Background:
- GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by
blocking the hepatitis C virus from dividing in the body. This medication has been used along
with other medications commonly used to treat hepatitis C, such as interferon and ribavirin.
When used with interferon and ribavirin, GS-7977 seems to be very effective in eliminating
the hepatitis C virus from the body. However, interferon can have serious side effects, so
researchers want to see if GS-7977 can work by itself or with only ribavirin.
Objectives:
- To test the safety and effectiveness of GS-7977 alone or given with ribavirin for hepatitis
C infection.
Eligibility:
- Individuals at least 18 years of age who have hepatitis C with liver disease, and have
never received drugs for it.
Design:
- This study will require multiple clinic visits over 18 months. A liver biopsy will be
required before the start of the study if participants have not had one within the past
3 years.
- Participants will be screened with a medical history and physical exam.
- Participants will have either GS-7977 alone or GS-7977 with ribavirin. GS-7977 is taken
by mouth once a day. Ribavirin is taken by mouth in the morning and evening.
- Participants will have study visits on Days 1, 3, 5, 7, 10, and 14. These visits will
involve regular blood tests and symptom monitoring.
- After the second week, participants will have study visits during Weeks 3, 4, 6, 8, 12,
16, and 20. Blood and urine tests will be given to study virus levels in the body, and
symptoms will be discussed.
- Participants will stop receiving the study drugs at Week 24.
- Followup clinic visits with blood tests will take place in Weeks 28, 36, 48, 52, 60, and
72. Another liver biopsy will be performed at 48 weeks.
- Some participants may also be part of a smaller study. This study involves frequent
blood draws to study drug and virus levels in the blood. The study will require a
36-hour hospital inpatient visit.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)