The interim results of a randomised phase-3/4 trial carried out in India to evaluate the safety and effectiveness of an all-oral, short-course treatment using just three drugs for people with pre-XDR TB or treatment intolerant/non-responsive MDR pulmonary TB appears promising.
The trial, which has enrolled 400 participants in all, began in October 2021 and is under way at eight sites across the country. The last of the 400 participants was enrolled in end-February 2023. The trial uses just three drugs — bedaquiline, pretomanid and linezolid (BPaL) — and the treatment lasts only for 26 weeks, in contrast to eight-nine tablets each day for 18 months in the case of conventional treatment for drug-resistant TB. While pretomanid and linezolid drugs have to be taken every day for 26 weeks, bedaquiline is to be taken daily for the first fortnight and then every alternate day for 24 weeks.
In all, a person with pre-XDR TB on BPaL regimen will consume over 500 tablets over 26 weeks compared with over 4,300 tablets over 18 months with conventional treatment for drug-resistant TB. The more the number of tablets a day and longer the treatment duration the lower will be the treatment adherence, thus resulting in poor outcomes. This is where the BPaL regimen, which has been approved by the WHO but yet to be implemented in India, becomes superior. India is targeting to reduce TB incidence by 80% and TB deaths by 90% by 2025.
