title: Induction doses of interferon-alpha-2a in combination with ribavirin and/or amantadine for the treatment of chronic hepatitis C in non-responders to interferon monotherapy: a randomized trial.
abstract: The benefit of the triple therapy (interferon + amantadine + ribavirim) is still unknown. The efficacy of induction doses of interferon-alpha-2a monotherapy or in combination with ribavirin and/or amantadine was evaluated in interferon non-responders with chronic hepatitis C. A total of 378 patients were randomized. All the groups received the same doses and duration of interferon-alpha-2a: (i) interferon 9 MUI/day for 4 weeks and then 3 MUI/3 t.i.w. for 44 weeks (n = 53); (ii) interferon in combination with amantadine 100 mg twice daily for 48 weeks (n = 111); (iii) interferon in combination with ribavirin 1000-1200 mg (n = 106); (iv) interferon in combination with amantadine and ribavirin (n = 108). Baseline parameters were similar in the four groups. Sustained virological and biochemical responses were 13%, 6%, 18% and 22% respectively. No significant differences were found between double ribavirin arm vs triple therapy, but the difference was significant between interferon-amantadine (P = 0.008) and triple therapy (P = 0.0005). Hence, the induction doses of interferon in combination with ribavirin or ribavirin plus amantadine showed encouraging results in patients with chronic hepatitis C who were resistant to interferon. However, triple therapy is not superior to double.
authors.affiliation: Gastroenterology Unit, Hospital Universitario San Cecilio, Granada, Spain. fsalmeronescobar@sepd.es
authors.forename: J
authors.initials: J
authors.lastname: Salmerón
authors.forename: M
authors.initials: M
authors.lastname: Diago
authors.forename: R
authors.initials: R
authors.lastname: Andrade
authors.forename: R
authors.initials: R
authors.lastname: Pérez
authors.forename: R
authors.initials: R
authors.lastname: Solá
authors.forename: M
authors.initials: M
authors.lastname: Romero
authors.forename: M
authors.initials: M
authors.lastname: de la Mata
authors.forename: R
authors.initials: R
authors.lastname: Granados
authors.forename: A
authors.initials: A
authors.lastname: Ruiz-Extremera
authors.forename: P
authors.initials: P
authors.lastname: Muñoz de Rueda
mesh_terms: D000328:Adult; D000547:Amantadine / Q000008:administration & dosage* / Q000009:adverse effects; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin; D000547:Amantadine