HPV vaccine for men against anal HPV infection

January 01, 0001

HPV vaccine for men against anal HPV infection

The rate of anal cancer is increasing among both women and men, particularly men who have sex with men. Caused by infection with human papillomavirus (HPV), primarily HPV type 16 or 18, anal cancer is preceded by high-grade anal intraepithelial neoplasia (grade 2 or 3). These US authors studied the safety and efficacy of quadrivalent HPV vaccine (qHPV) against anal intraepithelial neoplasia associated with HPV-6, 11, 16, or 18 infection in a substudy of a larger double-blind study. They randomly assigned 602 healthy men who have sex with men, 16 to 26 years of age, to receive either qHPV or placebo. The primary efficacy objective was prevention of anal intraepithelial neoplasia or anal cancer related to infection with HPV-6, 11, 16, or 18.

They found: "Efficacy of the qHPV vaccine against anal intraepithelial neoplasia associated with HPV-6, 11, 16, or 18 was 50.3% in the intention-to-treat population and 77.5% in the per-protocol efficacy population; the corresponding efficacies against anal intraepithelial neoplasia associated with HPV of any type were 25.7% and 54.9%, respectively. Rates of anal intraepithelial neoplasia per 100 person-years were 17.5 in the placebo group and 13.0 in the vaccine group in the intention-to-treat population and 8.9 in the placebo group and 4.0 in the vaccine group in the per-protocol efficacy population. The rate of grade 2 or 3 anal intraepithelial neoplasia related to infection with HPV-6, 11, 16, or 18 was reduced by 54.2% in the intention-to-treat population and by 74.9% in the per- protocol efficacy population. The corresponding risks of persistent anal infection with HPV-6, 11, 16, or 18 were reduced by 59.4% and 94.9%, respectively. No vaccine-related serious adverse events were reported."

The authors concluded: "Use of the qHPV vaccine reduced the rates of anal intraepithelial neoplasia, including of grade 2 or 3, among men who have sex with men. The vaccine had a favorable safety profile and may help to reduce the risk of anal cancer."

The vaccine is worth considering for this population.

For the full abstract, click here.

N Engl J Med 365:1576-1585, 27 October 2011 © 2011 to the Massachusetts Medical Society
HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia. Joel M. Palefsky, Anna R. Giuliano, Stephen Goldstone, et al. Correspondence to Dr. Palefsky: joel.palefsky@ucsf.edu

Category: Y. Male Genital System, Breast. Keywords: anal cancer, human papillomavirus, HPV, men who have sex with men, vaccine, anal intraepithelial lesion, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 15 November 2011

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.