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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214420
Recruitment Status : Completed
First Posted : August 12, 2014
Results First Posted : May 17, 2018
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Paul J. Pockros, MD, SC Liver Research Consortium, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Simeprevir Drug: Sofosbuvir Drug: Ribavirin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: SMV+SOF
IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)
 Drug: Simeprevir
Drug: Sofosbuvir
Active Comparator: SMV+SOF+RBV
IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day
 Drug: Simeprevir
Drug: Sofosbuvir
Drug: Ribavirin


Outcome Measures
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Primary Outcome Measures :
  1. Sustained Viral Response [ Time Frame: 12 weeks ]
    Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214420


Locations
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United States, California
Scripps Clinic
La Jolla, California, United States, 92037
United States, New York
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
United States, Utah
Clinical Research Centers of America, LLC
Murray, Utah, United States, 84123
Sponsors and Collaborators
SC Liver Research Consortium, LLC
Janssen, LP
Investigators
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Principal Investigator: Paul Pockros, MD Scripps Clinic
More Information
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Responsible Party: Paul J. Pockros, MD, Principal Investigator, SC Liver Research Consortium, LLC
ClinicalTrials.gov Identifier: NCT02214420    
Other Study ID Numbers: PJPIIS-01-14
First Posted: August 12, 2014    Key Record Dates
Results First Posted: May 17, 2018
Last Update Posted: June 19, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
 Flaviviridae Infections
Ribavirin
Sofosbuvir
Simeprevir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors