Evidence for the efficacy of BPaL regimen in DR-TB

Evidence for the efficacy of BPaL regimen in DR-TB
 

• The NIX-TB trial with three drugs Bdq, Pretomanid (Pa) and Lzd [BPaL] (Bdq 400 mg OD for two weeks followed by 200 mg three times a week for 24 weeks, Pa 200 mg daily for 26 weeks, Lzd 1200 mg daily for 26 weeks [six months] and extended to 39 weeks [nine months] if the 4th-month culture was positive) has shown 90% treatment success rate in patients with Pre-XDR-TB (erstwhile XDR-TB) patients and MDR-TB patients with treatment intolerance or nonresponse to standard treatment. 
   
• A study on the acceptability and feasibility of the BPaL regimen from the provider’s perspective was considered relevant evidence for the assessment of BPaL and indirectly for the assessment of BPaLM (13). This was a mixed-methods study among a cross-section of healthcare workers, programmatic and laboratory stakeholders carried out between May 2018 and May 2019 in Indonesia, Kyrgyzstan, and Nigeria.The results from this study suggested that acceptability and feasibility overall were high. BPaL was rated as acceptable by 93% across domains of study participants, and 88% of interviewed stakeholders stated that they would likely implement BPaL once available.

The Indian Council of Medical Research (ICMR) conducted health technology assessment (HTA) for cost-effectiveness of BPaLM/ BPaL treatment regimen for MDR/RR-TB and following key observations were reported:

1. Emerging global evidence suggests that 6-month Bedaquiline containing regimens like BPaL and BPaLM are cost-effective, and improve compliance and clinical outcomes in drug resistant TB patients.
2. HTA assessment of the regimens conducted by DHR, as compared to currently deployed protocols, concludes that the BPaL/BPaLM regimens are cost effective.
3. Pragmatic uptake of the above regimens could improve treatment success rate for MDR/RR-TB and free up resources for investment in other areas of TB programme.
4. Hence, introduction of BPaL and BPaLM regimens in the TB elimination mission merits consideration on priority. This could be a game-changing refinement of our efforts in making our nation TB-Mukt.