PredART trial shows TB-IRIS can be prevented in patients with HIV-TB co-infection
15 November 2018
The results of the PredART clinical trial co-funded by EDCTP were published in the New England Journal of Medicine on 14 November 2018. Prof. Graeme Meintjes (University of Cape Town) and his team showed that a moderate dose of prednisone given over four weeks to patients with HIV-TB co-infection most at risk of developing TB IRIS, reduces their risk by 30%. The results have already influenced national and international guidelines for managing HIV-TB co-infection.
“We are very pleased with the results from this important study demonstrating that an affordable steroid drug, prednisone, reduces the risk of damaging inflammatory responses in TB-infected HIV patients by 30%. Moreover, the research consortium that has generated these results demonstrates the true value of North-South collaboration which promotes African scientific excellence and leadership.”
Dr Michael Makanga, EDCTP Executive Director
TB-IRIS is a common complication in patients treated for HIV-TB co-infection. As Prof. Meintjes explained in the press release from the Wellcome Centre for Infectious Diseases research in Africa at the University of Cape Town: “In patients with HIV, tuberculosis and very low CD4 counts, it is critical to start antiretrovirals within the first two weeks of treatment for tuberculosis, because this saves lives. But this also comes at the cost of a two-fold higher risk of developing a common inflammatory complication—TB-IRIS. Until now no management strategy existed for preventing this complication. The findings of our study provide clinicians with a strategy for reducing the risk for this complication occurring.”
The PredART study was conducted at the Site B HIV–TB clinic (a public primary care clinic for outpatients) in Khayelitsha, a community of 500,000 people on the outskirts of Cape Town. In 2015, EDCTP published a video on the trial:
The PredART study was sponsored by the University of Cape Town, South Africa and funded by EDCTP supported by the European Union (grant number SP.2011.41304.074), and by the South African Department of Science and Technology, the Wellcome Trust (United Kingdom) and the Institute of Tropical Medicine in Antwerp, Belgium.
Graeme Meintjes et alii for the PredART trial team: Prednisone for the Prevention of Paradoxical Tuberculosis-Associated IRIS 15 November 2018, N Engl J Med 2018; 379:1915-1925 DOI: 10.1056/NEJMoa1800762