hdv-interferon in the treatment of chronic hepatitis c nonresponders and naive hepatitis c patients

Conditions: Chronic Hepatitis C

Summary: a phase ii, open label, multi-center, proof-of-concept study determing whether treatment with hdv-interferon (hdv-ifn), by oral or subcutaneous (injection) routes, and ribavirin results in similar efficacy \[rapid virologic response (rvr)\] and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin (historical control) in patients with chronic hepatitis c (treatment naïve by oral route and non-responders by sc route respectively).

part 1 ("initial part") - 4 weeks of treatment (28 days): * all patients will complete an initial 4 weeks of treatment with hdv-interferon (hdv-ifn) (treatment naïve by oral route and non-responders by sc route respectively) and ribavirin. * the part 1 of the study shall assess whether a 4-week treatment course with hdv-interferon (hdv-ifn), orally or by subcutaneous injection, and ribavirin results similar efficacy \[rapid virologic response (rvr)\] and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin (historical control) in patients with chronic hepatitis c (treatment naïve and non-responders). part 2 ("continuation part") - 44 or 20 weeks of treatment + 24 weeks (follow-up period): * patients with hepatitis c viral genotype 1, who achieve rvr, will be treated for another 44 weeks of therapy (to complete 48 weeks of active treatment) followed by 24 weeks of treatment-free follow-up period. * patients with hepatitis c viral genotype 3, who achieve rvr, will be treated for another 20 weeks of therapy (to complete 24 weeks of active treatment) followed by 24 weeks of treatment-free follow-up period. * follow-up period (24 weeks): thus, in addition to treatment in part 1 of study, each completed patient with viral genotype 1 will receive 44 weeks of therapy and 24 weeks of treatment-free follow-up; and viral genotype 3 patients will have 20 weeks of therapy \& 24 weeks of treatment study drug free follow-up. * overall study duration (72 or 48 weeks): patients with viral genotype 1 will have an overall study duration of 72 weeks (48 weeks of therapy plus 24 weeks follow-up) and patients with viral genotype 3 will have an overall study duration of 48 weeks (24 weeks of therapy plus 24 weeks follow-up).

Eligibility criteria:
inclusion criteria - nonresponders: * patients \>18 years with established chronic hepatitis c with viral genotype 1 or viral genotype 3 who have failed to respond to at least a 3-month course of a pegylated interferon alpha 2a + ribavirin and have a detectable hcv rna and baseline liver biopsy available from within the prior 12 months. inclusion criteria - naive: * treatment naïve patients \> 18 years, inclusive, are eligible for this study. * patients will be viral genotype 1 or viral genotype 3, have quantifiable hcv-rna \> 1000 iu/ml as demonstrated by pcr and an abnormal alt (within 6 months of screening) and compensated liver disease with or without cirrhosis. exclusion criteria - nonresponders: * patients with decompensated cirrhosis or other forms of liver disease * hb \< 10g/dl for males \& hb \< 9 g/dl for females * hepatocellular carcinoma * active hepatitis b infection * human immunodeficiency virus (hiv) * pre-existing severe or uncontrolled depression or other psychiatric disease * significant cardiac disease * renal disease * seizure disorders or retinopathy exclusion criteria - nonresponders: * patients with decompensated cirrhosis or other forms of liver disease * hb \< 10g/dl for males \& hb \< 9 g/dl for females * hepatocellular carcinoma * active hepatitis b infection * hiv * pre-existing severe or uncontrolled depression or other psychiatric disease - significant cardiac disease * renal disease * seizure disorders or retinopathy

Keywords: chronic hepatitis c naive nonresponders interferon patients with chronic hepatitis c