Anal Human Papillomavirus Infection Progression to Disease Among Men Who Have Sex With Men.

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.