Extension study of GS-7977 in patients with HCV infection

• Research type

  Research Study

• Full title

  An Open-Label Study of GS-7977 + Ribavirin with or without Peginterferon Alfa-2a in Subjects with Chronic HCV Infection who Participated in Prior Gilead HCV Studies

• IRAS ID

  112402

• Contact name

  Geoffrey Dusheiko

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2012-000571-16

• Research summary

  Study to evaluate the Efficacy and Safety of GS-7977 Ribavirin for 12 Weeks in subjects with Chronic HCV Infection who participated in prior studies evaluating GS-7977. Hepatitis C is a disease caused by a virus (known as HCV) which infects liver. A virus is a very small organism that attaches itself to healthy cells and forces them to make more of the virus. A persons immune response attempts to clear the hepatitis C virus, but the hepatitis C virus is very strong. In some people, the virus will change to fight back against your body's defenses. It may also change and become resistant to the drugs given to treat the virus (this is known as ??resistance?). The Hepatitis C virus (HCV) lives in liver. When it invades healthy liver cells, it causes those cells to become inflamed. Over time, this may cause scarring (fibrosis) of the liver or permanent liver damage (cirrhosis) which will affect the way that liver functions. In addition, people infected with chronic HCV may develop liver cancer and/or need a liver transplant. The main purpose of the study is to help determine if GS-7977 in combination with Ribavirin for 12 weeks is safe and able to eliminate the HCV infection. Approximately 200 participants will be enrolled into this study at around 200 study centres across the world. The participants will remain in the study up to 40 weeks and will attend the following study periods: ?½Screening: up to 4 weeks to have their eligibility assessed ?½Study Treatment (12 weeks of taking study medication): If the participant's eligible then he/she will start the treatment phase. Participants will take a 400 mg pill of GS-7977 by mouth once a day. Ribavirin will be taken by mouth and the dosage will depend on the participant's body weight. Participants will take the ribavirin pills both in the morning and the evening as directed by the study doctor. Follow-Up: Upon completion of the treatment period, participants will be followed up by the study doctor and the study team for up to 24 weeks after last dose of study medication. During this period some tests will be performed to determine if the HCV has been eliminated from participant's body.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0400

• Date of REC Opinion

  9 Nov 2012

• REC opinion

  Further Information Favourable Opinion