LAUSR

BACKGROUND The quadrivalent human papillomavirus (HPV) vaccine (qHPV; types 6, 11, 16, 18) is indicated for men and women 9-26 years to prevent HPV associated anogenital high grade squamous intraepithelial lesions (HSIL) and cancer. ACTG 5298 was a randomized placebo controlled Phase 3 study in HIV-infected men who have sex with men (MSM), and women of qHPV to prevent persistent anal HPV infection. Baseline data is presented here. METHODS HIV-infected MSM, and women ≥ 27 years without previous anogenital or oral cancer were enrolled. Baseline anal cytology, high resolution anoscopy and collection of anal, oral, and vaginal specimens for HPV genotyping were performed and acceptability assessed. RESULTS 575 participants were enrolled (82% male and 18% female). Median age was 47 years. Race/ethnicity was 46% White, 31% Black, and 20% Hispanic. Plasma HIV-1 RNA was <50 copies/mL in 83% and median CD4 T count was 602 cells/μL. Abnormal anal cytology was detected in 62%, with corresponding HSIL on biopsy (bHSIL) in 33%. Anal HPV 6, 11, 16 and 18 were detected in 25%, 13%, 32%, and 18% of participants respectively. Prevalence of 0, 1, 2, 3, and 4 qHPV types was 40%, 38%, 17%, 4%, and 1%, respectively. Oral infection with ≥ 1 qHPV type was detected in 10% of participants. Study procedures were generally acceptable. CONCLUSIONS At study baseline, there was a high prevalence of abnormal anal cytology, bHSIL, and HPV infection. Sixty percent of participants had anal infection with preventable qHPV types.