Objective : To evaluate the long-term benefit and risk of interferon (IFN) therapy for chronic hepatitis C.
Methods : Seventy-five patients with chronic hepatitis C who were treated with IFN at our hospitals in 1992 and 1993 were enrolled. Observation of general condition, incidence of hepatocellular carcinoma (HCC) and all events were followed up for ten years.
Results : HCC was observed in 12 patients (16%), six of whom died. In two cases, HCC was suspected and could not be ruled-out, and four patients died of other causes. Adverse events which needed continuous treatment or follow-up were observed in 34 cases (45%). No HCC was observed in cases whose ALT was maintained within the normal range. Sixteen cases (19%) have been in stable good condition, free from HCC or adverse events.
Discussion : Adverse events including drug adverse reactions after IFN were varied and some were irreversible. Patients who had such adverse reactions were forced to continue some treatments for adverse reactions and had difficulties in daily life. It is desirable that treatments for refractory cases are developed, but there are also new risks with long-term treatment. Monitoring and analysis of the adverse events and the total death rate will be more important.

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As of April 2005, “Shihango-rinsyoushiken” defined in the GPMSP was renamed “Seizouhanbaigo-rinsyoushiken” in the revised regulations (GPSP). The relevant part of the GCP was also modified at the same time. Strictly speaking, therefore, post-approval clinical trials are not the same as postmarketing clinical trials. This report provides an explanation of post-approval clinical trials and the related regulations. It is generally considered that post-approval clinical trials, which help gather more clinical information, should be actively pursued for the further development of approved drugs in the post-marketing setting. However, the results of the questionnaire show that pharmaceutical companies are not willing to conduct them, mainly due to the high cost. To improve the economic efficiency of post-approval clinical trials, it is necessary to streamline monitoring activities that account for 40% of the cost.

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