TB advocates stress the importance of the observational endTB study for expanding access to new treatments for multidrug-resistant TB in Peru.
In an open letter sent 10 March 2017, the Global TB Community Advisory Board (TB CAB) expressed its disappointment and concern regarding the decision made by the Ethics Committee of Peru's National Institute of Health to reject an observational study proposed by Partners in Health and urged the Committee to reconsider its decision.
The endTB study has the “potential to inform the safe and optimal implementation of new TB treatments, delamanid and bedaquiline, under program conditions in Peru.”
The letter states that “the immediate lack of registration and in-country guidance for delamanid should not preclude its administration under the conditions of operational research being proposed by the endTB study.”
The TB CAB previously sent two letters, one in October 2016 and a second in February 2017, encouraging the Ministry of Health to facilitate access to delamanid in Peru.
The group requested a response before 20 March 2017.
To read the full letter, click here.