On 13 May, TB Alliance announced the start of its Nix-TB (New Investigational Drugs for XDR-TB) clinical trial, the first to test a new all-oral regimen for extensively drug-resistant tuberculosis (XDR-TB).
Background info (statement follows):
Médecins Sans Frontières (MSF) provides TB treatment in about 30 countries and is one of the largest non-governmental agencies treating drug-resistant TB. XDR-TB is the deadliest form of drug-resistant TB and better treatments are urgently needed. People who manage to access and endure the debilitating side effects of the required two-year treatment regimen, including eight months of painful daily injections, still have less than a 20% chance of surviving the disease. Globally it is thought that XDR-TB affects nearly 50,000 people in more than 100 countries, with some regions very severely affected.
Faced with these realities on the ground, MSF has long been working on a number of fronts to deliver improved treatment regimens for drug-resistant TB, from advocating on principles for designing future regimens for multidrug-resistant tuberculosis to the patient-centered “Test Me, Treat Me” DR-TB Manifesto that called for more effective, tolerable, shorter and affordable DR-TB treatments. MSF is also working to implement a new drug development initiative, the '3P project', that aims to rapidly deliver affordable new TB treatment regimens that can ultimately cure all forms of TB. In March 2015, MSF announced its’ participation in the 'endTB project', which will conduct clinical trials for new regimens to treat multi-drug resistant TB.
Statement by Dr Bern-Thomas Nyang'wa, Project Manager and TB Specialist, Médecins Sans Frontières Manson Unit:
“MSF welcomes the start of the Nix-TB clinical trial as a first step towards delivering more tolerable, effective and shorter treatments that our patients and doctors have long called for. It’s true that the approval of new TB drugs is not sufficient progress in itself – the true impact of these new drugs won’t be realized until they are incorporated into treatment regimens that are proven effective and made accessible to people who need them. In the meantime, patients without other treatment options should be given access to new and promising drugs through early access programs.
Optimal treatment regimens shouldn’t contain injectable drugs, shouldn’t cause deafness, psychosis or other debilitating side effects, and should offer patients real hope of being cured. While these issues are most acute for XDR-TB patients, we hope that Nix-TB will be able to quickly expand to include MDR-TB patients, who are desperately in need of better treatment options as well.”