120 week results of Bedaquiline phase 2 study

Friday, August 22th, 2014 by hinrich

Structure of TMC207/R207910

The New England Journal of Medicine has just published the results of the Bedaquiline (TMC207/R207910) phase 2 study by Diacon et al. Having analysed the data after 120 weeks, the researchers demonstrated a statistically higher cure rate in patients infected with multi-drug resistant tuberculosis (MDR-TB) compared to placebo: nearly twice as many MDR-TB patients were cured when given bedaquiline.

In a second article, Edward Cox and Katherine Laessig of the FDA looked at the benefit-risk balance for treating drug-resistant tuberculosis also in the context of the finding that more patients in the bedaquiline group died than in the placebo group.

While the number of people who died in the bedaquiline is still small ("Among the 4 other patients in the bedaquiline group who died, there was no apparent common cause of death".), this is certainly of concern. Even though Cox and Laessig remark that "[...] the length of time between the last receipt of bedaquiline and death makes it difficult to discern a mechanism by which bedaquiline could be directly related to the deaths, even if we take bedaquiline's long half-life into consideration.", I hope we will be able to quickly either identify a link with bedaquiline or obtain information that show that these deaths were not linked to the use of bedaquiline.

Even more so as they remark that "The previously cited historical data show that outcomes are very poor in patients who do not receive adequate treatment."

Here are both articles:
http://www.nejm.org/doi/full/10.1056/NEJMp1314385
http://www.nejm.org/doi/full/10.1056/NEJMoa1313865

Posted in Tuberculosis


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