1: What to start: summary recommendations) (1A). Factors such as potential side effects, co-morbidities, drug interactions, patient preference and dosing convenience need to be see more considered in selecting ART in individual women. We recommend both HIV-positive women of childbearing potential and healthcare professionals

who prescribe ART are conversant with the benefits and risks of ARV agents for both the health of the HIV-positive woman and for that of an unborn child (GPP). We recommend that potential pharmacokinetic interactions between ARVs, hormonal contraceptive agents and hormone replacement therapy are checked before administration (with tools such as: http://www.hiv-druginteractions.org) (GPP]). There are few data to guide prescribing of initial ART specifically for women, as no RCT in patients starting ART has been powered to detect sex differences in efficacy. From the limited data available, virological outcomes within clinical trial settings generally appear to be no different between men and women. A meta-analysis of FDA registrational RCTs analysed data from 22 411 HIV-positive patients participating in 43 trials for 16 ARVs. Overall, 20% of study participants

were women. No significant differences in treatment response at week 48 were reported between men and women. C646 datasheet Rates of ART discontinuation for virological failure were higher in men (8.15%) than in women (4.25%) [214]. A subanalysis of an RCT comparing ATV/r and LPV/r in ART-naïve patients of whom 31% were women, showed comparable virological efficacy at week 96 between the two treatment arms in women [215], although virological response rates were lower in women when

compared with men. In a study comparing ATV/r and EFV in 1857 ART-naïve patients of whom 17% were women, female sex was associated with increased virological failure on ATV/r compared with EFV [216]. No difference was seen with EFV between Methane monooxygenase men and women. The efficacy and tolerability of RAL were shown not to be different between men and women at 48 weeks in one study of a diverse cohort of both treatment-naïve and -experienced patients [217]. RPV in ART-naïve men and women showed no difference in rates of virological suppression at 48 and 96 weeks between men and women, but the number of women included was low and the study was not designed to investigate sex differences [218, 219]. Cohort studies in the UK have reported similar virological outcomes during the first year of treatment in heterosexual men and women [220]. An Italian cohort study reported no significant effect of gender on clinical progression or the risk of developing a clinical event [221]. Data from Spain, which included both naïve and ARV-experienced women patients, showed them with similar virological responses to men [222].