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A Pilot Study to Evaluate the Safety and Efficacy of Multiple Anti-HCV Combination Therapy in Chronically Infected Hepatitis C Patients
This study is the first study done in the US to see if 12 weeks of treatment with one of these two-drug combinations, taken as pills, is safe and effective for the treatment of HCV. We have already enrolled 20 people who had never done HCV treatment before; we are now enrolling 20 people who have been treated for HCV with “interferons,” but did not achieve a good enough response in the first 12 weeks. This study will help us learn who may benefit from taking only pills, like the ones in this study, to cure hepatitis C. After starting the study medications, if you have to stop this study for certain reasons, you will be offered the FDA approved standard treatment for hepatitis C (which will contain interferon, ribavirin, and another drug that blocks hepatitis C, called an HCV protease inhibitor) under another clinical study.
GS-7977, GS-5885 and GS-9669 are new medications that are being developed for the treatment of hepatitis C infection. They are still being researched and are not approved by the Food and Drug Administration (FDA). The purpose of this study is to determine whether GS-7977 in combination with EITHER GS-5885, or with GS-9669, can be safe and effective for treating hepatitis C infection. The manufacturer, Gilead Sciences, Inc., will provide the study drugs. If you are eligible for the study, you will be enrolled in ONE of the two study groups where you will follow one of the following two possible medication plans for 12 weeks: GS-7977 and GS-5885, OR GS-7977 and GS-9669. Study medications and volunteer compensation will be provided.
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Last Updated August 05, 2013
Last Reviewed June 07, 2013