India is one of the countries which has the highest incidence of TB in the world, leading to an over 60% reduction in usage of the medicine. Now, to curb the existing scenario, a new, simple and more affordable treatment for latent tuberculosis are on the way!
A Mumbai-based pharma company Macleods pharma is all set to become the first company at a global level to create a novel-fixed dose of a combination drug to prevent latent TB infection from progressing to an active one. The combination drug has been recommended for preventing latent TB infection in people living with HIV (PLHIV), and household contacts, in high TB countries.
At present, household contacts, basically people who can be exposed to TB in normal settings, are now advised by WHO to take TB preventive therapy. With the launch of this drug, a substantial part of the population exposed to latent TB infection, household contacts will also be able to access treatment.
Isoniazid is the standard treatment of LTBI (latent TB infection) at present. It is taken daily for six to nine months only for PLHIV. Another course is taking two drugs, Rifapentine and Isoniazid together, for a specific period. Rifapentine has been recently registered in India by Sanofi and will be rolled out next year.
Macleods FDC, which contains Rifapentine and Isoniazid, will lead to an over 65% reduction in pill burden- 36 tablets vs 108 tablets over current single drugs and 80% over IPT (36 tablets vs 180 tablets). With its introduction, patients’ pill burden will substantially reduce, while compliance will improve.
In a report published by Times Of India, Vijay Agarwal, business development director of Macleods, said: “In our pursuit to provide novel and patient-friendly treatment for tuberculosis, we will soon introduce the first fixed-dose combination tablet of rifapentine and isoniazid. We will launch this product in high burden countries, including India by Q1, 2020 at an affordable price. We have asked the government for a waiver of Phase 3 clinical trials.”
The regimen referred to as 3HP, consists of Rifapentine and Isoniazid, once a week for 12 weeks. Though the US recommended this treatment for latent TB infection in 2011, there is no company which has made the fixed-dose combination till now, experts say.
While India carries the highest-burden with an estimated 2.7 million TB cases in 2018, more alarming is the possibility of a large pool of people harbouring the ‘silent infection.’ About 35-40% of the country’s population may have latent TB infection. Latent TB occurs when a person has the TB bacteria within their body, but it is present in very small numbers and does not cause any symptoms. It is recommended that only certain “target” groups, within those with latent TB infections, shall receive treatment.

Source: Times Of India.

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