Ceravix and Gardasil to Treat Gay Men

Two new HPV virus (human papilloma virus) vaccines, Gardasil and Cervarix, originally given to women to prevent and treat cervical cancer, have been found safe for use in HIV-positive patients with high-grade anal intraepithelial neoplasia (AIN), according to the results of a clinical trial published in the 12th May edition of AIDS.

AIN is a pre-cancerous condition caused by infection of the cells in the anus being infected with 'high risk' forms of HPV, the virus that causes warts. AIN can progress to anal cancer if left untreated and is more common in gay men than in men in general.

Anal cancer is most common in men who have histories of receptive anal intercourse; however, it can affect anyone. There is an annual rate of about 35 cases per 100,000, but that figure nearly doubles in people living with HIV. The reason that Gay men in the United Kingdom and in the United states are asking for the vaccine is best stated here:

"The cervix is similar biologically to the anus, so there's plenty of hope that it [the vaccine] will work there also," Dr. Joel Palefsky, a professor of medicine at the University of California San Francisco, told the Times.

Although individuals with HIV, and HIV-negative gay men are more likely to have anal HPV infection, and are more likely to be diagnosed with anal cancer than the general population, none of the data from studies into HPV vaccines so far have included gay men or HIV-positive men, women or children. That will soon change. Merck is studying their vaccine in 4000 young men, including those who engage in sex between men, and the United States' National Institutes of Health is evaluating the response to Merck's vaccine in preteen HIV-positive boys and girls. (www.aidsmap.org/en/news/3429199D-5FE5-4795-B0E6-CD957617C160.asp)

The United States is currently lagging behind Europe in developing and testing Gardasil and Cervarix. Gardasil has been causing controversy since it was launched in the UK late last year. Although it was developed to help treat and guard against Cervical Cancer in women, many Doctor's are also giving it to children before they become sexually active and can catch HPV. That idea has also garnered supporters here in the U.S., more recently in the news in Texas where one legislator wanted it mandatory in children as another childhood vaccine. Needless to say, that idea was defeated by organizations such as the mainstream Religious-Right, stating vaccinating children would be promoting sexual activity and promiscuity. Many supporters of the early vaccinations have called their detractors 'shortsighted', saying the vaccines have been shown to prevent cervical cancer later in the lives of women, to no avail. One UK doctor has considered vaccinating gay men after several of their patients have requested the vaccine to treat their HPV. Dr Anne Szarewski, clinical consultant for Cancer Research UK who has been involved in evaluating both Merck's Gardasil and GSK's rival jab Cervarix, says there may be a case for immunizing men. "Men who have sex with men are at a much higher risk than average of anal cancer and genital warts, particularly if they are HIV-positive. Clearly it would be very important if the vaccine could protect. The problem is we do need proof." (news.bbc.co.uk/2/hi/health/6342105.stm)

Current available treatments for AIN include surgical removal, use of infra-red radiation and treatment with trichloroacetic acid. However, these are often not completely successful in treating the condition, particularly where it is widespread or found in many different places in or around the anus. A study of HIV-positive gay men in San Francisco has found that 95% have anal HPV (human papilloma virus) infection, and more than 50% have grade 2 or 3 anal intraepithelial neoplasia (AIN). The study, which appears in the September 2nd edition of AIDS, confirms other studies which suggest that highly active antiretroviral therapy (HAART) is not protective of AIN, and found that the men on HAART actually had an increased risk of AIN. Although the study does not suggest that HAART itself increases the risk of AIN, it does, at the very least, support the conclusion that HAART does not reduce the risk, and that the prevalence of anal cancer amongst HIV-positive gay men on HAART continues to increase. (http://www.aidsmap.com/en/news/44E54C4A-27D9-45FE-8533-A0E7C70499B8.asp)

The success of the HIV vaccine is not unfounded against AIN in gay men. Investigators from the University of California, San Francisco, wished to assess the safety of a new vaccine in HIV-positive patients with high-grade AIN, following success with a similar vaccine in a group of HIV-negative patients. They used SGN-00101, which is also called HspE7, a vaccine made from the E7 (one of the strains of HPV that the vaccine treats) protein of HPV type 16 fused to a protein from a bacterium. A vaccine made from a fragment of the human papilloma virus (HPV) is safe for use in HIV-positive patients with high-grade anal intraepithelial neoplasia (AIN), according to the results of a clinical trial published in the 12th May edition of AIDS. The study also provided preliminary evidence that the vaccine may be useful in treating the condition. (http://www.nccc-online.org/health_news/research_treatment/ain.html)

With these highly promising studies being performed on both sides of the Atlantic, HPV may be another treatment option available for everyone with HPV.