Women living with HIV are at high risk for cervical HSIL and rates are especially high in sub-Saharan Africa. These women have high HSIL recurrence rates after loop electroexcision procedure (LEEP) requiring additional monitoring and treatment. More effective treatment for HSIL lesions in HIV infected women is needed. Some retrospective studies suggest that the Human Papillomavirus (HPV) vaccine used as adjuvant therapy with LEEP improves response to treatment of High-grade Squamous Intraepithelial lesions (HSIL) in HIV negative women. We evaluated the effectiveness of the HPV quadrivalent vaccine in preventing the recurrence of HSIL after LEEP in HIV infected women in Johannesburg South Africa.
We performed a double-blind, randomized clinical trial that enrolled 180 HIV infected women, between the ages of18-65 years and cervical HSIL on histology in Johannesburg South Africa according to Consort criteria. The women were excluded if they were pregnant. Women received the quadrivalent HPV or placebo vaccine (1:1) at entry, week 4, and week 26. LEEP was performed at week 4. Colposcopy and directed biopsies and cervical cytology were performed at week 26 and 52. The primary endpoint was cervical HSIL by histology or cytology at either week 26 or 52, and this was compared between arms using Chi-square analysis.
Participant characteristics included median age 39, median CD4 489, and 94% had HIV suppression (<200 copies/ml) on antiretroviral therapy. Of the 180 women enrolled, 179 women underwent LEEP and 174 women completed the vaccine/placebo series and had evaluable results at week 26 or 52. The proportion experiencing the primary endpoint of HSIL was similar in the vaccine and placebo groups, 53% vs. 45% (RR 1.16, 95% CI .87-1.6, P=.29). Similar results were seen when using only histologic results at 26 and 52 weeks (32% vs. 31%, RR 1.04, 95% CI .67-1.04, P=.9). HSIL recurrence was associated with a LEEP result of HSIL and positive margins on LEEP at week 4.
This randomized, double-blind clinical trial did not find evidence to support an adjuvant role for HPV vaccination for preventing recurrent HSIL post-LEEP in women living with HIV. Recurrent HSIL was high despite virologic suppression with antiretroviral therapy. More effective treatment strategies are needed to reduce the burden of recurrent cervical HSIL in this high risk population.