SMV + SOF With/Without RBV for IFN-II Patients With CHC

Inclusion criteria

• Targeted at least 20% enrollment of patients with cirrhosis
• Adults >/= age 18 years.
• Active infection with hepatitis C virus (HCV) genotype 1
• Must have health insurance that covers therapy with SOF+RBV
• Female patients of childbearing age must have a negative pregnancy test prior to initiating therapy, use at least two effective methods of contraception during treatment, and undergo monthly pregnancy tests.
• Patients must be either IFN-ineligible due to psychiatric, autoimmune, neurological, or other causes that are confirmed appropriate by the PI; OR,
• IFN-intolerant due to flu-like symptoms, psychiatric problems, cytopenia or other causes deemed appropriate by the PI.

Exclusion criteria

• Presence of HIV co-infection
• Presence of hepatocellular carcinoma (HCC)
• Prior organ transplantation
• Any history of hepatic decompensation
• Patients taking any of the following medications:

• Anticonvulsants- Carbamazepine, Oxcarbazepine, Phenobarbital, or Phenytoin.
• Anti-infectives-erythromycin, clarithromycin, or telithromycin.
• Antifungals- systemic itraconazole, ketoconazole, posaconazole, fluconazole, or voriconazole.
• Antimycobacterials- rifampin, rifabutin or rifapentine.
• Corticosteroids- systemic dexamethasone.
• Propulsives- Cisapride.
• Herbals- Milk thistle or St. John's Wart.
• Patients that have been exposed to direct acting anti-viral agents
• Patients with severe renal impairment (estimated Glomerular Filtration Rate (eGFR) <50 mL/min/1.73m2) or with end stage renal disease (ESRD).
• Patients with platelet count <50 x109/L, Hemoglobin <10 g/dL, or Neutrophils <0.5 x109/L.
• Women who are pregnant.
• Men whose partners are pregnant or plan on becoming pregnant.