FDA Approves Bictegravir for HIV-1

The US Food and Drug Administration (FDA) has approved Gilead Sciences, Inc.’s Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide), a tablet regimen to be taken once-daily for the treatment of HIV-1 infection.

“Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy (FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available,” according to a recent press release.

The regimen is indicated for the treatment of adults with HIV-1 with no history of antiretroviral therapy (ART) or as a replacement for a current antiretroviral regimen in adults who achieved virologic suppression (with HIV-1 RNA less than 50 copies per mL) who were on a stable ART regimen for at least 3 months without any history of treatment failure, and with “no known substitutions associated with resistance to the individual components of Biktarvy,” according to the Department of Health and Human Services’ letter.

The application for Biktarvy was not put before a FDA advisory committee meeting as there are drugs within this antiretroviral class that have already been approved and are already available, according to the letter. Furthermore, safety data did not reveal any unexpected issues for the class and data yielded by 4 ongoing phase 3 trials on the effectiveness of the regimen did not raise any specific concerns.

The 4 phase 3 studies include: studies 1489 and 1490 in treatment-naïve HIV-1 infected adults along with studies 1844 and 1878 in virologically suppressed adults. In all 4 studies, Biktarvy met its primary objective, which is non-inferiority at 48 weeks across all studies.

“In clinical trials through 48 weeks, no patients taking the regimen of bictegravir plus FTC/TAF developed treatment-emergence resistance, results that were observed both in people new to therapy and those who were virologically suppressed and chose to switch regimens,” lead clinical trial investigator Paul Sax, MD, clinical director of the division of Infectious Diseases at Brigham and Women’s Hospital, said in the press release.

“In addition, the clinical data show that the regimen’s antiviral efficacy, tolerability profile and limited drug interactions offer an effective new treatment option for a range of people living with HIV," Dr. Sax added.

More clinical trials are also being conducted, with one looking specifically at women and another looking at adolescents and children who are living with HIV. Gilead aims to present data pertaining to these studies at conferences held throughout this year.