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.
Mangia
A
A
Division of Gastroenterology and Department of Human Pathology, Ospedale "Casa Sollievo della Sofferenza," IRCCS, San Giovanni Rotondo, Ospedale Canosa, Italy. a.mangia@tin.it
Minerva
N
N
Annese
M
M
Leandro
G
G
Villani
M R
MR
Santoro
R
R
Carretta
V
V
Bacca
D
D
Giangaspero
A
A
Bisceglia
M
M
Ventrella
F
F
Dell'Erba
G
G
Andriulli
A
A
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