Discarding concerns of efficacy with a lower dose, a three-drugs-based new treatment regimen has a higher success rate than the existing drug-resistant TB treatment, says the latest ZeNix study published in the New England Journal of Medicine.
The “bedaquiline-pretomanid-linezolid” regimen, abbreviated as the BPaL regimen, has been reported to have around 90% efficacy against highly drug-resistant tuberculosis, but the incidence of adverse events with 1,200 milligrams of linezolid daily has been high.
According to the trial titled “Bedaquiline-Pretomanid-Linezolid Regimens for Drug-Resistant Tuberculosis” published on September 1, “A total of 84 to 93% of the participants across all four bedaquiline-pretomanid-linezolid treatment groups had a favourable outcome.”
The new trial was conducted to find the appropriate dose of linezolid, one of the three medicines in the regimen, and the duration of treatment with this agent to minimise toxic effects while maintaining efficacy against highly drug-resistant tuberculosis.
The study found that the latest treatment has shown a favourable outcome even with half the dose.
The study concluded that the overall risk-benefit ratio favoured the group that received the three-drug regimen with linezolid at a dose of 600 mg for 26 weeks, with a lower incidence of adverse events reported and fewer linezolid dose modifications.
It has been found that peripheral neuropathy is one of the most commonly observed side effects of linezolid.
“Risk factors for the development of neuropathy include the duration and dose of linezolid treatment, coexisting conditions, nutritional status, the use of concurrent medications, and possibly genetic factors,” says the report.
What is BPal?
A new drug for TB is finally in the process of a global roll-out, including in India. Developed by a non-profit organisation, TB Alliance, pretomanid is the newest anti-TB drug, prescribed as part of the BPaL regimen, which includes bedaquiline and linezolid.
Medical practitioners believe that this new drug in the BPaL combination will cut short the treatment duration by half (and more), and reduce the amount of medication an MDR-TB patient must take during treatment.
From a treatment duration range of 18 to 24 months, BPaL is likely to bring down the time to around 6 months.
Furthermore, the older “all oral drug regimen” included nearly 14 different anti-TB drugs for a patient to take every day.
With BPaL, it is likely to take just three daily tablets. A shorter regimen, which is all oral and requires fewer doses per day, makes it easier for a patient to adhere to and complete treatment.
Why is BPal important for India?
The introduction of the new drug as part of the BPaL regimen comes at a time when data from the India TB Report has revealed that the situation for drug-resistant forms of TB or multi-drug resistant TB needs urgent mitigation.
According to the Global TB Report 2021, the mortality rate due to all forms of TB between 2019 and 2020 increased by 11% in India. In absolute numbers, the total number of estimated deaths from all forms of TB, excluding HIV, for 2020 was 4.93 lakhs (4.53-5.36 lakhs) in the country, 13% higher than the 2019 estimate. India is also one of the top high-burden countries for TB, HIV-associated TB, and MDR/RR-TB, as estimated by the WHO for 2021–2025.
Recognising the disruptive potential of BPaL, the WHO has also shared rapid communication for TB treatment to allow for the programmatic implementation of BPaL. The US Food and Drug Administration (FDA) also approved pretomanid in August 2019.
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