Efficacy and safety data on pretomanid for drug-resistant TB

Abstract

OBJECTIVE: To summarise the efficacy and safety of pretomanid (Pa) based regimens in patients with drug-resistant TB (DR-TB). METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Keywords

• tuberculosis
• extensively drug-resistant tuberculosis
• pre-extensively drug-resistant tuberculosis
• multidrug-resistant tuberculosis
• adverse events