Hepatic safety of pretomanid- and pyrazinamide-containing regimens in TB Alliance clinical trials.

ABSTRACT:

Background

In STAND and SimpliciTB, clinical trials for drug-susceptible TB, regimens containing pretomanid, pyrazinamide, and other agents (PaZX) had more hepatotoxicity than the standard-of-care regimen of isoniazid, rifampicin, pyrazinamide, and ethambutol (HRZE). In Nix-TB and ZeNix, clinical trials for drug-resistant TB, the regimen of bedaquiline, pretomanid, and linezolid (BPaL) demonstrated a favorable benefit-risk profile. We compare the hepatic safety of HRZE, PaZX, and BPaL in their respective populations.

Methods

In this post-hoc analysis of data from six clinical trials, rates of treatment-emergent elevations of alanine transaminase (ALT) during the first 8 weeks of treatment were estimated by Kaplan-Meier (KM) analysis and compared via log-rank testing and Cox

SUBMITTER: Nedelman J 

PROVIDER: S-EPMC12352949 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature