Anal Human Papillomavirus Infection Progression to Disease Among Men Who Have Sex With Men.
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BACKGROUND: Critical gaps exist in our understanding of the progression from anal human papillomavirus (HPV) infection to same-type HPV-associated anal disease in human immunodeficiency virus (HIV)-negative men who have sex with men (MSM). We conducted a post hoc analysis of a phase 3 randomized 4-valent HPV vaccine trial (NCT00090285) to assess the natural progression of anal HPV infections to associated anal lesions among MSM. PARTICIPANTS: A total of 602 HIV-negative MSM aged 16-27 years. METHODS: HIV-negative MSM aged 16-27 years enrolled in the placebo arm from 18 countries were included. We estimated the distribution of 9-valent HPV (9vHPV) vaccine types in intra-anal lesions (anal condyloma and anal intraepithelial neoplasia [AIN] 1-3), proportions and rates of progression from incident-persistent (no associated anal disease at baseline) intra-anal HPV infections to the same-type HPV-associated anal lesion, and cumulative incidence over 30 months. RESULTS: Predominant 9vHPV types detected were HPV6 (55.7%) and HPV11 (25.3%) in MSM with anal condyloma/AIN1, and HPV6 (30.5%), HPV16 (22.0%), and HPV11 (15.3%) in those with pooled AIN2/3. Progression from incident-persistent intra-anal 9vHPV infection to anal disease was driven primarily by HPV6, HPV11, and HPV16/18 infections for MSM with anal condyloma/AIN1 (63.0%, 85.7%, and 16.3%, respectively) and AIN2/3 (25.9%, 14.3%, and 32.4%, respectively). Cumulative incidence of anal condyloma/AIN1 and AIN2/3 in MSM with incident-persistent infection was 43.1% and 34.4%, respectively. CONCLUSIONS: A high proportion of unvaccinated HIV-negative MSM with a new intra-anal 9vHPV infection developed same-type HPV-associated anal disease. These findings support HPV vaccination of young HIV-negative MSM to prevent anal HPV infection and associated anal disease. REGISTRATION: ClinicalTrials.gov, NCT00090285.