New patient-friendly tuberculosis preventive therapy to be rolled out in five countries

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Tuberculosis
Tuberculosis

• Fixed-dose combination treatments reduce the pill burden from nine to three pills a week for adults and prevent TB in those at highest risk of developing the disease

• Ethiopia, Ghana, Kenya, Mozambique, and Zimbabwe will be the first countries out of a total of 12 to provide the new regimen at a US$15 price thanks to funding from Unitaid, PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria

A new fixed-dose combination (FDC) of “3HP”, a short-course tuberculosis preventive treatment (TPT) combining two drugs, rifapentine and isoniazid, is starting to be rolled out in five TB high burden countries in Africa. This will reduce the number of pills that people who need the treatment have to take every week from nine to three. Enough treatments for up to 3 million patients are expected to be made available for eligible countries this year.

As the result of an agreement concluded by Unitaid, the Clinton Health Access Initiative (CHAI) and the manufacturer of the FDC, Macleods, the latter has agreed to offer a ceiling price of US$15 (ex works) for a three-month patient course of weekly rifapentine and isoniazid. Thanks to the IMPAACT4TB project funded by Unitaid and led by the Aurum Institute, five initial countries from a total of 12 targeted by the end of the year, will start providing the FDCs in February and March 2021: Ethiopia, Ghana, Kenya, Mozambique, and Zimbabwe. Other countries are expected to receive supplies with the support of PEPFAR and the Global Fund to Fight HIV, Tuberculosis and Malaria.

The partnership with Macleods will 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. 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 target to provide TPT to at least 30 million people by 2022.

“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,” said Dr Tereza Kasaeva, Director of World Health Organization’s (WHO) Global TB Programme. “This collaboration between Unitaid, the Clinton Health Access Initiative and manufacturers has been vital to support 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.”

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.

The agreement establishing the US$15 price and other access conditions was concluded by Unitaid, the Clinton Health Access Initiative (CHAI) and Macleods. The 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 low and middle-income countries,” 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. “This also has important implications for the HIV response, as TB remains the leading cause of death for people with HIV around the world.”

With both Sanofi and Macleods expected to ramp up their production in 2021, Unitaid expects that there will be global availability of enough 3H to reach more than 3 million patients in eligible countries this year, across both manufacturers.

“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.

Additional quotes

“The availability of this new fixed-dose combination is good news for everyone, especially patients and their families,” said Ahmed Bedru, KNCV Tuberculosis Foundation country representative for Ethiopia. “Getting people to adhere to a treatment when they are not sick has always been a challenge. The lower number of pills — three pills versus nine pills for an adult — means the treatment is now easier to take, stick to and complete.”

“I’ve started to notice patients taking their medication without difficulties or complaints,” said Dr. Tafadzwa Priscilla Sibanda, Medical Director of the Mpilo Centre and a public health specialist working with the AIDS Healthcare Foundation in Zimbabwe. “It really helps that the 3HP regimen is short. When we explain the doses to patients, they can see the light at the end of the tunnel, and they are encouraged knowing that they will complete the course within 12 weeks.”

“Adherence is always a challenge, especially when people have to take many pills for long periods of time. But 3HP is changing that. The FDC allows patients to take just three pills once a week for 12 weeks. This will be so much better,” said Dr. Pereira Zindoga, a clinician with the Mozambique Ministry of Health’s National TB Program.

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