OBJECTIVE: To compare efficacy and tolerance of recombinant interferon alfa-2b in the treatment of anti-HCV-positive chronic active hepatitis (CAH) in subjects aged 65 years and above with those less than 65. DESIGN: A randomized controlled trial. SETTING: Outpatients in two hospitals. PATIENTS: 65 consecutive outpatients with anti-HCV-positive CAH for 1 to 30 years, having basal aminotransferase levels at least twice the normal value. Those 65 and over were randomized to an interferon group (A, n = 22) or a no-treatment group (B, n = 22). All those under 65 received interferon (group C, n = 21). INTERVENTION: Interferon at a dose of 3 mU 3 times a week for a 6-month period. A normalization of serum aminotransferase levels was considered a positive response to therapy. RESULTS: Response to therapy was positive in 62% of the treated elderly compared to 57% of the adults (P = 0.85). The two groups of responders showed a common highly significant reduction of aminotransferase (P < 0.001). Side effects were similar in elderly and young. Two untreated elderly showed spontaneous normalization of aminotransferase. CONCLUSION:Interferon in anti-HCV-positive CAH is useful in the elderly, allowing normalization of aminotransferase, improvement of the histology and remission of the disease in 62% of the cases. Side effects seem to be independent of age. Further studies are required to assess both duration of remission and usefulness of cyclic therapy in previous responders.
RCT Entities:
OBJECTIVE: To compare efficacy and tolerance of recombinant interferon alfa-2b in the treatment of anti-HCV-positive chronic active hepatitis (CAH) in subjects aged 65 years and above with those less than 65. DESIGN: A randomized controlled trial. SETTING: Outpatients in two hospitals. PATIENTS: 65 consecutive outpatients with anti-HCV-positive CAH for 1 to 30 years, having basal aminotransferase levels at least twice the normal value. Those 65 and over were randomized to an interferon group (A, n = 22) or a no-treatment group (B, n = 22). All those under 65 received interferon (group C, n = 21). INTERVENTION: Interferon at a dose of 3 mU 3 times a week for a 6-month period. A normalization of serum aminotransferase levels was considered a positive response to therapy. RESULTS: Response to therapy was positive in 62% of the treated elderly compared to 57% of the adults (P = 0.85). The two groups of responders showed a common highly significant reduction of aminotransferase (P < 0.001). Side effects were similar in elderly and young. Two untreated elderly showed spontaneous normalization of aminotransferase. CONCLUSION: Interferon in anti-HCV-positive CAH is useful in the elderly, allowing normalization of aminotransferase, improvement of the histology and remission of the disease in 62% of the cases. Side effects seem to be independent of age. Further studies are required to assess both duration of remission and usefulness of cyclic therapy in previous responders.
Authors: Umberto Vespasiani-Gentilucci; Giovanni Galati; Paolo Gallo; Antonio De Vincentis; Elisabetta Riva; Antonio Picardi Journal: World J Gastroenterol Date: 2015-06-28 Impact factor: 5.742
Authors: J Hayashi; Y Kawakami; A Nabeshima; Y Kishihara; N Furusyo; Y Sawayama; N Kinukawa; S Kashiwagi Journal: Dig Dis Sci Date: 1998-02 Impact factor: 3.199