Thursday, February 18, 2010

Phase III Data Released on Gardasil and Anal Disease among MSM

via Merck Press Release

In Phase III Data Merck's GARDASIL® Was Efficacious Against Anal Disease Caused by HPV 6,11,16, and 18

Merck & Co., Inc. announced [February 17] that in new Phase III data, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] was 77.5 percent (95 percent CI: 39.6, 93.3) efficacious against anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men. The data were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference in Monte Carlo, Monaco.

“We are excited to learn more about the potential of GARDASIL to help prevent HPV and HPV-related cancers and diseases in both men and women,” said Richard M. Haupt, M.D., MPH, executive director, Merck Research Laboratories.

GARDASIL is approved in the U.S. for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. GARDASIL is also approved in the U.S. for use in boys and men ages 9 through 26 years of age for the prevention of genital warts (condylomata acuminata) caused by HPV types 6 and 11.

It is estimated that HPV types 16 and 18 account for 70 percent of cervical and vaginal cancer cases, and up to 50 percent of vulvar cancer cases and 85 percent of anal cancer cases. Types 6 and 11 cause approximately 90 percent of all genital warts cases.

The ability of GARDASIL to prevent HPV 6, 11, 16 and 18-AIN and anal cancer in males was evaluated in a randomized, double-blind, placebo-controlled trial. A total of 598 16- to 26- year old men who have sex with men received at least one dose of GARDASIL or placebo at the time of enrollment, and then again at two and six months.

This evaluation of efficacy of GARDASIL against HPV-related anal disease was conducted in a population of men having sex with men because of the known high risk of anal infection that occurs in this group.

Read the rest.

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