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 chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma deserve to be elucidated. The purposes of this study are: 1. To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma, compare to those without systemic malignancy. 2. To investigate the role of baseline and on-treatment factors on the response to pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma.
A prospective, hospital-based study enrolling 40 chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma and other sex- and age-matched 80 chronic hepatitis C patients without malignancy will be conducted. The 40 chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma will receive pegylated interferon-alpha 2a plus ribavirin combination therapy at remission phase after oncological treatments and/or interventions. The other 80 chronic hepatitis C patients without malignancy receiving the same antiviral therapy will serve as controls. The primary outcome measurement is sustained virological response and safety, whilst the secondary measurement is rapid virological and early virological response.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up 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
Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4.
Time frame: 1.5 year
Early virological response (EVR), by PCR-negative or at least 2 logs decline from baseline of serum HCV RNA at 12 weeks of treatment.
Time frame: 1.5 year
Safety - adverse event rate and profile
Time frame: 1.5 year
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