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Treatment Outcomes With an Oral Short Course Regimen for Rifampicin-resistant Tuberculosis in a High HIV Prevalence, Programmatic Setting in South Africa.

ABSTRACT:

Background

Bedaquiline-based oral short-course regimens (SCR) for rifampicin-resistant tuberculosis (RR-TB) are highly effective in clinical trials but outcomes in programmatic settings may be more modest. We evaluated clinical and bacteriological outcomes with a seven-drug, linezolid-containing SCR in a high-burden programmatic setting.

Methods

This prospective cohort study enrolled adults with newly diagnosed RR-TB who were started on the oral SCR in the Eastern Cape Province, South Africa. The primary outcome was World Health Organization-defined end-of-treatment success. Secondary outcomes were TB-free survival (composite of alive, absence of a positive Mycobacterium tuberculosis culture, and treatment completed or in care) at 18 months and time to sputum culture conversion (SCC).

Results

In total, 248 participants were included, 173 (69.8%) of whom were human immunodeficiency virus (HIV) positive. Culture conversion by 90 days was 96.8% (median time to SCC: 29 days, 95% confidence interval [CI]: 27-31). Treatment success was 37.5% (93/248). Reasons for unsuccessful treatment included switching to individualised regimens (35.1%, 87/248), loss to follow-up (19.4%, 48/348), and death (8.1%, 20/248). At 18 months, 157 (63.3%) participants achieved TB-free survival, with a cumulative mortality of 21.6% (95% CI: 16.1-29.0). Baseline 3+ smear (adjusted odds ratio [aOR]: 3.38, 95% CI: 1.28-8.95), higher age (aOR: 1.05, 1.01-1.08), and lower albumin (aOR: 0.94, 0.88-0.99), but not HIV status, were associated with unfavourable outcome at 18 months.

Conclusions

The oral SCR performed poorly in a high-burden TB programme. Strategies to support the implementation of effective new regimens for RR-TB are needed to translate outcomes from clinical trials into practice.

SUBMITTER: Stadler JAM 

PROVIDER: S-EPMC12596408 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature

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Treatment Outcomes With an Oral Short Course Regimen for Rifampicin-resistant Tuberculosis in a High HIV Prevalence, Programmatic Setting in South Africa.

Stadler Jacob A M JAM   Kuhlin Johanna J   Molloy Síle F SF   Mtwa Nomfuneko N   Hayes Cindy C   Maartens Gary G   Warren Robin R   Meintjes Graeme G   Wasserman Sean S  

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20251101 4

<h4>Background</h4>Bedaquiline-based oral short-course regimens (SCR) for rifampicin-resistant tuberculosis (RR-TB) are highly effective in clinical trials but outcomes in programmatic settings may be more modest. We evaluated clinical and bacteriological outcomes with a seven-drug, linezolid-containing SCR in a high-burden programmatic setting.<h4>Methods</h4>This prospective cohort study enrolled adults with newly diagnosed RR-TB who were started on the oral SCR in the Eastern Cape Province, S  ...[more]