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Cervical CANCER Prevention : Update 2017 for Indian Gynecologists Dr. Sharda Jain

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Cervical CANCER Prevention : Update 2017 for Indian Gynecologists Dr. Sharda Jain

  1. 1. CERVICAL CANCER Prevention: Update 2017 for Indian Gynecologists 1 DR. SHARDA JAIN Dr. Jyoti Agarwal Dr. Jyoti Bhaskar
  2. 2. Over 350 ppts are available on slideshare.net ***for use of public/Doctors www.slideshare.net / Lifecarecentre
  3. 3. SAY No to Cervical Cancer
  4. 4. Breast Cancer No 1 Ca. Cervix No 2
  5. 5. CERVICAL CANCER DISEASE BURDEN IN INDIA Bruni L, Barrionuevo-Rosas L, Albero G, Aldea M, Serrano B, Valencia S, Brotons M, Mena 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 2015-12-23. [Accessed on 2016-04-20 from http://hpvcentre.net/statistics/reports/IND.pdf] 2nd Common cause of female cancer 2nd Most common female cancer in women aged 15-44 years • India has a population of 436.76 million women aged 15 years and older who are at risk of developing cervical cancer.
  6. 6. 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% India accounts for ~ 1/4th of Cervical cases and deaths worldwide 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]
  7. 7. 7 67,477 Deaths Annually Approx. 185 women die every day A women is dies every 8 minutes Approx. 8 women die every hour CERVICAL CANCER MORTALITY IN INDIA Bruni L, Barrionuevo-Rosas L, Albero G, Aldea M, Serrano B, Valencia S, Brotons M, Mena 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 2015-12-23. [Accessed on 2016-04-20 from http://hpvcentre.net/statistics/reports/IND.pdf] 2nd Cause in female cancer deaths and 2nd leading cause of cancer deaths in women aged 15-44 years
  8. 8. An Airbus-320 full of WOMEN crashing every day in India Deaths Due to Ca Cx ..more than Deaths due to Pregnancy !!
  9. 9. Harald zur Hausen (1936 - ) won the Noble Prize in 2008 for discovering that a virus, human papilloma virus, causes cervical cancer.
  10. 10. HPVTHE CAUSE HPV infection is a necessary cause of cervical cancer and is linked to several other anogenital diseases 15/200 HPV Cause Cancer
  11. 11. 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
  12. 12. 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
  13. 13. At what Age Genital HPV Infection detected ? • There is no age at which all boys & girls are uninfected with oncogenic HPV types • Half of the new cases annually are coming from Adolescents • In Adolescents prevalence peaks at 60 --80% in young women between second & third decade due to onset of sexual exploration • 15% infections not associated with penetrative sex
  14. 14. Women Remains at Risk for Acquiring HPV Infection Throughout Their Lifetimes
  15. 15. Cervical Cancer and HPV infection • Human papillomavirus (HPV) infection is now a well-established cause of cervical cancer. HPV causes virtually 100% of cervical cancer cases • There is growing evidence of HPV being a relevant factor in other anogenital cancers (anus, vulva, vagina and penis) and head and neck cancers. • HPV is also responsible for other diseases such as recurrent juvenile respiratory papillomatosis and genital warts Bruni L, Barrionuevo-Rosas L, Albero G, Aldea M, Serrano B, Valencia S, Brotons M, Mena 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 2015-12- 23. [Accessed on 2016-04-20 from http://hpvcentre.net/statistics/reports/IND.pdf]
  16. 16. CERVICAL CANCER & HPV TYPES • HPV types 16 and 18 are responsible for about 70% of all cervical cancer cases worldwide. After HPV16/18, the six most common cervical cancer causing HPV types are 31, 33, 35, 45, 52 and 58 • In India 82.7% of invasive cervical cancers are attributed to HPVs 16 or 18. • In India about 5.0% of women in the general population are estimated to harbor cervical HPV-16/18 infection at a given time • HPV types 6 and 11 are responsible for over 90% of all anogenital warts Bruni L, Barrionuevo-Rosas L, Albero G, Aldea M, Serrano B, Valencia S, Brotons M, Mena 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 2015-12-23. [Accessed on 2016-04-20 from http://hpvcentre.net/statistics/reports/IND.pdf]
  17. 17. *Ray K et al, Indian J Med Res 2006; 124: 559-56 - done in STD clinic 18.1% 5.8% 11% 10.5% 0 2 4 6 8 10 12 14 16 18 20 1990-93 1994-97 1998-01 2002-04 Study Period Percentage Genital Warts – Disease Burden: India* THERE IS AN INCREASING TREND OF GENITAL WARTS INCIDENCE IN INDIA In approximately 10 years time the incidence of GW have increased 3 times
  18. 18. Diagnosis of GW was strongly related to Anal, Vulvar, Vaginal, Cervical and Head & Neck cancer with confirmed HPV association [DENMARK study ] Standardized Incidence Ratios (SIRs) of Cancer among women (n = 33,422) diagnosed of GW in Denmark during 1978–2009 2.8 1.5 5.9 7.8 14.8 4.7 4.8 0 2 4 6 8 10 12 14 16 All HPV related cancers Cervix uteri Vagina Anus Vulva Tonsils HPV Associat ed HNC StandardizedIncidenceRatios (SIRs) CI: 2.4- 3.1 CI: 5.5- 9.2 CI: 2.2-12.9 CI: 5.4- 11.0 CI: 11.7-18.6 CI: 2.3-8.4 CI: 2.7-8.0 Blomberg, Friis, Munk et al, Genital Warts and Risk of Cancer: A Danish Study of Nearly 50 000 Patients With Genital Warts, JID, 2012
  19. 19. CERVICAL CANCER PREVENTION 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
  20. 20. Rationale for Vaccination Natural Infection – Weak AB response Vaccination - High AB Response Higher AB level at cervical epithelium prevents HPV infection
  21. 21. PREVENTION STRATEGIES SCREENING: • Well-organised cervical screening programmes or widespread good quality cytology can reduce cervical cancer incidence and mortality.1 • However, competing health care priorities, insufficient financial resources, weak health systems, and limited numbers of trained providers have made high coverage for cervical cancer screening in most low- and middle-income countries difficult to achieve. 2 Vaccination: • The introduction of HPV vaccination has considerably reduced the burden of Cervical cancer. 1. Bruni L, Barrionuevo-Rosas L, Albero G, Aldea M, Serrano B, Valencia S, Brotons M, Mena 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 2015-12-23. [Accessed on 2016-04-20 from http://hpvcentre.net/statistics/reports/IND.pdf]; 2. WHO guidance note: comprehensive cervical cancer prevention and control: a healthier future for girls and women. Accessed online on 20-4-2016 from http://apps.who.int/iris/bitstream/10665/78128/3/9789241505147_eng.pdf?ua=1
  22. 22. HEALTH IMPACT OF HPV VACCINATION AND CERVICAL CANCER SCREENING IN INDIA Impact on cancer reduction* Diaz M, Kim JJ, Albero G et al. Health and economic impact of HPV 16 and 18 vaccination and cervical cancer screening in India. British Journal of Cancer (2008) 99, 230 – 238 *Base case assumes 70% vaccination and screening coverage Vaccination only Screening only (VIA – 1x, 2x, 3x)
  23. 23. COMBINING SCREENING AND VACCINATION HAS MAXIMUM IMPACT ON CERVICAL CANCER REDUCTION Impact on cancer reduction* Diaz M, Kim JJ, Albero G et al. Health and economic impact of HPV 16 and 18 vaccination and cervical cancer screening in India. British Journal of Cancer (2008) *Base case assumes 70% vaccination and screening coverage Vaccination only Screening only (VIA – 1x, 2x, 3x) Vaccination followed by screening (VIA – 1x, 2x, 3x) Health impact of HPV vaccination followed by cervical cancer screening in India
  24. 24. CERVICAL CANCER PREVENTION in India 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 Less than 1%C 2.6%
  25. 25. Cervical Cancer Prevention starts in the Adolescence 25
  26. 26. NEXT FEW SLIDES WILL FOCUS DIFFERENT ASPECT OF HPV VACCINATION • Adolescence is a vulnerable age – ACE10/10 involve pediatricians • Why to vaccinate early • The clinical evidence • Impact of early vaccination • Safety • The recommendations
  27. 27. Adolescence is a vulnerable age IAP’s initiative for involving pediatricians
  28. 28. ADOLESCENCE IS A VULNERABLE AGE • IAP launched Adolescent Care Endeavor (ACE) to drive awareness and education on comprehensive adolescent CARE targeting Health, nutrition and vaccination.2 1. http://www.who.int/topics/adolescent_health/en/ 2. http://health.economictimes.indiatimes.com/news/policy/indian-academy-of-paediatrics-launches- ace-10/10-healthcare-initiative-for-adolescents/50923836
  29. 29. ACE10/10 (Adolescent Care Endeavor) 1. http://health.economictimes.indiatimes.com/news/policy/indian-academy-of-paediatrics-launches-ace-10/10-healthcare-initiative-for-adolescents/50923836
  30. 30. WHO Two Vaccine are only needed 0 & 6 if given Between 9- 14 years
  31. 31. Why to VACCINATE EARLY with HPV vaccine?
  32. 32. Increased Risk of HPV Infection in Young Females: Progression of the Transformation Zone Adolescent females may have increased susceptibility to HPV infection, compared with adults. During and after puberty, the transformation zone is particularly vulnerable to infection and carcinogenesis.1,2  ~99% of HPV-related genital cancers arise within the transformation zone of the cervix.1 1. Castle PE. J Low Genit Tract Dis. 2004;8:224–230. 2. 2. ACOG Committee on Adolescent Health Care. Obstet Gynecol. 2004;104:891–898. SCJ = squamocolumnar junction.
  33. 33. Exposure to HPV at a Young Age Increases the Risk of Cervical Lesions and Cancer in Women[1] 1 2 3 4 5 6 7 CIN Invasive Cervical Cancer RelativeRiskEstimatesa ≤17 18–22 aMantle-Haenszel estimates adjusted for age only. 1. La Vecchia C et al. Cancer. 1986;58:935–941. Relative risks for CIN and invasive cancer increase with decreasing age of first sexual intercourse. Age at First Intercourse (Years) (n=206) (n=327) Reference Population: First intercourse 23 years of age or never 5 times higher risk of Invasive cancers
  34. 34. Optimal Timing for Primary Prevention Is Before Exposure1s “…HPV infection is sexually transmitted and is usually acquired within the first few years following sexual debut.” “Ideally, therefore, the vaccine should be administered before sexual debut, ie, before any risk of exposure to HPV.” World Health Organization 1. World Health Organization, United Nations Population Fund. Preparing for the Introduction of HPV Vaccines: Policy and Programme Guidance for Countries. World Health Organization; 2006.
  35. 35. The clinical evidence for early vaccination
  36. 36. Comparison of the Immunogenicity and Reactogenicity of a Prophylactic QHPV Vaccine in Male and Female Adolescents and Young Adult Women The Bridging study: Stan L Block etal Background • HPV vaccine efficacy studies were not conducted in adolescents younger than 16 years due to legal and ethical issues regarding evaluations of sexual activity in this population and the relatively low rate of exposure at this age. Stan L. Block, Terry Nolan, Carlos Sattle et al Comparison of the Immunogenicity and Reactogenicity of a Prophylactic Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) L1 Virus-Like Particle Vaccine in Male and Female Adolescents and Young Adult Women PEDIATRICS Volume 118, Number 5, November 2006
  37. 37. CONCLUSION • Non-inferior immunogenic responses to all 4 human papillomavirus types in the quadrivalent vaccine in young women & girls. • The vaccine generally was well tolerated. Stan L. Block, Terry Nolan, Carlos Sattle et al Comparison of the Immunogenicity and Reactogenicity of a Prophylactic Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) L1 Virus-Like Particle Vaccine in Male and Female Adolescents and Young Adult Women PEDIATRICS Volume 118, Number 5, November 2006
  38. 38. SAFETY and Persistent Immunogenicity of a qHPV Vaccine in Preadolescents and Adolescents - Keith S. Reisinger et al OBJECTIVE: • To evaluate the tolerability and immunogenicity of quadrivalent vaccine in males and females 9 to 15 years of age through 18 month post enrollment. STUDY POPULATION: • 1781 sexually naive children were assigned (2:1) to qHPV vaccine or saline placebo administered at day 1 and months 2 and 6. Keith S. Reisinger, Stan L. Block, Eduardo Lazcano-Ponce et al Safety and Persistent Immunogenicity of a Quadrivalent Human Papillomavirus Types 6, 11, 16, 18 L1 Virus-Like Particle Vaccine in Preadolescents and Adolescents The Pediatric Infectious Disease Journal Volume 26, Number 3, March 2007
  39. 39. Results: Anti-HPV Responses at Month 7 (PP) 0 10 20 30 40 50 60 70 80 90 100 Anti HPV 6 Anti HPV 11 Anti HPV 16 Anti HPV 18 Girls Boys %ageseroconversion 99.8% 99.8% 99.8% 99.6% 99.8% 99.5% 99.8% 99.8% Keith S. Reisinger, Stan L. Block, Eduardo Lazcano-Ponce et al Safety and Persistent Immunogenicity of a Quadrivalent Human Papillomavirus Types 6, 11, 16, 18 L1 Virus-Like Particle Vaccine in Preadolescents and Adolescents The Pediatric Infectious Disease Journal Volume 26, Number 3, March 2007 At month 7, seroconversion rates were 99.5% for all the 4 vaccine-HPV-types.
  40. 40. Results: Anti-HPV Responses at Month 18 (PP) %ageseroconversion 99.8% 99.8% 99.8% 99.6% 99.8% 99.5% 99.8% 99.8% Keith S. Reisinger, Stan L. Block, Eduardo Lazcano-Ponce et al Safety and Persistent Immunogenicity of a Quadrivalent Human Papillomavirus Types 6, 11, 16, 18 L1 Virus-Like Particle Vaccine in Preadolescents and Adolescents The Pediatric Infectious Disease Journal Volume 26, Number 3, March 2007 0 10 20 30 40 50 60 70 80 90 100 Anti HPV 6 Anti HPV 11 Anti HPV 16 Anti HPV 18 Girls Boys99.3% 97.8% 99.2% 92.5% 99.3% 99.8% 97.9% 91.5% At month 18, >/=91.5% of vaccine recipients were seropositive, regardless of gender.
  41. 41. CONCLUSION • In 9- to 15-year-old adolescents, the quadrivalent vaccine was generally well tolerated and induced persistent anti- HPV serologic responses in the majority of subjects for at least 12 months following completion of a three-dose regimen. • No serious vaccine-related adverse experiences were reported. • The vaccine durability supports universal HPV vaccination programs in adolescents . Keith S. Reisinger, Stan L. Block, Eduardo Lazcano-Ponce et al Safety and Persistent Immunogenicity of a Quadrivalent Human Papillomavirus Types 6, 11, 16, 18 L1 Virus-Like Particle Vaccine in Preadolescents and Adolescents The Pediatric Infectious Disease Journal Volume 26, Number 3, March 2007
  42. 42. Two – Dose regime of 4HPV : Indian Perspective Dr. Jyoti Agarwal …..Caring hearts, healing hands
  43. 43. Long-term Study (8 yr follow-up of Reisinger etal) of qHPV Vaccine in preadolescents and adolescents Daron Ferris et al Daron Ferris, Rudiwilai Samakoses, Stan L. Block et al Long-term Study of a Quadrivalent Human Papillomavirus Vaccine PEDIATRICS Volume 134, Number 3, September 2014
  44. 44. STUDY GROUPS • The cohort who received HPV4 vaccine at months 0, 2, and 6 in the base study are referred to as the Early Vaccination Group (EVG) (n=1179) • The cohort who received placebo in the base study and who later received a 3-dose regimen of HPV4 vaccine starting at month 30 are referred to as the Catch-up Vaccination Group (CVG) (n=482) Daron Ferris, Rudiwilai Samakoses, Stan L. Block et al Long-term Study of a Quadrivalent Human Papillomavirus Vaccine PEDIATRICS Volume 134, Number 3, September 2014
  45. 45. RESULTS – EFFECTIVENESS* Early vaccination Group (EVG) Female (n=256) - • No cases of HPV6/11/16- or 18-related disease were observed • No observed cases of HPV6/11/16 or 18 related persistent infection of >/=12 months duration 100% effectiveness at 8 years in EVG Catch-up Vaccination group (CVG) female (n=126) - • 2 cases of HPV16-related persistent infection and 4 cases of HPV 18-related persistent infection were detected. • There was also 1 case of CIN1 related to HPV18. Daron Ferris, Rudiwilai Samakoses, Stan L. Block et al Long-term Study of a Quadrivalent Human Papillomavirus Vaccine PEDIATRICS Volume 134, Number September 2014
  46. 46. LONG-TERM EFFECTIVENESS OF GARDASIL™ IN THE NORDIC COUNTRIES • Effectiveness and safety analyses occur ~2 years following completion of FUTURE II and every ~2 years thereafter for 10 yrs • Immunogenicity analyses occur after the year 5 Kjaer SK, An evaluation of the long-term effectiveness, immunogenicity and safety of the quadrivalent vaccine in previously vaccinated women, Presented at Eurogin 2015
  47. 47. 0 0 20 40 60 80 100 Zero number of cases Vaccine Effectiveness (N=1,984) HPV 16/18-Related CIN 2 or Worse Per Protocol Efficacy Population (N=1984) Longest follow up: 10 years Effectiveness Against HPV 16/18-Related CIN 2 or Worse VE:100 %VaccineEffectiveness*(VE) Percentage LONG-TERM EFFECTIVENESS OF GARDASIL™ IN THE NORDIC COUNTRIES. Kjaer et al. Poster presented at EUROGIN 2015.
  48. 48. Long term effectiveness of Gardasil in NORDIC COUNTRIES: Summary • This is the longest follow-up (10 years) effectiveness data available with Gardasil so far. • In HPV16 & 18 naïve women aged 15-26 years old, Gardasil has shown 100% effectiveness in preventing HPV 16/18-Related CIN 2 or Worse, when followed up for 10 years LONG-TERM EFFECTIVENESS OF GARDASIL™ IN THE NORDIC COUNTRIES. Kjaer et al. Poster presented at EUROGIN 2015.
  49. 49. SUMMARY so far on ADOLESCENTS • Adolescent females are at higher risk of HPV infection • Organization like WHO , FOGSI & IAP recommend early HPV vaccination • In adolescents qHPV vaccine is well tolerated • The 8 year follow up data showed that qHPV vaccine is safe and effective in adolescents • 10 year follow-up after qHPV vaccination showed 100% effectiveness against HPV 16/18 related CIN2 in HPV 16 & 18 naïve women aged 15-26 years old
  50. 50. Is it worth vaccinating sexually active women
  51. 51. Estimated Benefit of Vaccination With GARDASIL in Sexually Active Women 99.9% of women will benefit2 99.6% of women will benefit2 ► Women who have been exposed to at least 1 but not all vaccine- targeted HPV types will derive some benefit from vaccination.1 1. Wright TC Jr et al. Gynecol Oncol. 2008;109(2 suppl):S40-S47. 2. Data on file, MSD. Infected with all 4 types Infected with 3 types Infected with 2 types Infected with 1 typeWomen unexposed to any vaccine-targeted type
  52. 52. aEfficacy after 3 doses in women 24–45 years of age naïve to the relevant type at baseline. Per-Protocol Efficacy Populationa – Primary Endpoint Related Cases 5510 86 56 30 0 20 40 60 80 24- to 45-Year-Olds 24- to 34-Year-Olds 35- to 45-Year-Olds n=1910 n=1907 88.7% Reduction (78, 95) 91.3% Reduction (78.4, 97.3) 83.8% Reduction (57.9, 95.1) GARDASIL® PlaceboTotal Mean Follow-Up: 3.8 Years GARDASIL®: Adult Women Efficacy Study Combined Incidence of HPV 6/11/16/18-Related Persistent Infection or Cervical/Vulvar/Vaginal Disease in Women 24–45 Years of Age1 1. Castellsagué X et al. Br J Cancer. 2011.
  53. 53. GARDASIL®: FUTURE III: Adult Women Study (LTFU) Combined Incidence of HPV 6/11/16/18-Related CIN2 or worse in Women 24–45 Years of Agea a Effectiveness in the early vaccination group after 3 doses in women 24–45 years of age naïve to the relevant type at baseline in an extension study of FUTURE III trial in Columbia. Per-Protocol Efficacy Population a – Primary Endpoint Related Cases 1511 29 21 7 0 30 CIN & EGL or worse CIN or worse CIN 2 or worse GARDASIL® Expected cases Total Mean Follow-Up: 6.3 Years 1 20 10 una J, et al. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil™ in adult women PLoS One. 2013 Dec 31;8(12):e83431 High efficacy seen in adult women
  54. 54. Opportunity of HPV vaccination During Postpartum Period
  55. 55. The impact of vaccination with various National Immunization Programs
  56. 56. Impact of qHPV Vaccine in Public Vaccination Programs: Select Reportsa *Study links effectiveness data to vaccination status. aIncludes reports published in the peer-reviewed scientific literature and does not encompass reports at scientific conferences. Please see corresponding slide notes for references. Genital Warts Cervical Abnormalities HPV Prevalence New Zealand Denmark Sweden United States Germany Australia Canada Introduction of qHPV vaccine1–4 Fairley Sex Trans Infect5 Ali BMC Infect Dis13 Ali BMJ14 Baandrup Sex Transm Dis4 Baldur-Felskov Cancer Causes Control23 Baldur-Felskov JNCI24 Bauer Am J Public Health10 2006 2007 2008 2009 2010 2011 2012 2013 2014 Blomberg CID11 Brotherton Lancet18 Chow BMJ16 Crowe BMJ21 Deleré BMC Infect Dis28 Donovan Lancet Infect Dis7 Flagg Am J Public Health15 Gertig BMC Med20 Harrison PLOS One17 Leval J Infect Dis9 Leval JNCI3 Mahmud J Clin Oncol22 Markowitz JID26 Mikolajczyk Sex Transm Dis12 Oliphant NZMJ8 Powell Vaccine19 Read Sex Trans Infect6 Tabrizi JID25 Tabrizi Lancet Infect Dis27 * * * * * * * * * * *
  57. 57. Why Genital Wart data is Important? A reduction in the incidence of GWs is one of the first markers of the effectiveness of HPV vaccination at a population level, as they develop over a few months, whereas precancerous lesions and cancer usually develop over several years. 1 1. Blomberg et al: Clinical Infectious Diseases 2013;57(7):929–34
  58. 58. Five Years Into qHPV Vaccination Program, Significant Declines in Rates of Genital Warts in AUTRALIAN FEMALES<30 Years of Age1 aAnalyses included a total of 34,900 females. Figure reproduced from BMJ, Ali H et al, 346, f2032, 2013, with permission from BMJ Publishing Group Ltd. 1. Ali H et al. BMJ. 2013;346:f2032. Year 20 18 16 12 10 8 6 4 2 0 14 2004 2005 2006 2007 2008 2009 2010 2011 Prevaccine period Vaccination period Ptrend <0.001 Ptrend <0.001 Patients(%) –72.6% –92.6% qHPV vaccine introduced <21 years (n=9,405)a 21–30 years (n=15,228) >30 years (n=10,246) • Significant decline in proportion of females diagnosed with genital warts at first visit seen during qHPV vaccination period, especially in those <21 years of age. Proportion of Australian-Born Women Diagnosed as Having Genital Warts at First Visit, by Age Group, 2004 to 2011
  59. 59. 1. Oliphant J et al. N Z Med J. 2011;124:51–58. New Zealand: Impact of qHPV Vaccine on Genital Warts1 63% reduction %First-visitclients withgenitalwarts 2010a
  60. 60. 0 10 20 30 40 50 60 70 80 90 100 10–13 14–16 17–19 20–22 23–26 ≥27 Vaccine Effectiveness Against Genital Warts Was Greatest in Females Vaccinated at a Younger Age qHPV Vaccine Effectiveness: A Swedish National Cohort Study1 aEstimated effectiveness for women 27 years of age and older was <0 (95%CI: <0–13). Estimated Effectiveness of qHPV Vaccination on Incidence Rates of Genital Warts, by Age Group Age (years) Estimatedeffectiveness(%) • Maximum reduction in incidence decreased with increasing age. • No reduction in incidence was seen for those ≥27 years of age. a Amy Leval, Eva Herweijer, Alexander Ploner et al Quadrivalent Human Papillomavirus Vaccine Effectiveness: A Swedish National Cohort Study J Natl Cancer Vaccine effectiveness was highest in girls vaccinated before age 14 years (effectiveness = 93%, 95% CI = 73% to 98%)
  61. 61. 0 2 4 6 8 10 12 14 16 18 20 Female 14-19 yrs 20-24 yrs Prevaccine era (2003– 2006) Vaccine era (2009–2012) Prevalence of HPV After Introduction of the Vaccination Program in the United States 4vHPVtypeprevalencepercentage 11.5% 12.1% 18.5% 4.3% 34% 64% LE Markowitz etal - PEDIATRICS Volume 1 37, number 3 , March 2016: e2 0151968
  62. 62. Diagnosis qHPV Vaccination Reduced the Number of Precancerous Cervical Lesions Among Women in the USA aIncludes cases with known vaccination and trigger Pap dates. AIS=adenocarcinoma in situ; CIN=cervical intraepithelial neoplasia. 1. Powell SE et al. Vaccine. 2012;31:109–113. n=5 0 10 20 30 40 50 60 70 80 90 100 Overall CIN2 CIN2/3 CIN3 AIS/AIS+CIN Patients(%) ≥1 Dose before trigger Pap ≥1 Dose on/after trigger Pap Not vaccinated HPV Vaccination Status and Timing, by Diagnosis n=1,900a n=1,096a n=251a n=526a n=27a n=441 n=380 n=1,079 n=273 n=230 n=593 n=56 n=40 n=155 n=107 n=105 n=314 n=5 n=17 • Fewer diagnoses of CIN2+ seen in vaccinated (with ≥1dose) than in unvaccinated women. n=5
  63. 63. CANADA: Early Benefits of qHPV Vaccination on Cervical Dysplasia 1 • Vaccine exposure was ascertained in grades 8 to 9 and outcomes in grades 10 to 12. • Minimum Follow up time for Cervical Dysplasia: 2 Years post- Vaccination • Baseline Cervical Dysplasia: 9.4 per 1000 female • Outcome: Reduction in Cervical Dysplasia 5.7 per 1000 female 1. Smith et al: PEDIATRICS Volume 135, number 5, May 2015 0 1 2 3 4 5 6 7 8 9 10 BaseLine Vaccinated CervicalDysplasia:per1000female Reduction 5.7 per 1000 female Significant reduction in Cervical Dysplasia in Post - QHPV vaccination 1
  64. 64. SAFETY OF HPV VACCINE
  65. 65. 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 Health authorities reaffirm the positive safety Both Vaccine available in INDIA US CDC & other leading health organizations closely monitor the safety of GARDASIL, as they do with other vaccines
  66. 66. Evaluation of Safety QHPV vaccine: From clinical studies to surveillance in real-life populations Studied during a decade in large clinical studies, including >35,000 women from 33 countries 111 million doses worldwide1 Collect and evaluate reports of events occurring after vaccination Ongoing short-term and long-term studies including over 51,000 subjects, in coordination with regulatory and health authorities Clinical studies PharmacovigilanceSurveillance Evaluation by experts and authorities Regular update of and evaluation by authorities Regular update of and evaluation by authorities Published Reassuring safety statements by the authorities in Europe and the U.S. Licensed in 127 countries
  67. 67. Global Vaccine Safety Human papillomavirus vaccines safety (HPV) Extract from report of GACVS meeting of 11-12 December 2013, published in the WHO Weekly Epidemiological Record on 14 February 2014
  68. 68. THE Indian RECOMMENDATIONS on HPV vaccinations
  69. 69. IN INDIA, BOTH IAP AND FOGSI RECOMMEND THE HPV VACCINE AND SCREENING ► Both are equally efficacious against cervical cancer and precancerous lesions. The quadrivalent vaccine additionally protects against anogenital warts ► The recommended age for initiation of vaccination is 11-12 years. Catch up vaccination is permitted up to the age of 45 years ► Experience with the HPV vaccines used in the post-licensure observational study confirms the good safety profile reported in clinical trials Indian Academy of Pediatrics (IAP) 1,2 Efficacy Cohort Safety 1. Yewale V, Choudhury P, Thacker N. IAP Immunization Committee - IAP Guidebook on Immunization 2009-2011; 2. VIPIN M VASHISHTHA, AJAY KALRA, ANURADHA BOSE, PANNA CHOUDHURY, VIJAY N YEWALE, CP BANSAL, SAILESH G GUPTA Indian Academy of Pediatrics, Advisory Committee on Vaccines and Immunization Practices (ACVIP) , 2013; 3. Purandare CN and Saraiya UB. Recommendations for vaccination against Human Papilloma Virus (HPV) infection for the prevention of cervical cancer. FOGSI ICOG Good Clinical Practice Recommendations ► Both protect against HPV genotypes 16 and 18. The quadrivalent vaccine also protects against types 6 and 11 that are responsible for about 90% of genital warts ► Routine HPV vaccination is recommended for females aged 10 to 12 years. HPV vaccination may be offered to all upto 45 years, but offers less benefit if already sexually active Federation of Obstetric & Gynecology Societies of India (FOGSI)3 Efficacy Cohort
  70. 70. WHO SAGE recommendations for 9 to 14 years • SAGE recommends that the immunological evidence is sufficient to conclude that a • 2-dose prime-boost schedule (given with a minimal interval of 6 months) was non-inferior to a • 3-dose (prime-prime-boost, at 0, 1–2, and 6 months) schedule for adolescent/pre-adolescent girls aged 9-14 years
  71. 71. IAP Recommendations • Only 2 doses of either of the 2 HPV vaccines for adolescent/pre-adolescent girls aged 9-14 years. • For girls 15 years and older and immunocompromised individuals 3 doses are recommended • For 2 –dose schedule, the minimum interval between doses should be 6 months • For 3 dose schedule, the doses can be administered at 0, 1-2 (depending on brands) and 6 months. VASHISHTHA et al, Indian Academy of Pediatrics (IAP) Recommended Immunization Schedule for Children Aged 0 through 18 years – India, 2014 and Updates on Immunization VOLUME 51__OCTOBER 15, 2014
  72. 72. Adolescent vaccination: Summary • Adolescent females may have increased susceptibility to HPV infection, compared with adults • Exposure to HPV at a Young Age Increases the Risk of Cervical Lesions and Cancer • Studies have shown that early qHPV vaccination is effective and safe • Population based/national HPV immunization programs have shown significant reduction in the HPV infection and disease burden • Organization like WHO, FOGSI, IAP recommend early HPV vaccination
  73. 73. QUADRIVALENT BIVALENT HPV Types Indicated age and gender Female 9-45 years old Female 10-45 years old Indicated for preventing… Cervical cancer, Vulvar cancer, Vaginal cancer, Genital warts Cervical cancer Important Differences 1. Villa LL, Costa RLR, Petta CA, et al. Lancet Oncol. 2005;6:671–678. 2. Harper DM, Franco EL, Wheeler C, et al. Lancet. 2004;364:1757–1765. 2. PI of gardasil and Cervarix 6 11 16 18 16 18
  74. 74. Genital Warts2 Vulvar/ Vaginal Precancers (Grade 1- 3)2 Cervical Cancer & Precancers (Grade 2/ 3)1 99% 98% 100% HPV induced lesions Protection 1. The Future II Study Group. Lancet 2007; 369: 1861–68 2.Garland SM et al. New Engl J Med. 2007;356:1928–1943. Efficacy of Quadrivalent/ Bivalant HPV Vaccine: BIVALANT cervarix √ X √
  75. 75. Outcomes of phase III randomized controlled trials to date: per- protocol efficacy populations Quadrivalent HPV Vaccine Bivalent HPV Vaccine Trial FUTURE - Females United to Unilaterally Reduce Endo/Ectocervical Disease (N ~ 20,000, FUTURE I & II &Protocol 007) PATRICIA (PApilloma TRIal against Cancer In young Adults) (N=18,644) Efficacy HPV-16/18 CIN2/3 98%a (94-100) 93%a (79.9 – 98.3) - HPV-16/18 VIN3/VaIN3 100% (83–100) Not reported - HPV6-11/16/18 VIN1/VAIN1 100% (86–100) Not reported EGL 99% (97–100) Not reported Tolerability Well tolerated Well tolerated Therapeutic efficacy None None Efficacy in Adult women (> 26 years ) Proven with FUTURE 3 Trials with ~ 90% efficacy (N= 3819) Immunogenicity study done Lactation May be given in lactating women (SAFE) Data insufficient Margaret Stanley, Potential mechanisms for HPV vaccine-induced long-term protection, Gynecologic Oncology 118 (2010) S2–S7
  76. 76. Honored LIFE TIME ACHIEVEMENT AWARD for Prevention of Cx. Cancer on 8th march 2016
  77. 77. ADDRESS 11 Gagan Vihar, Near Karkari Morh Flyover, Delhi - 51 CONTACT US 9650588339 9599044257 011-22414049 WEBSITE : www.lifecareivf.in www.lifecarecentre.in www.lifecareabs.in ISO 14001:2004 (EMS) …..Caring hearts, healing hands ISO 9001:2008 Helpline : 9599044257 Web.www.lifecareivf.in Helpline : 9910081484 27 Year In your service

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