FDA Highlights – by Bruce Sylvester – The human papilloma virus (HPV) vaccine can help prevent anal cancer in men, researchers reported in the October 27, 2011, issue of New England Journal of Medicine.
“Almost 6,000 people every year in this country (the US) are diagnosed with anal cancer, and more than 700 people die from the disease,” said Joel Palefsky, MD, University of California at San Francisco (UCSF), and the Anal Neoplasia Clinic, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California. “What this trial showed is that those cancers and deaths could be prevented.”
Anal cancer is particularly common among men who have sex with men and in persons with HIV.
The investigators enrolled 602 men who have sex with men from Australia, Brazil, Canada, Croatia, Germany, Spain, and the United States, all of whom had at least one, but no more than five, sexual encounters and who were aged 16 to 26 years.
The subjects were randomised to placebo injection or a 3-shot injection of the HPV vaccine. They were followed for three years (2006-2008) after their last injection.
The vaccine reduced anal infections with HPV and high-grade anal intraepithelial neoplasia by nearly 75%, among those subjects who had not been exposed previously to any of the HPV types in the vaccine.
Among subjects who were previously exposed to one or more of the HPV types in the vaccine, the vaccine reduced precancerous lesions by 54%.
“Based on these data, the vaccine works well to prevent HPV infection and precancerous anal disease, and will likely prevent anal cancer in men,” said Dr. Palefsky. “The ideal time to begin vaccination would be before initiation of sexual activity, but vaccination may also be useful after initiation of sexual activity.”
After weighing the clinical evidence, including the data presented in the New England Journal of Medicine paper, the (USA) Advisory Committee on Immunisation Practices (ACIP) voted to make HPV vaccinations “routine” for boys up to the age of 21 years.