Effect of antiretroviral therapy on the incidence of genital warts and vulvar neoplasia among women with the human immunodeficiency virus L. Stewart Massad, MD, a, * Michael J. Silverberg, PhD, MPH, b Gayle Springer, MLA, b Howard Minkoff, MD, c Nancy Hessol, MSPH, d Joel M. Palefsky, MD, d Howard D. Strickler, MD, MPH, e Alexandra M. Levine, MD, f Henry S. Sacks, PhD, MD, g Michael Moxley, MD, h D. Heather Watts, MD i Southern Illinois University School of Medicine, Springfield, Ill a ; Johns Hopkins Bloomberg School of Public Health, Baltimore, Md b ; Maimonides Medical Center, State University of New York, Brooklyn, NY c ; University of California, San Francisco, Calif d ; Albert Einstein College of Medicine, Bronx, NY e ; Keck School of Medicine, University of Southern California, Los Angeles, Calif f ; Mt Sinai School of Medicine, New York, NY g ; Georgetown University Hospital, Washington, DC h ; National Institute of Child Health, Bethesda, Md i Received for publication November 5, 2003; revised December 18, 2003; accepted December 30, 2003 – Objective: The purpose of this study was to determine the incidence and predictors of genital warts and vulvar intraepithelial neoplasia among women with the human immunodeficiency virus. Study design: This was a multicenter prospective cohort study comprised of women without warts or vulvar intraepithelial neoplasia at baseline who underwent CD4 count, human immunodefi- ciency virus RNA measurement, examination, Papanicolaou test, and biopsy, as indicated, every 6 months. Human papillomavirus DNA typing was examined at baseline. Results: The incidence of warts among women who were human immunodeficiency virus seroneg- ative was 1.31 versus 5.01 per 100 person-years among women who were seropositive (P!.001). Incidence of vulvar intraepithelial neoplasia among women who were seronegative was 1.31 ver- sus 4.67 per 100 person-years among women who were seropositive (P!.001). In multivariable analysis, warts were associated with highly active antiretroviral therapy (relative hazard, 0.76), CD4 count (relative hazard, 0.91/100 cell/cm 2 increase), acquired immunodeficiency syndrome (relative hazard, 1.25), abnormal Papanicolaou test results (relative hazard, 2.18), high- or me- dium-risk human papillomavirus types (relative hazard, 1.91), low-risk human papillomavirus types (relative hazard, 1.48), smoking (relative hazard, 1.43), having 1 child (relative hazard, KEY WORDS Genital warts Vulvar neoplasia Vulvar cancer Human papillomavirus Human immunodeficiency virus Supported in part by the National Institute of Allergy and Infectious Diseases, with supplemental funding from the National Cancer Institute, the National Institute of Child Health & Human Development, The National Institute on Drug Abuse, and the National Institute of Craniofacial and Dental Research. U01-AI- 35004, U01-AI-31834, U01-AI-34994, U01-AI-34989, U01-HD-32632, U01-AI-34993, U01-AI-42590, M01-RR00079, M01-RR00083, and R01-CA85178-01. * Reprint requests: L. Stewart Massad, MD, Department of Obstetrics & Gynecology, Southern Illinois University, PO Box 19640, Springfield, IL 62794-9640. E-mail: LSMASSAD@ameritech.net www.elsevier.com/locate/ajog American Journal of Obstetrics and Gynecology (2004) 190, 1241e8 0002-9378/$ - see front matter Ó 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.ajog.2003.12.037