A new fixed-dose combination (FDC) of “3HP”, a short-course tuberculosis (TB) preventive treatment (TPT) combining two drugs, rifapentine and isoniazid, is to be rolled out in five TB high burden countries in Africa.
The countries – Ghana, Ethiopia, Kenya, Mozambique, and Zimbabwe, will start providing the FDCs in February and March 2021.
The development is expected to reduce the number of pills that people who need the treatment have to take every week from nine to three and enough treatments for up to three million patients are expected to be made available for eligible countries, this year.
This was contained in a statement jointly issued by Unitaid, The Global Fund, IMPAACT4TB, World Health Organisation, and USAID.
As the result of an agreement concluded by Unitaid, the Clinton Health Access Initiative (CHAI) and the manufacturer of the FDC, Macleods, the statement said, the latter had agreed to offer a ceiling price of US$15 (ex-works) for a three-month patient course of weekly rifapentine and isoniazid.
The statement thanked the IMPAACT4TB project, funded by Unitaid and led by the Aurum Institute, and said other countries were expected to receive supplies with the support of PEPFAR and the Global Fund to Fight HIV, Tuberculosis and Malaria.
The partnership with Macleods would bolster efforts to treat TB infection also known as “latent TB”, currently estimated to affect one-quarter of the world population, by broadening access to shorter and easier to use preventive therapies.
The statement said as part of a wider access strategy to facilitate the introduction of generic rifapentine-based formulations in low- and middle-income countries (LMICs), it would also contribute to moving towards the United Nations High-level Meeting (HLM) target to provide TPT to at least 30 million people by 2022.
Dr Tereza Kasaeva, Director of World Health Organization’s (WHO) Global TB Programme, said: “WHO welcomes the new fixed-dose combination TB preventive treatment that will result in reducing the pill burden for people with TB infection, enabling better adherence and outcomes.
“This collaboration between Unitaid, the Clinton Health Access Initiative and manufacturers has been vital to supporting the uptake of TB preventive treatment as recommended in WHO guidelines. We now look forward to a surge in action from national programmes supported by donors and partners to scale-up access to TB preventive treatment and reach the UN High-Level Meeting targets,” she said.
The statement explained that people with TB infection, often dubbed “latent”, had no symptoms, were not contagious and most did not know they were infected.
It said without treatment, five per cent to 10 per cent of the people would develop active TB, the form, which made people sick and could be transmitted from person to person.
Mr Robert Matiru, Director of the Programme Division at Unitaid, said: “The ceiling price agreement negotiated with Macleods is another example of our commitment to ensure that effective, quality-assured and affordable TB preventive therapies are made available in low- and middle-income countries.
“Beyond this deal, we will continue working hard to ensure a healthy market for all manufacturers that wish to develop and commercialize rifapentine-based products.”
Dr Angeli Achrekar, Acting U.S. Global AIDS Coordinator, reiterated: “The availability of a shorter, more easily tolerated, and safer regimen for TB prevention that is also affordable is critical for accelerating the fight against TB.
“This also has important implications for the HIV response, as TB remains the leading cause of death for people with HIV around the world.”
On the part of Professor Gavin Churchyard, Founder and CEO of the Aurum Institute, 2020 was a hard year for TB prevention and treatment, as many services were disrupted by lockdowns.
“But with the roll-out of this new FDC, alongside the existing formulation provided by Sanofi, I’m feeling a renewed sense of optimism that we can get back on track to meet our ambitious global TB prevention goals. Saving lives is the priority. We lose in the end if COVID-19 mortality goes down, but TB rates go up.”
The statement said in 2019 alone, 10 million people fell ill from TB, which killed close to 1.5 million people, over 95 per cent of whom were living in low- and middle-income countries.
About one-quarter of the world’s population is infected with TB bacilli and most of them do not have the disease and are not contagious.
If left untreated, TB infection may progress to TB disease, the form of TB that makes people sick and is capable of being transmitted from one person to another. TPT regimens like 3HP lower the risk of progression in people at risk.