Nine-month all-oral regimen for MDR/RR-TB in Lesotho: safety and effectiveness by HIV

Abstract

BackgroundIndividuals living with HIV have been under-represented in operational research and trials of all-oral regimens for multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB) treatment. We report outcomes from a prospective observational cohort study of a nine-month regimen comprised of bedaquiline, linezolid, a fluoroquinolone, delamanid, and clofazimine, in Lesotho, a setting with a high prevalence of HIV infection.

MethodsWe analyzed patients who initiated the regimen between 2020 and 2023. Overall, and by HIV status, we characterized treatment safety by summarizing the frequency and timing of clinically relevant adverse events. We described treatment effectiveness at the end of treatment and sustained treatment success eighteen months after treatment initiation.

ResultsTwo hundred and fifty-five patients who initiated the shortened all-oral regimen were included in the analysis, of whom 161 (63.1%) were living with HIV. Regardless of HIV status, the most frequent clinically relevant adverse event was peripheral neuropathy, followed by myelosuppression. The estimated unadjusted rates of sustained treatment success at 18 months post-treatment initiation were 86.4% (95% confidence interval (CI): 81.4%, 90.5%) overall, 85.0% (95% CI: 78.2%, 90.4%) among patients living with HIV, and 88.8% (95% CI: 80.3%, 94.5%) among people without HIV.

ConclusionsThe effectiveness of the nine-month all-oral regimen was excellent. Although adverse events were common, they were manageable and did not appear to substantially impact treatment success. Results were similar regardless of HIV status, supporting the use of this regimen in this population.

FundingSMS was supported by the National Institutes of Allergy and Infectious Diseases under Award Number T32 AI007433. MK, AL, RM, JM, DM, LM, TT, LT, EO, MC, LO, MFF, CDM, AL, KS, and MLR were supported by the National Institutes of Allergy and Infectious Diseases under Award Number R01AI46095. The funders had no role in the conceptualization, analysis, or presentation of findings of this study.

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BibTeX RIS

BibTeX

@misc{sauer2026ninemonth,
  title = {{Nine-month all-oral regimen for MDR/RR-TB in Lesotho: safety and effectiveness by HIV}},
  author = {S. M. Sauer and S. Mpinda and A. LaHood and L. Oyewusi and R. Maime and J. Makaka and M. Thoakana and D. Monyaesa and L. Musa and T. Thai and L. Trevisi and E. Osso and P. Sebakeng and M. Tamirat and M. Curtis and A. Lindeborg and E. Shen and M. L. Rich and C. Mitnick and K. Seung and M. F. Franke and M. K. Kunda and L. Maama},
  howpublished = {medRxiv},
  year = {2026},
  month = sep,
  doi = {10.64898/2026.09.04.26362253},
  url = {https://www.medrxiv.org/content/10.64898/2026.09.04.26362253v1},
  note = {CC BY},
}

RIS

TY  - UNPB
TI  - Nine-month all-oral regimen for MDR/RR-TB in Lesotho: safety and effectiveness by HIV
AU  - S. M. Sauer
AU  - S. Mpinda
AU  - A. LaHood
AU  - L. Oyewusi
AU  - R. Maime
AU  - J. Makaka
AU  - M. Thoakana
AU  - D. Monyaesa
AU  - L. Musa
AU  - T. Thai
AU  - L. Trevisi
AU  - E. Osso
AU  - P. Sebakeng
AU  - M. Tamirat
AU  - M. Curtis
AU  - A. Lindeborg
AU  - E. Shen
AU  - M. L. Rich
AU  - C. Mitnick
AU  - K. Seung
AU  - M. F. Franke
AU  - M. K. Kunda
AU  - L. Maama
PY  - 2026
DA  - 2026/09/04
PB  - medRxiv
DO  - 10.64898/2026.09.04.26362253
UR  - https://www.medrxiv.org/content/10.64898/2026.09.04.26362253v1
AB  - BackgroundIndividuals living with HIV have been under-represented in operational research and trials of all-oral regimens for multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB) treatment. We report outcomes from a prospective observational cohort study of a nine-month regimen comprised of bedaquiline, linezolid, a fluoroquinolone, delamanid, and clofazimine, in Lesotho, a setting with a high prevalence of HIV infection.  MethodsWe analyzed patients who initiated the regimen between 2020 and 2023. Overall, and by HIV status, we characterized treatment safety by summarizing the frequency and timing of clinically relevant adverse events. We described treatment effectiveness at the end of treatment and sustained treatment success eighteen months after treatment initiation.  ResultsTwo hundred and fifty-five patients who initiated the shortened all-oral regimen were included in the analysis, of whom 161 (63.1%) were living with HIV. Regardless of HIV status, the most frequent clinically relevant adverse event was peripheral neuropathy, followed by myelosuppression. The estimated unadjusted rates of sustained treatment success at 18 months post-treatment initiation were 86.4% (95% confidence interval (CI): 81.4%, 90.5%) overall, 85.0% (95% CI: 78.2%, 90.4%) among patients living with HIV, and 88.8% (95% CI: 80.3%, 94.5%) among people without HIV.  ConclusionsThe effectiveness of the nine-month all-oral regimen was excellent. Although adverse events were common, they were manageable and did not appear to substantially impact treatment success. Results were similar regardless of HIV status, supporting the use of this regimen in this population.  FundingSMS was supported by the National Institutes of Allergy and Infectious Diseases under Award Number T32 AI007433. MK, AL, RM, JM, DM, LM, TT, LT, EO, MC, LO, MFF, CDM, AL, KS, and MLR were supported by the National Institutes of Allergy and Infectious Diseases under Award Number R01AI46095. The funders had no role in the conceptualization, analysis, or presentation of findings of this study.
ER  -

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