Background:  The study objective was to characterize initial ART used by members of a representative cohort of HIV-infected women according to the U.S. Department of Health and Human Services (DHHS) HIV treatment guidelines, and to determine whether regimen characteristics predict short term treatment outcomes.  

Methods:  We used self-reports of first ART use between April 1998 and October 2004 from participants of the Women’s Interagency HIV Study (WIHS).  Regimens were classified as preferred/alternate, contraindicated, or unlisted in the DHHS guideline version in use at the time the information was reported. Univariate analysis and logistic regression was used to analyze factors potentially associated with regimen guideline category. 

Results:  During the study period, 217 non-pregnant WIHS participants reported first use of ART, of whom  54% reported receiving a preferred/alternate ART regimen, 17% reported receiving a guideline-contraindicated regimen, and 30% reported receiving a regimen unlisted in the guidelines. Reported contraindicated regimens (n = 37) included ART monotherapy (n = 14), ART dual therapy (n = 13), and interacting drug combinations (n = 10). In univariate and multivariate analyses WIHS study site, higher pre-treatment CD4 count, lower HIV-1 RNA levels, and ART initiation prior to 2001 were associated with use of a guideline-contraindicated regimen. Intravenous drug use (IVD), race, education, and payor status were not associated with regimen guideline category. Over 2 years of follow-up, women who reported use of preferred/alternate regimens had an average rise in CD4⁺ of 181 cells/mL:  61% had HIV-1 RNA <400 copies/mL compared with 20 cells/mL, 33% for women receiving contraindicated regimens (p = 0.0003), and 144 cells/mL with 56% for women who received unlisted regimens (p = 0.74). Of women on preferred/alternate regimens, 36% remained on their regimens for 2 years compared with 7% of those who received a contraindicated regimen. 

Conclusions:  The majority of first ART reported by HIV⁺ women in WIHS fit preferred or alternate guideline categories, though a surprisingly large proportion reported using contraindicated ART regimens, according to DHHS guidelines, at the time of treatment.  Use of contraindicated regimens was associated with a higher incidence of switching and poorer short-term immunologic and virologic outcomes. The proportion of women reporting use of a contraindicated initial ART regimen in WIHS appears to have decreased over the study period.