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. Rates of ART discontinuation for virological failure were higher in men (8.15%) than in women (4.25%) [5]. A subanalysis of an RCT comparing ATV/r and LPV/r in ART-naïve patients of whom 31% were women, showed comparable virological MK-1775 efficacy at week 96 between Fulvestrant the two treatment arms in women [6], 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 [7].

No difference was seen with EFV between 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 [8]. RPV in ART-naïve men and women showed no difference in rates of virological suppression Cyclin-dependent kinase 3 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 [9, 10]. Cohort studies in the

UK have reported similar virological outcomes during the first year of treatment in heterosexual men and women [11]. An Italian cohort study reported no significant effect of gender on clinical progression or the risk of developing a clinical event [12]. Data from Spain, which included both naïve and ARV-experienced women patients, showed them with similar virological responses to men [13]. HIV-positive women starting ART should use ARVs from the list of preferred and alternative drugs outlined in Section 5.1 (What to start: summary recommendations). Factors, including potential for side effects, drug interactions, patient preference, co-morbidities and dosing convenience need to be taken into consideration when selecting ART regimens in individual women. Adverse events and treatment discontinuations within ART clinical trials and cohort studies published between 2002 and 2007 have been systematically reviewed. The overall event rate is often the same but the adverse event profile may be different.