Significantly shorter treatment for drug-resistant TB likely soon

Mumbai: There’s some cheer in store for drug-resistant tuberculosis (DR-TB) patients, who have been abiding a prolonged treatment regimen with severe side-effects

Mumbai: There’s some cheer in store for drug-resistant tuberculosis (DR-TB) patients, who have been abiding a prolonged treatment regimen with severe side-effects. A new treatment which will reduce the existing 18-to-24 months’ regimen to six months, is on the horizon. The drugs too will reduce from 13 to 14 administered daily to a maximum of four to five.

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The present treatment guideline, which has 13 to 14 drugs given daily for a period of 18 to 24 months, was formulated two and a half years ago. The proposed new regimen will be BPaL (Bedaquiline, Pretomanid and Linezolid) and BPaLM (Bedaquiline, Pretomanid, Linezolid and Moxifloxacin), which includes a maximum of three to four drugs daily. While BPaL is for pre- Extensively-Drug-Resistant (pre-XDR) TB patients, BPaLM is for multi-drug-resistant TB patients.

One of the challenges faced in the management of drug-resistant forms of TB has been the highly toxic drugs/antibiotics. The World Health Organisation (WHO) in December 2022 had announced changes in the duration of multi-drug-resistant TB (MDR-TB) treatment from 18-to-24 months to six months.

The core committee of the National TB Elimination Programme (NTEP) submitted the new treatment guideline regimen 20 days ago to the ministry of health and family welfare and the Drugs Controller General of India for approval and implementation. A senior official from the Central TB division—the technical arm of the ministry of health and family welfare—said that the new guideline was being considered by the Union health ministry.

“Currently, the file has been sent for administrative approval to the higher authorities to make policy-level changes,” he said. “No state has been asked to start the regimen as of now even as trials regarding its effectiveness in Indian patients are going on. While WHO recommended its use last year, our technical experts felt that India should generate its own data and make a decision based on the results here.”

The BMC-run Shatabdi Hospital in Govandi is one of the 13 clinical trial sites in five states in the country to conduct the BPaL regimen for pre-Extensively-Drug-Resistant (pre-XDR) patients. Of the 400 patients in the trial, which started in October 2021 and is presently in the analysis stage, 94 are from Mumbai. The hospital will soon be the first in the country to start the trial of BPaLM for multi-drug-resistant TB.

Dr Lancelot Pinto, pulmonologist and epidemiologist at PD Hinduja Hospital, Mahim, said that DR-TB patients had two issues with the present regimen—adherence to a prolonged course of treatment and multidrug toxicity, often contributing to the poor adherence.

“When Bedaquiline isn’t accessible, the present regimen includes daily injections,” he said. “The multiple drug toxicity includes side-effects like hearing loss, peripheral neuropathy, renal problems, depression and suicidal tendencies. Adherence to the treatment with this drug toxicity becomes a huge problem for many patients, as it is a prolonged treatment course.” Dr Pinto added that if the government rolled out a shorter regime, it would be a huge relief, as the shorter regime comprised all oral drugs.

“We have to pilot-test it in India as we don’t know the tolerance and long-term outcomes,” he said. “But this will be a huge step forward, considering the regimen is for six months. Once we start using it, we will know how effective it is.”