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FDA Approves Single-Pill, Three-Drug Biktarvy for HIV

Gilead tablet contains bictegravir, emtricitabine, and tenofovir alafenamide

The FDA has approved Biktarvy (Gilead Sciences, Inc.), a once-daily, single-tablet regimen for the treatment of HIV-1 infection that includes 50 mg of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide.

Bictegravir is a novel, unboosted integrase strand transfer inhibitor (INSTI), while emtricitabine and tenofovir alafenamide (marketed as Descovy by Gilead) provide a dual nucleoside reverse transcriptase inhibitor (NRTI) backbone with demonstrated safety and efficacy. The new combination offers the smallest INSTI-based, triple-therapy, single-pill regimen available, Gilead says.

Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 c/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of the new combination. No dosage adjustment is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.

The medication does not require testing for HLA-B*5701, has no food intake requirements, and has no baseline viral load or CD4 count restrictions. According to its prescribing information, prior to or when initiating treatment with Biktarvy, health care providers should test for hepatitis B virus (HBV) infection and renal function, and they should monitor renal function as clinically appropriate during therapy.

The product has a boxed warning in its label regarding the risk of post-treatment acute exacerbation of hepatitis B.

“In clinical trials through 48 weeks, no patients taking the regimen of bictegravir plus [emtricitabine/tenofovir alafenamide] 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,” said Paul Sax, MD, Clinical Director of the Division of Infectious Diseases at Brigham and Women’s Hospital in Boston, Professor of Medicine at Harvard Medical School, and a lead clinical trial investigator. “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.”

The approval of Biktarvy is supported by data from four ongoing phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a diverse population of 2,415 participants, including a wide range of adult age groups and races/ethnicities.

The triple therapy met its primary objective of noninferiority at 48 weeks across all four studies. Through 48 weeks, no participants in any of the four studies failed Biktarvy with treatment-emergent virological resistance, no patients discontinued Biktarvy due to renal adverse events, and there were no cases of proximal renal tubulopathy or Fanconi syndrome. The most common adverse reactions in patients taking the new medication were diarrhea, nausea, and headache.

Source: Gilead Sciences; February 7, 2018.

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