Normal ALT in chronic HCV: OK to treat: no flaring seen.
BOSTON -- Persistently normal alanine aminotransferase levels should not preclude standard treatment in patients with chronic hepatitis C, Dr. Stefan Zeuzem said at the annual meeting of the American Association for the Study of Liver Diseases.
Recent U.S. and European consensus statements have recommended against treatment in patients with chronic hepatitis C virus (HCV) and persistently normal ALT levels (who account for one third of those with HCV) based on a lack of data and concerns that treatment in this population might cause ALT levels to flare.
But findings from a randomized controlled trial of 491 patients suggest that the efficacy of standard treatment in these patients is comparable with that reported in patients with elevated ALT" levels, said Dr. Zeuzem of Saarland University Hospital in Homburg/Saar, Germany.
The patients, who had normal ALT" levels on at least three occasions at 6-18 months alter a normal baseline test, were assigned to placebo or to 2.4 or 48 weeks of treatment with peginterferon alfa-2a (Pegasys 180 [micro]g weekly) or ribavirin (Copegus 800 mg/day). They were followed for 72 weeks. Sustained virologic responses were seen in 30% of those in the 24 week treatment group, in 52% of those in the 48-week treatment group, and in none of those in the control group.
Analysis by HCV genotype revealed that sustained virologic responses were seen in 13% of HCV genotype 1 patients in the 24 week treatment group, and in 40% of those in the 48 week treatment group. Such responses were seen in 72% of those with HCV genotype 2 and 3 in the 24-week treatment group, and in 78% of those in the 48 week treatment group.
ALT levels remained relatively stable in all the groups, with slight decreases in median levels from baseline in responders, and mild. transient increases at the end of treatment in relapsers. Two patients--one in the control group and one in the 24-week group had ALT flares. The safety profile was typical for Pegasys and Copegus in populations with abnormal ALT levels, Dr. Zeuzem said.
The efficacy of standard treatment for chronic HCV was "nearly identical" in this study of patients with normal ALT levels to that seen in a major trial involving those with elevated ALT levels (J. Hepatol. 361 [suppl. 1]:3, 2002).
The findings suggest that treatment is safe and efficacious in those with persistently normal ALT levels.
This is important because about one third of patients with normal ALT levels have substantial liver disease; there is no marker to determine which of these patients will progress to more serious liver disease.
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|Title Annotation:||Clinical Rounds; alanine aminotransferase; hepatitis C virus|
|Publication:||Family Practice News|
|Date:||Apr 15, 2004|
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