GRACE (Gender, Race And Clinical Experience): 48-week results of darunavir/r-based therapy in the largest trial in north america to focus on treatment-experienced women

Abstract

Women account for an increasing proportion of patients living with HIV/AIDS in the United States (US) yet data on the efficacy and safety of antiretrovirals (ARVs) in women are limited. – Several challenges, including socioeconomic factors, have led to diffi culties in recruiting and retaining women in ARV clinical trials • Darunavir (DRV; PREZISTA®), a protease inhibitor (PI) combined with a low dose of ritonavir (DRV/r), has been approved for use in the US as a therapeutic option for treatment-experienced, treatment-naïve and pediatric (aged 6 to <18 years) HIV-infected patients3 • We report 48-week results from the primary analysis of the GRACE (Gender, Race And Clinical Experience) trial, which was designed to enroll a high proportion of treatment-experienced women, in order to assess sex-based differences in the effi cacy and safety of DRV/r-based therapy – Analyses by race will be presented elsewhere