Gardasil efficacious against HPV 16 infection

In a study of an extended follow up of 290 women na?ve to HPV type 16, the HPV 16 component of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] was efficacious against HPV 16 infection for an average of 8.5 years after administration.

The women enrolled in this study are a subset of the original Phase II HPV 16 proof-of-concept study published in 2002. Follow up ranged from 7.2 years to up to 9.5 years.

In a different study, in women ages 16 to 26 who were na?ve to 14 common HPV types, GARDASIL reduced the number of abnormal Pap test results by 17 to 45 percent, depending on the abnormality, and reduced colposcopies by 20 percent, cervical biopsies by 22 percent and reduced surgery and other invasive treatments by 42 percent.

“We are encouraged by the extended efficacy data for the HPV 16 component of GARDASIL. Studies to examine the long-term efficacy of GARDASIL are underway,” said Laura A. Koutsky, Ph.D., MSPH, University of Washington, School of Public Health. Dr. Koutsky and the University of Washington study site led this study extension. Merck & Co., Inc. is a co-author of the original data and the new analysis.

GARDASIL is currently indicated 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.

HPV types 16 and 18 are responsible for approximately 70 percent of cervical cancer cases, and HPV types 6 and 11 are responsible for approximately 90 percent of genital warts and about 10 percent of low-grade cervical changes/lesions/dyplasias.

Source: Merck & Co., Inc., USA



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