HYDERABAD, INDIA – A Global Fund to Fight AIDS, Tuberculosis and Malaria, Unitaid and pharmaceutical company agreement will reduce the price of a three-month course of rifapentine – a key drug used in preventive therapy against tuberculosis – by 66% in 100 low- and middle-income countries, officials from Unitaid and pharmaceutical company Sanofi announced here today.
The reduction in price from $45 to $15 will pave the way for countries with high TB prevalence to rapidly scale up access to shorter, well-tolerated regimens to prevent progression to active tuberculosis disease among people latently infected, including the 3HP regimen consisting of a once-weekly dose of rifapentine and isoniazid for 12 weeks. Shorter courses that include 3HP and 1HP – once-daily rifapentine and isoniazid for one month – offer a critical improvement over the standard latent TB treatment of once-daily isoniazid for six to nine months, researchers said.
While more than 1.7 billion people globally are infected with the tuberculosis bacteria, Robert Matiru of Unitaid said, only 1.8 million people are on preventative therapy – a fraction of the UN High Level Meeting on Ending TB target of treating latent infection in 30 million people by 2023. The price reduction removes a significant barrier that has kept better TB prevention regimens out of reach for those who need them most, Matiru said.
While TB treatment advocates issued a joint statement calling the agreement “a major step” toward preventive treatment access for people at risk, they added that other factors limiting access to rifapentine also must be addressed. These include lack of registration for rifapentine with national regulatory authorities in the vast majority of the 100 countries eligible for the discount, and a lack of generic, patient-friendly and pediatric formulations of 3HP and 1HP.
While currently rifapentine is available in just eleven countries, including high tuberculosis prevalence countries China and India, it will be available in 12 more high prevalence countries starting early next year, Matiru said.
South Africa aims to rapidly scale up access to 3HP in the second quarter of 2020, Matiru said, while dozens more countries have indicated scaling up access to rifapentine as a priority. Ministries of Health are currently working with Ministries of Finance to find the money to roll out rifapentine, he said, while the Global Fund and the President’s Emergency Plan for AIDS Relief are working on identifying partner countries that would be able to support rapid scale up, he said. Several countries in sub-Saharan Africa and Southeast Asia have been identified so far, he said.
The U.S. President’s Emergency Plan for AIDS Relief, which has allocated $24.7 million for TB preventative therapy commodities in its 2019 Country Operational Plans and aims to initiate 4.6 million people living with HIV on preventative therapy in 2020, is currently reviewing the program’s budget to determine the locations and amounts of scale up that can be supported, Matiru said.
Tuberculosis treatment advocates worry that Sanofi’s supply of rifapentine won’t meet the demand, noting in their statement the company currently manufactures the drug at a single facility in Italy. Matiru noted Unitaid in collaboration with other partners is in advanced negotiations with a generic manufacturer to ensure supply of a second, affordable rifapentine-containing regimen in 2020.