PredART trial shows prednisone is safe and effective for preventing TB-IRIS

The findings of the PredART trial were presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) that took place in Seattle, United States, from 13-16 February 2017. This trial is the first to demonstrate the efficacy and safety of prednisone for preventing the tuberculosis-associated immune reconstitution inflammatory syndrome (TB-IRIS) in patients at high risk for this condition.

The trial was conducted as a collaboration between investigators from UCT, Imperial College London and the Institute of Tropical Medicine in Belgium. UCT investigators included Graeme Meintjes (Principal Investigator; CIDRI, Member of the IDM), Robert J. Wilkinson, Gary Maartens, Cari Stek, Liz Blumenthal, Friedrich Thienemann and Charlotte Schutz. The main funder of the trial was the the European and Developing Countries Clinical Trials Partnership (EDCTP), with co-funding received from the South African National Department of Science and Technology and the Wellcome Trust.

TB-IRIS is the most frequent complication of starting antiretroviral therapy in patients with advanced HIV being treated for active TB disease (it affects up to 50% of such patients). It manifests with recurrent or new inflammatory features of TB during the first few weeks of ART resulting in clinical deterioration frequently necessitating hospital admission. Patients complain of recurrence of their TB symptoms, and may develop enlarging lymph glands in their neck, TB abscesses or worsening of their chest X-rays.

The primary comparison was the proportion of participants who were diagnosed with TB-IRIS. In participants who received prednisone there was a significant (30%) relative reduction in the risk of developing TB-IRIS: 46.7% of patients in the placebo arm developed TB-IRIS compared with 32.5% in the prednisone arm. Also important is that prednisone appeared to be safe in these patients with advanced HIV. Adverse events and severe infections were not more common in the prednisone-treated participants.

FULL ARTICLE:
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WEBCAST PRESS CONFERENCE: results of their PredART trial:
http://www.croiwebcasts.org/console/player/33484?mediaType=slideVideo&

Links:

CROI ABSTRACT: http://www.croiconference.org/sessions/randomized-controlled-trial-prednisone-prevention-paradoxical-tb-iris

CROI press conference:
http://www.croiwebcasts.org/console/player/33488?mediaType=slideVideo&

Short film about PredART trial made in 2015 by EDCTP:
https://www.youtube.com/watch?v=BvnxfpWBsFU

PredART website:
https://www.predart.org/site/index