Acceptability, feasibility, and likelihood of stakeholders implementing the novel BPaL regimen to treat extensively drug-resistant tuberculosis patients.

BACKGROUND: BPaL, a 6 month oral regimen composed of bedaquiline, pretomanid, and linezolid for treating extensively drug-resistant tuberculosis (XDR-TB) is a potential alternative for at least 20 months of individualized treatment regimens (ITR). The ITR has low tolerability, treatment adherence, and success rates, and hence to limit patient burden, loss to follow-up and the emergence of resistance it is essential to implement new DR-TB regimens. The objective of this study was to assess the acceptability, feasibility, and likelihood of implementing BPaL in Indonesia, Kyrgyzstan, and Nigeria. METHODS: We conducted a concurrent mixed-methods study among a cross-section of health care workers, programmatic and laboratory stakeholders between May 2018 and May 2019. We conducted semi-structured interviews and focus group discussions to assess perceptions on acceptability and feasibility of implementing BPaL. We determined the proportions of a recoded 3-point Likert scale (acceptable; neutral; unacceptable), as well as the overall likelihood of implementing BPaL (likely; neutral; unlikely) that participants graded per regimen, pre-defined aspect and country. We analysed the qualitative results using a deductive framework analysis. RESULTS: In total 188 stakeholders participated in this study: 63 from Kyrgyzstan, 51 from Indonesia, and 74 from Nigeria The majority were health care workers (110). Overall, 88% (146/166) of the stakeholders would likely implement BPaL once available. Overall acceptability for BPaL was high, especially patient friendliness was often rated as acceptable (93%, 124/133). In contrast, patient friendliness of the ITR was rated as acceptable by 45%. Stakeholders appreciated that BPaL would reduce workload and financial burden on the health care system. However, several stakeholders expressed concerns regarding BPaL safety (monitoring), long-term efficacy, and national regulatory requirements regarding introduction of the regimen. Stakeholders stressed the importance of addressing current health systems constraints as well, especially in treatment and safety monitoring systems. CONCLUSIONS: Acceptability and feasibility of the BPaL regimen is high among TB stakeholders in Indonesia, Kyrgyzstan, and Nigeria. The majority is willing to start using BPaL as the standard of care for eligible patients despite country-specific health system constraints.

[Use of biological microchips in the determination of drug-resistance of Mycobacterium tuberculosis to rifampicin].

The present-day problems in tuberculosis control are associated with a difficulty in detecting Mycobacterium tuberculosis (MBT) in due time and in determining its drug sensitivity by conventional microbiological assays. The determination of the drug sensitivity of MBT takes much time from 2 weeks to 3 months, which fails to initiate and perform specific therapy timely. Molecular genetic techniques, including biochip analysis, yield results in 24-48 hours, which solves the problem of choosing and initiating adequate antibacterial therapy in the shortest possible time after tuberculosis is diagnosed. To assess the situation associated with the prevalence of rifampicin-resistant tuberculosis, by using the biochip analysis, the authors have examined 501 patients with tuberculosis who live in the Kyrghyz Republic. Drug resistance has been found in 40.3% of the examinees. At the same time, their primary and secondary drug resistance is 25.7 and 61.8%, respectively. In tuberculosis patients living in Kyrghyzstan, rifampicin resistance of MBT is more frequently due to mutations in 531 (59.2%), 526 (20.8%), and 516 (8.0%) codons in the rpoB gene.