To determine the efficacy of interferon-alpha 2a in chronic active hepatitis B, 238 patients were randomly divided, into four groups: three groups received either 2.5 MIU m-2, 5.0 MIU m-2 or 10.0 MIU m-2, three times weekly by intramuscular injection for 12-24 weeks; and a control group received no treatment. Patients were followed for up to 12 months after treatment was discontinued. There was a statistically significant difference in response [clearance of hepatitis B e antigen (HBeAg) and hepatitis B viral DNA (HBV-DNA)] between treated and untreated patients (37 vs 13%) but no statistically significant difference was seen between treatment groups (33%, 34% and 43% for the 2.5, 5.0 and 10.0 MIU m-2 groups, respectively). A transient rise in transaminases (seroconversion hepatitis) was seen in responders, but levels returned to within the normal range after response to treatment. In patients responding to interferon therapy there was a significant reduction in the severity of the hepatitis. Interferon-alpha 2a was generally well tolerated with respect to vital signs and laboratory parameters.

Liver biopsies from two groups of women receiving oral contraceptives from 1 to 6 months and from 12 to 30 months, respectively, were examined by electron microscopy. The fine structure of the liver cells from the first group appeared normal, except for an increase in the amount of smooth endoplasmic reticulum. In the second group, however, there were many cases with striking changes-altered shape, increase in size, and presence of paracrystalline inclusions-in the mitochondria. No significant correlation between mitochondrial changes and alterations in liver function was detected.

The effectiveness of recombinant interferon-alpha 2b (rIFN-alpha 2b) in eradicating hepatitis C virus (HCV) RNA from serum has not been completely assessed. We studied 39 patients with compensated chronic hepatitis C diagnosed by liver biopsy and positive HCV RNA measured by polymerase chain reaction (PCR). Group I consisted of 26 patients treated with 3 MU of rIFN-alpha 2b for 6 months; group II, 13 control patients observed for six months; and group III, 12 out of 13 patients from group II who subsequently received 5 MU of rIFN-alpha 2b for 6 months. In group I, 11 out of 23 (47.8%) patients who completed treatment had an immediate response and five (21.7%) had a sustained response to therapy six months after treatment. No response was observed in patients from group II. In group III, 7 out of 12 (58.3%) patients who completed treatment had an immediate response and none had a sustained response. Considering all patients who completed rIFN-alpha 2b treatment, HCV RNA remained positive at the end of therapy in three of five sustained responders (60%), six of 13 patients who relapsed (46.1%), and in all nonresponders (100%). HCV RNA was positive 6 months after therapy in four (80%), 13 (100%), and 17 (100%) patients respectively. All patients with a sustained response had normal aminotransferase levels 18 months after therapy. We conclude that in chronic hepatitis C rIFN-alpha 2b causes a significant immediate response but this is not sustained, only 2.8% of treated patients had a sustained loss of HCV RNA. Normal aminotransferase persist in the long term, despite persistence of HCV RNA.

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This study was designed to evaluate the safety and effectiveness of high dose interferon, with or without prednisone pretreatment, in patients with chronic hepatitis B. Patients were randomised to two treatment groups: group I (n=26) received six weeks of prednisone followed by a two week, drug free period, and then 10 million units (MU) ofinterferon alfa-2b three times weekly subcutaneously for 16 weeks; group II (n=24) were used as controls for 24 weeks and then treated with interferon. Loss of hepatitis B e antigen (HBeAg) and hepatitis B virus (HBV)-DNA, with a return to normal alanine aminotransferase (ALT) activity, was seen in 16 of 26 group I patients (61.5%), in one group II patient (4/2%) during the control phase, and in 13 of 23 group II patients (56/5%) after interferon. Three of 26 (11.5%) in group I and one of 23 (4/3%) in group II eliminated the surface antigen (HBsAg). There were no statistically significant differences in response between groups I and II. Liver biopsies carried out in 20 patients showed that responders had a noticeable reduction in inflammation and disappearance of core antigen in liver tissue, changes not seen in non-responders. On long term follow up (four years), nine out of 28 responders (32-/1%) eliminated HBsAg, and four initial non-responders had a late seroconversion.(Gut 1993; supplement: S91-S94) Patients in group II were followed without treatment for 24 weeks (control period) and then interferon alfa-2b was given in the same dose and for the same duration as in group I. Both groups were followed for 24 weeks. Efficacy was determined by HBeAg and hepatitis B surface antigen (HBsAg) seroconversion, a return to negative of HBV-DNA, ALT normalisation, and histological activity as measured by the Knodell index score. Safety was determined by assessing the number and type of adverse reactions, reduction of doses, and rates of withdrawal.

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