1%). For the LPV/r group the main reason was AEs (12.7%). The difference in discontinuation rates between the two treatment groups was mostly a result of the different rate of discontinuations because of AEs (4.7% with DRV/r and 12.7% with LPV/r; P = 0.005); this trend had been observed at week 48 and week 96 [6,7]. All other reasons for discontinuation were observed with comparable frequency between the two treatment groups (Table 1). At week 192, 68.8% of patients randomized to receive DRV/r and 57.2% of those randomized to receive LPV/r had a confirmed HIV-1 RNA < 50 copies/mL (ITT-TLOVR) (Fig. 1a). The estimated difference between the two groups was 11.6% (95% CI 4.4;

18.8%), thus demonstrating noninferiority of DRV/r to LPV/r (P < 0.001). Statistical superiority of DRV/r vs. LPV/r was also shown at week 192 (P = 0.002). Similar results were obtained for the Selleckchem AG-14699 sensitivity analyses (Fig. 1b). In an analysis where patients were censored out after they discontinued

treatment for any reason other than VF, the 192-week virological response rate remained higher in the DRV/r arm compared with LPV/r [87.4% (236 of 270) vs. 80.8% (198 of 245), respectively; P= 0.040; Fig. 1b]. Of the patients in the DRV/r arm with a confirmed virological response of < 50 copies/mL at week 48, 81.3% remained with HIV-1 RNA < 50 copies/mL at week 192. Of the patients in the LPV/r arm with a confirmed virological response < 50 copies/mL at week 48, 68.5% remained with < 50 copies/mL at week 192. Between week Rucaparib 48 and week 192, 28 patients in the DRV/r arm and 34 patients in the LPV/r arm who were virologically Raf inhibitor suppressed at the week 48 analysis had a virological rebound at the week 192 analysis. At week 192, 75.2% of patients randomized to receive DRV/r vs. 65.0% of those randomized to receive LPV/r had a confirmed HIV-1 RNA < 400 copies/mL (ITT-TLOVR). The estimated difference between the two groups was 10.1%

(95% CI 3.2; 16.9%), thus demonstrating noninferiority of DRV/r to LPV/r (P < 0.001) and also statistical superiority (P = 0.004). The week 192 analysis of the virological response by baseline HIV-1 RNA (< or ≥ 100 000 copies/mL) showed that both subgroups randomized to receive DRV/r had a statistically superior virological response (HIV-1 RNA < 50 copies/mL; ITT-TLOVR) compared with those randomized to receive LPV/r [baseline HIV-1 RNA < 100 000 copies/mL: 69.5% vs. 60.2% (P = 0.038; estimated difference in response 9.3%; 95% CI 0.5; 18.1%), respectively; baseline HIV-1 RNA ≥ 100 000 copies/mL: 67.5% vs. 51.7% (P = 0.012; estimated difference in response 15.9%; 95% CI 3.5; 28.3%), respectively; Fig. 2]. Analysis by baseline CD4 count (< and ≥ 200 cells/μL) showed that patients with baseline CD4 count ≥ 200 cells/μL randomized to receive DRV/r had statistically superior virological response rates vs. those randomized to receive LPV/r (71.3% vs.