Treatment of Acute Hepatitis C with Pegylated Interferon Monotherapy Produces
Better Results than Delayed Combination Therapy
hepatitis C virus (HCV) infection -- within the first 6 months -- is much
easier to treat with interferon-based
therapy than chronic infection, but the
optimal time for starting therapy, length of treatment, and need for ribavirin
are not clearly established.
In a late-breaker presentation at the 44th
Annual Meeting of the European Association for the Study of the Liver (EASL 2009)
last month in Copenhagen, K. Deterding and colleagues with the HEP-NET Acute HCV
Study Group described findings from a randomized trial of early versus delayed
treatment of acute hepatitis C.
treatment of acute hepatitis C with interferon monotherapy is highly effective,
producing sustained virological response
(SVR) rates of 85% or higher, the investigators noted as background. An alternative
strategy might be to delay treatment for 3 months, and only treat those patients
who did not spontaneously clear the virus during that time.
HEP-NET Acute HCV-III study was a prospective trial of patients with symptomatic
or asymptomatic acute hepatitis C. Eligible individuals were either HCV antibody
positive, had elevated ALT (> 10 x upper limit of normal), or were exposed
to HCV within the past 4 months. None had hepatitis A, hepatitis B, or HIV coinfection.
total of 108 participants at 72 centers in Germany enrolled between 2004 and 2008.
A majority (60%) were men, the mean age was 40 years, about half had HCV genotype
1, and about 60% had jaundice (icterus). The present efficacy analysis included
89 patents; the other 19 dropped out for various reasons after randomization.
were randomly assigned to receive either immediate treatment with pegylated
interferon alfa-2b (PegIntron) monotherapy for 6 months (n = 52), or else
delayed treatment with pegylated
interferon alfa-2b plus ribavirin for 6 months starting 12 weeks after randomization
in patients who remained HCV RNA positive (n = 20). All asymptomatic patients
received early treatment with pegylated interferon monotherapy.
In an intent-to-treat (ITT) analysis, the SVR rate was 78% for symptomatic patients
in the immediate treatment arm, compared with 54% in the delayed treatment arm
(P = 0.034).
Among symptomatic patients in the immediate treatment arm who achieved good adherence
-- defined as taking 80% of prescribed therapy -- the SVR rate was 88%.
22% of symptomatic patients (8 of 37) randomized to the delayed treatment arm
experienced spontaneous sustained HCV clearance.
The lower ITT SVR rate in the delayed treatment arm was mainly attributable to
the high drop-out rate (16 of 37 patients) during the initial 12-week observation
period prior to therapy.
When considering only adherent patients who remained in the study, delayed treatment
with pegylated interferon plus ribavirin was comparably effective, with an SVR
rate of 100% (12 of 12 patients).
Among the asymptomatic participants, the SVR rates were 69% in an ITT analysis
and 88% among adherent patients.
so far largest prospective and the first randomized European trial on acute hepatitis
C confirmed that early immediate treatment with [pegylated interferon alfa-2b]
is highly effective in both symptomatic and asymptomatic patients," the investigators
"Delayed [pegylated interferon alfa-2b] plus ribavirin
treatment resulted in lower overall response rates in this real-life treatment
setting," they added, "however, if adherence can be assured this strategy
seems to be of similar efficacy in symptomatic patients."
Medical School, HEP-NET: German Network of Competence on Viral Hepatitis, Hannover,
Germany; Ludwig-Maximillians-University, Munich, Germany; University of Leipzig,
Hannover, Germany; University Hamburg-Eppendorf, Hamburg, Germany; Johannes-Gutenberg
University Mainz, Mainz, Germany; University of Bonn, Bonn, Germany; University
of Schleswig-Holstein, Campus Kiel, Kiel, Germany; Charité Berlin Campus
Virchow-Klinikum, Berlin, Germany.
Deterding, N Gruner, J Wiegand, and others. Early versus delayed treatment of
acute hepatitis C: the German HEP-NET Acute HCV-III study -- a randomized controlled
trial. 44th Annual Meeting of the European Association for the Study of the Liver
(EASL 2009). Copenhagen, Denmark. April 22-26, 2009. Abstract 1047.
2009 MAIN PAGE
2009 Conference Coverage
HIV and Hepatitis.com Highlights from EASL 2009
Conference on Retroviruses and Opportunistic Infections (CROI 2009)
by HIV and Hepatitis.com - February 8 - 11, 2009, Montreal
HIV and AIDS Treatment
News, Experimental News, FDA-approved News
of the 15th Conference on Retroviruses and Opportunistic Infections (CROI 2009)
- Coverage by HIV and Hepatitis.com, February 8 - 11, 2009, Montreal