South Africa has a population of 59 million people and is among the 30 high burden TB countries in the world with a TB incidence of 304,000 cases in 2021 as listed by the World Health Organization. According to the WHO in 2021 an estimated 21,000 people suffered from DR-TB in South Africa and 55,000 deaths reported.

South Africa is not only one of the 30 high burden TB countries, but also MDR/RR-TB , and TB/HIV burden countries contributing to approximately 87% of the estimated incident TB cases. In 2020, during the COVID-19 pandemic, South Africa reported a total of 6,784 Laboratory-confirmed MDR/RR-TB cases. According to the latest drug resistance survey, the prevalence of MDR-TB nationally was measured at 2.1% in new cases and 4.6% in re-treatment cases with an overall MDR-TB estimate of 2.8%.

The National TB Program has developed a TB recovery plan to reverse the declining case-finding trend and address the missing cases. Part of this plan includes expediting access to novel, optimized regimens. As such, there is a scale-up plan expected to contribute to reversing the losses required to achieving TB recovery.

In 2018 the National Department of Health (NDoH) and Wits Health Consortium and under the guidance of NDoH, launched the BPaL CAP (Clinical Access Program for bedaquiline, pretomanid, and linezolid) as a follow-up to the Nix-TB and ZeNix trials conducted by TB Alliance in South Africa. TB-PRACTECAL, led by MSF, tests the safety and efficacy of a regimen containing the core BPaL components, with the addition of moxifloxacin (MFX).

The 6-Month BPaL (L) roll-out plan and the country’s level of preparedness benefit from the currently finalized policy guideline, including regulatory, clinical and implementation needs.

South Africa has taken part in the evidence generation around the BPaL(M) regimen through its participation in the studies NIX-TB, ZeNIX and TB-PRACTECAL. The NTP has updated the national DR-TB guidelines to align with the recent updated WHO communication on DR-TB regimens. South Africa will be able to share valuable lessons learned from the operationalization of the BPaL(M) regimen. This will be carried out using international platforms such as the BPaL Accelerator Platform or organizing regional meetings in the country. At the same time South Africa will benefit from an assessment of the programme’s performance to identify the critical gaps as the country is facing challenges with the missing cases.