GSK's Experimental HPV Vaccine Cervarix 100% Effective In Preventing Precancerous Lesions, Study Says

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 02 Jul 2007 - 6:00 PDT

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GlaxoSmithKline's experimental human papillomavirus vaccine Cervarix has shown as much as 100% effective in preventing advanced precancerous lesions caused by HPV strains 16 and 18, according to preliminary data of a phase III published in the online edition of the journal Lancet, the Wall Street Journal reports (Wall Street Journal, 6/28).

Cervarix and Merck's HPV vaccine Gardasil have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. Researchers in a 2006 study published in the online edition of the Lancet also found that Cervarix prevented infection with HPV strains 31 and 45, which together with strains 16 and 18 cause more than 80% of cervical cancer cases (Kaiser Daily Women's Health Policy Report, 6/7).

For the study, Jorma Paavonen of Helsinki University Central Hospital in Finland and colleagues examined 18,644 women ages 15 to 25 in the U.S., Latin America, Europe and Asia to determine the efficacy of the vaccine (Ricks, Long Island Newsday, 6/28).

The study found that Cervarix was 90.4% effective in preventing lesions caused by HPV strains 16 and 18, based on an analysis that only required detection of the virus in the lesion, Reuters reports. However, researchers found most of the lesions contained multiple HPV strains known to cause cancer, and GSK said the data showed Cervarix was 100% effective in preventing lesions caused by strains 16 and 18. According to the study, the vaccine also provided significant protection against HPV strains 31, 45 and 52, which together account for about 12% of cervical cancer cases.

In an accompanying editorial in the Lancet, Jessica Kahn of the University of Cincinnati College of Medicine and Robert Burk of the Albert Einstein College of Medicine at Yeshiva University said the results were encouraging but it is too early to assess the vaccine's efficacy because cervical cancer can evolve over several decades. The authors also underscore the adverse reactions among women vaccinated with Cervarix, including general symptoms and injection site symptoms (Hirschler, Reuters, 6/27).

The Australian Therapeutic Goods Administration last month granted the first major market license for Cervarix, approving the vaccine for girls and women ages 10 to 45. The European Medicines Agency could recommend the vaccine this month. FDA has granted a standard 10-month review of Cervarix and will most likely take action on GSK's application in January 2008, according to analysts at Evolution Securities (Kaiser Daily Women's Health Policy Report, 6/7).

American Public Media's "Marketplace Morning Report" on Thursday included a discussion with "Marketplace" correspondent Stephen Beard about Cervarix (Napoli, "Marketplace Morning Report," American Public Media, 6/28). Audio and a transcript of the segment are available online.

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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