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Background:  Although HAART has lowered the incidence of various opportunistic diseases, its effect on incidence of cervical intraepithelial neoplasia (CIN) is unclear. Our objective was to compare the incidence of CIN in HIV-infected women under HAART versus non-treated women and to determine the role of risk factors in the pathogenesis of CIN.

Methods:  A prospective study of cervical disease in HIV-positive women with a semestrial follow-up—including colposcopy, Pap smears, and biopsy—was initiated in 1993. A total of 316 women with no evidence of CIN at study entry were followed-up until incident CIN confirmed by biopsy or last follow-up visit. Cox analyses were used to assess the risk of incident CIN associated with HAART. HAART was entered as a time-dependent covariate according to the date of first prescription.

Results:  During a median follow-up of 26.5 months (14.0 to 54.8), 101 women developed CIN (incidence of 10 cases per 100 person-years). Of CIN, 86 were low-grade. No invasive cervical cancers were identified. By multivariate analysis, significant risk factors for incident lesion were age below 40 (relative risk 2.8; 95% CI 1.1 to 7.0, p = 0.03 ) and tobacco use (RR, 1.6; 95% CI 1.0 to 2.5, p = 0.05). Incidence decreased from 12 to 8/100 person-years in non treated versus treated women and women under HAART had a twice reduced risk to develop CIN during follow-up (RR 0.5; 95% CI 0.3 to 0.9, p = 0.01).

Conclusions:  HAART modified the course of CIN by significantly reducing the incidence of lesions. Nevertheless, although HAART likely delays occurrence of lesions, all HIV⁺ women should participate in cervical cancer screening programs.

Keywords: cervical dysplasia; women; surgery