A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3

Hoffmann-La Roche395 enrolled

Overview

This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

395

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a [Pegasys]DRUG

180 mcg sc weekly, 24 weeks

peginterferon alfa-2a [Pegasys]DRUG

180 mcg sc weekly, 16 weeks

ribavirinDRUG

800 mg orally daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, 18-65 years of age * Chronic hepatitis C, genotype 2 or 3 * Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test) * Abdominal sonography within 3 months prior to study start Exclusion Criteria: * Previous interferon and/or pegylated interferon and ribavirin therapy * Liver cirrhosis, class B or C (Child-Pugh) * Systemic anti-neoplastic or immunomodulatory treatment \<=6 months before study drug * History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C * Decompensated liver disease * Positive for HIV

Locations (18)

Unnamed facility

Gratwein, Austria

Unnamed facility

Graz, Austria

Unnamed facility

Innsbruck, Austria

Outcomes

Primary Outcomes

Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment

Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment.

Time frame: Up to Week 48 (24 weeks post completion of the treatment)

Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48

Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively.

Time frame: At Week 24 and Week 48

Secondary Outcomes

Percentage of Participants With Virological Response at the End of the Treatment

Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24.

Time frame: At Week 16 and Week 24

Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment

Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24.

Time frame: At Week 16 and Week 24

Number of Participants With Any Adverse Events and Any Serious Adverse Events

An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.

Data from ClinicalTrials.gov

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Unnamed facility

Linz, Austria

Unnamed facility

Linz, Austria

Unnamed facility

Oberndorf, Austria

Unnamed facility

Ried-innkreis, Austria

Unnamed facility

Salzburg, Austria

Unnamed facility

Vienna, Austria

Unnamed facility

Vienna, Austria

...and 8 more locations

Time frame: Up to Week 48

Median Hemoglobin Levels at End of Treatment

Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was \>=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day.

Time frame: At Week 16 and Week 24

Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48

Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0.

Time frame: At Baseline (Week 0) and Weeks 16, 24 and 48

Mean FSS Scores at Baseline and Weeks 16, 24 and 48

The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0.

Time frame: At Baseline (Week 0) and Weeks 16, 24 and 48

Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48

Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1="stark" (affliction is strong) to 4="gar nicht" (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0.

Time frame: At Baseline (Week 0) and Weeks 16, 24 and 48

Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48

For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0.

Time frame: At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48

Time to Viral Response

Time to viral response was calculated as Date of first negative PCR result after screening - date of PCR screening sample + 1 \[in days\]. Mean of number of days to viral response for overall population were reported.

Time frame: Up to Week 48