WHO recommends MSF-led endTB clinical trial treatments

These new regimens—comprised of all-oral medicines and a much shorter treatment duration of nine months compared to 18—are at least as effective as conventional regimens for patients with multidrug-/rifampicin-resistant TB (MDR-/RR-TB). Easier and shorter treatment options are key to encouraging adherence and effective treatment. Adherence is especially critical for infectious diseases like TB that, if left untreated, can spread to others. MDR-TB is particularly difficult to treat because it is resistant to the two most powerful first-line antibiotics typically used, rifampicin and isoniazid.

“WHO’s recommendations are 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’s director of the endTB project and co-principal investigator of the clinical trial. “It should be remembered that around half a million people fall ill with MDR-TB/RR-TB every year, and many die from it.”

The WHO-recommended endTB regimens were studied in seven countries between 2017 and 2023 in collaboration with Partners In Health (PIH) and Interactive Research and Development (IRD) and funding from Unitaid.

The endTB clinical trial was launched seven years ago to find shorter, more tolerable, injection-free treatments for people with MDR-TB/RR-TB using combinations of drugs including bedaquiline and delamanid. Bedaquiline and delamanid were the first new TB drugs developed in almost 50 years since pharmaceutical companies didn’t see the value in creating medicines for a disease that predominately affects poorer communities. MSF carried out the endTB clinical trial—along with another TB trial called TB PRACTECAL—because the pharmaceutical industry failed to do so. Both trials have found better treatments for people with TB and influenced WHO recommendations and guidelines.

“After several decades of therapeutic status quo—and for the second time in two years, along with TB PRACTECAL—new treatments evaluated by independent actors, including NGOs, have been rapidly incorporated by WHO into its recommendations for combating the scourge of MDR-TB,” Dr. Guglielmetti said. “It’s important to remember that the pharmaceutical industry, despite significant public financing, has only brought new drugs to market. They have not informed the use of these drugs in regimens. It has been left to NGOs to conduct controlled trials to inform practical use of, and innovations with, novel products.”

Two of the newly-WHO-recommended MDR-TB/RR-TB regimens include delamanid. However, Japanese pharmaceutical corporation Otsuka—through its exclusive licensee Viatris—keeps the price of delamanid excessively high, limiting people’s access. Otsuka and Viatris must urgently drop their prices for delamanid so that many more people with DR-TB can access this lifesaving drug.

“We call on Otsuka and Viatris to stop blocking price-lowering generics from entering the market and to immediately share delamanid with every company interested in making more affordable quality-assured generic versions of this lifesaving TB drug,” said Christophe Perrin, TB advocacy pharmacist at MSF’s Access Campaign. “Otsuka and Viatris must also urgently drop their prices for delamanid so that many more people with DR-TB can access this lifesaving drug as part of shorter, all-oral regimens.”