New trial evaluates whether the efficacy of the BPaL drug regimen can be maintained with reduced toxicity
NEW YORK (7 February, 2018) — TB Alliance has announced the start of a clinical trial of a three-drug regimen to treat extensively drug resistant tuberculosis (XDR-TB)—one of the deadliest forms of tuberculosis (TB)—and those with pre-XDR-TB and multi-drug resident TB (MDR-TB) whose prior treatment has failed or who have not tolerated their treatment.
The trial, called ZeNix, will evaluate whether the efficacy of the BPaL (bedaquiline, pretomanid and linezolid) drug regimen can be maintained, while reducing toxicity by testing a lower dose and shorter duration of the drug linezolid. The first ZeNix patients have been enrolled in Georgia and South Africa, with sites in Russia joining later in 2018.
“Too few people with XDR-TB are successfully cured with the current treatments,” said Dr. Mel Spigelman, president and CEO of TB Alliance. “The present treatments take far too long and are made up of complex patchworks of drugs, many of which are toxic or ineffective—further contributing to TB drug resistance. With ZeNix, we are attempting to optimize a potentially safer, quicker and less complicated treatment to address this dire situation.”
According to the World Health Organization’s most recent Global Tuberculosis Report, 123 countries have reported cases of XDR-TB as of the end of 2016. Current efforts to treat XDR-TB typically last two years or longer and consist of multiple drugs, usually including at least six months of daily injections. Even then, it is estimated that only 30 percent of XDR-TB patients are successfully treated. XDR-TB can be spread through the air or emerge through treatment with an insufficient number of active drugs or poor adherence to treatment for less resistant forms of the disease.
The BPaL regimen contains three oral drugs and is designed to be taken once a day for six months.
This regimen has also been tested by TB Alliance in the Nix-TB trial. In that trial, participants were treated for six months and are monitored for relapse for 24 months following the initiation of treatment. A preliminary report on the first patients enrolled in Nix-TB was presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in February 2017. The ZeNix trial is designed to test whether the BPaL regimen can be further optimized by limiting the duration or dosage of linezolid.
Tuberculosis (TB) is a global disease, found in every country in the world. It is the leading infectious cause of death worldwide. The World Health Organization estimates that two billion people—one third of the world’s population—are infected with Mycobacterium tuberculosis (M.tb), the bacteria that causes TB. In 2016, 10.4 million fell ill from TB and 1.7 million died. TB is an airborne disease that can be spread by coughing or sneezing. There is growing resistance to available drugs, which means the disease is becoming more deadly and difficult to treat. There are 490,000 cases of multidrug-resistant TB each year.
About TB Alliance
TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis (TB). Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia’s Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Germany’s Federal Ministry of Education and Research through KfW, Global Health Innovative Technology Fund, Irish Aid, Indonesia Health Fund, National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, United Kingdom Department for International Development, United States Agency for International Development, and the United States Food and Drug Administration. For more information, please visit: www.tballiance.org