Wednesday 27 March 2019: A ground breaking new programme, BEAT Tuberculosis, was launched today in Port Elizabeth. It is a world first in the fight against Drug Resistant Tuberculosis (DR TB) that is expected to slash treatment time-frames, make taking treatment far easier and minimise devastating side-effects.
The emergence of DR TB, particularly Rifampicin Resistant TB (RR TB), poses a serious threat to the goal of TB eradication both in South Africa and worldwide. Until August 2018, the treatment of DR TB infection involved 9-11 months of medicines, a painful injection and a significant risk of permanent hearing loss. Only 50 percent of DR TB patients were successfully treated.
BEAT Tuberculosis will test a new treatment protocol that reduces both the treatment time frames and severity of side effects. It is a global first and will be conducted in Port Elizabeth, an area in South Africa that bears a disproportionally high burden of RR TB. It is expected to lead to a safer, more tolerable and more effective all-oral regimen for the treatment of DR TB.
The cutting-edge clinical trial has been made possible by the United States Agency for International Development (USAID) which awarded a research grant to the Clinical HIV Research Unit (CHRU) of the Wits Health Consortium (WHC) based on its track-record as an internationally acclaimed clinical trial unit.
Dr Francesca Conradie, Principal Investigator at CHRU, says, “BEAT Tuberculosis will see treatment provided to participants or patients with DR TB that involves a combination of the new and repurposed medications used together for just 6 months.
“There are over 15 000 cases of RR TB diagnosed every year in South Africa. It is mostly transmitted from one person to another and not acquired because an individual was not adherent to their TB medicines. Approximately 1 000 people are diagnosed with Extensively Drug Resistant TB in South Africa every year which means that the four most commonly used TB medications will not cure them.
“We are optimistic that this programme will add to a number of gains already recorded in the treatment of DR TB under the leadership of Dr. Norbert Ndjeka, director in the DR TB Directorate of the National Department of Health” says Dr Conradie These include:
- Better diagnostics tests which have been rolled since 2011 out enabling earlier detection of resistance.
- Decentralised care of those with DR TB enabling patients to get their treatment closer to where they live and work.
- The inclusion of Bedaquiline, the first new medication registered in over 50 years for the treatment of RR TB, in the National Guidelines within three years of registration.
- The provision of Bedaquiline to all people within our borders that had RR TB, an intervention that halved the mortality of patients with DR TB in South Africa.
- Confirmation of sufficient evidence to stop the use of the injectable agents and to give an all oral 9-month course of treatment instead.
- The addition of other new or repurposed medications including linezolid, delamanid and clofazimine for the treatment of RR TB.
Dr. Norbert Ndjeka says that, “Much of this has been achieved by close collaboration between the South African National TB program, the health care workers that implement the program and other stakeholders including NGOs and academics. BEAT Tuberculosis will mark an important milestone in eradication DR TB, and this launch today comes at a fitting time during national TB awareness month in March when we focus on raising awareness about TB prevention and treatment.”
Mr. John Groarke, USAID Mission Director, says, “Working with the Government of South Africa, USAID is committed to ensuring that results from the BEAT Tuberculosis clinical trial are used to inform policies and clinical management of individuals with drug resistant TB, thereby improving the quality of patient care. It’s time to end TB.”
Tuberculosis is the major co-infection with HIV in South Africa. There are over 8 million South African who are HIV infected, putting them at higher risk of getting TB. While the successful antiretroviral program has helped to reduce the risk of TB infection on a community level, there are still many new TB infections every year. The most common symptoms of TB are a cough last more than 2 weeks, weight loss, drenching night sweats and a fever. IF any person has any of these, they should go to their local clinic. There they will be asked to produce a specimen of sputum or phlegm which will be tested for TB. IF the test is positive, the correct treatment will be started.
USAID leads international development and humanitarian efforts to save lives, reduce poverty, strengthen democratic governance and help people progress beyond assistance. On behalf of the American people, USAID promotes and demonstrates democratic values abroad, and advances a free, peaceful, and prosperous world. In support of America’s foreign policy, USAID leads the U.S. Government’s international development and disaster assistance through partnerships and investments that save lives, reduce poverty and strengthen democratic governance.
The Wits Health Consortium (Pty) Limited (WHC) is wholly-owned by the University of the Witwatersrand. WHC supports operations 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 key task of WHC is to provide the governance, legal framework, human resource management, financial and grant management to over 100 research entities, one of which is Clinical HIV Research Unit (CHRU), in various academic departments. This role is performed through WHC’s Shared Services Centre (SSC) which employs over 200 skilled staff.
CHRU is a division of WHC. It was established in Gauteng, South Africa in 2001 and primarily focused on the optimization of treatment for HIV in resource limited settings. CHRU has completed a number of large-scale antiretroviral therapy trials. In 2008 CHRU shifted the emphasis in clinical research activities to include the treatment of TB. The first MDR TB trials conducted by CHRU which started in 2008 were the registrational trials for bedaquiline. The footprint of CHRU was subsequently extended to other centres beyond Johannesburg, Gauteng. In 2015, CHRU took over the management of the MDR TB research site at King DiniZulu Hospital Complex in Durban, KwaZulu Natal. In 2017/8, CHRU under the leadership of Dr Francesca Conradie established a research site in Nelson Mandela Bay, in the Eastern Cape where BEAT Tuberculosis will be conducted. The leadership at CHRU has always supported and encouraged members from the communities it serves to participate in Research Specific Community Advisory Boards. One such board was established in Port Elizabeth in January 2018 and members from this board are present at this launch.