Throughout 2024, one of TB Alliance’s foremost priorities has been ensuring that pretomanid and BPaL-based regimens reach all people with drug-resistant TB (DR-TB) around the world. To meet this challenge, TB Alliance has been working with and empowering a diverse set of stakeholders to help scale access to this treatment more quickly and widely than had been achieved for a TB therapy in the modern era.
We are heartened to share an update on approval and programmatic implementation milestones in the five BRICS countries, four of which are among the world’s ten highest DR-TB burden countries.
South Africa continues to make dramatic progress against DR-TB
South Africa is a prime example of what a country can achieve when they truly commit to tackling DR-TB. Between 2015 and 2022, South Africa reduced its DR-TB burden by nearly 80%. Following first approval of pretomanid, South Africa rapidly implemented the BPaL Clinical Access Programme (BCAP), which helped inform local implementation. Working with the National TB Programme and a local partner, TB Alliance helped develop a national implementation plan. South Africa is firmly on the path toward full national implementation of BPaL-based regimens launched on September 1, 2023. By November 2024, more than 5,000 individuals had been enrolled on the treatments. At least 90% of all individuals who are eligible for these regimens are now receiving them.
Brazil rolls out BPaL/M following visit to PeerLINC Knowledge Hub
Brazil, a leader in implementing health innovations and making them rapidly available to all who need them in the country, began rolling out BPaL/M in December 2024. This follows a training and capacity building visit by a delegation of TB experts and policymakers from the Brazilian National TB Program to the PeerLINC Knowledge Hub in Manila. PeerLINC is a collaboration between TB Alliance and the Tropical Disease Foundation, Inc. (TDF) and works closely with the Department of Health, Philippines and provides practical training, technical support and peer-to-peer thought partnership to NTPs to develop implementation plans and help speed programmatic implementation of new TB technologies.
India issues national guidelines; initiates BPaL rollout
With the largest DR-TB burden of any country in the world, India was one of the first countries in the world to approve pretomanid and the BPaL regimen. However, the path from approval to national implementation requires many steps. Upon approval, a study on BPaL was conducted by Indian researchers under India’s National TB Elimination Programme to generate local evidence and confirm the global clinical trial results of the regimen. Having completed this study, India updated its national treatment guidelines in December 2024 to include BPaL/M. National and regional trainings have been rolled out rapidly by the Central TB Division which will enable roll-out of BPaL/M under programmatic settings.
Russia approves pretomanid/BPaL
One of only three countries in the world that reports 30,000 or more cases of DR-TB annually, Russia is a key high DR-TB burden country with a complex and independent approval process for new medicines. Regulatory approval for pretomanid and BPaL was granted in December 2024. Plans to make pretomanid available in the country have commenced.
China approves pretomanid/BPaL
With the world’s fourth-highest DR-TB burden, pretomanid and BPaL could prove to be a crucial tool to speed up China’s intention to eliminate DR-TB and build on the country’s efforts that have already led to a reduction in overall DR-TB burden by approximately 50% over the previous decade. In December 2024, pretomanid and BPaL received regulatory approval in China and TB Alliance is working closely with national stakeholders including the China Anti-Tuberculosis Association and the manufacturer in the country to ensure rapid roll-out of the regimen.