WHO recommendations, supported by Unitaid clinical trials, now allow for better treatment for all people with drug-resistant TB, including children and pregnant women

• The World Health Organization recommended four new all-oral regimens for multidrug or rifampicin-resistant tuberculosis, three of which were studied in the endTB clinical trial funded by Unitaid.

• For the first time, young children and pregnant women can benefit from improved treatment with the novel, shorter, all-oral regimens. These groups have historically been excluded from, or delayed in gaining access to, therapeutic innovations.

• One of the newly recommended treatments from the endTB trial relies on the most affordable medicines on the market, off primary patent, and well-known to clinicians.

Geneva – The World Health Organization (WHO) has recommended four new, shorter all-oral regimens for drug-resistant tuberculosis (TB), expanding treatment options for people with drug-resistant TB in low- and middle-income countries. For the first time, shorter treatment regimens are recommended for young children and pregnant women – groups historically excluded from or delayed in accessing new treatments.  Three of the new regimens were developed through the Unitaid-funded endTB clinical trials led by Médecins Sans Frontières (MSF), Partners In Health (PIH), and Interactive Research and Development (IRD)  were conducted in seven countries and concluded in 2023.

Although TB can be prevented and cured, over 10 million people still fall ill with this airborne disease each year, making it one of the world’s deadliest infectious killers. Among those affected, half a million contract a strain of TB that is resistant to one of more of the first-line antibiotics used in treatment.

In late 2022, WHO recommended a treatment containing bedaquiline, pretomanid, linezolid and moxifloxacin (BPaLM) as an alternative to the much longer and more painful traditional treatments for drug-resistant TB. While this regimen offered better outcomes and significantly shortened the treatment duration to six months, BPaLM has not been approved for the treatment of key populations such as children, adolescents, pregnant and breastfeeding women, and individuals with bedaquiline resistance or allergies.

The new treatments recommended by WHO rely on both new and pre-existing drugs that are already available on the market, off primary patent, and well-known to clinicians. Notably, the endTB1 regimen is half the price of BPaLM, has a lower pill burden, and uses a combination of drugs that are widely available in low- and middle-income countries, including child-adapted formulations. With these new regimens, all patients, including historically overlooked populations, can now be cured in nine months or less with all-oral treatments.

“With reduced treatment complexity and short duration, these new regimens put us one step closer to closing the treatment gap for the most dangerous and difficult to treat forms of tuberculosis worldwide,” said Dr. Philippe Duneton, Executive Director of Unitaid. “These drugs are already on the market where they are needed most. Now, we must focus on ensuring all barriers to timely and high-quality care are removed, so that every patient can benefit from this game changing advancement in the fight against drug-resistant TB.”

Additionally, resistance to all the drugs used in the endTB regimens can be identified using newly recommended genome sequencing diagnostic technologies, making it feasible to monitor resistance and adapt treatment regimens as needed. This provides an opportunity to leverage infrastructure installed during the COVID-19 pandemic to improve diagnosis and treatment of drug-resistant TB

Note to editors:

About the endTB clinical trials
The endTB clinical trial used a combination of new and repurposed drugs: bedaquiline, delamanid, clofazimine, linezolid, moxifloxacin or levofloxacin, and pyrazinamide. Clofazimine, linezolid, levofloxacin, and moxifloxacin, originally developed for other diseases, were repurposed for TB.

The clinical trials enrolled 754 patients across eleven sites in seven countries—Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, and South Africa—all of which have significant TB burdens and where MSF, PIH, or IRD support local drug-resistant TB treatment activities.

Each experimental regimen included at least one new drug combined with up to four companion drugs. The control regimen followed the local standard of care for drug-resistant TB as per the latest WHO recommendations.