Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 200 mg) |
Drug Class | Antimycobacterials |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).
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Summary
- Pretomanid (pretomanid) is indicated as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug-resistant (XDR), treatment-intolerant, or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- The pooled proportion estimate of relapse in all and BPaL-based regimens for RR-TB was 2.0% (95% CI: 1.0-3.0%), which is similar to relapse rates in drug-susceptible TB treated with rifampicin-containing regimens.
- Among 237 DR-TB patients treated with pretomanid-containing regimens, 204 (86%) had a favorable outcome (cured), with ORs of 46.73 (95% CI: 11.76-185.7) for the Pretomanid regimen and 41.67 (95% CI: 8.86-196.73) for the BPaLM/BPaL regimen.
- In a systematic review, pretomanid-containing regimens showed 91% (95% CI: 59-100) favorable outcomes in patients with uncomplicated rifampicin-resistant TB and 90% (95% CI: 83-95) in those with highly resistant TB six months post-treatment.
- Serious hepatotoxic adverse events, including three deaths, were observed in 4% (95% CI 2-8) of patients on pretomanid-moxifloxacin-pyrazinamide. Linezolid-related toxicity was frequent in patients with highly resistant TB on pretomanid-bedaquiline-linezolid.
- No acquired resistance to pretomanid was reported, and the study highlighted significant adverse effects related to pretomanid-containing regimens, without providing comparative safety outcomes against other drugs.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Pretomanid (pretomanid) Prescribing Information. | 2019 | The Global Alliance for TB Drug Development., New York, NY |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Relapse after treatment with standardized all-oral short regimens for rifampicin-resistant tuberculosis (RR-TB): a systematic review and meta-analysis. | 2024 | Journal of Clinical Tuberculosis and Other Mycobacterial Diseases |
Efficacy of pretomanid-containing regiments for drug-resistant tuberculosis: a systematic review and meta-analysis of clinical trials. | 2023 | Narra J |
Pretomanid for tuberculosis: a systematic review. | 2022 | Clinical Microbiology and Infection |
Systematic review of mutations associated with resistance to the new and repurposed mycobacterium tuberculosis drugs bedaquiline, clofazimine, linezolid, delamanid and pretomanid. | 2020 | Journal of Antimicrobial Chemotherapy |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
WHO consolidated guidelines on tuberculosis: module 4: treatment - drug-resistant tuberculosis treatment. | 2020 | World Health Organization |