Phase 2
N=67
Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT02716779 ↗Enrolled (actual)
67
Serious AEs
3.8%
Results posted
Jul 2016
Primary outcome: Primary: Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action — -27.0; -21.4; -22.2; -28.2 log likelihood function value
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pegylated Interferon (PEG-IFN) alfa-2a (Drug); Placebo (Drug); Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action |
-27.0; -21.4; -22.2; -28.2; -23.8; -23.9 | — |
| SECONDARY Score in Quality of Life Assessed Using Short Form-36 (SF-36) Health Questionnaire |
95.6; 76.5; 79.7; 90.8; 72.3; 68.4 | — |
| SECONDARY Percentage of Participants With Treatment Response |
79; 65; 72; 43; 30; 20 | — |
| SECONDARY Area Under the Concentration-Time Curve (AUC) of Ribavirin |
186.6; 179.4; 290.1 | — |
| SECONDARY Maximum Concentration (Cmax) of Ribavirin |
2.95; 2.83; 3.37 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Ribavirin |
6.0; 8.0; 6.4 | — |
| SECONDARY Area Under the Concentration-Time Curve (AUC) of PEG-IFN |
2097.9; 1270.4; 1164.9 | — |
| SECONDARY Maximum Concentration (Cmax) of PEG-IFN |
28.77; 20.36; 19.8 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of PEG-IFN |
6.3; 12.0; 6.0 | — |
| SECONDARY Area Under the Concentration-Time Curve (AUC) of Glutamate-Pyruvate Transaminase (GPT) |
5078.3; 7233.5; 5231.3 | — |
| SECONDARY Maximum Concentration (Cmax) of GPT |
68.5; 88.0; 75.0 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of GPT |
2.8; 14.0; 3.0 | — |
Summary
This study examined the influence of ribavirin on the initial virological response in treatment-naïve participants with chronic hepatitis C, genotype 1. Participants were randomized to 1 of 3 treatment groups to receive placebo, ribavirin monotherapy 1000 milligrams (mg) to 1200 mg orally daily depending on body weight or pegylated interferon (PEG-IFN) alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously (SC) weekly, for 6 weeks. Following the initial 6 weeks, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin (Copegus®) for 12 weeks. If there was an initial virological response after 12 weeks of combination therapy, treatment could be continued for a further 36 weeks outside of the study.
Eligibility Criteria
Inclusion Criteria
- Caucasians, male or female aged between 18 and 70 years
- Indication: serological proof of a chronic hepatitis C infection with positive result of anti-Hepatitis C virus (HCV) test and detectable HCV- Ribo Nucleic Acid (RNA) in serum
- Proven HCV genotype 1 by means of the reverse hybridization assays
- Proven histological infection activity within the liver with or without proven compensated cirrhosis within the last 24 months prior to start of the study (Child-Pugh degree A)
- Participants without previous anti-HCV therapy
Exclusion Criteria
- Known hypersensitivity to interferon or ribavirin or any of the other component parts
- Pregnant or nursing women, women with child bearing potential and without using a high effective method of contraception. The urine and serum pregnancy test at visit 0 in fertile participants or cohabitants of participants must show a negative result
- Male partners of pregnant women
- Infection with HCV genotype 2, 3, 4, 5, or 6
- Pretreatment with interferon and/or ribavirin
- Immunocompromised participants
- Treatment of systemic anti-neoplastic or immunomodulatoric medication (including supraphysiological doses of steroids or radiation therapy) within the last 6 months prior to the start of treatment and during the complete time interval of study treatment
- Chronic hepatitis due to hepatitis C virus (e.g. haemochromatosis, autoimmunohepatitis, metabolic or alcohol-related liver disease)
- Decompensated liver cirrhosis or liver disease Child-Pugh degree B or C or condition after decompensation
- Signs of a hepatocellular carcinoma within 2 months prior to randomization in case of a cirrhosis or a transition to cirrhosis
- Ascites or esophagus varices with bleedings as documented in anamnesis
- Any medical condition that questions in the opinion of the investigator the participant's enrollment and participation in the trial
- Hemoglobin <13 grams/deciliter (g/dl) in females and <14 g/dl in males in screening phase
- Patients with an increased anemia risk (e.g. thalassemia, spherocytosis, etc.) or patients which would be at a particular medical risk in case of an anemia
- Diagnosed neutropenia <1.500/microliter (mcl) or thrombocytopenia <90.000/mcl in screening phase
Data sourced from ClinicalTrials.gov (NCT02716779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.