Five African Countries To Pilot New Short-Course TB Therapy, Which Can Put World On Track To End TB Malaria & Neglected Diseases 04/02/2021 • Paul Adepoju Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Doctors reviewing a patient’s medication in a rural TB clinic in South Sudan. IBADAN, NIGERIA — A new fixed-dose combination (FDC) tuberculosis (TB) treatment could improve the ease of treatment regimes, increase the availability of treatments, and get the world back on track to achieve the goal of ending TB. The short-course preventative treatment, consisting of two drugs – rifapentine and isoniazid – will reduce the pill burden from nine to three pills a week for adults and will be first rolled out in five TB high burden countries: Ethiopia, Ghana, Kenya, Mozambique, and Zimbabwe, beginning in February and March. According to the World Health Organisation (WHO), about 1.4 million people died from TB-related illnesses in 2019. Of the estimated 10 million people who fall ill with TB every year, some 3 million are underdiagnosed or underreported, preventing them from receiving adequate care and treatment. World map of the countries that had at least 100 000 incident cases of TB in 2019. Dr Tedros Adhanom Ghebreyesus, WHO Director General, described equitable access to quality and timely diagnosis, prevention, treatment and care as major current challenges. “Accelerated action is urgently needed worldwide if we are to meet our targets by 2022,” Tedros said. New TB Treatment to Reduce Pill Burden The large number of pills that a patient is required to take in the current treatment regimen has been a major bottleneck, making it difficult for many individuals living with tuberculosis to stick to the treatment plan as recommended by health authorities. Under the new TB therapy, rolled out through a partnership between Unitaid, the Clinton Health Access Initiative (CHAI), and Macleods, a pharma company, the number of pills required for treatment reduces from nine to three. The fixed-dose combination tablets, which include rifapentine and isoniazid. Dr. Pereira Zindoga, a clinician with the Mozambique Ministry of Health’s National TB Program noted that adherence has always been a challenge for patients with TB, especially when people have to take many pills for long periods of time. “This is changing. The FDC allows patients to take just three pills once a week for 12 weeks. This will be so much better,” Zindoga said. Efforts to treat latent TB, a specific form of TB where individuals have no symptoms, are not contagious and often don’t know they are infected, will be strengthened by this partnership. Global data shows that without treatment, up to 1 in 10 of these people will develop active TB, the form which makes people sick and can be transmitted to others. By creating a more affordable, accessible, shorter and more easily tolerated regimen, patients with latent TB could have fewer difficulties with accessing and adhering to the treatment program. “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,” said Ahmed Bedru, KNCV Tuberculosis Foundation country representative for Ethiopia. In addition, with fewer drugs required, treatments could be provided to more people. In 2021 alone, enough treatments for up to 3 million patients are expected to be made available for countries that are eligible for the new fixed-dose combination. Partnership Helps Make Progress on Global TB Targets This treatment and partnership, combined with the effort to introduce generic TB medications in low- and middle-income countries, could contribute to moving towards the UN High-level Meeting target to provide TB preventative treatments to at least 30 million people by 2022. Progress towards global TB targets as of late 2019. WHO has thrown its weight behind the new treatment plans. Dr Tereza Kasaeva, Director of the WHO Global TB Programme, said the global health body welcomes the new fixed-dose combination TB preventive treatment, noting that it 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 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,” Kasaeva said. The manufacturer of the FDC, Macleods, agreed to offer a ceiling price of US$15 for a three-month patient course of weekly rifapentine and isoniazid, making this an affordable treatment for low- and middle-income countries. The agreement joins one announced in 2019 between Unitaid, the Global Fund to Fight AIDS, Tuberculosis and Malaria and Sanofi, a biopharmaceutical company, to lower the price of rifapentine by nearly 70% for the governments of 100 countries burdened by TB and TB/HIV coinfection. “Effective TB prevention will be a game-changer in the global fight to eliminate one of the major killer diseases,” said Unitaid’s Executive Director Lelio Marmora. “This life saving drug has, until now, been completely unaffordable in developing countries. This agreement will help transform political commitment to tangible action.” A total of 12 countries are expected to start receiving the treatment before the end of the year, while the five pilot countries will begin in February and March through IMPAACT4TB, a four-year project introducing a new way to tackle latent TB infection, that is funded by Unitaid and is led by the Aurum Institute. Other countries are expected to receive supplies with the support of PEPFAR and the Global Fund to Fight HIV, Tuberculosis and Malaria. TB, HIV and COVID-19 Although TB on its own is a disease of major public and global health concern, it is also often seen in the light of the HIV pandemic, since the risk of co-infection with HIV and TB is high, particularly in high burden regions. Dr. Angeli Achrekar, Acting U.S. Global AIDS Coordinator, noted that this agreement also has important implications for HIV/AIDS programmes. “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,” Achrekar said. The COVID-19 pandemic has disrupted numerous TB programmes and services worldwide, threatening the progress made and potentially worsening outcomes in patients and creating new challenges. But Professor Gavin Churchyard, founder and CEO of the Aurum Institute, argued that the emergence of preventive and short-course therapy could quickly get the world back on track to meet the goals of TB prevention and control. “2020 was a hard year for TB prevention and treatment, as many services were disrupted by lockdowns,” said Churchyard. “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.” Instead of having patients visiting a health center to replenish their TB drug supply, a complete course of treatment for eligible adults is now included in one box, which also ensures that prevention therapy can be provided conveniently for individuals at risk for TB. Even as advancements in closing TB treatment gaps continue to be made, Dr Osman Eltayeb, Country Representative of Damien Foundation, a key partner for TB case detection and management in Nigeria, told Health Policy Watch that a major challenge that still exists in the global fight against TB is case finding in TB high burden countries like Nigeria. “It appears that we are going to meet the set targets for treatment outcomes but we may never close the gap of case finding,” he told Health Policy Watch. Trends in monthly notifications of TB cases during the COVID-19 pandemic. WHO modelling suggests that a 50% drop in TB case detection over 3 months could result in 400 000 additional TB deaths in 2020 alone. Image Credits: WHO/John Rae Photography, WHO, IMPAACT4TB. 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