GS-7977 With Ribavirin for Hepatitis C (SPARE)

-INCLUSION CRITERIA:

• Over 18 years of age at screening

A female is allowed to enter and participate in the study if she is either of:

• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
• Has had a hysterectomy or
• Has had a bilateral oophorectomy (ovariectomy) or
• Is post-menopausal (a demonstration of a total cessation of menses for greater than or equal to 1 year)
• Has had a bilateral tubal ligation or fallopian tube inserts
• Childbearing potential, has a negative serum pregnancy test at Screening, and agrees to acceptable birth control such as any of the following:
• Complete abstinence from sexual intercourse from 2 weeks prior to administration of the study drug until completion of the follow-up procedures and at least 6 months after the last dose of RBV
• Vasectomized partner
• Use of an intrauterine device from 2 weeks prior to administration of study drug until completion of the Follow-up procedures and at least 6 months after the last dose of RBV
• Double contraceptive method (condom or occlusive cap [diaphragm or cervical/vault caps]; spermicidal foam/gel/film/cream/suppository; oral, implantable, transdermal, or injectable contraceptives)

This is advised on the basis of using RBV, which may have a potential teratogenic effect on the fetus in pregnant women. Furthermore reproductive and developmental toxicity studies have not been conducted with GS-7977.

A male is allowed to enter and participate in the study if he either:

• Is sterile or
• Agrees to use from 2 weeks prior to administration of the study drug until completion of the follow up procedures and at least 6 months after the last dose of RBV at least 1 of the following approved methods of contraception:
• a male condom with spermicide
• a sterile sexual partner
• use by female sexual partner of an IUD
• use by female sexual partner of a female condom with spermicide; an intravaginal system (e.g., NuvaRing )
• use by female sexual partner of a diaphragm with spermicide
• use by female sexual partner of a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives
• Chronic Genotype 1 infection as documented by at least one measurement of serum HCV RNA greater than or equal to 2,000 IU/mL during screening and at least one of the following:
• A positive anti-HCV antibody, HCV RNA, or an HCV genotype test at least 12 months prior to baseline (Day 0) visit together with positive HCV RNA test and anti-HCV antibody.

or

• A positive HCV RNA test and anti-HCV antibody test together with either a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis).
• Na(SqrRoot) ve to all HCV antiviral treatment(s), including but not limited to immunomodulatory and nucleoside/tide treatments for chronic HCV infection.
• Body mass index (BMI) of greater than or equal to 18 kg/m(2).
• Otherwise healthy as determined by the medical history, physical examination, ECG, and clinical laboratory measurements performed at Screening.
• Liver biopsy obtained within 3 years (36 calendar months) prior to the Day 0 visit, with a fibrosis classification of less than or equal to stage 2 fibrosis. If no recent ( 12.5 kPa
• A FibroSURE(r) score of > 0.75 AND an AST:platelet ratio (APRI) of > 2 performed during screening.

Absence of cirrhosis is defined as one of the following:

• A liver biopsy performed within 24 calendar months of screening showing absence of cirrhosis
• Where approved by the local regulatory agency, transient elastography performed within 12 calendar months preceding Day 1 with a result of Grade 1 Stage 1 non-alcoholic steatohepatitis and toxin exposures).
• Treatment with unlicensed herbal/natural remedies suggested to be taken for hepatitis treatment such as Milk thistle or Cats Claw within 28 days of Day 0.
• Participants with a history of ascites,