Combination of Ribavirin-Peginterferon Safe, Effective in Chronic Hepatitis C
By Laurie Barclay, MD
Medscape Medical News
Nov. 10, 2003 — The combination of ribavirin with peginterferon-alfa-2a for
22 weeks resulted in a higher sustained virological response (SVR) rate than
with peginterferon alone in patients with chronic hepatitis C virus (HCV) who
responded to 24 weeks of combined therapy, according to the results of a
multicenter trial presented on Oct. 27 at the 54th annual meeting of the
American Association for the Study of Liver Diseases held in Boston,
Massachusetts.
"Long-term ribavirin administration is associated with frequent side effects
and high cost of therapy," lead author Jean-Pierre Bronowicki, from Hospital
Brabois in Nancy, France, told Medscape. "The need for maintaining ribavirin
in combination with peginterferon for the entire 48-week period of treatment
in HCV genotype 1 infection has not been documented."
In this prospective, open-label, randomized trial at 80 French centers,
524 previously untreated patients with HCV genotype 1 infection,
biopsy-proven chronic hepatitis, persistently elevated ALT levels and
detectable HCV RNA were enrolled between January 2001 and January 2002.
Mean age was 46.3 years; 59.4% were men; mean body weight was 70.7 kg;
and 8.8% had cirrhosis. All patients received peginterferon alfa-2a (40KD)
180 μg/week plus ribavirin 800mg/day for 24 weeks.
Virologic response rate, defined at week 24 by undetectable HCV RNA, was 70%.
Of the 366 responders, six patients were not randomized because of ribavirin
intolerance, and 360 patients were randomized at week 26 to receive
peginterferon alfa-2a (40KD) plus ribavirin, or peginterferon alfa-2a (40KD)
alone, for 22 additional weeks.
At week 72, 69.3% of patients receiving peginterferon plus ribavirin had a
sustained virological response compared with 53.4% of patients receiving
peginterferon alone (P = .002). At least one adverse effect related to therapy
occurred in 53.1% of the combination therapy group and in 41.6% of the
peginterferon monotherapy group (P = .034).
"HCV genotype 1 patients required a full course of 48 weeks of peginterferon
plus ribavirin to prevent viral breakthroughs and relapses," Dr. Bronowicki
said. "Ribavirin discontinuation after 24 weeks of treatment can improve
treatment tolerance. It is important for us to identify those patients who
can obtain an SVR with the discontinuation of ribavirin."
Roche Pharma funded this study. The authors report no pertinent financial
disclosures.
AASLD 54th Annual Meeting. Presented Oct. 27, 2003
Reviewed by Gary D. Vogin, MD
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