4%) > OBR alone (11/23, 47.8%), p = 0.76** DST: resistant to INH and RIF HIV positive

and CD4 <300 cells/μL     Mortality  BDQ + OBR (2/23, 8.7%) vs OBR alone (2/24, 8.3%), P = 0.8. Onset of death: median 347 days [17]   Received antiretroviral therapy or antifungal therapy within the last 90 days         History of significant cardiac arrhythmia MCC-950         Drug hypersensitivity         Alcohol and drug abuse         Abnormal laboratory tests         Breast feeding or pregnancy       AG aminoglycosides, BDQ bedaquiline, BMI body mass index, DST drug susceptibility testing, HIV human immunodeficiency virus, HR Hazard ratio, INH isoniazid, MDR multi-drug resistant, OBR optimized background regimen, RIF rifampicin, TB tuberculosis, XDR extensively drug resistant ** P value calculated using Pearson’s χ 2 test, from available data aCalculation based on modified intention to treat analysis The primary end point of this study, time to culture conversion at 8 weeks, was significantly shorter for patients taking bedaquiline than for those taking an OBR with placebo (hazard ratio [HR] 11.8 [2.3, 61.3], P = 0.0034), with adjustment for cavitation and study Selleck HDAC inhibitor center) [18]. In addition, patients taking bedaquiline

plus OBR had significantly greater proportion of culture conversion at 8 weeks compared to OBR plus placebo (47.6% versus 8.7%, respectively). Culture conversion at 24 weeks was also significantly greater among patients taking bedaquiline compared to OBR with placebo (81.0% versus 65.2%) [19], and time to culture conversion at 24 weeks was also shorter (HR 2.3, 95% CI 1.1, 4.7) [19]. When an intention to treat analysis was performed for all subjects up to 104 weeks, the rate of microbiological

conversion was not significantly different between the bedaquiline group and placebo (52.4% versus 47.8%, P = 0.76) [19]. This is due in part to the high drop-out rates seen in both arms (44% drop-out in the bedaquiline group and 54% in the placebo group). The study was not powered to detect relapse, although at the end of the study two members of the bedaquiline group and four members of the control PD184352 (CI-1040) group had experienced click here treatment failure [17, 61]. The Second Phase 2 Study of Bedaquiline Data from a second Phase 2 study of the clinical effectiveness of bedaquiline (Study C208, Stage 2) have been presented in a public submission to the US FDA, although the results have not yet appeared in a peer-reviewed publication. This study enrolled 161 patients with MDR-TB, at 15 study sites in eight countries [17]. Patients were randomized either to 24 weeks of bedaquiline with a five-drug OBR or the OBR plus placebo. OBR was continued after stopping bedaquiline or placebo. The primary end point was time to sputum culture conversion at 24 weeks (Table 4) [15, 17]. The two groups were comparable.