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Meta-Analysis
. 2024 Aug 9:2024:5542658.
doi: 10.1155/2024/5542658. eCollection 2024.

Establishing the Safety and Efficacy of Bedaquiline-Containing Regimen for the Treatment of Drug-Resistant Tuberculosis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Muhammad Candragupta Jihwaprani  1 , Yipeng Sun  1 , Wahyu Choirur Rizky  2 , Idris Sula  1 , Nazmus Saquib  1
Affiliations
Meta-Analysis

Establishing the Safety and Efficacy of Bedaquiline-Containing Regimen for the Treatment of Drug-Resistant Tuberculosis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Muhammad Candragupta Jihwaprani et al. Pulm Med. .

Abstract

The risks and benefits of bedaquiline (BDQ) for treatment of drug-resistant tuberculosis (DR-TB) have not been firmly established. We aimed to assess the safety and efficacy of BDQ-containing regimens for the treatment of DR-TB as evidenced in available randomized controlled trials (RCTs). In this systematic review and meta-analysis, five databases (i.e., ClinicalTrials.gov, Cochrane CENTRAL, PubMed, ScienceDirect, and SinoMed) were searched. RCTs among DR-TB patients that had a control arm were eligible. The safety endpoints were all-cause mortality and serious adverse effects (SAEs). Efficacy outcomes were sputum culture conversion rate at 8-12 weeks and 24-26 weeks, treatment success, and time to culture conversion. A total of 476 records were screened; 18 met the eligibility criteria. The pooled analysis included 2520 participants (55.8% received BDQ-containing regimens, n = 1408). Pooled safety outcomes showed no significant reduction in all-cause mortality (relative risk [RR] [95%confidence interval (CI)] = 0.94 [0.41-2.20]) or SAEs (RR [95%CI] = 0.91 [0.67-1.23]) in the BDQ-regimen group. Pooled efficacy outcomes showed significantly superior culture conversion rates at 8-12 weeks (RR [95%CI] = 1.35 [1.10-1.65]) and 24-26 weeks (RR [95%CI] = 1.25 [1.15-1.36]), more treatment success (RR [95%CI] = 1.30 [1.17-1.44]), and a 17-day reduction in the time to culture conversion (standardized mean difference [SMD] [95%CI] = -17.46 [-34.82 to -0.11]) in the BDQ-regimen group (reference: non-BDQ regimen). Overall, BDQ regimens showed significant treatment effect against DR-TB but did not reduce mortality or SAEs.

Keywords: bedaquiline; diarylquinolines; drug-resistant tuberculosis; meta-analysis; systematic review; tuberculosis.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
PRISMA flow chart.
Figure 2
Figure 2
Forest plot of safety outcomes, including (a) all-cause mortality, (b) serious adverse events, and (c) adverse events.
Figure 3
Figure 3
Forest plot of efficacy outcomes, including sputum culture conversion rate at (a) 8–12 weeks and at (b) 24–26 weeks, (c) treatment success, and (d) time to culture conversion (days). SMD, standardized mean difference.
See this image and copyright information in PMC

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