By Ashok Ramsarup :: A new clinical trial has found a novel way to a safer and more effective treatment regimen in treating rifampicin-resistant tuberculosis (RR-TB). The TB-PRACTECAL clinical trial was undertaken by the international, independent, medical humanitarian organisation – Doctors Without Borders/Medecins Sans Frontieres (MSF).
MSF made the announcement at the 52nd Union Conference on Lung Health. The TB-PRACTECAL, discovered that a new all-oral six-month treatment regimen was safer and more effective than the currently accepted standard of care. The latest results present a new chapter to patients with drug-resistant (DR)-TB who currently face lengthy treatment regimens of up to 20 months, including painful injections. MSF says some patients take close to 20 pills daily that leads to severe side effects. “These gruelling regimens only cure one in two patients and can have a catastrophic effect on people’s physical and mental health, as well as their financial and social lives.
“We are also sharing the data with the World Health Organization (WHO) ahead of the WHO DR-TB treatment guideline review with the hope of influencing national DR-TB guidelines and ultimately clinical practice,” says MSF.
The success of the TB-PRACTECAL has been dubbed the first-ever multi-country, randomised, supervised clinical trial. More than 550 patients from South Africa, Belarus and Uzbekistan undertook the research. The programme involved a six-month regimen of bedaquiline, pretomanid, linezolid and moxifloxacin (BPaLM).
MSF established that the new phase II/III clinical trial was a shorter treatment regimen and very effective against RR-TB. About 89 percent of patients in the BPaLM group were cured compared to 52 percent in the standard of care group. Sadly four patients died from TB or treatment side effects in the control group, while there were no deaths among patients on the new regimen.
MSF Medical Director and Chief Investigator Bern-Thomas Nyang’wa say the research had been undertaken nine years ago to find a solution to help patients with DR-TB around the world facing lengthy, ineffective and exhaustive treatment.
Nyang’wa says patients were telling chilling stories, explaining how difficult it was to adhere to treatment. “Little progress was being made to find humane treatment as the diseases had been most prevalent in low-and-middle-income countries that did not attract investment.
“We were compelled to pursue new DR-TB treatment options to bring hope to patients, their families and healthcare workers globally, ” says Nyang”wa.
Nosipho Ngubane, Principal Investigator at King DinuZulu Hospital in South Africa says it has been an honour to serve the communities in one of the seven TB-PRACTECAL trials sites in the Province of KwaZulu-Natal. Ngubane says they found it was easier to comply with the treatment as it was a shorter regimen to complete, using fewer tablets.
Ashok Ramsarup 👉 Prominent Journalist of South Africa