Efficacy and safety data on pretomanid for drug-resistant TB

Abstract

To summarise the efficacy and safety of pretomanid (Pa) based regimens in patients with drug-resistant TB (DR-TB). We included clinical trials, operational research and observational studies reporting the efficacy and safety of Pa-based regimens in DR-TB. The duration of the treatment was at least 24 weeks. Efficacy was reported as a favourable/unfavourable outcome and culture conversion. Safety was reported in terms of death and frequency of adverse events of special interest. Of the 127 articles identified, 13 were included. The proportion of favourable outcomes reported was 76−100%, and the median time to culture conversion was 4−6 weeks. Culture conversion rates ranged from 80–100% by the end of 3 months of treatment, regardless of the type of drug resistance. Treatment completion rates in the operational research studies varied between 18–93%. Safety events were not proportionate among the studies included, possibly due to the differing linezolid dosing (more frequent in the 1,200 mg dose regimen). Our review supports the use of Pa-based regimens in patients with DR-TB. The results indicate that Pa-based regimens are efficacious with tolerable safety profile in DR-TB patients