Interferon alpha-2b and ribavirin in combination for patients with chronic hepatitis C who failed to respond to, or relapsed after, interferon alpha therapy: a randomized trial

• Published in: The American journal of medicine Vol. 107; no. 2; pp. 112 - 118
• Main Authors: Barbaro, Giuseppe, Di Lorenzo, Gabriella, Belloni, Giancarlo, Ferrari, Luisella, Paiano, Aldo, Del Poggio, Paolo, Bacca, Donato, Fruttaldo, Luigi, Mongiò, Franco, Francavilla, Ruggiero, Scotto, Gaetano, Grisorio, Benvenuto, Calleri, Guido, Annese, Mauro, Barelli, Andrea, Rocchetto, Piero, Rizzo, Giovanni, Gualandi, Guido, Poltronieri, Italo, Barbarini, Giorgio
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.08.1999; Elsevier; Elsevier Sequoia S.A
• Subjects: Adolescent; Adult; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Antiviral Agents - therapeutic use; Biological and medical sciences; Clinical trials; Drug therapy; Drug Therapy, Combination; Enzyme-Linked Immunosorbent Assay; Female; Hepatitis; Hepatitis C; Hepatitis C, Chronic - diagnosis; Hepatitis C, Chronic - drug therapy; Humans; Immunoblotting; Interferon alpha-2; Interferon-alpha - therapeutic use; Liver Function Tests; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Recombinant Proteins; Recurrence; Ribavirin - therapeutic use; Treatment Failure; Treatment Outcome; Italy; Europe; Human; Treatment efficiency; Cytokine; Hepatic disease; Ribavirin; Infection; Chemotherapy; Chronic; Treatment; Viral disease; Digestive diseases; Adult; Antiviral; Combined treatment; Comparative study; Viral hepatitis C
• ISSN: 0002-9343; 1555-7162
• DOI: 10.1016/S0002-9343(99)00160-6

PURPOSE: To assess the efficacy of interferon alpha-2b and ribavirin in combination in the treatment of patients with chronic hepatitis C who had either failed to respond to therapy with interferon alpha (nonresponders), or who had relapsed after interferon therapy (relapsers). SUBJECTS AND METHODS: Four hundred patients with chronic hepatitis C (200 nonresponders and 200 relapsers) were randomly assigned in equal numbers to receive either subcutaneous administration of recombinant interferon alpha-2b (3 million units three times per week) and ribavirin (1,000 to 1,200 mg/daily orally) or interferon alpha-2b alone (6 million units three times per week). Both ribavirin and interferon alpha-2b were given for 24 weeks. The patients were then followed for an additional 24 weeks. RESULTS: At the end of the treatment period, normalization of serum alanine aminotransferase levels and absence of hepatitis C virus RNA were seen in 21% of nonresponders and in 39% of relapsers who were treated with interferon alpha-2b and ribavirin, compared with 5% of nonresponders ( P = 0.001) and 9% of relapsers treated with interferon alpha-2b alone ( P <0.001). At the end of follow-up, 14% of nonresponders and 30% of relapsers treated with the combination therapy had a sustained response, compared with 1% of nonresponders ( P = 0.001) and 5% of relapsers treated with interferon alpha alone ( P <0.001). CONCLUSIONS: A 24-week course of treatment with interferon alpha-2b and ribavirin offers a chance of sustained response, whereas retreatment with interferon alpha-2b alone does not give satisfactory results. The role of long-term therapy in inducing prolonged remission remains to be explored.