Mission SAY No to Cervical Cancer With HPV Vaccination DR. SHARDA JAIN Secretary General of Delhi Gynaecologist Forum Dr.Jyoti Aggarwal Dr.Jyoti Bhaskar
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Mission SAY No to Cervical Cancer With HPV Vaccination DR. SHARDA JAIN Secretary General of Delhi Gynaecologist Forum Dr.Jyoti Aggarwal Dr.Jyoti Bhaskar
1. SAY No
to Cervical Cancer
With HPV Vaccination
DR. SHARDA JAIN
Secretary General of
Delhi Gynaecologist Forum
Dr.Jyoti Aggarwal
Dr.Jyoti Bhaskar
5. India ~1,22,844
Total world ~ 5,27,624
India ~23% of new
Cervical Cancer cases in world
India ~ 67,477
Total world ~ 2,65,653
India ~23%
Rest of World - 77%
India ~25% of deaths
due to Cervical Cancer in world
Rest of World - 73%
India - 27%
2013
Cervical Cancer Disease Burden INDIA
Incidence Mortality
India ~25%
Rest of World - 75%
2. Bruni L, Barrionuevo-Rosas L, Serrano B, Brotons M, Cosano R, Muñoz J, Bosch FX, de Sanjosé S, Castellsagué X. ICO Information Centre on HPV and
Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in India. Summary Report 2014-01-31. [Accessed on 11th Feb 14]
6. An Airbus-320 full of WOMEN crashing every day in India
Deaths Due to CaCx - Just Think !
7. Incidence of Ca Cervix in
Metros in INDIA
“The cervical cancer incidence
rates in our metro cities, be it
Mumbai, Delhi or Kolkata, are
almost to the rates in the USA”
In Mumbai stood at 8 per 1,00,000
population.
Dr. Badwe
Chief Tata Memorial Hospital Bombay
8. Incidence of Ca Cervix
in TOWNS INDIA
Moderately urbanised
town ---- stands at 17
per 1,00,000 population
9. RURAL INDIA
Cervical cancer incidence
rates in India’s rural areas
have been steady at
30 per 1,00,000
population.
10. WHY THIS DIFFERENCE ?
• To difference in education,
• Screening ----availability of
medical examination & pap
smear,
• Hygiene--- running water and
bathrooms.
11. Harald zur Hausen (1936 - ) won the Noble Prize in 2008 for discovering
that a virus, human papilloma virus, causes cervical cancer.
12. HPVTHE CAUSE
HPV infection is a necessary cause of cervical cancer and is
linked to several other anogenital diseases
15/200 HPV
Cause
Cancer
13. What Genders are infected by Oncogenic
HPV
• 90% of Cancers caused by Oncogenic HPV
occur in Women only.
• 2% of Cancers caused by Oncogenic HPV
occur in Men only
• 7% case Anal & Oropharangeal cancers in
both men & women
14. At what age Genital HPV Infection
detected ?
• There is no age at which all boys
& girls are uninfected with
oncogenic HPV types
• In Adolescence point prevalence peaks at 30-
50% in young women between second & third
decade due to onset of sexual exploration
• 15% infections not associated with penetrative
sex
15. Women Remains at Risk for Acquiring
HPV Infection Throughout Their
Lifetimes
16. HPV 16
HPV 18
HPV 6
HPV 11
Cancer causing Types
High risk group-16,18,
31,33,45,52,58
Non-cancer causing types
Low risk group- 6,11.
• >75% of Cervical Cancer5,6
• >50% of Vaginal & Vulvar Cancer5
90% of Anogenital warts5
HPV is a necessary cause of cervical cancer – 99.7%4
HPV
1.Schiffman M, Castle PE. Arch Pathol Lab Med. 2003;127:930–934. 2. Wiley DJ, Douglas J, Beutner K, et al. Clin Infect Dis. 2002;35(suppl 2):S210–S224. 3. Muñoz N, Bosch FX, Castellsagué X, et al. Int J
Cancer. 2004;111:278–285. Reprinted from J Virol. 1994;68:4503–4505 with permission from the American Society for Microbiology Journals Department. 4. Walboomers JM, Jacobs MV, Manos MM, et al. J
Pathol. 1999;189:12–19. 5. X. Castellsagué, S. de Sanjose, T. Aguado, K. S. Louie, L. Bruni, J.Muñoz, M. Diaz, K. Irwin, M. Gacic, O. Beauvais, G. Albero, E. Ferrer, S. Byrne,F. X. Bosch. HPV and Cervical
Cancer in the World. 2007 Report. WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Available at: www.who.int/hpvcentre6. Bhatla N et al.Vaccine (2008;26; 2811-17
Human Papillomavirus (HPV)
Need for multivalent HPV vaccine for broader HPV protection
17. 1. Forman D et al. Vaccine 30S (2012) F12– F23; 2. Lacey CJ et al (2006). Vaccine, 24 (Suppl 3), S35–S41.
HPV Causes More Than Cervical Cancer
Genital
Warts ~100%
70%
~100%
43%
88%
Cervical
Cancer
Vaginal
Cancer
Vulvar
Cancer
Anal
Cancer
13-56%
Orophar
yngeal
Cancer
50%
Penile
Cancer
HPV
Percent of cases attributable to HPV infection 1,2
18. HPV Vaccination: The Basis of Cancer Control
World Health Organization, United Nations Population Fund. Preparing for the Introduction of HPV
Vaccines: Policy and Programme Guidance for Countries. Geneva, Switzerland: World Health
Organization; 2006.
Palliative
care
Cancer treatment
Secondary prevention:
Screening and treatment
of precancers
Primary prevention:
Vaccination
19. 3 HPV Vaccine
available in the World
Gardasil 0 2 6 (MSD)
Cevarix 0 1 6 (GSK)
Nano valent vaccine (MSD)
(3 doses in six months)
20. Rationale for Vaccination
Natural Infection – Weak AB response
Vaccination - High AB Response
Higher AB level at
cervical epithelium
prevents HPV infection
21. The need for Vaccination against Cervical Cancer
No inflammation,
no danger signals
Local immunosuppression
No viremia
Natural HPV infection induces a weak
immune response1-4
• Vaccine induces higher antibody levels in the blood which means higher
antibody levels at the site of infection8
• These Antibodies neutralize the virus & prevent entry into cells4,9
1.Stanley M. Vaccine 2006; 24: S106-13, 2.Tindle, Nat Rev Cancer 2002; 2, 59, 3.Stanley M. Vaccine 2006; 24: S16-
22, 4. Stanley M. HPV Today 2007; 11: 1-16 . 5 Parr EL et al. J Virol 1997;71(11):8109-15, 6. Nardelli-Haefliger D et al. J Natl
Cancer Inst 2003;95(15):1128-37, 7. Schiller JT et al. Nat Rev Microbiol 2004;2(4):343-7, 8. Poncelet et al. ESPID, Porto, Portugal
2007; Abstract 37, session ES2, 9. Einstein M, Cancer Immunol Immunother 2007; 57(4):443-51
22. Antibody response with Cervarix® significantly higher than with qHPV vaccine
in months 7–60 (18–26 age group)*
1. Einstein MH, et al. Hum Vaccin 2009; 5: 1–15; 2. Einstein MH, et al. Hum Vaccin 2011; 7: 1343–58; 3.Einstein M, Takacs P et al. Hum Vaccin
Immunother. 2014 ;10(12):3435-45; 4. Einstein M, Levin MJ et al. Hum Vaccin Immunother. 2014 10(12):3455-655. Pederson et al, Journal of Adolescent
Health 40 (2007) 564–571
1
10
100
1000
10000
100000
4 8 12 16 20 24 28 32 36 40 44 48 52 56 60
GMTLog10
Month
1
10
100
1000
10000
100000
4 8 12 16 20 24 28 32 36 40 44 48 52 56 60GMTLog10
Month
GMR
7.8 GMR
12.1
Data above derived from individual ATP cohorts of M7, M12, M18, M24, M36, M48 and M60; For each antigen, positivity was defined as a sample dilution ≥40
ED50 (< ED50 at baseline); PBNA, pseudovirion-based neutralisation assay
Cervarix® qHPV vaccine
HPV-16 HPV-18
Cervarix® qHPV vaccine
This study did not compare clinical outcomes and the correlation between antibody levels and clinical outcomes is unclear
Natural infection Natural infection
HPV-010
Younger age girls show better immune response
Cervarix produces 2-3 times higher antibody
titres given in 10-14 years naive girls as
compared to older girls and women5
Dr. Manoj Patki | GSK Biologicals | Cervical Cancer Prevention: choosing the right vaccine | Pedicon, 2016 | Hyderabad
24. Right vaccine for Cervical
cancer prevention ?
Higher
antibody
response
Efficacy
beyond
vaccine
HPV types
Long
Duration
of
Protection
25. Impact of HPV Vaccine in Public
Vaccination Programs:
26. Over 100 countries
qHPV=quadrivalent human papillomavirus. Please see corresponding slide note for references.
Markowitz. IPV 2012.
2006–2007 Dec ‘09 Jul ‘11Jan ‘11 Dec ‘11 May ‘12Jun ‘11 Jul ‘12 Jan ‘13Dec ‘12Oct ‘12
Introduction of
qHPV vaccine
Oliphant et al.
NZ Med J. 2011.
Bauer et al. Am J
Pub Health.
2012.
Wikström et al.
EUROGIN 2012.
Mikolajczyk et al.
Sex Transm Dis. 2013.
Baandrup et
al. Sex
Transm Dis.
2013.
Fairley et al. Sex
Transm Infect.
2009; Donovan
et al. Lancet
Infect Dis. 2011. Kliewer et al. IPV 2012.
Kjaer et al. IPV 2012.
Brotherton et al.
Lancet. 2011.
Van Tielen;
Weyers et al.
EUROGIN 2012.
Leval et al.
J Infect Dis. 2012.
Ali et al. IUSTI
2012.
Read et al. Sex
Transm Infect. 2011.
Powell et al.
Vaccine. 2012.
Tabrizi et al.
J Infect Dis.
2012.
2012
Sep ‘12 Feb ‘13
Leval et al.
J Natl Cancer
Inst. 2013.
Mar ‘13
Ali et al.
BMJ 2013
Apr ‘13
Ali et al.
BMC Infect Dis
2013.
27. HPV vaccine has been approved for
use in over 100 countries, including
UK, Australia, Israel, the
Netherlands, USA, Switzerland &
many countries in South east Asia.
Many of these countries the vaccine
are given free.
28. American Society of Clinical Oncology
Vaccine was doing
significantly well in
countries where it was
being offered free or
even at cost .
29. 1. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2009/11/news_detail_000389.jsp&mid=WC0b01ac058004d5c1 2. Centers for Disease control website. Available at:
http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm- last accessed on 16.04.10. 3. RELEVE EPIDEMIOLOGIQUE HEBDOMADAIRE, No. 15, 2009, 84, http://www.who.int/wer 4. Press release Spain MINISTERIO DE
SANIDAD Y POLÍTICA SOCIAL 23.04.2009
Post licensure: Health authorities reaffirm the
positive safety profile of Gardasil®
US CDC & other leading health organizations closely monitor the safety of GARDASIL,
as they do with other vaccines
30. The USA took decision in Feb
2016 that
“All Children Under 11 years
of age will be vaccinated
free of charge”
HPV in new in 2016
31. Time is Slipping Out ….
GOI should do something
for Prevention of Cervical
Cancer
WHO – Criticism for India
Director south East Asia
32. “It is astounding and shaming that
cervical cancer is the number one
killer in India DESPITE it’s a 100%
preventable cancer” .
Criticism for India
American Society of Clinical
Oncology
Dr. Daniel Hayes, elected president
33. Problems in Our Country
• We don’t have a Compulsory
National vaccination & screening
program.
• Vaccination is expensive
• Screening by Pap smear requires
expertise & follow up
34. Cervical Cancer Screening Practices in India
Estimated coverage of cervical cancer screening in India, by age & study
(1) WHO Household Surveys with geographical information system (GIS) multistage cluster sampling. Screening coverage among women aged 18-69.
2. Bruni L, Barrionuevo-Rosas L, Serrano B, Brotons M, Cosano R, Muñoz J, Bosch FX, de Sanjosé S, Castellsagué X. ICO Information Centre on HPV and
Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in India. Summary Report 2014-01-31. [Accessed on 11th Feb 14]
36. While the vaccine is approved for
use in India, cost has been big
issue.
Recently, the Union government
indicated that it may include it in
National immunization plan.
GOI – National Immunisation Programme
38. Summary
1. 25% of the world burden of Cervical Cancer is
seen in India.
2.Cervical Cancer is caused by Human Papilloma
Virus
3.Cervical Cancer is usually diagnosed in late
stages in India.
4. Screening is recommended in sexually
active women of >21yrs by WHO
39. Summary
5.Cervical Cancer Vaccination: Recommended
age : 9-45yrs.
6.Vaccination efficacy 98-100%
7.No screening required for unmarried girls
before vaccination
8. Vaccination safety is well documented