European Commission issued marketing authorization to Gilead for the drug Biktarvy
June 25, the pharmaceutical company Gilead Sciences Inc. announced that the European Commission has granted permission for the sale in Europe of the ARV drug Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide). The drug, intended for the treatment of HIV-1 in adults, combines of the novel integrase strand transfer inhibitor (INSTI) bictegravir with the already proven Descovy ARV (emtricitabine / tenofovir alafenamide).
In Europe, the drug will be used as a therapy in adult patients with HIV-1 who have not had resistance to the integrase-based virus in the past, as well as emtricitabine or tenofovir.
As explained in Gilead, Biktarvy has a convenient dosing, - one tablet once a day, - and has no food intake or baseline viral load or CD4 count restrictions.
“To help support the long-term health of people living with HIV, it is crucial to have regimens that deliver durable viral suppression with a high barrier to resistance,” said Professor Alan Winston, Professor of HIV and Genitourinary Medicine at Imperial College and Consultant Physician at St. Mary’s Hospital, London, UK.
“In clinical trials through 48 weeks, BIC/FTC/TAF has shown high efficacy and zero resistance. With convenient dosing and few pre-screening or ongoing monitoring requirements, it has the potential to simplify treatment initiation, and follow-up over time.”
The European Commission's decision is based on four current phase 3 studies: Studies 1489 and 1490 in native HIV +, and Studies 1844 and 1878 in adults with suppressed viral load. In the trials were involved 2415 people. The drug Biktarvy for 48 weeks reached the manufacturer's declared endpoints in all four studies.
At the same time, none of them reported any cases of resistance and refusal of participants to receive therapy because of side effects.
“We are pleased to offer BIC/FTC/TAF, the latest innovation in our comprehensive HIV research and development program, which encompasses prevention, treatment and cure,” said Andrew Cheng, MD, PhD, Chief Medical Officer, Gilead Sciences.
“The approval of BIC/FTC/TAF demonstrates our continued commitment to improving care for people living with HIV, and we look forward to working with health authorities across Europe to ensure that BIC/FTC/TAF is made widely available as soon as possible.”
According to the press release, additional studies of Biktarvy, not included in the marketing authorization application, among women, adolescents and children, are also ongoing.