October 25, 2010
Cobicistat, also known as GS-9350, is a type of medicine called a pharmacoenhancer or "boosting agent." This type of medicine works by raising blood levels of other drugs that are broken down by the same protein. Cobicistat, itself, does not have any antiviral activity.
Cobicistat is an investigational medicine that is not yet approved by the U.S. Food and Drug Administration (FDA) for use outside of clinical trials. It is being studied in combination with other drugs for the treatment of HIV infection.
Cobicistat is being studied in Phase III clinical trials as part of a single tablet fixed-dose combination regimen (also known as the "Quad" tablet). The "Quad" tablet contains the following four drugs: elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate.
In addition, cobicistats stand-alone role in boosting currently available HIV protease inhibitors is being studied in a clinical trial. This clinical trial involves studying cobicistat-boosted atazanavir, taken with emtricitabine/tenofovir disoproxil fumarate.
Cobicistat does not cure HIV infection and may not prevent you from developing HIV-related illnesses. Cobicistat does not prevent you from spreading HIV to other people.
Cobicistat is currently used only in clinical trials. In these trials, cobicistat is taken by mouth. If you are currently taking cobicistat as part of a clinical trial, make sure to follow any specific instructions that have been given to you about participating in the trial. Unless your doctor or the research team tells you otherwise, please remember the following:
Individuals should tell a doctor about any medical problems before taking this medicine.
If you are participating in a clinical trial or expanded access program, before taking cobicistat,
The following life threatening or serious side effects have been reported in clinical trials. Contact your doctor immediately if you experience:
Other nonserious side effects have also been reported in clinical trials:
Cobicistat may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/Safety/MedWatch or by phone 1-800-332-1088.
Certain medications or foods may interact with cobicistat.
Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
Click here to search ClinicalTrials.gov for trials that use Cobicistat.
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Phone: (650) 574-3000
Fax: (650) 578-9264