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Background/aim: Persistence of HCV-RNA in serum early in treatment is a strong predictor of failure of alpha-interferon therapy for chronic hepatitis C. Therefore, we compared the efficacy of ribavirin addition to alpha-interferon with a doubling of the dosage of alpha-interferon in case of lack of early virological response to alpha-interferon therapy., Methods: Sixty patients were administered interferon alpha2b at the dosage of 3 million units 3 times a week. After the first 4 weeks of therapy, serum HCV-RNA was evaluated. The patients with negative HCV-RNA test received the same treatment for a further 11 months, while those with detectable HCV-RNA were randomized to receive either the same dosage of alpha-interferon plus ribavirin (1000 mg/day) or double dosage of alpha-interferon (6 million units tiw) for 11 months. We considered sustained response to be the maintenance of normal alanine aminotransferase and negativity at HCV-RNA testing until the end of a 6-month post-treatment follow-up., Results: After the first 4 weeks of treatment, 12 (20%) patients showed virological response and 48 patients (80%) remained positive on HCV-RNA testing. Sustained response was observed in 5/12 (42%) patients with early virological response, in 10/24 (42%) patients without early virological response who were administered ribavirin and alpha-interferon, and in only 1/24 (4%) patients who were administered the double dosage of alpha-interferon (p=0.006)., Conclusions: This study shows the efficacy of the addition of ribavirin to alpha-interferon and the lack of efficacy of doubling the dosage of alpha-interferon in patients without clearance of hepatitis C virus early on in treatment.

Objective: After non-response to the initial course of therapy, retreatment with alpha-interferon is not effective. The aim of this study was to ascertain whether the administration of N-acetyl cysteine and vitamin E could increase the response rate to retreatment with alpha-interferon., Design: Prospective, multicentre clinical trial., Setting: Twelve hospitals in Lombardy, Italy., Participants: 120 consecutive patients affected by biopsy-proven chronic hepatitis C who had been non-responders to a previous course of alpha-interferon, administered at the dosage of 3-6 million units (MU) three times a week (tiw) for 6 months., Interventions: The patients were randomly assigned to one of two groups of treatment: group A, natural interferon-alphaN3, 6 or 9 MU tiw, when the body weight was < 60 kg or > or = 60 kg, respectively; group B, the same dosage of natural interferon-alphaN3 in association with oral administration of N-acetyl cysteine 1200 mg/day and vitamin E 600 mg/day. The period of treatment was 6 months in both groups., Results: Neither end-therapy biochemical response nor sustained biochemical response rates were improved by the combination treatment, and in no case was clearance of the virus from serum observed., Conclusions: In this randomized study carried out on 120 patients with chronic hepatitis C not responsive to alpha-interferon, oral supplementation with N-acetyl cysteine and vitamin E did not improve the poor efficacy of retreatment with alpha-interferon alone.

Background/aims: Retrospective studies have suggested that early loss of serum HCV-RNA predicts sustained response to alpha-interferon treatment in chronic hepatitis C, but the optimal duration of therapy after loss of HCV-RNA is not known. The aims of this study were: a) to prospectively evaluate the effectiveness of HCV-RNA testing after 1 month of alpha-interferon treatment in the prediction of sustained response, and b) to compare the efficacy of 6 and 12 months of therapy in patients with a negative serum HCV-RNA test after the first month of treatment., Methods: One hundred and thirty patients were administered interferon alpha-2b at doses related to body weight (< or > or = 60 kg) and to HCV genotype: 5 or 8 MU tiw for type 1, and 3 or 5 MU tiw for genotypes non-1. Serum HCV-RNA testing was performed using in-house nested RT-PCR at month 1, at the end of treatment and 6 months afterwards. We considered sustained response to be the maintenance of normal alanine aminotransferase and negativity at serum HCV-RNA testing until the end of follow-up., Results: Sustained response was observed in 2/72 (2.8%) patients with detectable HCV-RNA after the initial month of therapy, in 8/30 (26.7%) patients with early loss of HCV-RNA treated for 6 months and in 20/28 (71.4%) patients treated for 12 months (p<0.01)., Conclusions: Serum HCV-RNA detectability after the first month is strongly associated with a very poor chance of sustained response, and these cases should be offered other treatments. Patients with early loss of HCV-RNA should complete a 12-month treatment, which appeared more effective than a 6-month treatment.

Background and Aims: The intramuscular use of beta interferon has been tested in the treatment of chronic hepatitis C, but it did not prove effective when the schedule was 3 million units three times a week for six months. Since the lack of effectiveness of this treatment might be due to the low bioavailability of beta interferon when administered intramuscularly, we tested a higher dosage of the drug: 6 million units three times a week for twelve months., Patients and Methods: Ninety-two patients were randomized to receive, intramuscularly, either 3 or 6 million units of natural human fibroblast beta interferon three times a week for 12 months., Results: The short-term biochemical response was significantly more frequent in the group of patients who received the higher dosage of beta interferon: 21% vs 4.5% (p < 0.05). Nevertheless, a sustained biochemical response was obtained in only one patient (2%), who received the higher dosage of beta interferon., Conclusions: Since the better short-term response rate was obtained with the higher dosage of beta interferon, a further increase in the dosage might improve the short-term and, possibly, the long-term response to treatment. However, due to the high cost of beta interferon, this high-dose schedule would probably not be cost-effective in the treatment of chronic hepatitis C.