Placebo-controlled trial of 400 mg amantadine combined with peginterferon alfa-2a and ribavirin for 48 weeks in chronic hepatitis C virus-1 infection

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Hepatology. 2008 Jun 19. [Epub ahead of print]

Placebo-controlled trial of 400 mg amantadine combined with peginterferon

alfa-2a and ribavirin for 48 weeks in chronic hepatitis C virus-1 infection.

von Wagner M, Hofmann WP, Teuber G, Berg T, Goeser T, Spengler U, Hinrichsen H,

Weidenbach H, Gerken G, Manns M, Buggisch P, Herrmann E, Zeuzem S.

Johann Wolfgang Goethe-Universität, furt/Main, Germany.

The impact of amantadine on virologic response rates of interferon-based

treatment of chronic hepatitis C is controversial. The aim of this study was to

compare virological response rates in patients with chronic hepatitis C virus

(HCV)-1 infection treated with 400 mg amantadine or placebo in combination with

peginterferon alfa-2a (40 kD) and ribavirin for 48 weeks. Seven hundred four

previously untreated chronically HCV-1-infected patients (mean age, 46 +/- 12

years) were randomized to (A) amantadine-sulphate (400 mg/day) (n = 352) or (

placebo (n = 352), both in combination with 180 mug peginterferon alfa-2a once

weekly and ribavirin (1000-1200 mg/day) for 48 weeks. End of treatment and

sustained virological response after a 24-week follow-up period were assessed by

qualitative reverse transcription polymerase chain reaction (RT-PCR)

(sensitivity, 50 IU/mL). Demographic and baseline virological parameters were

similar in both treatment groups. In groups A and B, 231 of 352 patients (66%)

and 256 of 352 patients (72%) achieved an end of treatment response, and 171 of

352 patients (49 %) and 186 of 352 patients (53 %) a sustained virological

response, respectively. On-treatment dropout rate in the amantadine group was

significantly higher than in the placebo group (32% versus 23%; P = 0.01).

However, adverse events and laboratory abnormalities were similar between both

groups. Per-protocol analysis revealed similar sustained virological response

rates in both treatment groups (53% versus 55%). Conclusion: In this large

placebo-controlled multicenter study, amantadine even at a dose of 400 mg/day

did not improve virological response rates of peginterferon alfa-2a and

ribavirin in patients with chronic genotype HCV-1 infection. (HEPATOLOGY 2008.).

PMID: 18846541 [PubMed - as supplied by publisher]