New clinical access program to expand access to TB treatment
Pretoria, 10 December 2020 — TB Alliance welcomes the Wits Health Consortium and the South African National Department of Health (DoH)’s announcement of an initiative to provide a new, shorter treatment regimen for people affected with highly drug-resistant forms of tuberculosis (TB). Funded by the United States Agency for International Development, a new clinical access program (CAP) will enroll 400 people in South Africa for treatment with a three-drug, six-month, all-oral regimen of bedaquiline, pretomanid and linezolid (known as the BPaL regimen) that has been shown to demonstrate a favorable outcome in 90% of patients.1 This treatment was developed by TB Alliance and studied in its pivotal Nix-TB trial, which was also conducted in South Africa.
“There have been significant strides on drug-resistant TB treatment in South Africa in the past years. Treatment success rate for extensively drug-resistant (XDR)-TB individuals has improved from 9% (2010 – cohort) to 60 % (2017 – cohort). Death rate has decreased from 45 % to 26 % among XDR-TB individuals during the same period” said Norbert Ndjeka, Director for Drug-Resistant TB, TB & HIV at South Africa’s National Department of Health. “However, this is work in progress and programs like this offer an opportunity to provide people enduring some of the deadliest forms of TB with innovative treatment and care.”
Coordinated by Wits Health Consortium, the BPaL CAP will take place at multiple sites including Durban and Johannesburg. The open label, single arm intervention study will enroll up to 400 male or female participants aged 14 and older with confirmed sputum pulmonary XDR-TB, fluoroquinolone-resistant TB and selected rifampicin-resistant TB cases that have been pre-approved for treatment by the National Department of Health.
“This program represents the first time this regimen will be available outside of a clinical trial setting in Africa,” said Dr. Mel Spigelman, President and CEO of TB Alliance. “We very much welcome the opportunity to expand access to the BPaL regimen in South Africa under this Clinical Access Program.”
Treatment of highly drug-resistant forms of TB has often been lengthy and complex; most XDR-TB patients are treated with a combination of as many as eight antibiotics, some involving daily injections, for 18 months or longer.2 Previous treatments have also been expensive, with severe side-effects.2,3
South Africa is among the World Health Organization’s (WHO) list of 30 countries with the highest burden of TB, multi-drug resistant TB (MDR-TB) and TB/HIV coinfection.3 In 2019, 360,000 TB cases and 14,000 MDR-TB cases were reported in the country.3
“I’ve seen firsthand the difference this treatment can make in a person’s life,” said Dr. Francesca Conradie, Clinical Principal Investigator of the Clinical Access Program in South Africa. “And in the current COVID-19 context, short, all-oral TB regimens are even more important, as they eliminate the need for frequent clinic visits to receive injectable medicines, minimizing potential exposure to the virus.”
Doses of pretomanid are being donated to the program by Mylan, a Viatris Company, and TB Alliance’s global commercialization partner for pretomanid, which was added to the WHO’s list of prequalified medicines in November 2020.4 In addition to the South African Clinical Access Program, efforts are underway in other parts of the world to increase access to novel treatment regimens for drug-resistant TB. This includes a partnership between TB Alliance and the Korean International Cooperation Agency focusing on some of the countries most affected by these forms of TB, namely The Philippines, Vietnam, Indonesia, Myanmar, Uzbekistan, Ukraine, and Kyrgyzstan.
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, Germany’s Federal Ministry of Education and Research through KfW, Global Health Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Medical Research Council (United Kingdom), National Institute of Allergy and Infectious Diseases, Netherlands Ministry of Foreign Affairs, United Kingdom Foreign, Commonwealth, and Development Office, and the United States Agency for International Development.
About Wits Health Consortium
The Wits Health Consortium (Pty) Limited (WHC) is wholly-owned by the University of the Witwatersrand. We are the support operation through which the University - primarily its Faculty of Health Sciences - conducts research, manages donor-funded activities, pursues entrepreneurial innovation in health and supports clinical trials. The Clinical HIV Research Unit has a substantial track record of innovative research and implementation of novel treatment for Drug Resistant TB. The BPaL regimen is one of these.
1. 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.
2. The Review on Antimicrobial Resistance. Tackling Drug- Resistant Infections Globally. May 2016. Available at: https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf
3. World Health Organization (WHO). Global TB Report 2020. Available at: https://apps.who.int/iris/bitstream/handle/10665/336069/9789240013131-eng.pdf
4. WHO. Prequalified Medicinal Products, Reference Number: TB386 (a). https://extranet.who.int/pqweb/medicine/4296
Source: TB Alliance