ArticleIJTLD open2025
Hepatic safety of pretomanid- and pyrazinamide-containing regimens in TB Alliance clinical trials.
Article in IJTLD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- Recent advances in antituberculosis drugs and therapeutics: from mechanistic breakthroughs to clinical translation.Molecular biomedicine · 2026Review
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn 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.
methodsIn 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 modeling.
resultsThe KM-estimated probabilities of treatment-emergent ALT elevations greater than 3x the upper limit of normal (>3xULN) were 5.36%, 12.7%, and 11.4% for HRZE, PaZX, and BPaL, respectively. The only significant (p < 0.05) difference was HRZE versus PaZX. The probabilities of ALT elevations >8xULN were 2.68%, 4.58%, and 1.05%, with the only significant difference being PaZX versus BPaL.
conclusionsBPaL and HRZE have similar hepatic safety profiles in their respective populations. Pretomanid and pyrazinamide should be co-administered only when the benefit outweighs the risk.
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