Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its impact on the outcome in older patients with chronic hepatitis C deserve to be elucidated. The purposes of this study are: 1. To evaluate the efficacy of pegylated interferon-alpha 2a plus ribavirin combination therapy in older patients with chronic hepatitis C 2. To investigate the safety of pegylated interferon-alpha 2a plus ribavirin combination therapy in older patients with chronic hepatitis C
A prospective, hospital-based, case-control study enrolling 70 chronic hepatitis C patients who are 65 to 80 years of age and other sex- and HCV genotype-matched 140 chronic hepatitis C patients who are 50 to 64 years of age will be conducted for comparison. The 210 patients chronic hepatitis C patients will receive pegylated interferon-alpha plus ribavirin combination therapy. Genotype 1 infected patients will received 48 weeks of treatment and genotype non-1 patients will received 24 weeks of treatment. Another 40 HCV-1 infected patients who are 65-80 years of age and have a rapid virological response ( defined as seronegative of HCV RNA at week 4 of treatment) will receive 24 weeks of treatment and are enrolled for comparison since Jan 2008. The primary outcome measurement is sustained virological response and safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks
pegylated interferon alpha 180 ug/week and ribavirin 1000-1200 mg/day for 24 weeks
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Efficacy: Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.
Time frame: 1.5 year
RVR, rapid virological response, defined as HCV RNA < 50 IU/mL at treatment week 4
Time frame: 1.5 year
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