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

Completed

• Conditions: Hepatitis C Virus
• Interventions: Drug: No intervention

• Registration Number: NCT02103699
• Lead Sponsor: Janssen Scientific Affairs, LLC

Brief 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).

Detailed Description

This is a multicenter, observational (a study in which the investigators/ physicians observe the patients and measure their outcomes), prospective study (a study in which the patients are identified and then followed forward in time for the outcome of the study) designed to reflect routine clinical practice. Approximately 300 Hepatitis C virus (HCV) infected patients who are prescribed simeprevir by their health care provider as part of their routine HCV treatment regimen, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (\<=) 28 days will be enrolled in this and observed to evaluate the effectiveness of a simeprevir. Practice setting features will be documented at the initiation of the study by each participating site. The decision of patients to participate in this study will in no way impact upon the standard of care that they are receiving. All treatment decisions will be made at the discretion of the health care provider. Safety assessments will include assessment of adverse events, and clinical laboratory parameters (hematology, clotting tests, human immunodeficiency virus tests, chemistry, and liver function tests). The maximum study duration for each patient will be approximately 2 years.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Primary Completion: 2015-11
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatitis C virus infected patients receiving simeprevir	No intervention	-

Primary Outcome Measures

Name	Time	Method
Number of Patients who Achieve Sustained Virologic Response(SVR)	12 weeks after the actual end of treatment (an expected average of up to 2 years)	SVR is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at least 12 weeks after the actual end of all HCV treatment. Actual end of treatment will be determined by health care provider.

Secondary Outcome Measures

Name	Time	Method
Total duration of therapy	Up to actual end of treatment (an expected average of up to 2 years)	Actual end of treatment will be determined by health care provider.
Determination of Prognostic Factors of Virologic Response	12 weeks after the actual end of treatment (an expected average of up to 2 years)	Prognostic factors of virologic response includes patient and disease characteristics, treatment paradigm, Rapid Virologic Response (RVR), and select practice setting features. Actual end of treatment will be determined by health care provider.
Number of Patients who Achieve Rapid Virologic Response (RVR)	Week 4	RVR is defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
Number of Patients who Achieve Sustained Virologic Response(SVR) According to Patient Demographics, Baseline Disease Characteristics, Treatment Paradigm, and Select Practice Setting Features	12 weeks after the actual end of treatment (an expected average of up to 2 years)	Actual end of treatment will be determined by health care provider.
Number of Patients With Changes in Clinical Laboratory Parameters by Grade and Causality	Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)	Actual end of treatment will be determined by health care provider.
Number of Patients With Serious Adverse Event	Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)	Actual end of treatment will be determined by health care provider.
Number of Patients who Discontinue Therapy by reason	Up to actual end of treatment (an expected average of up to 2 years)	Actual end of treatment will be determined by health care provider.
Number of Patients who Achieve Sustained Virologic Response(SVR) Among Participants who Achieve Rapid Virologic Response (RVR)	12 weeks after the actual end of treatment (an expected average of up to 2 years)	SVR is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at least 12 weeks after the actual end of all HCV treatment. RVR is defined as undetectable HCV RNA at Week 4. Actual end of treatment will be determined by health care provider. Actual end of treatment will be determined by health care provider.
Number of Patients With On-treatment Virologic Failure	Up to actual end of treatment (an expected average of up to 2 years)	On-treatment virologic failure is defined as a confirmed increase of \>1 log10 IU/mL in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached, or a confirmed HCV RNA level of \>100 IU/mL in patients whose HCV RNA had previously been \<25 IU/mL. Actual end of treatment will be determined by health care provider.
Number of Patients With Viral Relapse	Up to actual end of treatment (an expected average of up to 2 years)	Viral Relapse is defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) after concluding treatment with undetectable HCV RNA. Actual end of treatment will be determined by health care provider.
Number of Patients With Adverse Events by Grade and Causality	Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)	Actual end of treatment will be determined by health care provider.
Number of Patients With Adverse Event Determined to be Related to Simeprevir	Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)	Actual end of treatment will be determined by health care provider.
Number of Patients who Develop Mutations at the Time of Virologic Failure	Up to actual end of treatment (an expected average of up to 2 years)	Actual end of treatment will be determined by health care provider.