Paris – Médecins Sans Frontières / Doctors Without Borders (MSF), together with its partners, is happy to announce that the endTB clinical trials have started in India. The trials are implemented in the country in close collaboration with the Indian Council for Medical Research (ICMR), the National AIDS Research Institute (NARI), and the Department of Health Service, Government of Maharashtra.
India accounts for 27% of the 10 million TB cases globally, of which an estimated 130,000 are multi-drug-resistant (MDR-TB). The current treatment of MDR-TB has duration of 18-24 months for most patients and is burdened by frequent and potentially permanent side effects. Most Indian MDR-TB patients prefer to visit private practitioners with different quality standards in desperate attempts to cure their disease, often having to bear high costs for their treatment, and experiencing frequent treatment interruptions.
The two Phase III randomized controlled clinical trials, endTB & endTB-Q, use the new generation of TB drugs, which were developed after almost 50 years of draught of new anti-TB drug classes, to find radically shorter (6 or 9 months), more tolerable, injection-free treatments for MDR-TB. The endTB trial is targeting MDR-TB which is susceptible to fluoroquinolones, the most effective drug class for drug-resistant TB, while the endTB-Q trial aims to treat forms of MDR-TB that are also resistant to fluoroquinolones. The control regimen for both trials is the standard of care, evolving dynamically to provide the best possible treatment in concordance with latest WHO guidance.
Between March 2017 and end of September 2020, 484 patients were already enrolled in the endTB trial across six countries, namely Georgia, Kazakhstan, Lesotho, Pakistan, Peru and South Africa.
Since the first sites activation, 9 patients were included in the endTB-Q trial in Pakistan and Lesotho.
In India, the endTB trials will be run at two sites in Maharashtra - Pune and Mumbai. The trial site in Pune has been activated on September 29th, and the first patient has been screened for the trials at Aundh Chest Hospital on October 7th, 2020. Screening and recruitment will be performed in parallel for endTB and endTB-Q, supervised by a team of over 30 medical and paramedical staff. The second site in Mumbai is expected to be activated by the end of 2020. Overall, approximately 220 patients are expected to be enrolled in the trials at the two sites in India by the end of 2021.