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Table 4 Perceived benefits and challenges regarding the treatment of (X)DR-TB with the novel BPaL regimen and practical requirements for implementation

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

  Indonesia Kyrgyzstan Nigeria
Acceptability Anticipated benefits of the BPaL regimen • Shorter duration of treatment
• Lower pill burden
• Absence of injectables
• Reduction AEs
• Shorter duration of AEs
• Expected reduction of treatment costs
• Expected reduction of healthcare facility visits
• Expected increase in quality of life for patients
• Expected increase in treatment adherence
Expected increase likelihood to undergo treatment
Expected reduction of financial burden on patient and health system
Increased treatment success also in PLHIV
Currently low resistance to the drugs in the regimen
Expected reduction of workload for HW
Existing experience with Bdq and Lzd
Expected reduction of TB transmission
• Expected reduction of hospitalization
• Absence of risk of hearing loss
• Expected reduction of workload for HW in hospitals
• Possibility of decentralization of treatment
• Improvement of treatment outcomes
• Expected easier PSCM
• Expected reduction of financial burden on the patient
Challenges related to overall system barriers for effective M/XDR TB management • Concerns regarding lack of capacity for monitoring and management of AE’s, especially in ambulatory care settings
• High rate of LTFU
Relatively high price of locally procured Lzd
Lack of DST capacity for Lzd and Bdq
In some areas insufficient access to Xpert and SL LPA
  • Lack of health insurance coverage
• Lack of coverage of monitoring tests
• Insufficient access to Xpert, SL LPA,
• Lack of DST capacity for Lzd and Bdq
• Insufficient patient and transportation support
• Lack of ancillary drugs
• Lack of attention to DOT
• Lack of community infection control measures
BPaL regimen specific concerns • Concerns about AEs related to high dose Lzd
• Concerns about generalizability of Nix study results to local population, pregnant women, children
• Lack of DST capacity for Pa
Concerns about interaction between Pa and ARV drugs • Uncertainties about BPaL treatment among patients with comorbidities
• Worries about possible high price of Pa
• Worries about lack of salvage regimen
• Lack of experience with Pa among clinicians
• Worries about possible high cost
•Worries about resistance development for BPaL especially if Lzd needs to be stopped
Feasibility Practical requirements for BPaL implementation • International recommendations for use, especially from WHO
• Final study publications, including relapse rate
• Additional evidence on pregnant women, children and in local populations
• Capacity building / training for the monitoring and management of AEs
• Ancillary drugs for management of AEs
• Continuation of counseling, patient support and enablers
Development of capacity for DST for Bdq, Lzd, Pa
Overall strengthening of programmatic management of DR-TB
Strengthening of the laboratory system: increasing access to Xpert testing, SL PLA
Community infection control in case of decentralization of treatment
Ruling from the Advisory Committee to the MoH
Innovative ways for DOT at the home of the patients (video etc.)
• Development of DST capacity for Pa
• Hospitalization for some patients, good ambulatory management for others
• Salvage regimen for failures of BPaL
• Political involvement
• Low price of Pa, especially in relation to transitioning of SLD’s to domestic budgets
• Innovative ways for DOT at the home of the patients (video etc.)
• Development of capacity for DST for Bdq, Lzd, Pa
• Overall strengthening of programmatic management of DR-TB
• Overall strengthening of the laboratory system: increasing access to Xpert testing, SL PLA
• Sufficient patient support / transportation
• Well planned transition to more community-based treatment
• Sufficient funding
• Low price of Pa, for domestic and international procurement
  1. AE adverse event, ARV anti-retroviral, Bdq Bedaquilline, DOT directly observed treatment, DR drug-resistant, DST drug susceptibility testing, HW health workers, LTFU loss to follow-up, Lzd Linezolid, MoH Ministry of Health, Pa pretomanid, PLHIV people living with HIV, PSCM procurement and supply chain management, SLD second-line drugs, SL LPA second-line line probe assay, TB tuberculosis