Médecins Sans Frontières - endTB clinical trial results

Unique Identifier Code / URN MSB178715

Date taken / Date Recorded 11/11/2023 5:22 PM

Country Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, South Africa

Commissioning section MSF-FRANCE

Copyright MSF

Usage Rights (MSF) External Media, MSF Fundraising, MSF Publications, Social Media

Formal Consent Copy available yes

Editor's rating ★★★ (F)

Video format h264 (High) (avc1 / 0x31637661)

Duration 5m26s

Maximum Size 1920px × 1080px 733.45 MB

Additional Information / Shotlist Lorenzo Guglielmetti
endTB trial Co-Principal Investigator

Each year, there are nearly 500,000 new cases of rifampicin and multidrug-resistant tuberculosis.

We call this MDR-TB, which is defined as a disease caused by a TB bacterium which is resistant to rifampicin, the most effective of the first-line antibiotics, with or without resistance to another important drug, isoniazid.

In the last 5 years, only 31% of all these cases have been treated and less than 15% have actually been cured.
For some patients, MDR-TB treatment is long - up to 24 months. It includes thousands of pills, may require painful daily injections and has frequent side-effects. Moreover guidelines by the World Health Organization on the treatment of MDR-TB rely on very low certainty evidence.

Carole D. Mitnick
endTB trial Co-Principal Investigator

In partnership with Médecins Sans Frontières, Partners In Health, Interactive Research and Development, the Unitaid-funded clinical trial was launched in 2017 to address the problem. The endTB clinical trial used the first new anti-TB drugs developed in almost 50 years — bedaquiline and delamanid — to find shorter, tolerable, injection-free treatments for people affected by Rifampin-Resistant TB.
The endTB clinical trial is a randomized, controlled, Phase III trial that tested five new, all-oral, 9-month regimens compared to the local standard of care, according to WHO Guidelines.

The endTB clinical trial enrolled 754 patients across seven countries: Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru and South Africa.
The endTB clinical trial picked up where the pharmaceutical industry had left off in its development of bedaquiline and delamanid. Those companies did just enough to secure marketing authorization of the two new anti-TB drugs, but showed no interest in optimizing their use in shortened all-oral regimens. That’s why the Unitaid funding and this partnership among non-governmental organizations was so important.

endTB Clinical Trial participant in Pune, India

I was coughing badly, my chest was also painful. When we did a sputum test, we discovered that I have MDR-TB.
I had a sister who died from TB about 3-4 months before I was diagnosed with TB.
Because of this, my family members were afraid. Even I was afraid; I thought, if something happens to me, what will happen to my daughter.

endTB Clinical Trial participant in Pune, India

When you get TB, your body becomes weak; your body is really affected.
If you are studying or working, then it’s very difficult to manage while undergoing treatment,
because there are lots of side-effects from the drugs. If you are taking bedaquiline and delamanid for two years and follow a two-year treatment programme, then you will be behind in everything. Your life will be set back a bit.
After I came here, in Pune,
the team guided me, informed me about
the clinical trial which they were starting. They had these tablets, bedaquiline and delamanid, which they were studying.
It meant that if I was interested in this and participated, then I would be contributing to changing the future [for patients].
This new treatment is useful for the future of young people like me.

Six years later, we are excited to share the endTB clinical trial results. They provide evidence for 4 all-oral, shortened regimens for Rifampin-Resistant-TB: 3 of them have robust evidence for nearly every patient, and one is an alternative for patients unable to receive other recommended treatments.
The results offer patient-centered treatment options and empower clinicians to tailor drug regimens based on individual patient characteristics and conditions, thereby aligning treatment with patient preferences for a more personalized approach to care.

Today, I am feeling very good, I am completely fine. I don’t have any disease ; I am healthy!
This is my personal experience. I am a science student. This [shorter treatment] is excellent. It is important that the government should try and implement it.

Trial results provide new treatment options for all patients: adults, adolescents, children, and pregnant people. endTB shows excellent results in a population with severe disease, and with a high prevalence of important comorbidities such as diabetes, infection with HIV and hepatitis B and C.
It also offers alternatives in case of drug intolerances or other contraindications, drug-drug interactions, drug resistance or lack of drug availability.

Following these exciting findings allowing additional, safer and shorter treatments for MDR-TB, the next step is making sure people can actually access them. That means governments and providers need to be able to afford them.

We will continue to advocate for lower prices for RR-TB treatments and diagnosis.

Today, we finally have five new all-oral, shorter, patient-friendly MDR-TB regimens which can be composed with a formulary of only 8 drugs. The results of endTB, together with other recent clinical trials, have completely transformed the landscape of MDR-TB treatment – and the evidence underlying it.

endTB clinical trial results_INT

endTB clinical trial results_INT