The International Union Against TB and Lung Disease (The Union) is hopeful that India would agree to participate in the second stage of the ambitious STREAM trials for the shortened Multi-Drug resistant (MDR)-TB Regimen. According to I.D. Rusen, Senior Vice President (research and Development) who leads the TREAT-TB Initiative and coordinates STREAM clinical trials for shortened regimens going on since 2010. The Union is in talks with the Indian government on the issue and is hopeful that India would agree to participate in the trials.
India has the largest burden of TB and MDR-TB in the world, and according to the Global Tuberculosis Report 2015, there were an estimated 220,000 TB-related deaths in India in 2014 Ã¢ÂÂ marginally lesser than 240,000 deaths reported in 2013. The number of patients living with TB had also declined from 2.6 million in 2013 to 2.5 million in 2014. However, the new cases increased in the same period from 2.1 million to 2.2 million. As per the World Health Organisation, there were 480,000 new MDR-TB in 2014 globally. Only a quarter of these cases are detected and treated, and of the reported MDR-TB patients treated only 50% are treated successfully. The current standard treatment regimen for MDR-Tb lasts up to 24 months and requires frequent injections, which pose a significant burden both on patients and for the health systems tasked with administering treatment. Permanent hearing loss is a serious side effect of the injected medicines used to treat MDR-TB.
“”The Union strongly believes that a more accessible and tolerable treatment for MDR-TB was urgently needed. Experience from a pilot programme in Bangladesh utilizing a nine-month treatment regimen demonstrated impressive outcome,”” Dr Rusen adds. Results of the Phase-1 trial of Bangladesh Project with nine-month treatment regimen, which was a pilot, have shown as overall success rate of 87.9% with a cure rate of 82.5% and only 5.25 death rate. Updated trials showed a success rate of 84.5% with a cure rate of 82.1%. the updated trials had 515 patients.
Further evaluation was conducted on 1,000 patients in West African countries on a modified Bangladesh regimen. The nine West African countries are Benin, Burkina Faso, Burudi, Cameroon, Central African Republic, Cote dÃ¢ÂÂIvoire, Democratic Republic of Congo, Niger and Rwanda. An interim analysis of 408 patients in this evaluation demonstrated a success rate of 82.1%. STREAM trial is among the ambitious randomized controlled trial going on at present. In STREAM stage -1, the Bangladesh regimen is compared to the locally used WHO regimen in the participating countries.
Stage-1 trials sites for STREAM were Addis Ababa in Ethiopia, Ulan Bataar in Mongolia, Ho Chi Minh in Vietnam and Sizure, Durban and Pietermartizburg in South Africa. So far, 424 patients have been enrolled for the trial and the final patient follow-up will be done in the last quarter of 2017 and the results are expected in early 2018. After extensive discussion between the study team, the local investigators and other experts it was agreed that additional regimen would be evaluated which would be a fully oral 9-month regimen and a 6-month simplified regimen. Both include the latest TB drugÃ¢ÂÂbedaquiline.
The first patient was enrolled for STREAM Stage-2 in March this year and so far 10 patients have been enrolled. The size of the patients is likely to be 1155 with the recruitment patient to be completed by middle of 2018. The first patient follow-up is scheduled for early 2021 and the initial end point results are expected to come by the middle of 2030. The project is funded by USAID, DFID, MRC, AFD and bedaquiline provided by Janssen Pharmaceuticals, developers of the new drug.”