The Union

New cohort study shows promise of shorter MDR-TB treatment

New cohort study shows promise of dramatically shorter treatment option for multidrug-resistant TB

Initial results show 80% success rate using 9-month treatment option for MDR-TB, compared with 24-month treatment standard

Thursday, 3 December 2015 (Cape Town, South Africa) – New findings from clinical studies presented at the 46th Union World Conference on Lung Health show promise for a shorter, 9-month treatment course for MDR-TB. The standard treatment length recommended by the World Health Organization requires 24 months of treatment.

First results reported from 9-country observational study in francophone Africa

Researchers participating in a cohort study coordinated by the International Union Against Tuberculosis and Lung Disease (The Union) announced results from the first multi-country cohort of MDR-TB patients treated using a shortened, 9-month treatment regimen. Among a cohort of 507 adult patients, 80.9% had treatment success, 7.7% died, 6.5% were lost to follow-up and 4.9% were treatment failures. Patients participated from nine francophone countries in sub-Saharan Africa: Benin, Burkina Faso, Burundi, Cameroon, Cote d’Ivoire, Niger, Central African Republic, Democratic Republic of Congo and Rwanda.

“These preliminary results from using a 9-month MDR-TB treatment regimen are excellent,” said Dr Arnaud Trebucq of The Union, a lead investigator of the study. “Implementing the shortened regimen is proving feasible and with improved outcomes compared with the standard MDR-TB treatment regimen.”

Update from STREAM randomised clinical trial

The STREAM trial, sponsored by The Union and implemented with support the Medical Research Council (UK) and USAID, is also testing the efficacy of a 9-month MDR-TB treatment regimen. The first phase of the trial is ongoing in Ethiopia; in this trial, sites are also located in South Africa – Durban, Sizwe and Pietermaritzburg; Vietnam and Mongolia. STREAM is the first randomised clinical trial of this scope being conducted in Mongolia for any disease. Patient enrolment has completed with 420 patients included in the study. Results are anticipated in 2017.

STREAM is now expanding to test another 9-month MDR-TB treatment regimen using bedaquiline, a novel medicine produced by Janssen Pharmaceuticals. This expanded arm of the STREAM trial will test two additional MDR-TB treatment regimens: a 9-month all-oral regimen that does not require injections, and an even shorter 6-month regimen. A total of 1155 patients in at least 10 countries will be included in the second stage of the STREAM trial. The expansion of STREAM is made possible through collaboration between USAID, The Union and Janssen Pharmaceuticals.

“Among all the infectious diseases, MDR-TB has required one of the longest and most complex courses of treatment,” said Dr I.D. Rusen, Senior Vice President, Research and Development for The Union, which coordinated the study. “Updates to WHO’s MDR-TB treatment guidelines are anticipated in 2016, and we’re hopeful the data provided by the francophone cohort study and ultimately STREAM will have an important impact on these new treatment guidelines. This shortened course of treatment could provide a powerful alternative for a country like South Africa, which is battling an ongoing epidemic of drug- resistant TB.”

The results from these studies build on the successful outcomes of using a 9-month MDR- TB treatment regimen to treat patients in Bangladesh, an approach pioneered by The Union. While the shortened regimen showed promise in Bangladesh, it is necessary to prove that it can be equally effective when used to treat patient populations elsewhere, particularly in countries with high rates of TB drug resistance and high rates of TB-HIV co-infection. The current standard treatment regimen for MDR-TB, recommended by WHO, lasts up to 24 months and requires frequent injections, which pose a significant burden both for patients and for health systems tasked with administering treatment.