WHO recommends three shorter oral treatments for drug-resistant tuberculosis

The World Health Organization (WHO) this week recommended three new treatment regimens for multidrug-resistant or rifampicin-resistant tuberculosis (MDR/RR-TB) that are significantly shorter than current treatment regimens and can be taken orally.

The new treatment plans will allow patients to be cured in six to nine months instead of the usual 18 months, and will eliminate the painful injections that people with DR-TB have had to undergo as part of their treatment.

Nearly half a million people contract MDR-TB/RR-TB each year and many die from it, partly because they have difficulty adhering to treatment.

“The use of new and repurposed medicines such as bedaquiline, pretomanid, linezolid and delamanid and the move away from older injectable treatment regimens has led to incremental improvements in treatment success rates in people with MDR/RR-TB,” the WHO said in a statement.

“Globally, the treatment success rate for MDR/RR-TB patients who started treatment in 2021 was 63% in 2022, a steady improvement from 50% in 2012.”

Bedaquiline and delamanid are the first new tuberculosis drugs in 50 years.

Tested on a wide range of patients

The WHO recommendations are based on the results of the BEAT-TB clinical trial conducted in South Africa and the endTB trial conducted in seven countries between 2017 and 2023 by Médecins Sans Frontières (MSF), Partners In Health (PIH) and Interactive Research and Development (IRD) and funded by Unitaid.

The study participants included children, adolescents and pregnant and breastfeeding women.

“Doctors can now offer these advances to almost all patients, increasing the chance of cure while reducing the burden of treatment toxicity and curbing the spread of drug-resistant forms of TB in society,” says Professor Carole Mitnick, PID Principal Investigator for the endTB project, co-leader of the study and Professor of Global Health and Social Medicine at Harvard Medical School.

“By reducing the complexity, duration and toxicity of treatment and expanding options, the prospects of closing the gap between need (approximately 500,000 patients/year) and the percentage treated (no more than 35%/year) improve significantly,” she added.

Drug cost barrier

“The WHO recommendations represent a major step forward for the health of millions of patients affected by this form of the disease, which is particularly difficult to treat,” said Dr. Lorenzo Guglielmetti, MSF director of the endTB project and co-leader of the clinical trial.

“MSF conducted the endTB clinical trial – together with another TB study called TB PRACTICAL – because the pharmaceutical industry has not done so. Both studies have found better treatments for people with TB and influenced WHO recommendations and guidelines,” MSF said in a Media release published on Thursday.

“After several decades of therapeutic status quo, for the second time in two years, together with TB PRACTECAL, new treatments evaluated by independent actors, including NGOs, have been rapidly incorporated by WHO into its recommendations to combat the scourge of MDR-TB,” added Guglielmetti.

“It is important to remember that despite significant public funding, the pharmaceutical industry has simply brought new drugs to market. It has not provided information on the use of these drugs in treatment plans. It has been left to NGOs to conduct controlled trials to inform practical use and innovation in new products.”

However, the success of the new guidelines depends on a reduction in the price of delamanid, which Doctors Without Borders describes as “excessively high”.

The Japanese pharmaceutical company Otsuka produces delamanid under an exclusive license with Viatris.

“We call on Otsuka and Viatris to stop blocking the entry of low-cost generics and to immediately share delamanid with all companies interested in producing cheaper, quality-assured generics of this life-saving tuberculosis drug,” said Christophe Perrin, tuberculosis pharmacist at MSF’s Access Campaign.

“Otsuka and Viatris also need to urgently reduce their prices for delamanid so that many more people with DR-TB have access to this life-saving medicine as part of shorter, all-oral treatment regimens.”

Photo credit: TB Alliance.