Clinical trial NCT02214420: SMV + SOF With/Without RBV for IFN-II Patients With CHC
Official title: Simeprevir (SMV) + Sofosbuvir (SOF) With or Without Ribavirin (RBV) for Interferon-intolerant or Ineligible (IFN-II) Patients With Chronic Hepatitis C (CHC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Lead sponsor: SC Liver Research Consortium, LLC
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2014-08-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Sustained Viral Response
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Murray
country: United States
facility: Clinical Research Centers of America, LLC
state: Utah
Study officials:
affiliation: Scripps Clinic
name: Paul Pockros, MD
role: PRINCIPAL_INVESTIGATOR
References: