circa +9 p.p. sul Pil
Usa: poco meno +13 p.p.
Proiezioni FMI costo sistemi sanitari
16. Spesa
pro
capite
in
$
PPP
$0,00
$1.000,00
$2.000,00
$3.000,00
$4.000,00
$5.000,00
$6.000,00
$7.000,00
$8.000,00
$9.000,00
$10.000,00
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
Australia
Brasile
Russia
India
Cina
Sudafrica
Canada
Giappone
USA
Italia
Francia
Germania
Spagna
Regno
Unito
Norvegia
Svezia
Svizzera
Fonte: WHO, National Health Accounts, 2013, rielaborazione CREMS
BRICS
USA
18. Anno
Debito
Pubblico
(milioni
di
€)
PIL
(milioni
di
€)
2007 1.602.115 1.546.177
2008 1.666.603 1.567.761
2009 1.763.864 1.519.702
2010 1.843.015 1.548.816
Fonte:
Ministero
dell'economia
e
delle
finanze
PIL/debito
pubblico
italiano
29. Il
contesto
lombardo
(punto
di
vista
RL)
0.00
2,000.00
4,000.00
6,000.00
8,000.00
10,000.00
12,000.00
2004 2005 2006 2007
Total cost and percentage impact per year
Euros
HAART Outpatient visits Admission Other drugs
30. Il
contesto
lombardo
(punto
di
vista
RL)
The cost of HIV disease in Northern Italy 2007-2009
Year
Euros
P<0.0001
P=0.0002
31. Andamento
spesa
annua
pazienP
HIV+
e
totale
pazienP
traRaP
HIV+
dal
2004
al
2012
2004
2005
2006
2007
2008
2009
2010
2011
2012
N°
pz.
HIV+
tragab
17.955
18.544
19.849
20.917
21.721
22.653
23.803
24.920
26.222
Spesa
pro
capite
pz.
HIV+
tragab
[€]
5.135
5.747
5.960
6.682
7.113
7.484,16
(1)
7.351,74
(2)
7.886,32
(1)
7.749,60
(2)
7.782,16
(1)
7.556,80
(2)
7.681,45
(1)
7.839,84
(2)
Spesa
totale
p z .
H I V +
tragab
[€]
92.200.976
106.566.894
118.295.815
139.758.191
154.503.861
169.538.677
187.718.193
193.931.438
201.423.090
Incremento
della
spesa
totale
-‐
15,58%
11,01%
18,14%
10,55%
9,73%
10,72%
3,31%
3,86%
(1)
Dato
medio,
(2)
Dato
mediano.
.
32. Costo
tragamento
farmacologico
per
HIV
in
Lombardia
(file
F)
200
milioni
di
euro,
per
il
s e r v i z i o
s a n i t a r i o
e q u i v a l e n t e
a l
finanziamento
dell’Azienda
Ospedaliera
della
Provincia
di
Lodi
1.
Presidio
di
Casalpusterlengo
2.
Presidio
di
Codogno
3.
Presidio
di
Lodi
4.
Presidio
di
Sant'Angelo
Lodigiano
33. HIV-COI (Cost of Illness)
• Il costo complessivo della malattia (trattamento File F, ricoveri,
farmaceutica territoriale, specialistica ambulatoriale, prevenzione e
test) dal punto di vista della Regione Lombardia (senza il costo delle
giornate di lavoro perse o l’indennità per inabilità/reddito di
sostegno) si aggira (stima CREMS) su quasi 300 milioni di € pari
all’1,7% delle intere risorse a disposizione dal SSR.
• Di questi, circa due terzi sono determinati da farmaci
antiretrovirali.
36. Annual
UK
HIV
treatment
and
care
costs
could
reach
£750
million
by
2013
37. ClinicoEconomics and Outcomes Research
New strategies for lowering the costs
of antiretroviral treatment and care for
people with HIV/AIDS in the United Kingdom
Brian Gazzard1
Christiane Moecklinghoff2
Andrew Hill3
1
St Stephens Centre, Chelsea and
Westminster Hospital, London,
UK; 2
Janssen, Neuss, Germany;
3
Department of Pharmacology
and Therapeutics, University
of Liverpool, UK
Abstract: In the UK, the annual cost of treatment and care for people with human
immunodeficiency virus (HIV)/acquired immune deficiency virus (AIDS) rose by over 600%
from £104 million in 1997 to £762 million in 2010; approximately two-thirds of the £762 million
cost of treatment and care in 2010 was for the procurement of antiretrovirals and other related
drugs.The number of people accessing care for HIV/AIDS rose from 22,000 in 2000 to 65,000 in
2009.Adoption of “test and treat” guidelines for treating all HIV-infected people with antiretro-
virals would further increase the burden of costs. Given the current economic situation, there is
now a new focus on strategies for treatment and care of people with HIV-1 infection which can
maintain efficacy but at a lower cost. In this review, we propose three strategies which could
potentially lower the costs of treatment and care, ie, stopping testing CD4 counts for patients with
full HIV RNA suppression on antiretroviral treatment and recent CD4 counts above 350 cells/ L;
more widespread use of generic antiretrovirals as replacements for patients currently taking
patented versions; and use of darunavir-ritonavir monotherapy as a switch option for patients
with full HIV RNA suppression on other antiretrovirals and no history of virological failure.
However, it is important that high standards of clinical care are maintained despite cost-saving
measures.Antiretrovirals with generic alternatives may have toxicity issues, eg, zidovudine and
nevirapine. There could be ethical issues in starting patients on these drugs if they are currently
tolerating other treatments. The use of darunavir-ritonavir monotherapy is not consistently
recommended in international HIV treatment guidelines.
Keywords: health economics, generics, darunavir-ritonavir monotherapy, nucleoside analogs,
non-nucleoside reverse transcriptase inhibitors
Dovepress
R E V I E W
open access to scientific and medical research
Open Access Full Text Article
40. London consortium
Efavirenz
Preferred
first
line
treatment
in
all
naïve
paPents
unless:
§ Pabent
has
baseline
resistance
§ Pabent
wants
to
become
pregnant
§ Concern
over
CNS
side
effects
(previous
history
or
current
psychological
state)
If
switching
due
to
toxicity
recommend:
§ Boosted
atazanavir
§ Nevirapine
(within
CD4
criteria)
Kivexa
Preferred
first
line
treatment
in
all
naïve
paPents
unless:
§ HLA
B-‐5701
posibve
§ Baseline
HIV
viral
load
>
100,000
copies/mL
§ Cardiovascular
(CVD)
risk
over
10
years
>10%
(before
adjustment
for
DAD
abacavir
risk)
§ Hepabbs
B:
HBsAg
+ve
or
HBV
DNA
+ve
§ Hepabbs
C:
Expecbng
to
start
HCV
treatment
Recommendabons
by
the
London
HIV
Consorbum
for
prescribing
anbretrovirals,
April
2011
41. Antiretroviral Treatment of Adult HIV Infection
2012 Recommendations of the International
Antiviral Society–USA Panel
Melanie A. Thompson, MD
Judith A. Aberg, MD
Jennifer F. Hoy, MBBS, FRACP
Amalio Telenti, MD, PhD
Constance Benson, MD
Pedro Cahn, MD, PhD
Joseph J. Eron Jr, MD
Huldrych F. Gu¨nthard, MD
Scott M. Hammer, MD
Peter Reiss, MD, PhD
Douglas D. Richman, MD
Giuliano Rizzardini, MD
David L. Thomas, MD
Donna M. Jacobsen, BS
Paul A. Volberding, MD
S
INCE THE FIRST ANTIRETROVIRAL
drug was approved 25 years ago,
improvements in the potency,
tolerability, simplicity, and avail-
ability of antiretroviral therapy (ART)
have resulted in dramatically reduced
numbers of opportunistic diseases and
deaths where ART is accessible.1
New
data show that viral suppression due to
ART results in decreased human immu-
nodeficiencyvirus(HIV)transmissionon
individual2
and population levels1
and
that, when used consistently by HIV-
sions of the “beginning of the end of
AIDS.”6
This revision of the Interna-
tionalAntiviral(formerlyAIDS)Society–
USA (IAS-USA) guidelines reflects new
data informing consideration of when to
initiate ART, new options for initial and
Context New trial data and drug regimens that have become available in the last 2
years warrant an update to guidelines for antiretroviral therapy (ART) in human immu-
nodeficiency virus (HIV)–infected adults in resource-rich settings.
Objective To provide current recommendations for the treatment of adult HIV in-
fection with ART and use of laboratory-monitoring tools. Guidelines include when to
start therapy and with what drugs, monitoring for response and toxic effects, special
considerations in therapy, and managing antiretroviral failure.
Data Sources, Study Selection, and Data Extraction Data that had been pub-
lished or presented in abstract form at scientific conferences in the past 2 years were sys-
tematically searched and reviewed by an International Antiviral Society–USA panel. The
panel reviewed available evidence and formed recommendations by full panel consensus.
Data Synthesis Treatment is recommended for all adults with HIV infection; the strength
of the recommendation and the quality of the evidence increase with decreasing CD4
cell count and the presence of certain concurrent conditions. Recommended initial regi-
mens include 2 nucleoside reverse transcriptase inhibitors (tenofovir/emtricitabine or aba-
cavir/lamivudine)plusanonnucleosidereversetranscriptaseinhibitor(efavirenz),aritonavir-
boosted protease inhibitor (atazanavir or darunavir), or an integrase strand transfer inhibitor
(raltegravir). Alternatives in each class are recommended for patients with or at risk of
certain concurrent conditions. CD4 cell count and HIV-1 RNA level should be monitored,
as should engagement in care, ART adherence, HIV drug resistance, and quality-of-care
indicators. Reasons for regimen switching include virologic, immunologic, or clinical fail-
ure and drug toxicity or intolerance. Confirmed treatment failure should be addressed
promptly and multiple factors considered.
Conclusion New recommendations for HIV patient care include offering ART to all
patients regardless of CD4 cell count, changes in therapeutic options, and modifica-
tions in the timing and choice of ART in the setting of opportunistic illnesses such as
cryptococcal disease and tuberculosis.
JAMA. 2012;308(4):387-402 www.jama.com
d persons.
eginterferon alfa
n routinely used
nfected persons.
ed with didano-
ng toxicity with
clear whether
ribavirin is less
th abacavir than
itionoftheHCV
previr to pegin-
virin improves
for genotype 1
drug interaction profile.106
Recomm
dations for initial regimen in the ab
specific circumstances are sum
rized in BOX 2.
MONITORING
Suppression of plasma HIV-1 RN
less than 50 copies/mL by 24 w
should occur with effective therapy
gardless of prior treatment exp
ence. No recent work has defined
optimal frequency of monitoring i
source-rich economies, despite the
g monitor-
s (telapre-
used with
actions are
known to
sed or de-
he drugs.
or drug in-
s is impor-
s been fo-
surements,
e entry into
nitoring of
e ART ad-
ationshave
virologicfailuretoconfirmsuppression
of viremia below 50 copies/mL (AIa).
CD4 cell count should be moni-
toredatleastevery3monthsafterini-
tiation of therapy, especially among
patients with less than 200/µL, to de-
termine the need for primary oppor-
tunistic infection prophylaxis (BIII).
Onceviralloadissuppressedfor1year
andCD4cellcountisstableat350/µL
or greater, HIV-1 RNA and CD4 cell
countcanbemonitoredatintervalsof
up to 6 months in patients with de-
pendable adherence (CIII).
Detectable HIV-1 RNA (Ͼ50 copies/
mL) during therapy should be con-
firmedinasubsequentsamplebetween
e end of
Interna-
Society–
USA (IAS-USA) guidelines reflects new
data informing consideration of when to
initiate ART, new options for initial and
www.jama.com
rtium of At-
w York Uni-
d Columbia
urgeons (Dr
red Hospital
lia (Dr Hoy);
ne, Switzer-
a San Diego
an) and Vet-
System (Dr
Fernandez/
ol and Fun-
a (Dr Cahn);
University of North Carolina at Chapel Hill (Dr Eron);
University Hospital Zurich, Zurich, Switzerland (Dr Gu¨n-
thard); Academic Medical Center University of Am-
sterdam, Amsterdam, the Netherlands (Dr Reiss); Os-
pedale Luigi Sacco-Milano, Milan, Italy (Dr Rizzardini);
The Johns Hopkins University School of Medicine, Bal-
timore, Maryland (Dr Thomas); International Antivi-
ral Society–USA (Ms Jacobsen) and University of Cali-
fornia San Francisco (Dr Volberding), San Francisco.
Corresponding Author: Melanie A. Thompson, MD,
AIDS Research Consortium of Atlanta, 131 Ponce de
Leon Ave NE, Ste 130, Atlanta, GA 30308 (drmt
@mindspring.com).
JAMA, July 25, 2012—Vol 308, No. 4 387
