title: A randomized trial to assess the efficacy of interferon-alpha daily in combination with ribavirin in the treatment of naïve patients with chronic hepatitis C.
abstract: A randomized trial was conducted to assess the efficacy of interferon-alpha (IFN) daily in combination with ribavirin in 301 naïve patients with chronic hepatitis C (CHC). Patients were randomized to receive ribavirin 1.2 g daily (QD) for 48 weeks with either IFN 5 MU (thrice weekly) TIW for 8 weeks followed by IFN 3 MU TIW for 40 weeks (IFN TIW, n = 154) or IFN 5 MU QD for 8 weeks followed by IFN 3 MU QD for 16 weeks followed by IFN 3 MU TIW for 24 weeks (IFN QD, n = 147). Treatment discontinuation rates, because of adverse events, were similar in the two arms (14.9% in IFN TIW and 14.3% in IFN QD, P = 0.87). The proportion of patients with sustained virological response (SVR) was 27.9% for patients treated TIW and 38.8% for those treated QD (P = 0.046). According to logistic regression analysis, patients in the IFN QD arm had 1.7 times higher probability of achieving SVR, than those receiving IFN TIW (P = 0.038). Low baseline viral load (P = 0.017) and genotype non-1 (P = 0.036) were associated with higher SVR rates. Combination of IFN/ribavirin for 48 weeks is more effective when IFN is administered daily for the first 24 weeks in naïve patients with CHC.
authors.affiliation: Western Attica General Hospital, Athens; Hippokration General Hospital, Athens, Greece.
authors.forename: N C
authors.initials: NC
authors.lastname: Tassopoulos
authors.forename: I
authors.initials: I
authors.lastname: Ketikoglou
authors.forename: D
authors.initials: D
authors.lastname: Tsantoulas
authors.forename: M
authors.initials: M
authors.lastname: Raptopoulou
authors.forename: G
authors.initials: G
authors.lastname: Hatzis
authors.forename: I
authors.initials: I
authors.lastname: Vafiadis
authors.forename: L
authors.initials: L
authors.lastname: Sidiropoulos
authors.forename: S
authors.initials: S
authors.lastname: Kanatakis
authors.forename: G
authors.initials: G
authors.lastname: Anagnostopoulos
authors.forename: V
authors.initials: V
authors.lastname: Sypsa
authors.forename: A
authors.initials: A
authors.lastname: Hatzakis
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012254:Ribavirin