People at high risk of developing tuberculosis will soon get access to a once-weekly pill that prevents TB bacteria from developing into a contagious case. The rollout will start this month in five African countries with high rates of the disease: Ethiopia, Ghana, Kenya, Mozambique, and Zimbabwe.
The three-month preventive treatment, administered via an Aurum Institute program, will replace a daily regimen that is already widely used in the five countries. The new treatment, called 3HP, combines antibiotics rifapentine and isoniazid into one pill, which program managers hope will encourage more people to stick to the therapy and help contain the disease. 3HP is also available as two pills.
Though TB is both preventable and treatable, it is one of the top 10 causes of death globally. It was the leading cause of death from a single infectious agent until it was overtaken by COVID-19. In 2019, 10 million people suffered from TB, and close to 1.5 million people — over 95% of whom were living in lower- and middle-income nations — died due to the disease.
“Right now, COVID is killing more people — but for maybe the first six months of the pandemic TB was killing more people than COVID. But nobody speaks about TB,” said Emilio Jose Valverde, Aurum Institute country director in Mozambique.
About one-quarter of the world’s population is infected with TB bacteria. Though the majority of these people have latent TB — meaning they are infected with the bacteria but do not have symptoms or spread the disease — if left untreated, 5% to 10% will develop active TB. Preventive treatments such as 3HP lower that risk, but people must see the full treatment regimen through to ensure it works.
“It's not good enough waiting for people to come because they are sick with TB.”— Gavin Churchyard, founder and CEO, Aurum Institute
The five countries will start providing the pills in February and March, and the rollout will be expanded to seven additional countries globally in 2021, including Brazil and India. Treatments for up to 3 million patients are expected to be made available this year through funding from Unitaid. Governments are expected to receive supplies of the new treatment through funding from the President's Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
The initiative is part of Unitaid’s IMPAACT4TB project — a four-year investment of $59 million led by the Aurum Institute and implemented by a consortium that launched in 2018. The project is aimed at protecting people most vulnerable to developing active TB, prioritizing treatment for people who are under 5, living with HIV, or in close contact with TB patients.
The IMPAACT4TB consortium has also been working with manufacturers to reduce prices of 3HP — and locking in those low rates long-term so that countries and their funding partners can scale up the treatment, said Robert Matiru, director of the program division at Unitaid.
Unitaid, the Clinton Health Access Initiative, an implementation partner in the consortium, and treatment manufacturer Macleods reached an agreement to make the new single-pill 3HP treatment available at a ceiling price of $15 to governments in 138 low- and middle-income countries, along with international organizations in charge of the procurement.
Although the previous six-month daily regimen costs around $9, Matiru added that lowering the number of pills will also lower distribution costs. “When you have to distribute less boxes of medicine and less packaging the logistics are simplified … meaning it will be easier to distribute and also cost less,” he said.
People may also be more likely to complete it. “In six months, many people abandon treatment,” Valverde said. “They do not feel sick, they don't think they should be taking pills, and they just stop,” he said.
Among the benefits of the short-course regimen are that it is associated with better treatment completion and fewer side effects, said Gavin Churchyard, the Aurum Institute’s founder and CEO.
“We hear from patients all the time that they find it very hard to take so many tablets at one time,” he said. “So we think that having reduced the number of tablets people have to take … will further increase the number of people taking the treatment and completing the treatment, which is very important.”
Scaling up prevention is particularly important amongst vulnerable groups, said Jabina Anaman, program manager for Ghana at the Aurum Institute. Mortality and TB co-infection is particularly high among people living with HIV: In 2019, over 200,000 died as a result of TB.
“It's not good enough waiting for people to come because they are sick with TB,” Churchyard said. The new approach is to find those who are at high risk of developing active TB and giving them access to preventative therapy.
“For decades, our focus was on finding and treating TB,” he said, “And we have realized that we can't treat our way out of this epidemic,” he said.