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Alpha Feto-Protein Levels in Hepatitis C Subjects Treated with Combination Therapy: Abnormal Levels Decline with Therapy
Matthew J. Hepburn, Eric J. Lawitz, Alamo Study Group, San Antonio, TX

Patients with hepatitis C infection and advanced liver disease are routinely screened for hepatocellular carcinoma (HCC) with alpha fetoprotein (AFP) levels. AFP can be abnormally elevated in patients with hepatic injury but no evidence of HCC. Prior studies have correlated higher AFP levels with fibrosis in patients with hepatitis C, but no prior study has examined the effect of combination interferon and ribavirin therapy on AFP levels.

Data were retrospectively analyzed from 3 interferon/ribavirin therapy trials. The following baseline characteristics were recorded: gender, ethnicity, age, histologic stage, genotype, body mass index, HCV RNA viral load, and ALT. Viral clearance at 12 or 24 weeks of therapy was also noted. AFP was drawn at baseline and every 3 months while on therapy at our institution. Data were analyzed with multiple measures ANOVA, and paired t-tests as appropriate. A multiple linear regression model was utilized to assess baseline characteristics independently associated with AFP levels.

An initial AFP was available on 195 subjects. The overall mean AFP was 8.8 ng/ml (range 1.1 to 156 ng/ml). Thirty (15%) subjects had AFP >10 ng/ml, which is elevated at our laboratory. Among subjects with a normal baseline AFP, the level declines from 3.6ng/ml initially to 3.2 ng/ml at 3 months and 3.2 ng/ml at 6 months. For subjects with abnormal baseline AFP values, these mean levels declined from 24.1 ng/ml to 9.4ng/ml at 3 months to 8.0 ng/ml at 6 months (p<0.05). During therapy, 21/27 (78%) subjects with an elevated baseline AFP normalized to a level below 10ng/ml. Subjects with viral clearance had a lower baseline mean value (4.5 ng/ml) compared to the baseline value of subjects who were unable to achieve viral clearance (12.2 ng/ml). In subjects that did not achieve viral clearance, the mean AFP declines significantly, from 12.2 ng/ml to 5.5 ng/ml (p<0.05). On multivariate analysis, histologic stage was independently associated with AFP (p=0.03).

In summary, in subjects with hepatitis C treated with combination therapy, abnormal baseline AFP levels substantially decline, usually to below 10ng/ml. Subjects unable to achieve viral clearance on therapy also have a significant decline in AFP.


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