Central Idea

The interim results of a randomized phase-3/4 trial conducted in India to evaluate the safety and effectiveness of BPaL Regimen, an all-oral, short-course treatment are promising.
BPaL is administered for individuals with pre-XDR TB or treatment-intolerant/non-responsive MDR pulmonary TB

What is BPaL?

The trial uses only three drugs—Bedaquiline, Pretomanid, and Linezolid (BPaL).
The treatment duration is only 26 weeks, contrasting with the conventional 18-month treatment involving eight to nine tablets per day.

It offered a significantly reduced number of tablets per day, resulting in better treatment adherence and improved outcomes.
Approximately 70% of the trial participants have completed the 26-week treatment, with a cure rate exceeding 85%.
In comparison, the cure rate for conventional treatment for DR-TB is 60-65% even with strict adherence.

Advanced TB Cases: The trial participants had advanced TB affecting both lungs, yet the cure rate was above 85%, demonstrating the superiority of the BPaL short-course therapy.
Importance of Early Diagnosis: Early diagnosis and initiation of treatment with the three-drug regimen can lead to even better outcomes for patients with pre-XDR TB.

Three to four trial participants experienced serious adverse effects, but these were either managed or occurred too late in the disease’s progression to be helped.
Some cases of mild adverse effects caused by linezolid included a drop in haemoglobin and platelet counts, as well as neuropathy (tingling sensation and numbness in the legs).

Total TB Cases: In 2021, there were approximately 21.3 lakh (2.13 million) reported TB cases in India.
Incidence Rate: The incidence rate of TB in India in 2021 was 210 cases per lakh population.
Drug-Resistant TB: The number of drug-resistant TB cases in India declined from around 1.49 lakh in 2015 to 1.19 lakh in 2021.
Government Initiatives: To combat TB, India has set the target of eliminating the disease by 2025, and various initiatives have been implemented, including active case finding, screening, and improved access to diagnostic tests and treatment.

XDR TB (Extensively Drug-Resistant TB)	Treatment-Intolerant/Non-Responsive MDR Pulmonary TB
Resistant to most effective first-line and some second-line TB drugs.	Patient cannot tolerate prescribed medications or infection does not respond to treatment.
More dangerous and difficult to treat than MDR TB.	Requires exploration of alternative treatment regimens.
Limited treatment options, higher mortality, and increased transmission risk.	Adjustments in drug combinations or dosages may be needed.
Spreads rapidly, posing a serious public health threat.	Crucial to prevent development of extensively drug-resistant strains.
Requires preventive measures and early diagnosis.	Identifying reasons for treatment intolerance and providing support.