Scoping review: QT interval prolongation in regimen containing bedaquiline and delamanid in patients with drug-resistant tuberculosis

Putra, Oki Nugraha; Yulistiani, Yulistiani; Soedarsono, Soedarsono

doi:10.4103/ijmy.ijmy_178_22

Cited by 3 publications

(1 citation statement)

References 34 publications

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“…Unfortunately, second-line anti-TB drugs are known to cause QT interval prolongation, including bedaquiline, clofazimine, fluoroquinolones, and delamanid. At least two, and often three such agents are used together in recommended regimens ( 5 – 7 ). In the initial C208 phase IIB study on the efficacy and safety of bedaquiline, the more frequent QT prolongation events and deaths in the bedaquiline arm brought this issue to the fore for RR-TB treatment ( 8 ).…”

Section: Introductionmentioning

confidence: 99%

How much should we still worry about QTc prolongation in rifampicin-resistant tuberculosis? ECG findings from TB-PRACTECAL clinical trial

Motta,

Cusinato,

Ludman

et al. 2024

Antimicrob Agents Chemother

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Regimens for the treatment of rifampicin-resistant tuberculosis currently rely on the use of QT-prolonging agents. Using data from the randomized controlled trial, TB-PRACTECAL, we investigated differences in QTcF among participants in the three interventional arms: BPaL (bedaquiline, pretomanid, and linezolid), BPaLC (BPaL with clofazimine), and BPaLM (BPaL with moxifloxacin). Additionally, we assessed whether age, body mass index, and country were causally associated with QTcF prolongation. The trial included participants from South Africa, Uzbekistan, and Belarus. A post hoc analysis of electrocardiogram data was undertaken. Random effects regression was used to model QTcF longitudinally over 24 weeks and causal frameworks guided the analysis of non-randomized independent variables. 328 participants were included in BPaL-based arms. The longitudinal analysis of investigational arms showed an initial QTcF steep increase in the first week. QTcF trajectories between weeks 2 and 24 differed slightly by regimen, with highest mean peak for BPaLC (QTcF 446.5 ms). Overall, there were 397 QTcF >450 ms (of 3,744) and only one QTcF >500 ms. The odds of QTcF >450 ms among participants in any investigational arm, was 8.33 times higher in Uzbekistan compared to Belarus (95% confidence interval: 3.25–21.33). No effect on QTcF prolongation was found for baseline age or body mass index (BMI). Clinically significant QTc prolongation was rare in this cohort of closely monitored participants. Across BPaL-based regimens, BPaLC showed a slightly longer and sustained effect on QTcF prolongation, but the differences (both in magnitude of change and trajectory over time) were clinically unimportant. The disparity in the risk of QTc prolongation across countries would be an important factor to further investigate when evaluating monitoring strategies. CLINICAL TRIALS This study is registered with ClinicalTrials.gov as NCT02589782 .

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Section: Introductionmentioning

confidence: 99%

How much should we still worry about QTc prolongation in rifampicin-resistant tuberculosis? ECG findings from TB-PRACTECAL clinical trial

Motta,

Cusinato,

Ludman

et al. 2024

Antimicrob Agents Chemother

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Monitoring medication adherence using smart digital technology in patients with pulmonary tuberculosis

Setiyowati,

Firdaus,

Wardani

et al. 2024

Healthc Low-resour S

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Pulmonary tuberculosis cases can arise due to various factors, including treatment fatigue resulting from prolonged therapy, insufficient patient knowledge about the condition, geographical distance between patients’ residences and healthcare facilities, a lack of reminders from healthcare workers regarding medication adherence, and the perception that treatment provided at community health centers may be inadequate. This study aimed to investigate the effectiveness of digital smart applications in enhancing medication adherence among pulmonary tuberculosis patients. Utilizing a trial survey approach, the research focused on patients seeking treatment at the Surabaya Community Health Center. Smart digital applications were employed to monitor medication adherence, with patients inputting their data via cell phones. The study recorded data over one month and found that while some patients struggled to operationalize the smart digital application, many were able to utilize it effectively. Overall, the findings suggest that smart digital applications can be valuable tools for monitoring medication adherence among pulmonary tuberculosis patients, particularly for older adults.

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Favorable Outcome of Individual Regimens Containing Bedaquiline and Delamanid in Drug-Resistant Tuberculosis: A Systematic Review

Yulistiani

Putra

Soedarsono

et al. 2023

The International Journal of Mycobacteriology

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Background: Drug-resistant tuberculosis (DR-TB) is a public health concern that is difficult to treat, requiring long and complex treatment with highly effective drugs. Bedaquiline and/or delamanid have already shown promising outcomes in patients with DR-TB, increasing the rate of culture conversion and lowering TB-related mortality. Methods: We comprehensively searched and evaluated the effectiveness of individual regimens containing bedaquiline and delamanid on culture conversion and treatment success. We assessed for quality either observational or experimental studies. Results: We identified 14 studies that met the inclusion criteria using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flowchart with 12 observational and 2 experimental studies. Of 1691 DR-TB patients enrolled in the included studies, 1407 of them concomitantly received regimens containing bedaquiline and delamanid. Overall multidrug resistant (MDR), preextensively drug resistant (XDR), and XDR-TB were seen in 21.4%, 44.1%, and 34.5%, respectively. Of 14 studies, 8 of them reported favorable outcomes including sputum culture conversion and cure rate at the end of treatment, meanwhile 6 studies only reported sputum culture conversion. Sputum culture conversion at the end of the 6th month was 63.6%–94.7% for observational studies, and 87.6%–95.0% for experimental studies. The favorable outcome at the end of treatment was 67.5%–91.4%. With high pre-XDR and XDR cases among DR-TB patients with limited treatment options, regimens containing bedaquiline and delamanid provide successful treatment. Conclusion: In DR-TB patients receiving regimens containing bedaquiline and delamanid, favorable outcomes were high including sputum conversion and cure rate.

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Scoping review: QT interval prolongation in regimen containing bedaquiline and delamanid in patients with drug-resistant tuberculosis

Cited by 3 publications

References 34 publications

How much should we still worry about QTc prolongation in rifampicin-resistant tuberculosis? ECG findings from TB-PRACTECAL clinical trial

How much should we still worry about QTc prolongation in rifampicin-resistant tuberculosis? ECG findings from TB-PRACTECAL clinical trial

Monitoring medication adherence using smart digital technology in patients with pulmonary tuberculosis

Favorable Outcome of Individual Regimens Containing Bedaquiline and Delamanid in Drug-Resistant Tuberculosis: A Systematic Review

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