Long-Term Gender-Based Outcomes for Atazanavir/Ritonavir (ATV/r)- Containing Regimens in Treatment-Experienced Patients with HIV

Abstract

Clinical data on antiretroviral effectiveness in women are limited,especially long-term data, because women are usually underrepresented inclinical trials. This sub-analysis of a large European non-comparative,retrospective, observational cohort study evaluated gender differencesin long-term outcomes in antiretroviral-experienced adult patients withHIV-1 infection switched to an ATV/r-based regimen between October 2004and March 2007. Data were extracted from 3 European HIV databases every6 months (maximum follow-up 5 years). Time to virological failure (VF),defined as two consecutive HIV-1 RNA >= 50 c/mL or one HIV-1 RNA >= 50c/mL followed by treatment discontinuation (TD), and time to TD wereanalyzed using the Kaplan-Meier method. Associations of gender with VFand TD were analyzed using multivariate Cox proportional models. Safetyand tolerability were evaluated. In total, 1294 patients (336 women, 958men) were analyzed. No gender differences in time to VF were observed;at 3 years, the probability of not having VF was 0.59 (95% CI: 0.52,0.65) and 0.63 (95% CI: 0.59, 0.67) for women and men, respectively. Inmultivariate analyses, women had a higher risk of TD than men (hazardratio {[}HR], 1.54; 95% CI: 1.28, 1.85) but no increased risk of VF(HR, 1.06; 95% CI: 0.85, 1.33). Safety and tolerability were comparablebetween genders. In a clinical setting, long-term efficacy and safetyoutcomes of ATV/r-based regimens were similar by gender. Women had ahigher risk of TD but no increased risk of VF. ATV/r is an effective andwell-tolerated therapeutic option for treatment-experienced men andwomen with HIV-1 infection.