By Sharon Atieno
A new fixed dose combination (FDC) treatment for tuberculosis(TB) will be rolled out in five high burden countries in Africa-Ethiopia, Ghana, Kenya, Mozambique and Zimbabwe.
The treatment which is a combination of two drugs- rifapentine and isoniazid- will reduce the number of pills taken by people with TB infection every week from nine to three and is expected to cater for a maximum of three million patients.
People with TB infection, often dubbed latent, have no symptoms, are not contagious and most do not know they are infected. Without treatment, 5% to 10% of these people will develop active TB, the form which makes people sick and can be transmitted from person to person.
Though 12 countries are being targeted before the year ends, the five selected will be offered the new regimen at USD 15 for a three-month patient course. The treatment will be provided as from February and March, 2021.
The partnership between Unitaid, the Clinton Health Access Initiative (CHAI) and the manufacturer, Macleods, will strengthen efforts to treat TB infection, also known as latent TB- currently affects a quarter of the world’s population-by broadening access to shorter and easier to use preventive therapies.
As part of a wider access strategy to facilitate the introduction of generic rifapentine-based formulations in low- and middle-income countries (LMICs), it will contribute to move towards the United Nations High-level Meeting (HLM) target to provide TB preventive treatment (TPT) to at least 30 million people by 2022.
In a statement, Dr Tereza Kasaeva, Director of World Health Organization’s (WHO) Global TB Programme welcoming the new treatment noted that it will reduce the pill burden for people with TB infection, enabling better adherence and outcomes.
She added that the collaboration was vital to support the uptake of TPT as recommended in WHO guidelines and were looking forward to a surge in action from national programmes supported by donors and partners to scale-up access to TPT and reach the UN High-Level Meeting targets.
The USD 15 price will be available to government institutions in 138 LMICs, as well as for the international organizations in charge of the procurement.
“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 LMICs,” said Robert Matiru, Director of the Programme Division at Unitaid.
“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.”
The first phase of the access strategy resulted in a price discount offer by Sanofi for rifapentine 150 milligram tablets (Priftin®), announced in 2019, lowering a patient treatment course of Priftin® from US$45 to US$15.
“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,” said Dr. Angeli Achrekar, Acting U.S. Global AIDS Coordinator, noting that it also had important implications for the HIV response, as TB remains the leading cause of death for people with HIV around the world.
“2020 was a hard year for TB prevention and treatment, as many services were disrupted by lockdowns,” said Prof. Gavin Churchyard, founder and CEO of the Aurum Institute.
“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.”
With the FDC, a complete course of treatment for eligible adults is included in one box, addressing many concerns about the pill burden of 3HP and ensuring that TPT can be provided conveniently for individuals at risk for TB.
With this more convenient product in hand that is easier to dispense, take and adhere to, the IMPAACT4TB consortium members are now working to accelerate the delivery of 3HP in 12 high TB burden countries in Africa, Asia, and South America.