February 17, 2010
In Phase III Data Merck’s GARDASIL(R) Was Efficacious Against Anal Disease Caused by HPV-6,11,16 and 18
Investigational Data Also Presented on Efficacy Against HPV 6,11,16 and 18 – Related Persistent Infection, CIN and EGL in Women Aged 24 Through 45 Naïve to the Relevant HPV Type
WHITEHOUSE STATION, N.J.–(HSMN NewsFeed)–Merck & Co., Inc. announced today 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.
Data on efficacy against intra anal disease
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.
….In this new end-of-study per protocol efficacy analysis of women naïve to the respective vaccine types when they entered the study, GARDASIL was 88.7 percent (95 percent CI: 78.1.; 94.8) efficacious against persistent infection, CIN or EGL (including vulvar intraepithelial neoplasia [VIN], vaginal intraepithelial neoplasia [VaIN] and condyloma) associated with HPV types 6, 11, 16 and 18.
In this study, 87 percent of the vaccine group and 81 percent of the placebo group reported one or more AEs. These were predominantly injection-site AEs (77 percent of the vaccine group and 64 percent of the placebo group). Serious adverse events were reported rarely and occurred comparably in the vaccine (0.7 percent) and placebo (0.8 percent) groups, and none were deemed to be vaccine-related by the study investigators.
Comment from Leslie
Healthcare Sales and Marketing – that says it all in a nutshell. All of the BS above is just what they say it is. All Merck needs to do is hire a slick PR person who knows how to put a spin on the numbers.
It is time for an independent study. Merck has lost too much credibility to most of the population.