PRETORIA (24 March 2021)—On World TB Day, as society reflects on how COVID-19 became the world’s most lethal infection in the span of a year, progress against tuberculosis (TB) can be found in the swift rollout of a short, all-oral regimen for highly drug-resistant TB infections.
Earlier in March, Dr. Pauline Howell of the University of the Witwatersrand, South Africa, gave a presentation at CROI on an analysis based on two years of follow up from the Nix-TB clinical trial, in which approximately nine out of ten patients with highly drug-resistant TB who were treated with a six-month, all-oral, three-drug regimen of remained free of their disease.1
“We are reassured by both the durability of the response seen in the trial as well as the general reversibility of the neuropathy” said Mel Spigelman, M.D., President and CEO of TB Alliance, which developed the regimen. “TB Alliance’s job is not done until our innovations reach the people who need them. We are also heartened by the pace of rollout and look forward to achieving public health impact on a global scale.”
The World Health Organization (WHO) has recommended the product under operational research conditions and it has already been authorized by stringent regulatory authorities including the European Medicines Agency.2 From first approval in 2019, approximately 28 countries have procured the product and are or will soon be providing it to patients under operational research conditions. These include: Ghana, Indonesia, Kyrgyzstan, Laos, Myanmar, Nigeria, the Philippines, South Africa, Tajikistan, Ukraine, Uzbekistan and Vietnam. TB Alliance’s global commercialization partner for this treatment is Viatris.
About the Regimen The six-month, all-oral, three-drug regimen was studied in TB Alliance’s pivotal Nix-TB trial, which demonstrated a favorable outcome in 90% of patients, as published in the 5 March 2020 issue of the New England Journal of Medicine.3 It includes a new chemical entity developed by TB Alliance and commercialized by their global partner Viatris as part of the regimen, which has been approved as an oral tablet formulation for the treatment of adult patients with highly drug-resistant TB strains.
Treatment of highly drug-resistant TB strains has historically been lengthy and complex; most patients are treated with a combination of as many as eight antibiotics, some involving daily injections, for 18 months or longer.
About TB Alliance TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight 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, Foreign, Commonwealth and Development Office (United Kingdom), Cystic Fibrosis Foundation, Germany’s Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (Korea), Global Health Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Korea International Cooperation Agency, Medical Research Council (United Kingdom), National Institute of Allergy and Infectious Diseases, Netherlands Ministry of Foreign Affairs, Republic of Korea’s Ministry of Foreign Affairs, and the United States Agency for International Development. For more information, visit www.tballiance.org
1. Conference on Retroviruses and Opportunistic Infections. Final Results of the Nix-TB Clinical Study of BPaL Regimen for Highly Resistant TB https://www.croiconference.org/abstract/final-results-of-the-nix-tb-clinical-study-of-bpal-regimen-for-highly-resistant-tb/
2. European Medicines Agency. Dovprela (previously Pretomanid FGK). https://www.ema.europa.eu/en/medicines/human/EPAR/dovprela-previously-pretomanid-fgk#authorisation-details-section
3. Conradie F, et al. Bedaquiline, pretomanid and linezolid for treatment of extensively drug resistant, intolerant or non-responsive multidrug resistant pulmonary tuberculosis. N Eng J Med 2020;382:893-902.