Gilead Sciences said it has obtained approval for Biktarvy, a three-in-one single combination drug for the HIV (human immunodeficiency virus) treatment. Its ingredients are bictegravir, emtricitabine, and tenofovir alafenamide.
|Gilead Sciences’ HIV combination treatment Biktarvy|
The Ministry of Food and Drug Safety granted the nod for the medicine on Friday.
Biktarvy enhanced the efficacy by adding bictegravir, an integrase strand transfer inhibitor (INSTI), to the combo treatment, emtricitabine plus tenofovir alafenamide.
The drug can be used by adults who have no experience of receiving antiretroviral treatment, those who have had a stable suppressed viral level (HIV-1 RNA < 50 copies/mL) for at least three months with no history of antiretroviral treatment failure, and those with HIV-1 infection who have no evidence of mutations to their virus that are associated with resistance to each ingredient of the drug.
Patients can take the pill once daily, regardless of food intake, and they must not chew, crush, or divide the tablet. If patients vomit less than one hour of the intake of the drug, they should take a new pill. If vomit occurs after an hour, no additional dose is necessary.
Gilead won approval for Biktarvy in the U.S. and Europe in 2018. Unlike other HIV therapies, Biktarvy can be used for patients with a renal disease without dose control. The most common side effects include diarrhea, nausea, and vomiting.
The FDA ordered Gilead to place a black box warning label on the new drug due to the risk that hepatitis B could severely exacerbate. The black box label warning on the surface of the outer packaging of the drug gives patients the strongest warning against dangerous side effects.
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