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Gilead's Biktarvy maintains HIV suppression for 48 weeks in children and adolescents

Published on 07/03/19 at 11:16am

Gilead has lifted the curtain on new Phase 2/3 efficacy data for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, also known as BIC/FTC/TAF), revealing that the drug demonstrated high efficacy in maintaining virologic suppression in already virologically suppressed adolescents and children aged six years and older living with HIV.

The trial evaluated the drug’s effects when administered once daily in 50 patients aged 12 to <18 and 50 patients aged six to 12 years of age, all of whom had an undetectable viral load (HIV-1 RNA <50 c/mL) for at least six months before screening and CD4 cell counts of ≥200 cells/µL. After 48 weeks of treatment, 98% if of participants maintained an undetectable viral load, according to the FDA’s snapshot algorithm.

There was only one participant who did not: they reported a HIV-1 RNA level of 85 c/ml at Week 48, but two weeks’ later this patient also achieved an undetectable viral load. Furthermore, none of the trial participants experienced treatment-emergent resistance.

As for patient adherence, Gilead noted that all participants reported the shape and taste of the medication to be acceptable and palatable, with a median adherence by pill count of 99%.

“These findings indicate that Biktarvy, an oral single-tablet regimen that can be taken with or without food, has the potential to be an effective and well tolerated treatment option for some children and adolescents living with HIV,” explained Dr Aditya H Gaur, lead study investigator  and Clinical Director, Department of Infectious Diseases at St Jude Children’s Research Hospital. “Importantly, Biktarvy was not associated with any cases of treatment-emergent resistance through 48 weeks of treatment, a result observed consistently to date across the Biktarvy clinical research programmes and a significant consideration for children and adolescents who are facing the prospect of long-term treatment

Dr John McHutchison, Chief Scientific Officer and Head of Research and Development at Gilead, added: “Gilead’s ongoing investment in HIV treatment research and development is focused on bringing the latest innovations and the potential for successful long-term treatment to as many people living with HIV as possible. Results from these studies in specific populations presented at CROI demonstrate that Biktarvy has the potential to be appropriate for use in a broad range of patients who are new to therapy or switching therapies, including young people and aging adults, as well as women who have been traditionally underrepresented in HIV clinical trials.”

Matt Fellows

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