New research published today in The Lancet Infectious Diseases journal by the international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) provides strong evidence that a combination of two new drugs for tuberculosis (TB)—the world’s leading infectious disease killer—could be used to treat drug-resistant (DR-TB) forms of the disease. These findings encourage the wider use of these medicines in combination for DR-TB patients worldwide.
The drugs, delamanid and bedaquiline, have been registered for use for several years, but little evidence or guidance exists for using both in combination. The results published today—from early data from patients with drug-resistant TB treated with a combination of bedaquiline and delamanid in MSF-supported projects in Armenia, India, and South Africa—offer promising evidence that the treatment may be safe and effective. Of the 23 patients, 17 (74 percent) tested negative for TB after six months of treatment, an early indicator that the treatment will ultimately be successful. Additionally, no significant side effects were observed despite concerns about the effects both drugs could have on heart rhythm.
“With data coming from three TB epidemic hotspots around the world, the study offers concrete and practical insights into the potential of this drug combination,” said Dr. Petros Isaakidis, operational research coordinator for MSF. “We were excited to find such promising results under real field conditions. Even more reassuring was that safety concerns about how both drugs would affect the electrical activity of the heart weren’t justified, with no cases of cardiac arrhythmias or unexplained deaths reported.”
Of the ten million people who had TB in 2016 alone, more than half a million are estimated to have resistance to the most effective drugs used to treat TB. For those with highly resistant strains of TB, very few treatment options exist, and the tools to diagnose and treat patients with these strains remain limited and often ineffective. In fact, until recently, only one in five people treated for the most extensive form of resistance were cured, and often only after years of painful and toxic treatment with drug regimens containing up to seven different drugs.
This peer-reviewed MSF study helps contribute to building evidence and informs much-needed guidance for national health departments and clinicians in using this combination of drugs. While two clinical trials using both drugs have started enrolling participants, results aren’t expected to be released for several years.
“Our patients simply can’t wait for clinical trials,” said MSF TB Advisor Dr. Gabriella Ferlazzo. “These small but highly reassuring results from field conditions suggest that these drugs are safe and effective for use in combination among DR-TB patients with high levels of resistance. We believe it’s a clinical and public health responsibility to provide the best treatment available, and currently these drugs offer the best hope we have.”
Although bedaquiline and delamanid have been registered for use for several years, MSF estimates that globally in 2016 fewer than 5 percent of people who could benefit from these drugs had access to them.
MSF has been treating DR-TB for over 30 years and is now one of the biggest non-government providers of DR-TB care worldwide, currently treating patients with TB and DR-TB in 24 countries including India, Central African Republic, South Africa, and Uzbekistan. As of July 2017, MSF has treated 1,554 patients with the newer drugs in 13 MSF projects across 11 countries. Of those treated, 1,110 patients received bedaquiline, 444 received delamanid, and 117 received a combination of both medicines. MSF is participating in two clinical trials, endTB and TB PRACTECAL, to find new TB treatment regimens and supports an initiative called The Life Prize to find a better way to develop newer molecules for effective DR-TB treatments in the future.