The human papillomavirus (HPV) vaccine Gardasil provides no benefit to anal health among older people with HIV but may reduce the risk of oral HPV infection, aidsmap reports. The ACTG A5298 trial, a Phase III, randomized, placebo-controlled study of Gardasil, included 575 HIV-positive people older than 26 who did not have anal cancer. Findings were presented at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.
The median age of the participants was 47.
The participants were randomized to receive doses of Gardasil or a placebo at the beginning of the three-year study and at weeks eight and 24. The researchers tested the participants for HPV DNA in their oral and anal tissues and screened them for precancerous lesions at these sites at the beginning of the study and then every six months.
After 130 weeks of follow-up, there was no statistically significant difference—meaning that any difference that did occur could have been the result of chance— between the two study groups in the risk of having detectable HPV at any of the screenings, in having persistently detectable anal HPV or in having abnormal results in the tests looking for anal precancerous lesions.
There was also no statistically significant difference between the two study arms in the rate of detectable oral HPV infection at any visit. However, there was a statistically significant difference in the rate of persistent oral HPV infection: One person fell into this category in the vaccinated group, compared with eight in the unvaccinated group, for a risk reduction associated with the vaccine of 88 percent. However, the estimate range for the actual risk reduction was 2 to 98 percent, so the findings on this point are not very solid.
To read the aidsmap article, click here.
To read the conference abstract, click here.