A study following outcomes of 28 patients with drug-resistant tuberculosis in three countries with high burdens of the disease found what the researchers cite as strong evidence that a combination of the two newest TB drugs could be part of a safe and effective treatment regimen.
The drugs, bedaquiline — which was approved by the U.S. Food and Drug Administration and the European Medicines Agency in 2012 — and delamanid — approved by the EMA and the Japanese pharmaceutical regulatory body in 2014, represent the only two innovative medicines to treat TB developed in the last half century, and have offered a lifeline to patients for whom treatment with older drugs is ineffective or harmful. But although the World Health Organization followed the approval of each drug with recommendations for their use, access to each drug remains limited. And because of concerns about heart rhythm abnormalities associated with the use of each drug, no large-scale studies have examined the effects of both drugs used together. The authors of the study, which was launched by Médecins Sans Frontières researchers at MSF treatment sites in South Africa, India and Armenia, note that leaves patients for whom an effective and tolerable four-drug regimen can’t be completed without both drugs open to other, greater risks.
Researchers followed patients over the course of six months between January and August of 2016. Within six months of starting treatment, 22 of the 28 patients tested negative for tuberculosis in consecutive tests conducted two weeks apart. One patient, who also was sick with untreated and advanced HIV when treatment for tuberculosis began, died. Two still tested positive for the disease, two had only one negative TB test result and one could not cough up a sufficient amount of sputum to be tested.
While noting that larger studies are needed to provide further evidence of the safety and potential effectiveness of treatments using the two drugs together, the authors write their findings support the continued use of the combined treatment for patients lacking other options, and whose treatment can be monitored. Their results, they add, make withholding the combined treatment for those patients unjustifiable.