The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Study Type
OBSERVATIONAL
Enrollment
505
PegIntron administered in accordance with approved labeling Subcutaneous injection once weekly for 24 weeks.
Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.
Overall incidence of adverse events and adverse drug reactions.
Time frame: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Assessment of trends of adverse drug reactions by patient factors and concomitant medications; Incidence, severity, and outcome of adverse events (AEs) between the elderly vs younger patients
Time frame: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics
Time frame: Assessed at 24 weeks post-treatment
Rate of ALT normalization at end of treatment period and at 24 weeks post completing therapy.
Time frame: End of treatment and 24 weeks after end of treatment
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