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

SC Liver Research Consortium, LLC

Status and phase: Completed; Phase 4

Conditions: Hepatitis C

Treatments: Drug: Simeprevir; Drug: Ribavirin; Drug: Sofosbuvir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02214420

PJPIIS-01-14

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

SMV+SOF

Active Comparator group

Description:

IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)

Treatment:

Drug: Sofosbuvir

Drug: Simeprevir

SMV+SOF+RBV

Active Comparator group

Description:

IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day

Treatment:

Drug: Sofosbuvir

Drug: Simeprevir

Drug: Ribavirin