Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1

NCT02485080 | Withdrawn Phase 4

• 1 other identifier: 33431
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.

Conditions

PT-NANBH

Keywords

hepatitis C; liver transplantation; genotype 1

Outcome Measures

Primary Outcomes (1)

• Sustained virologic response (SVR) HCV RNA PCR <25 IU/mL 12 weeks post-treatment

  12 weeks after end of treatment or virologic response after liver transplantation, whichever comes first, assessed up to 12 weeks after end of treatment

Secondary Outcomes (1)

• Serious adverse events, adverse events grade 3 and above

  24 weeks while on treatment and 24 weeks after end of treatment

Study Arms (1)

Simeprevir + sofosbuvir daily, 24 weeks

EXPERIMENTAL

Eligible and consenting patients will be treated with sofosbuvir (SOF) 400 mg daily and simeprevir (SMV) 150 mg daily for 24 weeks. Both drugs will be administered orally, per manufacturers' instructions.

Drug: Simeprevir; Drug: Sofosbuvir

Interventions

Simeprevir DRUG

Also known as: Olysio

Simeprevir + sofosbuvir daily, 24 weeks

Sofosbuvir DRUG

Also known as: Sovaldi

Simeprevir + sofosbuvir daily, 24 weeks

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult 18-72 years
• Cirrhosis: defined by stage 4 on biopsy or noninvasive tests or presence of splenomegaly and platelet of 130K or lower, or presence of shrunken nodular liver on CT or MRI, or presence of varices or encephalopathy or ascites.
• HCV genotype 1 or indeterminate and later assessed at Screening and confirmed as genotype 1

You may not qualify if:

• Uncontrolled ascites, uncontrolled hepatic encephalopathy, or uncontrolled esophageal/gastric varices
• Co-infection with HIV or hepatitis B (HBV)
• CPT 7 or above, or MELD \>10
• Total bilirubin 4.0 mg/dL or above
• CrCl (creatinine clearance) \< 30 mL/min
• Any unstable active medical illnesses.
• Active use of illicit substances, alcohol, or smoking.
• Any malignancy within last 5 years except for basal cell skin cancer that has been adequately treated or HCC within Milan or UCSF criteria, which will be acceptable
• Any prior treatment with direct acting antivirals (approved or investigational), including HCV protease inhibitors, such as SMV. Patients who received prior treatment with SOF, and/or NS5A inhibitors (e.g. ledipasvir or Daclatasvir) can be included in this study
• Platelet \< 30 K/uL

Sponsors & Collaborators

• Stanford University: lead
• Janssen Scientific Affairs, LLC: collaborator
• Yale University: collaborator

Study Sites (2)

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Yale University Medical Center

New Haven, Connecticut, 06520, United States

Location

Related Publications (3)

• Roche B, Samuel D. Hepatitis C virus treatment pre- and post-liver transplantation. Liver Int. 2012 Feb;32 Suppl 1:120-8. doi: 10.1111/j.1478-3231.2011.02714.x.

  PMID: 22212582 BACKGROUND

• Carrion JA, Martinez-Bauer E, Crespo G, Ramirez S, Perez-del-Pulgar S, Garcia-Valdecasas JC, Navasa M, Forns X. Antiviral therapy increases the risk of bacterial infections in HCV-infected cirrhotic patients awaiting liver transplantation: A retrospective study. J Hepatol. 2009 Apr;50(4):719-28. doi: 10.1016/j.jhep.2008.11.015. Epub 2008 Dec 29.

  PMID: 19217183 BACKGROUND

• Iacobellis A, Siciliano M, Perri F, Annicchiarico BE, Leandro G, Caruso N, Accadia L, Bombardieri G, Andriulli A. Peginterferon alfa-2b and ribavirin in patients with hepatitis C virus and decompensated cirrhosis: a controlled study. J Hepatol. 2007 Feb;46(2):206-12. doi: 10.1016/j.jhep.2006.08.020. Epub 2006 Oct 20.

  PMID: 17125876 BACKGROUND

Related Links

• Recommendations for Testing, Managing, and Treating Hepatitis C by the American Association for the Study of Liver Diseases and Infectious Disease Society of America
• OLYSIO (Simeprevir) package insert
• SOLVALDI (Sofosbuvir) package insert

MeSH Terms

Conditions

Hepatitis C

Interventions

Simeprevir; Sofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Mindie H Nguyen, MD, MAS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 30, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)