NEXT Trial Approved by MCC in South Africa
The NEXT trial, an open-label RCT to evaluate a new treatment regimen for patients with MDR-TB, has been approved in South Africa by the Medicine Controls Council. The NEXT trial aims to evaluate the impact of a new injection-free six-to-nine month treatment regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide and ethionamide/high dose isoniazid compared to the conventional empiric injection-based regimen of 21-24 months treatment. The secondary aim is to determine if other treatment-related outcomes including adverse events, adherence to treatment, culture conversion, and cure/completion are significantly different in the intervention and conventional arms. To read more about the NEXT trial, visit the ClinicalTrials.gov listing here.
Recent News and Announcements
Join RESIST-TB at the symposium “Pre-approval access to new TB drugs: What, where, and how” on Friday, December 4th from 10:30-12:00. For the full program, see the Union website here. RESIST-TB’s annual meeting is scheduled for Saturday, December 5th from 08:00-09:00. This meeting is open to all registered for the conference and should be attended […]
Cycloserine, an important drug used in regimens for the treatment of MDR-TB, increased in price last week from $500 to $10,800 for 30 capsules. The price increase came after the drug was acquired by Rodelis Therapeutics from The Chao Center. Following a swift response from providers, advocates, and policy makes, the drug was reacquired by the […]
Treatment Action Group and i-Base released the 2015 Pipeline Report for HIV, HCV, and TB, entitled “Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.” The Pipeline Report summarizes progress and activities in HIV, Hepatitis C, and tuberculosis research. View the Pipeline Report here.
TB Alliance has announced the start of the Nix-TB trial, aimed at testing all-oral drug regimen, that has the potential to shorten, simplify, and improve treatment for XDR-TB. Nix-TB will study a three-drug regimen of bedaquiline, pretonamid, and linezolid. To read more on the launch of the trial, visit the TB Alliance website here, and the […]
The WHO Expert Committee on Selection and Use of Essential Medicines has recommended the inclusion of five TB medications in the WHO Model List of Essential Medicines. The recommended drugs include bedaquiline, delamanid, linezolid, rifapentine and terizidone. Rifapentine is indicated for the treatment of TB infection, while the other four medicines are included for the treatment of […]