Prolonged treatment of chronic C hepatitis by means of medium-high doses of recombinant alpha-2b interferon: an open study to evaluate response and long-term relapse.

Thirty-six patients with hepatitis C virus-RNA positive chronic hepatitis were studied to evaluate whether recombinant alpha-2b interferon, in medium-high doses, (6-9 MU 3 times/week) over a long period (12-18 months), was more effective in reducing or normalizing alanine aminotransferase values, and in reducing the relapsing percentage than the historical trials. At the end of the 12th and 18th month of treatment, mean alanine aminotransferase values were significantly reduced; the level of complete responses was 36.1%, at the end of the 12th month, and 19.4% at the end of the 18th month (intention to treat). These results were no better than comparable findings in the literature. At the end of the first follow-up (12th month), percent complete responses fell to 15.5%, with a relapse rate of 14.3%. At the end of the second follow-up (24th month), percent complete responses fell further to 11.1% (all 4 patients with a 24 months sustained response showed absence of viraemia), with a relapse rate of 42.9%; even these percentages were judged unsatisfactory. In conclusion, no significant advantage was obtained by prolonging interferon treatment and/or using higher dosages. However, the possible virus clearance in all the long-term responders seems to justify further investigation in terms of cost-benefit analysis.

Effects of long-term administration of low-dose lactitol in patients with cirrhosis but without overt encephalopathy.

To investigate the efficacy and the acceptability of different doses of lactitol in patients with subclinical hepatic encephalopathy, 28 patients with cirrhosis were enrolled in a controlled clinical trial comparing 5-month therapies with lactitol at two different doses: 0.3 and 0.5 g/kg bw per day. This period was followed by 1 month of recovery. Patients were monitored with venous blood ammonia determination, three psychometric tests, clinical evaluation of mental status and EEG. The porto-systemic encephalopathy index of Conn was determined periodically. Twenty-two patients completed the trial (11 for each dose of lactitol). Both doses of lactitol decreased plasma ammonia levels and improved the porto-systemic encephalopathy index. The higher dose was more effective in improving performance in the psychometric tests. After the period of recovery, both the porto-systemic encephalopathy index and the psychometric test scores returned to pretreatment values. Lactitol was tolerated well by patients. Three patients given the higher dose reported periodic intestinal discomfort, but did not stop taking lactitol or reduce the dosage; no side-effects were reported by the patients taking the lower dose. These results indicate that lactitol in doses ranging from 0.3 to 0.5 g/kg bw is a well-tolerated and effective treatment for subclinical encephalopathy.