Phase II/III trial of Biktarvy positive for children and adolescents with HIV

Gilead Sciences, Inc. announced 48-week results from a Phase II/III study (Study GS-US-380-1474) evaluating the efficacy and safety of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, BIC/FTC/TAF), a once-daily single tablet regimen, in virologically suppressed adolescents and children at least 6 years of age who are living with HIV.

Through Week 48, Biktarvy maintained high rates of virologic suppression with a low incidence of study drug-related adverse events and no treatment-emergent resistance. The data were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

“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,” said Aditya H. Gaur, MD, Clinical Director, Department of Infectious Diseases at St. Jude Children’s Research Hospital and lead study investigator. “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 programs and a significant consideration for children and adolescents who are facing the prospect of long-term treatment.”

Biktarvy is indicated in the U.S. as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history. Biktarvy is also indicated to replace the current antiretroviral regimen in those adults who are virologically suppressed on a stable antiretroviral regimen for at least three months. Virologically suppressed adults must have no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Biktarvy carries a Boxed Warning in its U.S. product label regarding the risk of post-treatment acute exacerbation of hepatitis B..