A randomized trial of amantadine and interferon versus interferon alone as initial treatment for chronic hepatitis C.
The aim of this study was to compare, in an open-label study, the efficacy and safety of a combination of interferon (IFN) and amantadine (AMA) with that of IFN alone in previously untreated patients with chronic hepatitis C. A total of 200 patients were randomized to 6 MU of IFN-alpha2a 3 times per week, with 200 mg of AMA daily (n = 99) or to an identical dose of interferon alpha2a (n = 101). Patients were treated for 12 months and observed for 6 months' posttreatment. At the completion of treatment, 28.7% of patients in the monotherapy group and 45.5% in the combination group had a virologic response (P =.014). At 6 months' posttreatment, a sustained virologic response was observed in 16.8% (95% CI: 9-23) of patients with IFN alone versus 29.3% (95% CI: 19-37) of patients who were treated with combination therapy (P =.036). In each of the 2 treatments, genotype was the only predictive parameter for a sustained response. At the logistic regression analysis, therapy and genotype were the only 2 parameters with an independent predictive value. In the combination group, at examination of month 3, hepatitis C virus (HCV)-RNA status had a 97.6% (95% CI: 93-102) positive predictive value and a 50% (95% CI: 37-63) negative predictive value for a sustained virologic clearance. A substantial proportion of naïve patients with chronic hepatitis C have an end-of-treatment and end-of-follow-up virologic and biochemical response to a combination of IFN and AMA. This new treatment appears safe and well tolerated.
Division of Gastroenterology and Department of Human Pathology, Ospedale "Casa Sollievo della Sofferenza," IRCCS, San Giovanni Rotondo, Ospedale Canosa, Italy. a.mangia@tin.it
A
A
Mangia
N
N
Minerva
M
M
Annese
G
G
Leandro
M R
MR
Villani
R
R
Santoro
V
V
Carretta
D
D
Bacca
A
A
Giangaspero
M
M
Bisceglia
F
F
Ventrella
G
G
Dell'Erba
A
A
Andriulli
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000547:Amantadine / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007372:Interferons / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000032:analysis; D012449:Safety
D000998:Antiviral Agents; D012367:RNA, Viral; D007372:Interferons; D000547:Amantadine; D000410:Alanine Transaminase