Centre to roll out new drug to tackle latent tuberculosis

Mumbai: Patients with latent tuberculosis infection (LTBI) can expect a more effective, safer and simpler treatment soon. In keeping with its objective of eliminating the dreaded disease by 2025, the government, through the National TB Control Programme, is planning to roll out a new drug combination therapy for LTBI. For this purpose, Union health ministry has recently allowed drug major Sanofi to import Rifapentine into the country, subject to certain riders, official sources told TOI.

Rifapentine, a once-a-week drug regimen for three months to treat LTBI, is on the World Health Organisation’s Essential List and is approved in US and other countries.

Treatment of LTBI is an important component in elimination of TB, with nearly 40% of Indians estimated to be latently infected. Presently, many with LTBI do not complete the treatment as the duration is too long — six to nine months of daily pills.

Experts say the rollout of Rifapentine and other logistics are subject to approval from Revised National Tuberculosis Control Programme (RNTCP). The government-monitored RNTCP distributes TB drugs through its designated centres.

“Although latent TB can be treated to prevent progression to active TB, LTBI treatment programs have always struggled to ensure treatment completion. This is because using drug Isoniazid for six to nine months was the most common treatment. To overcome this problem, shorter drug regimens have been shown to be effective in clinical trials. One such regimen is called 3HP, which includes Isoniazid (H) and Rifapentine (P), given once a week for three months. But the challenge is access. Rifapentine is not registered in most countries. Concerns have been raised about pricing of Rifapentine, although the situation today is better than it was in the past,” Dr Madhukar Pai, director of Canada’s McGill International TB Centre, said.

The approval was given in a recent meeting of Central Drugs Standard Control Organization’s technical committee, set up to supervise clinical trials of new chemical entities. It noted an unmet need for Rifapentine and hence recommended approval in public interest with a waiver to conduct local clinical trials. The approval is subject to certain conditions: the drug would be available only through the National TB Control Programme and the company will need to conduct Phase IV clinical trials.

Details regarding pricing of the drug could not be obtained. However, Sanofi reportedly markets it at $32 per blister pack of 32 tablets for US public health programs.

When contacted, a Sanofi spokesperson said the company has received a Phase III clinical trial waiver for product Priftin (Rifapentine), based on factors such as the drug’s safety and efficacy profile, it’s WHO pre-qualification, successful use in treating latent TB in other countries, and requirement for public health in India, which has the highest global burden of TB cases.