Biktarvy - a product with a new integrase inhibitor, a single tablet regimen in treatment ofHIV infection
Abstract
Bictegravir (BIC) is a novel, second-generation HIV-1 and HlV-2 integrase strand transfer inhibitor. In February 2018, it has been approved by the Food and Drug Administration (FDA) in combination with emtricitabine and tenofovir alafenamide (BIC/F/TAF - 50/200/25 mg, Biktarvy(R)) for the treatment of adult patients with HlV-1 infection.
It is adrrŇnistered with one tablet once daily. its efftciency, safety, tolerability and drug interactions were elucidated in four (GS-US-380-1489, 1490, 1844 and T878) studies using a comparator - dolutegravir, oř protease inhibitor in naivě patients. The indications of BIC/F/TAF include HIV-1 infection in treatment-naive patients, or in previously treated patients with no signs of failure of the previous regimen and without a proven resistance to any component.
In the period 96 weeks, no resistance to BIC was found. Other studies, including the post-marketing ones, are underway.