At a glance
ClinicalIndex Comparison Record- ✓Chronic hepatitis C with positive HCV RNA by PCR and confirmed genotype 1
- ✓Age 18-65 years
- ✓Documented chronic hepatitis C by liver biopsy (within 5 years) or clinical diagnosis if biopsy refused
- ✓Compensated liver disease with specified lab parameters
- ✕Decompensated liver disease, history of encephalopathy, variceal bleeding, ascites, or Child-Pugh class B or C
- ✕HBsAg positive or other liver disease in addition to chronic hepatitis C (autoimmune, hemochromatosis, PBC, PSC, alpha-1 antitrypsin deficiency, Wilson's disease)
- ✕Active or uncontrolled psychiatric disease, or recent hospitalization for severe psychiatric disease within last 2 years
- ✕Current substance use disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Randomized Pilot Study of Daily Consensus Interferon (CIFN) and Ribavirin for 52 Wks vs Extended Duration 72 Wks Based on Virologic Response for the Initial Treatment of Difficult-to-treat Patients With Chronic HCV Genotype 1
In Brief
A Phase 3 clinical trial evaluating consensus interferon (Interferon Alfacon-1) and ribavirin and Consensus Interferon alfa (CIFN) and ribavirin for Chronic Hepatitis C. Completed, enrolled 64 participants.
Detailed Summary
Data have suggested that consensus interferon (CIFN) has greater antiviral activity in vitro compared with interferon alfa-2a or alfa-2b. Several clinical studies also suggest that CIFN has greater antiviral activity in patients with genotype 1 hepatitis C infection, particularly if given as a daily injection. These data indicate that the use of a regimen of daily CIFN and ribavirin will lead to greater virologic response rates compared with pegylated interferon alfa-2b and ribavirin in patients with genotype 1 infection, with comparable adverse events. Emerging data indicate that HCV genotype 1 patients with a delayed virologic response to initial therapy may benefit from an extended duration of therapy. Therefore, the goals of this pilot study are to determine the tolerability and efficacy of daily CIFN plus ribavirin when given for 52 weeks or an extended duration of therapy. The target population will consist of "difficult-to-treat" patients, defined as having the following characteristics: genotype 1, a North American patient population, predominantly male gender, and no specific exclusions for pre-existing psychiatric or substance abuse co-morbidities.
Study Details
Timeline
Interventions
CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B)
CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B)