FDA Approves Bictegravir/FTC/TAF Combination HIV Therapy

The US Food and Drug Administration (FDA) has approved bictegravir/emtricitabine/tenofovir alafenamide, or BIC/FTC/TAF, (Biktarvy, Gilead Sciences), a once-daily tablet regimen for the treatment of HIV-1 infection.

The therapy is a combination of a novel, unboosted integrase strand transfer inhibitor (INSTI)—bictegravir—and Descovy (FTC/TAF, Gilead) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, which has proven safety and efficacy. It is the smallest INSTI-based triple-therapy STR available, according to a statement.

The application for bictegravir/emtricitabine/tenofovir alafenamide was not put before an FDA advisory committee meeting as other therapies within its antiretroviral class have already been approved, so the Gilead product's bio-similarity was enough for assessment. Its safety data did not reveal any unexpected issues for the class and data from 4 ongoing phase 3 trials on the effectiveness of the regimen did not raise any specific concerns for the FDA.

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.

One of the trials compared a once-daily 75 mg bictegravir tablet paired with a 200/25 mg FTC/TAF once-daily tablet against a fixed-dose combination Dolutegravir (DTG) placebo for a length of 48 weeks. After Week 48, the patients were asked to continue with their treatment and attend visits every 12 weeks until the treatment options were unblinded.

Gilead announced that the trial had met its primary endpoint on May 30, 2017, stating that “BIC/FTC/TAF met the definition of non-inferiority in all four studies, with comparable proportions of patients having HIV-1 RNA <50 copies/mL (Studies 1489 and 1490) and HIV-1 RNA ≥50 copies/mL (Studies 1844 and 1878),” in a 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.

“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 a statement.

“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," Sax added.

More clinical trials are also being conducted, one of which is examining specifically 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 2018.

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