{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Stadler JAM"],"funding":["Bill & Melinda Gates Foundation","Bill &amp; Melinda Gates Foundation","NIAID NIH HHS","National Institutes of Health","Swedish Society of Medicine","South African Medical Research Council","NIH HHS","Swedish Heart-Lung Foundation"],"pagination":["e153-e162"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12596408"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["81(4)"],"pubmed_abstract":["<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, 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).<h4>Results</h4>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.<h4>Conclusions</h4>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."],"journal":["Clinical infectious diseases : an official publication of the Infectious Diseases Society of America"],"pubmed_title":["Treatment Outcomes With an Oral Short Course Regimen for Rifampicin-resistant Tuberculosis in a High HIV Prevalence, Programmatic Setting in South Africa."],"pmcid":["PMC12596408"],"funding_grant_id":["U01AI170426","20220859","MRC-RFA-SHIP 02-2018","U01 AI170426","SLS-985976"],"pubmed_authors":["Molloy SF","Mtwa N","Maartens G","Kuhlin J","Warren R","Stadler JAM","Wasserman S","Hayes C","Meintjes G"],"additional_accession":[]},"is_claimable":false,"name":"Treatment Outcomes With an Oral Short Course Regimen for Rifampicin-resistant Tuberculosis in a High HIV Prevalence, Programmatic Setting in South Africa.","description":"<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, 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).<h4>Results</h4>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.<h4>Conclusions</h4>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.","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Nov","modification":"2026-06-04T03:19:57.726Z","creation":"2026-06-04T03:12:48.109Z"},"accession":"S-EPMC12596408","cross_references":{"pubmed":["40342012"],"doi":["10.1093/cid/ciaf112"]}}