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

Inclusion Criteria:

1. Targeted at least 20% enrollment of patients with cirrhosis
2. Adults >/= age 18 years.
3. Active infection with hepatitis C virus (HCV) genotype 1
4. Must have health insurance that covers therapy with SOF+RBV
5. 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.
6. Patients must be either IFN-ineligible due to psychiatric, autoimmune, neurological, or other causes that are confirmed appropriate by the PI; OR,
7. IFN-intolerant due to flu-like symptoms, psychiatric problems, cytopenia or other causes deemed appropriate by the PI.

Exclusion Criteria:

1. Presence of HIV co-infection
2. Presence of hepatocellular carcinoma (HCC)
3. Prior organ transplantation
4. Any history of hepatic decompensation

5. 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.
6. Patients that have been exposed to direct acting anti-viral agents
7. Patients with severe renal impairment (estimated Glomerular Filtration Rate (eGFR) <50 mL/min/1.73m2) or with end stage renal disease (ESRD).
8. Patients with platelet count <50 x109/L, Hemoglobin <10 g/dL, or Neutrophils <0.5 x109/L.
9. Women who are pregnant.
10. Men whose partners are pregnant or plan on becoming pregnant.