TB CAB statement on safety of using bedaquiline and delamanid together
Global TB CAB welcomes confirmation of safety of using bedaquiline and delamanid together, urges uptake.
March 12, 2019 – The Global TB Community Advisory Board (TB CAB) welcomes the important finding from the AIDS Clinical Trials Group Deliberate Trial that newer drugs bedaquiline and delamanid are safe to use together. These findings should erase any remaining reluctance to use these two important drugs together, as the benefits of these safer drugs outweigh the risks--especially for patients with drug-resistant TB who have few other treatment options.
The TB CAB congratulates the researchers and sponsors of the Deliberate Trial trial, and calls for countries to scale up the use of bedaquiline and delamanid, including in combination. Additionally, since this pivotal research was conducted with public investment from U.S. taxpayers, the TB CAB reiterates its call for bedaquiline and delamanid to each be fairly priced at USD $1/day.
The TB CAB has called for this trial since 2011, when both drugs were in late-stage clinical development from different sponsors, and both had evidence of causing QT prolongation (a change in the electrical system of the heart that can be a risk factor for potentially dangerous irregular heartbeats). While we are happy to finally have these results, they come far later than they should have. We urge all drug developers and sponsors to plan earlier for and move faster on developing drugs in combination, including through innovative mechanisms such as the Life Prize.
About the TB CAB: The Global Tuberculosis Community Advisory Board (TB CAB) is a group of strong, research-literate community activists from HIV and TB networks in Asia, Europe, Africa, and North and South America. Founded in 2011, the TB CAB acts in an advisory capacity to:
- product developers and institutions conducting clinical trials of new TB drugs, regimens, diagnostics and vaccines; and
- provide input on study design, early access, regulatory approval, post marketing, and implementation strategies.
The TB CAB is dedicated to increasing community involvement in TB research and access to tools to fight TB and mobilizing political will.
