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The results of an ODYSSEY pharmacokinetic sub-study investigating dolutegravir (DTG) based antiretroviral (ARV) treatments for children weighing 3 to less than 20kg have recently been published in The Lancet HIV as an Open Access article. DTG has been available for treating HIV in adults globally for many years with paediatric formulations only developed in recent years. Very little pharmacokinetic data were available in young children when the ODYSSEY trial was opened to young children. With this in mind, the team nested a sub-study to evaluate pharmacokinetics and safety and confirm the optimal […]

The ODYSSEY trial’s final paper Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children has been published in the New England Journal of Medicine. ODYSSEY, sponsored by Penta and funded by ViiV Healthcare, is the first randomised controlled trial to compare the efficacy and safety of dolutegravir-based regimens to non-dolutegravir-based standard-of-care regimens in children and adolescents. Dolutegravir (DTG) is a drug shown to be highly effective and safe in treating HIV in adults, and ODYSSEY, enrolling more than 700 children from Uganda, South Africa, Zimbabwe, Thailand, UK, Germany, […]

On November 12th, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending marketing authorisation for dolutegravir 5mg dispersible tablets for young children living with HIV. This decision was based, in part, on data from the ODYSSEY trial. These small tablets can now be used in combination with other medicines for treating children living with HIV who are aged at least four weeks and weigh at least 3kg. CHMP’s positive opinion also supported the updated dosing recommendations for dolutegravir film-coated […]