Pretomanid

(Pretomanid®)

Pretomanid

Drug updated on 9/4/2024

Dosage FormTablet (oral; 200 mg)
Drug ClassAntimycobacterials
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
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  • 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.