Clinical Studies

Two clinical studies have investigated treatment of hepatitis C patients with INTRON® A (Interferon alfa-2b, recombinant) for Injection for up to 24 months. Patients in the two studies to evaluate longer duration of treatment had hepatitis with or without cirrhosis in the absence of decompensated liver disease. Complete response to treatment was defined as normalization of the final two serum alanine aminotransferase (ALT) levels during the treatment period. A sustained response was defined as a complete response at the end of the treatment period with sustained normal ALT values lasting at least 6 months following discontinuation of therapy.

In Study 1, all patients were initially treated with INTRON® A 3 million IU TIW subcutaneously for 24 weeks (run-in period).1 Patients who completed the initial 24-week treatment period were then randomly assigned to receive no further treatment, or to receive 3 million IU TIW for an additional 48 weeks. In Study 2, patients who met the entry criteria were randomly assigned to receive INTRON® A 3 million IU TIW subcutaneously for 24 weeks or to receive INTRON® A 3 million IU TIW subcutaneously for 96 weeks.2 In both studies, patient follow-up was variable and some data collection was retrospective.

Results show that longer durations of INTRON A therapy improved the sustained response rate. Of all patients randomized, the sustained response rate in the patients receiving 18 or 24 months of therapy was 22% and 26%, respectively, in the two trials.

A subset (<50%) of patients from the combined extended dosing studies had liver biopsies performed both before and after INTRON A treatment. Improvement in necroinflammatory activity as assessed retrospectively by the Knodell (Study 1) and Scheuer (Study 2) Histology Activity Indices was observed in both studies. Fifty-eight percent (45/78) of patients improved with extended therapy in this subset.

An option for relapsing patients

For previously untreated HCV patients and those who relapse after alpha interferon treatment, combination therapy may be more effective. In 1998, REBETRON™ Combination Therapy containing REBETOL® (Ribavirin, USP) Capsules and INTRON® A (Interferon alfa-2b, recombinant) Injection was approved as initial treatment of chronic hepatitis C patients with compensated liver disease. In mid-1998, it was approved to treat patients with compensated liver disease who relapse following INTRON A therapy.

To review clinical trial data, administration guidelines, and safety information for the new combination therapy, see "REBETRON Combination Therapy" and "Important Safety Information."

  1. Poynard T, et al. N Engl J Med. 1995;332:1457-1462.
  2. Lin R, et al. J Hepatol. 1995;23:487-496

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