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#125 HPV Vaccine: Shot of Cancer (and Wart) Prevention


CLINICAL QUESTION
QUESTION CLINIQUE
 How effective is the Human Papillomavirus (HPV) vaccine in preventing cervical lesions or genital warts (condyloma)?

BOTTOM LINE
RÉSULTAT FINAL
 HPV vaccine is effective in preventing advanced cervical lesions (CIN≥2) in one in 60-125 women and condyloma in one in 40-50 men and women over 3-4 years. 


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EVIDENCE
DONNÉES PROBANTES
 Focusing on three largest, international, randomized, placebo-controlled trials (RCTs) in women aged 15-26 using modified intention-to-treat analysis (including patients who were HPV positive at baseline), for all HPV lesions.1-4 
  • Quadrivalent (HPV 6, 11, 16, 18) vaccine (Gardasil®):  
    • FUTURE 1:1 5,455 women followed four years. Decreased:  
      • External genital lesions (most commonly condyloma): 3.8% vs. 5.7% (placebo), number needed to vaccinate (NNV)=50. 
      • Cervical intra-epithelial lesions (CIN)≥2: 6.6% vs. 7.1% (placebo), not statistically significant. 
    • FUTURE 2:2 12,167 women followed three years. Decreased:  
      • CIN≥2: 3.6% vs. 4.4% (placebo), NNV=125. 
    • FUTURE 1/2 Combination:3 Followed four years. Decreased: 
      • External genital lesions (most commonly condyloma): 1.5% vs. 4% (placebo), NNV=40. 
      • CIN≥2 not reported. 
  • Bivalent (HPV 16, 18 vaccine) (Cervarix®):4 18,644 women followed four years. Decreased CIN≥2: 3.3% vs. 4.9% (placebo), NNV=60. 
  • Smaller studies showed similar effects.5,6 All studies:  
    • Excluded those pregnant, with previous abnormal pap results or genital warts, or with >4-6 lifetime sexual partners. 
    • Funded by vaccine manufacturers. 
Similar relative efficacy seen in males aged 16-26 (for condyloma).7  Context:  
  • Worldwide cervical cancer affects >500,000 women/year, most commonly in developing countries,8,9 while in Canada ~1500 women/year are diagnosed.10  
  • ~90% of women with cervical cancer have HPV.8,9  Women have ~50% chance of becoming HPV positive after three years of sexual activity.11 
  • Safety: serious adverse event rate similar to placebo. 1,2,4-7 
  • Future longer-term studies will delineate true impact on cervical cancer and whether booster needed.   
  • Current Canadian recommendations:12 
    • Gardasil®: Girls 9-45 years, boys 9-26 years.  
    • Cervarix®: Girls 10-25 years.

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November 10, 2014

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Author(s)
Auteur(s)
  • Adrienne J Lindblad BSP ACPR PharmD
  • Michael R Kolber BSc MD CCFP MSc

1. Garland SM, Hernandez-Avila M, Wheeler CM, et al. Quadrivalent Vaccine against Human Papillomavirus to Prevent Anogenital Diseases. N Engl J Med. 2007; 356:1928-43.

2. The FUTURE II Study Group. Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions. N Engl J Med. 2007; 356:1915-27.

3. The FUTURE I/II Study Group, Dillner J, Kjaer SK, Wheeler CM, et al. Four-year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial. BMJ. 2010; 340:c3493.

4. Lehtinen M, Paavonen J, Wheeler CM, et al. Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomized double-blind PATRICIA trial. Lancet Oncol. 2012; 13:89-99.

5. GlaxoSmithKline Vaccine HPV-007 Study Group, Romanowski B, de Borba PC, Naud PS, et al. Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet. 2009; 374:1975-85.

6. Harper DM, Franco EL, Wheeler CM, et al. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet 2006; 367:1247-55.

7. Giuliano AR, Palefsky JM, Goldstone S, et al. Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males. N Engl J Med 2011; 364:401-11.

8. Forman D, de Martelb C, Lacey CJ, et al. Global Burden of Human Papillomavirus and Related Diseases. Vaccine. 2012; 30S:F12–F23.

9. Muñoz N, Bosch FX, de Sanjosé S, et al. Epidemiologic Classification of Human Papillomavirus Types Associated with Cervical Cancer. N Engl J Med. 2003; 348:518-27.

10. Canadian Cancer Society’s Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2014. Toronto, ON: Canadian Cancer Society; 2014. Accessed September 21, 2014.

11. Winer RL, Lee S-K, Hughes JP, et al. Genital Human Papillomavirus Infection: Incidence and Risk Factors in a Cohort of Female University Students. Am J Epidemiol. 2003; 157:218-26.

12. National Advisory Committee on Immunization (NACI) Update on Human Papillomavirus (HPV) Vaccines. Canadian Communicable Disease Report 2012; 38:1:ISSN;1481-8351.

Authors do not have any conflicts to disclose.