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Maitri Porecha
India has received 400 doses of crucial anti-Tuberculosis drug Delamanid and is rolling out a pilot for administering the drug in seven States.
“400 multi-drug resistant (MDR) patients from Punjab, Rajasthan, Karnataka, Odisha, Kerala, Lakshadweep are slated to receive Delamanid,” a senior official from the Ministry of Health and Family Welfare (MoHFW) told Businessline. “However, domicile would not be considered as criteria to offer the drug to the eligible patient.”
In MDR-TB, patients stop reacting to first-line TB medications and develop more complicated forms of the disease, where rate of recovery reduces drastically.
One in four patients has developed resistance to at least one of the 13 drugs available to treat the scourge on this date, the first ever drug-resistance survey carried out in India has pointed out.
Pilot basis
India has an estimated 1,47,000 MDR-TB patients, according to the latest World Health Organization TB report. However, only 400 patients will be identified and treated in the pilot, as Delamanid is prescribed to be meted out in a highly individualised regimen to the patient under supervision.
The official further said that two patients from Kerala have already started receiving the drug. India has received Delamanid doses as a donation with the help of the United States Agency for International Development (USAID), which enables foreign aid on behalf of the US government.
Phase-3 trials
In the pilot, all patients will receive 100 mg Delamanid tablets (two tablets of 50 mg) orally twice a day for 24 weeks (6 months) in combination with a regimen of second-line TB drugs.
In phase III trials, conducted by Japanese drugmaker Otsuka Pharmaceuticals Pvt Ltd, Delamanid as well as other drugs were associated with the side-effect of developing QT prolongation or irregular heart beat in a minority of patients. That is why all Indian patients eligible for Delamanid containing regimen will be managed in an in-patient setting — preferably for a period of two weeks to observe tolerance level of the patients to the regimen. “Periodic electrocardiograms and close clinical monitoring for any adverse side-effects will be carried out,” the official explained.
While earlier there had been uncertainty on use of Delamanid, the phase III trial results by Otsuka threw more light on the efficacy of the drug, imply the MoHFW guidelines, which recommend its use in Indian patients. Businessline has reviewed the guidelines. They state that of the two arms of multi-drug resistant (MDR)-TB patients included in the trial, one arm was given Delamanid additionally to the normal drug regimen, while the other arm was given a placebo in addition to the normal regimen. Participants in the Delamanid arm achieved culture conversion (absence of TB bacteria in sputum culture) on average 6-13 days earlier than the placebo arm.
Safety concerns
The guidelines state that although the data from phase III trials were limited, Delamanid may have a protective role in preventing the emergence of additional drug resistance. “The decision to use Delamanid in such regimens should be made by treating clinicians based on individual patient assessment.”
While India has waived off local clinical trials and given approvals for import and use based on European and Japanese data, it has recommended that the pharma company should submit post-marketing surveillance data for periodic safety review and submit the data of monitoring after three years for further review to DCGI’s office.
Even as the Drug Controller General of India (DCGI) had given the nod to administer Delamanid in June last year itself, MoHFW has been reeling under delays to roll the drug out, as it was in the process of training staff, identifying locations and framing guidelines for its administration, another official of the Ministry said.
Otsuka and US-based Mylan Pharmaceuticals had last year entered into a license agreement to commercialise Delamanid for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income countries.
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