HPV

Merck s Study Show Gardasil Effective In anal diseases In Gays Update

2/17/2010 3:22 PM  ET

(RTTNews) -  Wednesday, Merck & Co., Inc. (MRK: News ) said its phase 3 trial of Gardasil was efficacious in preventing anal diseases and anal cancer in gay men.

The drug was found to be 77.5% efficacious against anal intraepithelial neoplasia, associated with certain human papillomavirus or HPV types, in 16-to-26 year-old men who have sex with men.

Gardasil was shown to be effective against HPV types 6, 11, 16 and 18. It is estimated that HPV types 16 and 18 account for 70% of cervical and vaginal cancer cases, about 50% of vulvar cancer cases and 85% of anal cancer cases. Types 6 and 11 cause approximately 90% of all genital warts cases.

Currently, Gardasil is approved in the U.S. for prevention of cervical, vulvar and vaginal cancers in women, genital warts in young men and boys and precancerous or dysplastic lesions.

Gardasil's ability to prevent HPV 6, 11, 16 and 18 anal diseases and anal cancer in males was evaluated in a randomized, double-blind, placebo-controlled trial. A total of 598 gay men, aged 16 to 26, were enrolled. It was found that Gardasil prevented 77.5% of HPV 6, 11, 16, and 18 related anal diseases
and anal cancer.
 
During the study, 29 men were diagnosed with HPV 6, 11, 16 or 18-related anal diseases - 24 cases in the placebo group and 5 in the vaccine group. In the study, 69% of the vaccine group and 64% of the placebo group reported one or more adverse events.

In another study, enrolling 3,817 women, aged 24 to 45, to evaluate the ability of Gardasil in preventing cervical and genital disease in women, it was found that the drug was 88.7% efficacious against persistent infection and vaginal intraepithelial neoplasia, associated with HPV types 6, 11, 16 and 18. In this study, 87% of the vaccine group and 81% of the placebo group reported one or more adverse events.

Currently, Gardasil is approved in 119 countries and additional applications are under review with regulatory agencies in some countries.

MRK is currently trading at $37.30, down $0.36 or 0.96%, on a volume of 9.21 million shares on the NYSE.
by RTT Staff Writer

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