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An Open Label Trial to Assess Safety, Tolerability, and Efficacy of the Fixed Dose Combination of GS-7977 and GS-5885 in HCV Genotype 1 Subjects Coinfected with HIV
You are being asked to participate in this study because you have HIV infection and you have liver disease caused by infection with the hepatitis C virus (HCV). Your blood tests show that the HCV infection continues to be a problem (i.e., the virus continues to reproduce), causing a chronic infection. Currently there are about 4 million people with HCV in the United States and only about 10–20 percent are being treated for their HCV, many with advanced liver disease.
GS-7977 and GS-5885 are new medications being developed for the treatment of HCV 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 GS-5885 for 12 weeks can be safe and effective for treating HCV infection in people with HIV infection who are not on anti-retroviral medications for HIV. Both drugs will be provided by the manufacturer, Gilead Sciences, Inc.
GS-7977 works by blocking the HCV from dividing in your body. This drug has been used along with other medications commonly used to treat HCV such as interferon (IFN) and ribavirin (RBV). As of July 15, 2012, over 1700 people with HCV and 500 healthy volunteers have been taking GS-7977 alone or in various combinations with RBV, interferon or other new study drugs such as GS-5885. When used with IFN and RBV, this drug seems to be very effective in eliminating the HCV from the body. However, IFN (given as weekly injection) and RBV (pills taken twice a day) are associated with several serious side effects. Development of drugs that may cure HCV infection without using IFN or RBV would be extremely beneficial for the large number of patients infected with HCV.
GS-5885 also appears to help lower the amount of HCV in your body, and its effects have been studied when taken alone for a short time and when combined with other medications. More than 700 people have taken this drug for at least 12 weeks as part of other studies.
This study will enroll 25 participants with HIV infection who also have HCV infection by HCV genotype 1 to receive 12 weeks of GS-7977 and GS-5885. No studies have been completed to evaluate whether we can treat HCV effectively using only pills instead of the usual combination of pills with IFN injections in co-infected individuals with genotype 1 coinfection, which can be more difficult to treat than other genotypes. The GS-7977/GS-5885 are combined into one pill, and will be taken once a day. Participants will be followed during the treatment and for 48 weeks afterwards. After starting the study drugs, if you have to stop them for any reason, you will be offered treatment for HCV (which will contain interferon, RBV, and another drug that blocks HCV called HCV protease inhibitors) under another clinical study. Volunteer compensation will be provided.
Last Updated June 12, 2013
Last Reviewed June 12, 2013