Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)

Hoffmann-La Roche10,228 enrolled

Overview

This observational study will examine the efficacy and safety of pegylated interferon (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis C (CHC). Quality of care will also be assessed. Approximately 12% of the interferon-treated CHC patient population in Germany is expected to be studied over a period of 5 years.

Study Type

OBSERVATIONAL

Enrollment

10,228

Conditions

Chronic Hepatitis C

Interventions

Pegylated interferon alfa-2aDRUG

Pegylated interferon alfa-2a administered according to corresponding summary of product characteristics (SmPC).

RibavirinDRUG

Ribavirin administered according to corresponding summary of product characteristics (SmPC).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or over * Clinically diagnosed CHC with detectable virus replication * Women of childbearing potential should use adequate contraception. It is important that female participants of childbearing potential and their sexual partners use 2 contraceptive methods at the same time during treatment and 4 months after treatment discontinuation. During this time pregnancy tests have to be performed monthly. Particular attention is also required and pregnancy should be avoided 7 months after treatment discontinuation in female sexual partners of male participants taking ribavirin (Copegus®). Both should use adequate contraception. Exclusion Criteria: * Any contraindications for peginterferon alfa-2a or ribavirin treatment * Pregnant or breast-feeding

Locations (1)

Unnamed facility

Herne, Germany

Outcomes

Primary Outcomes

Percentage of Participants With Rapid Virologic Response (RVR)

RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.

Time frame: At Week 4

Percentage of Participants With Early Virologic Response (EVR)

EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.

Time frame: At Week 12

Percentage of Participants With End of Treatment (EOT) Response

EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.

Time frame: Up to Week 72

Percentage of Participants With Sustained Virologic Response (SVR)

SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.

Time frame: Up to Week 96

Percentage of Participants With Serious Adverse Drug Reactions (SADR)

Time frame: Up to Week 96

Secondary Outcomes

Percentage Cumulative Dose of Peginterferon Alfa-2a Received

Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.

Data from ClinicalTrials.gov

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