A new three-drug combination pill for HIV-1 infection won FDA approval late Wednesday, said manufacturer Gilead Sciences.
To be sold as Biktarvy, the product includes the integrase inhibitor bictegravir and two reverse transcriptase inhibitors, emtricitabine and tenofovir alafenamide. It is approved for once-daily oral administration, with no food intake requirement, baseline viral load, or CD4+ cell count restrictions, Gilead said.
The drug combination was tested in numerous clinical trials. Last July, for example, investigators reported on two phase III studies in which the product was given as first-line therapy, achieving undetectable viral loads in 90% of patients. Those studies also suggested that resistance to the combination would be slow to develop.
Another trial reported late last year indicated that patients on protease-inhibitor regimens could switch to the bictegravir combo without losing efficacy. All those trials were sponsored by Gilead.
The product’s wholesale acquisition cost will reportedly be about $36,000 annually. Gilead said it will provide assistance to patients who otherwise can’t afford the drug.