Gilead receives approval for two HIV-1 cocktail drugs

FDA has approved two new HIV-1 cocktail drugs: elvitegravir (Vitekta, Gilead), an integrase inhibitor and cobicistat (Tybost, Gilead), a protease-inhibitor booster.

According to Medscape, elvitegravir is approved in patients with HIV-1 who have previously received antiretroviral treatment. It should be used in combination with an HIV protease inhibitor coadministered with ritonavir and another antiretroviral.

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Cobicistat is indicated for patients with HIV-1 at a dose of 150 mg to increase blood levels of the protease inhibitors atazanavir or darunavir in a once-a-day regimen.

“Gilead Sciences' product pipeline continues to show its strength with the approval of the two new HIV-1 cocktail drugs,” said John Santilli of Access Market Intelligence, which provides market intelligence to the pharmaceutical and healthcare industries.

“The new drugs will offer the opportunity for a wider field of infected patients to be treated,” Santilli said. “The approval also offers an additional line of therapy to serve HIV patients in this market.”

FDA’s approval of elvitegravir is based on a phase 3 clinical trial of more than 700 adults with HIV-1 and a history of antiretroviral treatment. They were randomly assigned to receive either elvitegravir once daily or a 400-mg dose of raltegravir twice daily in combination with a fully active protease inhibitor, ritonavir, and another antiretroviral drug for at least 96 weeks.

The most common adverse events reported in the trial were diarrhea (7%), nausea (4%), and headache (3%). Similar rates of these adverse events were reported in the group receiving raltegravir.

Available in 85- and 150-mg tablets, elvitegravir must be taken once daily with food and the other drugs. Patients with severe hepatic impairment should not take elvitegravir.

In a clinical trial to evaluate cobicistat, treatment-naïve adult patients received the combination of cobicistat (150 mg), atazanavir (300 mg), and emtricitabine/tenofovir (Truvada, Gilead Sciences), which was demonstrated to be noninferior to ritonavir and the other two drugs. In a multiple-dose trial in healthy patients, cobicistat (150 mg) and darunavir (800 mg) was demonstrated to be an appropriate booster compared with a 100-mg dose of ritonavir and darunavir, according to FDA.

The most common adverse events seen with cobicistat in combination with atazanavir included jaundice, ocular icterus, and nausea.