Hepatitis C Clinical Trial
Official title:
A Randomized Controlled Study To Assess Safety, Tolerability And Efficacy Of GS-7977 In Combination With Full or Low Dose RBV In HCV Genotype 1, Monoinfected Treatment Naive Participants
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.
Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated
180 million people infected worldwide. In the United States an estimated 4.1 million people
are infected and HCV is the principal cause of death from liver disease and leading
indication for liver transplantation. A combination of ribavirin (RBV) and pegylated
interferon (PegIFN) is the currently recommended therapy for chronic HCV infection and this
may achieve viral clearance in 19% to 52% of patients infected with HCV genotype 1 (GT-1)
and in 76% -80% of patients infected with HCV genotypes 2 and 3. The standard of care is
changing and will soon become an HCV protease inhibitor [Boceprevir/ Telaprevir in
combination with PegIFN and RBV]. The registration studies for the new protease inhibitors
demonstrated increased sustained virologic response (SVR) rates of 60 70%. However, this is
still associated with a high incidence of adverse events (AEs) and lower cure rates in
several populations. Novel therapies that do not rely on an Interferon backbone will be
required to enhance cure rates in various populations.
This is a randomized controlled open-label study to assess safety, tolerability and efficacy
of GS-7977 (a potent and selective HCV NS5B inhibitor) given at a dose of 400 mg daily in
combination with RBV to a total of 60 treatment-na(SqrRoot) ve HCV genotype 1 mono-infected
individuals with less than or equal to stage 2 fibrosis.
The findings from this study will aid in the understanding of antiviral and host responses
to an interferon (IFN) free regimen as well as determine the role of RBV in IFN-free
therapies.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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