FDA News

FDA approves once-daily Biktarvy for HIV treatment

The FDA has approved once-daily Biktarvy — a bictegravir/emtricitabine/tenofovir alfenamide regimen — for the treatment of HIV.

Marketed by Gilead Sciences, the treatment is the smallest integrase strand transfer inhibitor (INSTI)-based triple-therapy regimen currently available in a single tablet, according to a news release. It combines the unboosted INSTI bictegravir with the Descovy (Gilead Sciences) dual nucleoside reverse transcriptase inhibitor backbone of emtricitabine and tenofovir alafenamide (FTC/TAF).

“In clinical trials through 48 weeks, no patients taking the regimen of bictegravir plus FTC/TAF developed treatment-emergent resistance, results that were observed both in people new to therapy and those who were virologically suppressed and chose to switch regimens,” clinical trial investigator Paul E. Sax, MD, clinical director of the division of infectious diseases at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, said in the 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.”

Bictegravir/FTC/TAF is indicated as a complete regimen for HIV in adults with no ART history, according to the company. It can also replace another ART regimen in patients who are virologically suppressed (with HIV RNA less than 50 c/mL) on a stable ART regimen for at least 3 months, with no history of treatment failure and no known substitutions associated with resistance to individual components of the treatment.

A prescription for bictegravir/FTC/TAF does not require testing for HLA-B*5701, an allele whose properties include a link to possible adverse effects with the use of abacavir. Nor does Bictegravir/FTC/TAF come with food intake requirements, baseline viral load or CD4 count restrictions.

However, clinicians should test patients for hepatitis B virus infection and renal function before starting treatment with bictegravir/FTC/TAF, and monitor renal function during therapy as appropriate, according to the drug’s prescribing information.

Data from four ongoing phase 3 studies have supported the FDA approval, according to Gilead. Other trials are also ongoing and include one involving women and another involving adolescents and children. The company says it plans to present data from those trials at scientific conferences this year.

Disclosure: Cohen is Executive Vice President of BD Global Health and a board director for the Perrigo Company.

The FDA has approved once-daily Biktarvy — a bictegravir/emtricitabine/tenofovir alfenamide regimen — for the treatment of HIV.

Marketed by Gilead Sciences, the treatment is the smallest integrase strand transfer inhibitor (INSTI)-based triple-therapy regimen currently available in a single tablet, according to a news release. It combines the unboosted INSTI bictegravir with the Descovy (Gilead Sciences) dual nucleoside reverse transcriptase inhibitor backbone of emtricitabine and tenofovir alafenamide (FTC/TAF).

“In clinical trials through 48 weeks, no patients taking the regimen of bictegravir plus FTC/TAF developed treatment-emergent resistance, results that were observed both in people new to therapy and those who were virologically suppressed and chose to switch regimens,” clinical trial investigator Paul E. Sax, MD, clinical director of the division of infectious diseases at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, said in the 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.”

Bictegravir/FTC/TAF is indicated as a complete regimen for HIV in adults with no ART history, according to the company. It can also replace another ART regimen in patients who are virologically suppressed (with HIV RNA less than 50 c/mL) on a stable ART regimen for at least 3 months, with no history of treatment failure and no known substitutions associated with resistance to individual components of the treatment.

A prescription for bictegravir/FTC/TAF does not require testing for HLA-B*5701, an allele whose properties include a link to possible adverse effects with the use of abacavir. Nor does Bictegravir/FTC/TAF come with food intake requirements, baseline viral load or CD4 count restrictions.

However, clinicians should test patients for hepatitis B virus infection and renal function before starting treatment with bictegravir/FTC/TAF, and monitor renal function during therapy as appropriate, according to the drug’s prescribing information.

Data from four ongoing phase 3 studies have supported the FDA approval, according to Gilead. Other trials are also ongoing and include one involving women and another involving adolescents and children. The company says it plans to present data from those trials at scientific conferences this year.

Disclosure: Cohen is Executive Vice President of BD Global Health and a board director for the Perrigo Company.