Interim analysis of a randomized controlled trial of combination of ribavirin and high dose interferon‐α in interferon nonresponders with chronic hepatitis C

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Abstract
This trial investigated the efficacy of a combination of high‐dose interferon‐α (IFN‐α) with ribavirin in IFN nonresponders. Study protocol: 304 patients with chronic hepatitis C were treated with 5 MU IFN‐α2b (IntronA®, Schering‐Plough) per TIW for 3 months. Nonresponders (defined by HCV‐RNA positivity in serum after the 3 months of therapy) were randomized either to continue with IFN (5 MU IFN per TIW followed by 10 MU per TIW for each 3 months) alone (group A) or in combination with ribavirin (1–1.2 g per day) (group B). ALT was measured in monthly intervals, HCV‐RNA in 3 monthly intervals. Pretreatment characteristics of the randomized patients were as follows: group A, n = 76; m/f, 54/22; 16% cirrhosis, age, 45.7 ± 12 years; ALT (U per litre), 66 ± 35; group B, n = 81; m/f, 57/24; 17% cirrhosis, age, 48.2 ± 12; ALT, 71 ± 40. After 9 months of treatment, nine (11.6%) and 27 (32.5%, P = 0.0066) patients were HCV‐RNA negative and 51 and 39 were HCV‐RNA positive, in groups A and B, respectively. There were 17 drop‐outs in group A and 15 in group B. Six months after treatment only two patients in group A (2.5%) and five (6%, P = 0.06) in group B had normal ALT and no detectable HCV‐RNA in serum. In addition to the well‐known side‐effects of IFN the mean haemoglobin concentration dropped by 2 g per litre in group B. These data indicate that a combination of high‐dose IFN with ribavirin is effective in inducing a short‐lasting complete response in one‐third of IFN nonresponders. Prolonged treatment with IFN/ribavirin may be necessary to obtain a sustained response.