Geneva – A Unitaid-funded study has found that 3HP, a new, shorter preventive therapy for tuberculosis, is safe for people who also take the HIV drug dolutegravir. The results mark a critical milestone for countries and funding partners seeking to expand preventive TB therapy.
“These are the results we have all been waiting for,” Unitaid Executive Director Lelio Marmora said. “The evidence that 3HP is safe to use with dolutegravir, today’s most advanced HIV treatment, is critical for the scale up of short-course preventive therapy for TB. We now need to focus on affordable pricing for access.”
TB kills some 340,000 people living with HIV every year and accounts for about a third of HIV-related deaths. TB preventive therapy protects people already infected with TB bacteria from falling ill with the active disease and shields those at risk of exposure. A third of the world’s population is infected with latent TB, and HIV infection makes them much more likely to develop active TB.
The new therapy, a rifapentine-based regimen known as 3HP, requires only once-weekly treatment for 12 weeks, compared to the 6-to-36 month daily regimen required under the older standard of care, isoniazid preventive therapy (IPT). Patients are more likely to complete shorter treatments.
The study was carried out in South Africa by Unitaid grantee Aurum Institute and the Johns Hopkins University Center for TB Research as part of the IMPAACT4TB project.
Unitaid is investing US$ 59 million in the Aurum-led IMPAACT4TB (2017-2021) project, which seeks to establish rifapentine-based preventative regimens as affordable, quality-assured, less-toxic therapies suitable for wide introduction in countries most affected by TB.
The study also found that people who take 3HP do not require a higher dose of dolutegravir, and that all viral loads were suppressed while the patients were taking 3HP.
The findings were presented today (March 6) in Seattle at the Conference on Retroviruses and Opportunistic Infections (CROI).
“Latent TB infection is the reservoir from which active cases develop, which in turn fuels transmission of the disease,” said Aurum Institute Group CEO Gavin Churchyard. “Scaling up new, safer, shorter prevention therapies, such as 3HP, is key to ending the TB epidemic.”
Today’s results allow IMPAACT4TB to move forward with activities to improve the affordability and feasibility of TB prevention using 3HP. This work is expected to pave the way for the scale-up of 3HP by key funders of TB prevention interventions, including the Global Fund, PEPFAR and Stop TB Partnership.
“The news that 3HP is safe for people being treated with DTG opens the door to healthy, productive lives for a vast number of people who would otherwise die of tuberculosis,” said Dr Tereza Kasaeva, Director of the Global Tuberculosis Programme at WHO. “With scale-up as recommended by WHO’s new guidelines on latent TB infection, 3HP has enormous potential as a tool to help achieve the target of reaching 30 million people with TB preventive treatment by 2022, as outlined in the political declaration of the first UN High Level Meeting on TB in September 2018.”
The project is being implemented in the following countries: Brazil, Ghana, Ethiopia, Kenya, Tanzania, Malawi, Zimbabwe, Mozambique, South Africa, India, Cambodia and Indonesia.
IMPAACT4TB stands for the full project name: Increasing Market and Public health outcomes through scaling up Affordable Access models of short Course preventive therapy for TB.