Summary
In the light of recent research, which suggests an interferon (IFN) therapy schedule on the basis of single patient characteristics (e.g. histological pattern, viral genotype) and the cost/benefits of such therapy, we studied the efficacy and tolerability of an intermediate dose (4.5MU 3 times a week) of alpha-recombinant interferon-2a (α-r IFN-2a) in 28 patients with histologically proven chronic hepatitis C. 20 were hepatitis C virus (HCV)-RNA +ve, 5 were HCV-RNA −ve, and in 3 patients HCV-RNA status was not carried out. The viral genotypes were: 13 (65%) 1b, 2 (10%) 1a, 1 (5%) 1a + 1b, 3 (15%) 2a, 1 (5%) 3a; histological pattern: 21 (75%) mild chronic active hepatitis (CAH), 7 (25%) moderate CAH. 4.5MU of α-r IFN-2a were given 3 times a week for 6 months, followed by 3MU 3 times a week for 6 months. Six patients (21.4%) had a biochemical and virological sustained response (SR), 8 patients (28%) had ALT normalisation during therapy (transient complete response [TCR]) followed by relapse, 3 patients (10.7%) had a TCR with breakthrough (BT), 4 patients (14.3%) had a partial response (PR) and 7 patients (25%) were nonresponders (NR). We observed persistent HCV-RNA serum loss in all patients with SR, transient HCV-RNA serum loss in 8 patients with TCR, TCR with BT and PR; in 5 patients who were NR no HCV-RNA serum loss occurred. The prevalence of HCV genotype 1b and the duration of disease in SR and NR groups showed a significant difference. Moreover, we found a significant correlation between prevalence of HCV genotype 1b and type of response (r = 0.899, p < 0.05) between mean age in the different patient response groups and prevalence of HCV genotype 1b (r = 0.881, p < 0.05), and between disease duration and type of response (r = 0.874, p < 0.05). The schedule we used can be considered as well tolerated and efficacious at least in chronic hepatitis C with nonsevere histological pattern, with an HCV genotype other than 1b.
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References
Tinè F, Magrin S, Craxì A, et al. Interferon for non-A, non-B chronic hepatitis. A meta-analysis of randomised clinicals trials. J Hepatol 1991; 13: 192–9
Malaguarnera M, Restuccia S, Trovato G, et al. Interferon-alpha treatment in patients with chronic hepatitis C. A meta-analytic evaluation. Clin Drug Invest 1995; 9(3): 141–9
Davis GL. Interferon therapy on chronic hepatitis C: update 1995. In: Arroyo V, Bosch J, Rodes J, editors. Treatment in hepatology. Barcelona: Masson, 1995: 155–60
Ryff JC. Usefulness of interferon for treatment of hepatitis C. J Hepatol 1995; 22 1 Suppl.: 101S–109S
Poynard T, Leroy V, Cohard M, et al. Meta-analysis of interferon randomised trials in the treatment of viral hepatitis C. Effects of dose and duration. In: Postgraduate Course & 46th Annual Meeting of the American Association for the Study of Liver Disease: 1995 November 3–7: Chicago. Hepatology 1995 October; 22 4 Suppl. Pt 2: 113A
Benhamou JP, Hopf U, Rizzetto M, et al. on behalf of Non A Non B (C) Study Group. Long term lymphoblastoid interferon enhances sustained responses and improves histological activity up to 12 months post-treatment. In: Postgraduate Course & 46th Annual Meeting for the Study of Liver Disease. 1995 November 3–7: Chicago. Hepatology 1995 October; 22 4 Suppl. Pt 2: 151A
Poynard T, Bedossa P, Chevallier M, et al. on behalf of the Multicenter Study Group: A comparison of three interferon alpha-2b regimens for the long term treatment of chronic Non-A Non-B hepatitis. N Engl J Med 1995; 322: 1457–62
Chemello L, and the TriVeneto Viral Hepatitis Group: Randomised trial comparing three different regimens of alpha-2a-interferon in chronic hepatitis C. Hepatology 1995; 22(3): 700–6
Chemello L, Alberti A, Rose K, et al. Hepatitis C serotype and response to interferon therapy. N Engl J Med 1994; 330: 143
Martinot M, Marcellin P, Pouteau C, et al. Predictors of response to alpha interferon therapy in chronic hepatitis C [abstract no. D-143]. In: IX Triennial International Symposium on Viral Hepatitis and Liver Disease: 1996 April 21–25; Rome, 316
Jenkins PJ, Cromie SL, Bowden DS, et al. Pre-treatment predictors of a long term virological response to alpha interferon therapy in Australian patients with chronic hepatitis C: a multivariate analysis [abstract no. D141]. In: IX Triennial International Symposium on Viral Hepatitis and Liver Disease: 1996 April 21–25: Rome, 315
Martinot-Peignoux M, Marcellin P, Pouteau M, et al. Pre-treatment serum hepatitis C virus RNA levels and hepatitis C virus genotype are the main independent prognostic factors of sustained response to interferon alpha therapy in chronic hepatitis C. Hepatology 1995; 22: 1050–6
Magrin S, Craxì A, Fabiano C, et al. HCV viraemia is more important than genotype as a predictor of response to interferon in Sicily (Southern Italy). J Hepatol 1996; 25: 583–90
Cammà C, Craxì A, Tinè F, et al. Predictors of response to alpha-interferon (IFN) in chronic hepatitis C: a multivariate analysis on 361 treated patients. J Hepatol 1992; 17 1 Suppl.: 20S
Pagliaro L, Craxì A, Cammà C, et al. Interferon-α for chronic hepatitis C: an analysis of pretreatment clinical predictors of response. Hepatology 1994; 19: 820–8
Craxì A, Linea C, Magrin S. Non response to interferon in chronic hepatitis B and C: features and mechanisms. In: Arroyo V, Bosch J, Rodes J, editors. Treatment in hepatology. Barcelona: Masson, 1995: 169–86
De Salvo GL, Noventa F, Chemello L, et al. on behalf of TVVH Study Group: A model to predict sustained response to therapy and to optimise the dose of interferon in chronic hepatitis C. J Hepatol 1995; 23(1): 93
Alberti A. Interferon therapy: status report [abstract no 152]. In: IX Triennial International Symposium on Viral Hepatitis and Liver Disease: 1996 April 21–25: Rome, 42
Menghini G, Ghergo GF. Biopsy of the liver. In: Bockhus HL, editor. Gastroenterology. Vol. III, 3rd ed. Philadelphia: Saunders, 1976
Knodell RG, Ishak KG, Black WC, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology 1981; 1: 431–5
Scheuer PJ. Classification of chronic viral hepatitis: a need for reassessment. J Hepatol 1991; 16: 372–4
Desmet VJ, Gerber M, Hoofnagle JF, et al. Classification of chronic hepatitis: diagnosis, grading and staging. Hepatology 1994; 19: 1513–20
Simmonds P. Variability of hepatitis C virus. Hepatology 1995; 21: 570–83
Craxì A, Cammà C, Magrin S, et al. Interferon for chronic hepatitis C: prediction of response in the individual patient [abstract no. 29]. Milan 3rd International Symposium on Hepatology: La terapia delle malattie epatiche. 1995: October 2–4. Milan, 32
Carreño V, Gerken G, Trépo C, et al. on behalf of Multicenter Study Group: Four years of follow-up (LTFUP) of patients with chronic hepatitis C (CHC) treated with Interferon α-2a. In: Postgraduate Course & 46th Annual Meeting for the Study of Liver Disease: 1995 November 3–7: Chicago. Hepatology 1995 October; 22 4 Suppl. Pt 2: 173A
Bacon BR, Farrell G, Benhamou GP, et al. Lymphoblastoid interferon improves long term response to a six months course of treatment when compared with recombinant interferon alpha 2b: results of an international trial. In: Postgraduate Course & 46th Annual Meeting for the Study of Liver Disease: 1995 November 3–7: Chicago. Hepatology 1995 October; 22 4 Suppl. Pt 2: 152A
Bellobuono A, Mondazzi L, Tempini S, et al. Comparison between fixed and escalating doses of alpha-interferon treatment in chronic hepatitis C. In: Postgraduate Course & 46th Annual Meeting for the Study of Liver Disease: 1995 November 3–7: Chicago. Hepatology 1995 October; 22 4 Suppl. Pt 2: 152A
Shiffman ML, Hoffman CM, Luketic VA, et al. Treatment of chronic hepatitis C (HCV) with escalating doses of interferon-α-2b (IFN) increases both biochemical and virological response. In: Postgraduate Course & 46th Annual Meeting for the Study of Liver Disease: 1995 November 3–7: Chicago. Hepatology 1995 October; 22 4 Suppl. Pt 2: 152A
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Siciliano, R., Rosso, D., Elia, G. et al. An Intermediate Dose of Alpha-Recombinant Interferon-2a for Chronic Hepatitis C with Nonsevere Histological Pattern. Clin. Drug Invest. 14, 200–205 (1997). https://doi.org/10.2165/00044011-199714030-00006
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DOI: https://doi.org/10.2165/00044011-199714030-00006