Mycobacterial disease · Treating highly drug-resistant TB
Treatment of Highly Drug-Resistant Pulmonary Tuberculosis
| Design | Open-label, single-group study |
|---|---|
| Treatment | Bedaquiline, pretomanid and linezolid for 26 weeks |
| Control | None — single-group design |
| Population | 109 patients with extensively drug-resistant tuberculosis, or treatment-intolerant or non-responsive multidrug-resistant tuberculosis |
| Follow-up | 6 months after the end of treatment |
| Primary endpoint | Unfavourable outcome at 6 months after treatment |
| Result | At 6 months after treatment, 98 of 109 (90%, 95% CI 83 to 95) had a favourable outcome. The 11 unfavourable outcomes were 7 deaths, 1 withdrawal, 2 relapses and 1 loss to follow-up. Peripheral neuropathy occurred in 81% of patients. |
| Secondary endpoints | Culture conversion, linezolid toxicity, mortality |
The combination of bedaquiline, pretomanid, and linezolid led to a favorable outcome at 6 months after the end of therapy in a high percentage of patients with highly drug-resistant forms of tuberculosis; some associated toxic effects were observed.
The trial authors, in the published abstract
Transformed a disease that previously required 18 to 24 months of injectable therapy with cure rates near 30%. Single-group and uncontrolled, which was defensible given how poor the alternative was. The 81% peripheral neuropathy rate is the reason ZeNix was needed to find the right linezolid dose.
Conradie F, Diacon AH, Ngubane N, et al. Treatment of Highly Drug-Resistant Pulmonary Tuberculosis. N Engl J Med 2020 Mar 5;382(10):893-902.