COVID-19 Media

19

Feb, 2021

ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing

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Authors: Cecilia L. Moore, Anna Turkova , Hilda Mujuru , Adeodata Kekitiinwa, Abbas Lugemwa, Cissy M. Kityo, Linda N. Barlow-Mosha, et al, ODYSSEY trial team Published in: BMC Infectious Diseases   Background: Dolutegravir (DTG)-based antiretroviral therapy (ART) is highly effective and well-tolerated in adults and is rapidly being adopted globally. We describe the design of the ODYSSEY trial which evaluates the efficacy and safety of DTG-based ART compared with standard-of-care in children and adolescents. The ODYSSEY trial includes nested pharmacokinetic (PK) sub-studies which evaluated pragmatic World Health Organization (WHO) weight-band-based […]

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21

Jan, 2021

EU grants Marketing Authorisation to first-ever dispersible-tablet dolutegravir

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On 12 January 2021, the European Medicine Agency approved the use of dolutegravir 5mg dispersible tablets for treating HIV in young children living in Europe. This decision was based, in part, on data from our ODYSSEY trial, which we are conducting in close collaboration with the MRC CTU at the University College London. The EMA also authorised updating dosing recommendations for dolutegravir film-coated tablets (10mg, 25mg and 50mg) for children six years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands. […]

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