A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients

Hoffmann-La Roche270 enrolled

Overview

In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.

Study Type

OBSERVATIONAL

Enrollment

270

Conditions

Hepatitis C, Chronic

Interventions

Peginterferon alfa-2aDRUG

Peginterferon alfa-2a according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.

RibavirinDRUG

Ribavirin according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients \>/= 18 years * Positive test for HCV * Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels Exclusion Criteria: * Concomitant infection with HIV or hepatitis B * Participation in a clinical trial within 30 days prior to study start * Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels

Locations (4)

Unnamed facility

Celje, Slovenia

Unnamed facility

Ljubljana, Slovenia

Unnamed facility

Maribor, Slovenia

Unnamed facility

Novo Mesto, Slovenia

Outcomes

Primary Outcomes

Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment

SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (\<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).

Time frame: 6 months after the last study drug administration (up to 123.6 weeks)

Secondary Outcomes

Percentage of Participants With Undetectable HCV RNA

Undetectable HCV RNA=a single last HCV RNA \<20 IU/mL

Time frame: Weeks 4, 12 and at end of treatment (up to 99.6 weeks)

HCV RNA Values

Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

Thrombocyte Values

Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

Leukocyte Values

Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

Hemoglobin Values

Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin

Time frame: Up to 99.6 Weeks

Data from ClinicalTrials.gov

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