FDA Approves Vitekta
FDA Approves Vitekta (elvitegravir) for HIV-1 Infection
September 24, 2014 -- The U.S. Food and Drug Administration (FDA) has approved Vitekta (elvitegravir), an integrase strand transfer inhibitor for the combination treatment of human immunodeficiency virus type 1 (HIV-1) infection in treatment-experienced adults.
Elvitegravir is an HIV integrase strand transfer inhibitor that works by interfering with one of the enzymes that HIV needs to multiply. It is indicated in combination with an HIV protease inhibitor coadministered with ritonavir and with other antiretroviral drugs. It is one of the ingredients in the combination HIV drug Stribild, which was approved by the FDA in August, 2012.
Vitekta (elvitegravir) comes in 85 mg and 150 mg tablets. It is administered once daily with food.
The approval of Vitekta is based on the analyses through 96 weeks from one randomized, double-blind, active-controlled trial, Study 145, in treatment‑experienced, HIV-1 infected subjects (N=702). In Study 145, subjects were randomized in a 1:1 ratio to receive either Vitekta (150 mg or 85 mg) once daily or raltegravir 400 mg twice daily, each administered with a background regimen (BR) containing a fully active protease inhibitor coadministered with ritonavir and a second antiretroviral drug. The BR was selected by the investigator based on genotypic/phenotypic resistance testing and prior antiretroviral treatment history. Virologic outcomes were similar across the treatment arms through 96 weeks.
The most common side effects of Vitekta observed in clinical trials were diarrhea, nausea and headache.
Vitekta is a product of Gilead Sciences, Foster City, CA.
Posted: September 2014
- Gilead Sciences’ New Drug Application for Elvitegravir for HIV Therapy Accepted by U.S. FDA - April 21, 2014
- Gilead Receives Complete Response Letters from U.S. Food and Drug Administration for Elvitegravir and Cobicistat - April 29, 2013
- Gilead Submits New Drug Application to U.S. FDA for HIV Integrase Inhibitor Elvitegravir for Treatment-Experienced Patients - June 27, 2012
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