High Baseline Anal Human Papillomavirus and Abnormal Anal Cytology in a Phase 3 Trial of the Quadrivalent Human Papillomavirus Vaccine in Human Immunodeficiency Virus–Infected Individuals Older Than 26 Years: ACTG 5298. Issue 4 (April 2018)

• Record Type: Journal Article
• Authors: Cranston, Ross D.; Cespedes, Michelle S.; Paczuski, Pawel; Yang, Ming; Coombs, Robert W.; Dragavon, Joan; Saah, Alfred; Godfrey, Catherine; Webster-Cyriaque, Jennifer Y.; Chiao, Elizabeth Y.; Bastow, Barbara; Wilkin, Timothy
• Is Part Of: Sexually transmitted diseases. Volume 45:Issue 4(2018)
• Publication Date: 2018-04
• Subjects: Sexually transmitted diseases -- Periodicals; Sexual health -- Periodicals; 616.951005
• DOI: 10.1097/OLQ.0000000000000745
• Languages: English
• ISSNs: 0148-5717

Abstract

Abstract : Background: The quadrivalent human papillomavirus (HPV) vaccine (qHPV; types 6, 11, 16, 18) is indicated for men and women aged 9 to 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 human immunodeficiency virus (HIV)-infected men who have sex with men, and women of qHPV to prevent persistent anal HPV infection. Baseline data are presented here. Methods: Human immunodeficiency virus–infected men who have sex with men, and women 27 years or older 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: Five hundred seventy-five (575) participants were enrolled (82% men and 18% women). Median age was 47 years. Race/ethnicity was 46% white, 31% black, and 20% Hispanic. Plasma HIV-1 RNA was less than 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 the participants, respectively. Prevalence of 0, 1, 2, 3, and 4 qHPV types was 40%, 38%, 17%, 4%, and 1%, respectively. Oral infection with 1 or more qHPV type was detected in 10% of the 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 the participants had anal infection with preventable qHPV types. Abstract : In both human immunodeficiency virus–infected men and women older than 26 years, there was a high prevalence of abnormal anal cytology, high-grade anal dysplasia, and quadrivalent vaccine-type HPV infection.Supplemental digital content is available in the text.