SMV + SOF With/Without RBV for IFN-II Patients With CHC
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: Simeprevir; Sofosbuvir; Ribavirin
Intervention MeSH terms: Ribavirin; Sofosbuvir; Simeprevir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Prior trials have shown that many G1 CHC patients are ineligible or intolerant to pegylated
      (PEG)-based regimens due to prior severe side effects, worsening of cytopenias, exacerbation
      of underlying psychiatric disorders, or autoimmune disorders. These patients will not be
      candidates for treatment with the approvals of SMV and SOF in early 2014 due to the
      combination with PEG-regimens. Results of the COSMOS study suggest that these patients are
      likely to have excellent responses to SMV+SOF with or without RBV with 12 weeks of therapy,
      and that 24 weeks are unnecessary. This trial is designed to rapidly enroll and be completed
      in order to confirm this hypothesis.
    

Eligibility criteria:

        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.