Sustained outcomes 3 years after all-oral 9-month regimen for rifampicin-resistant TB

Sustained outcomes 3 years after all-oral 9-month regimen for rifampicin-resistant TBDear Editor, TB remains one of the most common life-threatening infectious diseases worldwide.Vietnam is one of the high TB and rifampicin-resistant TB (RR-TB) burden countries in the world, with an estimated 182,000 new TB cases in 2023.This includes about 9,900 RR-TB cases, of which only 36% received treatment in the same year. 1 In 2025, the WHO recommended different regimens for RR-TB patients without confirmed fluoroquinolones (FQ) resistance, one of which is a 5-drug 9-month treatment regimen, based on results of the endTB clinical trial.This so called BCLLfxZ regimen includes bedaquiline (BDQ or B), clofazimine (CFZ or C), linezolid (LZD or L), levofloxacin (Lfx), and pyrazinamide (PZA or Z). [2][3]3][4] In Vietnam, between 2020 and 2021, 106 patients were enrolled on BCLLfxZ.Interim analysis of this study demonstrated high (89.6%;95/106) end-oftreatment success. 5Besides the 17-month endTB outcome data, 3 there is no evidence on post-treatment outcomes for this regimen.We therefore complement our previously published results 5 by showing long-term outcomes of BCLLfxZ regimen, until month 45 following treatment initiation (or the 36th post-treatment month).In addition, we show the final outcome of patients with treatment failure or a new TB episode after BCLLfxZ treatment completion.In this prospective cohort study, conducted at six large treatment sites in Vietnam, 106 RR-TB patients without proof of initial FQ resistance (71 with FQsusceptible TB, 35 without drug susceptibility testing [DST] result) were enrolled on the BCLLfxZ regimen and followed up until 36 months post-treatment.RR-TB was diagnosed via Xpert MTB/RIF (Cepheid Inc., USA), followed by FQ resistance screening using genotypic (GenoType MTBDRsl, Hain Lifescience, Germany) or phenotypic second-line DST.Exclusion criteria included prior exposure to second-line drugs (1 month), QTcF .500ms, extra-pulmonary TB, severe electrolyte abnormality, end-stage liver or kidney disease, and pregnancy or breastfeeding.Eligible RR-TB patients started the BCLLfxZ regimen for 9-11 months (11 months if positive on culture or lack of clinical progression at month 4).After completing treatment, patients were scheduled for follow-up consultations at months 6 and 12 posttreatment, including clinical evaluation, smear, culture, and chest X-ray.A final assessment was conducted by treatment site's nurses, by phone interviews at 36 months post-treatment.If symptoms were detected during the interview, participants were called for medical examinations and sputum collection.

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Journal
IJTLD OPEN
Published
2026-02-01
DOI
https://doi.org/10.5588/ijtldopen.25.0494
Primary Topic
Tuberculosis Research and Epidemiology
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article
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article

Sustained outcomes 3 years after all-oral 9-month regimen for rifampicin-resistant TB

Tmp Nguyen, B.H. Nguyen, L. Guglielmetti, V.L. Dinh et al.
IJTLD OPEN
Tuberculosis Research and Epidemiology
article

Sustained outcomes 3 years after all-oral 9-month regimen for rifampicin-resistant TB

Tmp Nguyen, B.H. Nguyen, L. Guglielmetti, V.L. Dinh, T.H.M. Le, N.L. Nguyen, V.N. Nguyen, T.T.T. Hoang, C.S.C. Merle, S. Callens, T. Decroo
article en

Abstract

Sustained outcomes 3 years after all-oral 9-month regimen for rifampicin-resistant TBDear Editor, TB remains one of the most common life-threatening infectious diseases worldwide.Vietnam is one of the high TB and rifampicin-resistant TB (RR-TB) burden countries in the world, with an estimated 182,000 new TB cases in 2023.This includes about 9,900 RR-TB cases, of which only 36% received treatment in the same year. 1 In 2025, the WHO recommended different regimens for RR-TB patients without confirmed fluoroquinolones (FQ) resistance, one of which is a 5-drug 9-month treatment regimen, based on results of the endTB clinical trial.This so called BCLLfxZ regimen includes bedaquiline (BDQ or B), clofazimine (CFZ or C), linezolid (LZD or L), levofloxacin (Lfx), and pyrazinamide (PZA or Z). [2][3]3][4] In Vietnam, between 2020 and 2021, 106 patients were enrolled on BCLLfxZ.Interim analysis of this study demonstrated high (89.6%;95/106) end-oftreatment success. 5Besides the 17-month endTB outcome data, 3 there is no evidence on post-treatment outcomes for this regimen.We therefore complement our previously published results 5 by showing long-term outcomes of BCLLfxZ regimen, until month 45 following treatment initiation (or the 36th post-treatment month).In addition, we show the final outcome of patients with treatment failure or a new TB episode after BCLLfxZ treatment completion.In this prospective cohort study, conducted at six large treatment sites in Vietnam, 106 RR-TB patients without proof of initial FQ resistance (71 with FQsusceptible TB, 35 without drug susceptibility testing [DST] result) were enrolled on the BCLLfxZ regimen and followed up until 36 months post-treatment.RR-TB was diagnosed via Xpert MTB/RIF (Cepheid Inc., USA), followed by FQ resistance screening using genotypic (GenoType MTBDRsl, Hain Lifescience, Germany) or phenotypic second-line DST.Exclusion criteria included prior exposure to second-line drugs (1 month), QTcF .500ms, extra-pulmonary TB, severe electrolyte abnormality, end-stage liver or kidney disease, and pregnancy or breastfeeding.Eligible RR-TB patients started the BCLLfxZ regimen for 9-11 months (11 months if positive on culture or lack of clinical progression at month 4).After completing treatment, patients were scheduled for follow-up consultations at months 6 and 12 posttreatment, including clinical evaluation, smear, culture, and chest X-ray.A final assessment was conducted by treatment site's nurses, by phone interviews at 36 months post-treatment.If symptoms were detected during the interview, participants were called for medical examinations and sputum collection.

IJTLD OPENVol. 3(2)
Vietnam National University, Hanoi (VN), Hanoi Medical University (VN), Ghent University Hospital (BE), Ospedale Sacro Cuore Don Calabria (IT), World Health Organization (CH), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Hanoi Lung Hospital (VN), Instituut voor Tropische Geneeskunde (BE)
Openalex Percentile: Top 52%
Tuberculosis Research and Epidemiology
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