CIDRI-Africa investigators to lead research on injection-free regimen for drug resistant TB
10 Jun 2019 - 13:45
The MRC Clinical and Community HIV-TB Research Collaborating Centre (administered within CIDRI-Africa) has been awarded support by the South African Medical Research Council (SAMRC) to evaluate the real-world safety and performance of a shorter injection-free multi-drug resistant/rifampicin resistant tuberculosis (MDR/RR-TB) treatment regimen.
In 2017, more than half a million people worldwide, and 14 000 South Africans, developed MDR/RR-TB. Drug resistant TB is a public health emergency, requiring rapid, concerted treatment and prevention efforts. In response, the South African National Department of Health decided to implement an injection-free 9 to 12-month regimen for certain patients with MDR/RR-TB. The regimen includes bedaquiline, the repurposed drugs clofazimine and linezolid, the older antituberculosis drug pyrazinamide, and 3-4 other agents.
However, high-quality evidence on the safety and efficacy of this regimen is required to support more widespread implementation, and there are important uncertainties that need to be addressed.
The MRC Clinical and Community HIV-TB Research Collaborating Centre project “Determinants of treatment outcomes with an injection-free shorter regimen for MDR/RR-TB” will evaluate the safety and efficacy of the shorter injection-free regimen in a large TB treatment programme. There will be a specific focus on outcomes amongst HIV-infected patients, in whom there was a trend towards worse outcomes with a shorter regimen in a recent trial. The study will also explore determinants of poor outcome, including the presence of baseline drug-resistance, treatment adherence, and how drug concentrations in blood relate to side effects.
The study will take place at TB hospitals in the Eastern Cape from September 2019 until mid-2022. Approximately 260 eligible adolescents and adults will be invited to participate.
Importantly, the project will support capacity development in under-researched sites in the Eastern Cape by investing in research infrastructure and equipment, establishing networks with local academic institutions, and setting up a biorepository of M. tuberculosis isolates for future research within the RePORT network. The project is also responsive to the WHO request that countries undertake operational research on short course regimen safety and outcomes to inform ongoing scale-up.
In partnership with the Eastern Cape Department of Health, the project will bring together expertise from the University of Cape Town (UCT), Stellenbosch University (SUN), Radboud UMC (The Netherlands), Walter Sisulu University, under the leadership of Prof. Graeme Meintjes and Dr Sean Wasserman (UCT) and Prof. Robin Warren (SUN).