A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of a simeprevir-containing hepatitis C virus (HCV) treatment regimen as measured by sustained virologic response (SVR).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC
• Treatments: Simeprevir

Criteria

Inclusion Criteria:

• Patients who have genotype 1 chronic hepatitis C infection

• Hepatitis C virus (HCV) ribonucleic acid (RNA) test result above the limit of quantification before initiation of simeprevir-based therapy

• Health care provider decision to treat patient with a simeprevir-based therapy, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (<=) 28 days will be enrolled into the study

• Prior HCV treatment must be completed more than 3 months before initiation of simeprevir-based therapy

• In the opinion of the health care provider, the patient will attend routine standard of care visits, either at enrolled site or by virtual/telemedicine

Exclusion Criteria:

• Non-genotype 1 HCV infected patients

• Absolute contraindication to any component of prescribed HCV treatment per prescribing information

• Patient is currently enrolled in an interventional study

• Past use of an HCV direct-acting antiviral therapy

• Any investigational drug use within 30 days before initiation of simeprevir-based therapy