HealthDay News — The FDA has approved Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg; Gilead Sciences) to treat adults with HIV.
The combination drug, which only has to be taken once a day, interferes with enzymes that are needed for the virus to multiply, the agency said in a press release.
The safety and effectiveness of Stribild were evaluated in clinical studies involving 1,408 adults. Of those treated with the new drug, between 88% and 90% had undetectable levels of HIV in their blood, compared with the roughly 84% of those treated with other anti-HIV drugs, who had undetectable levels.
As with similar HIV medications, Stribild’s label will include a boxed warning about the potential for a lethal build-up of lactic acid in the blood or severe liver problems, the FDA said.
The most common side effects reported during clinical trials included nausea and diarrhea. More serious, but less common adverse reactions included new or worsening kidney problems, a drop in bone mineral density and immune system changes.
Drug maker Gilead Sciences will have to conduct additional studies to evaluate the drug’s safety in women and children, how the drug may become resistant to the AIDS virus and possible interactions with other drugs, the agency said.