The significance of baseline serum alanine aminotransferase on pretreatment disease characteristics and response to antiviral therapy in chronic hepatitis C.

We sought to determine whether pretreatment serum alanine aminotransferase (ALT) levels in patients with chronic hepatitis C virus (HCV) correlate with demographic features and other disease characteristics and whether these values influence response to therapy. A total of 1,744 patients with HCV received either interferon alfa-2b and placebo or combination interferon alfa-2b and ribavirin for 24 or 48 weeks. Of these, 105 individuals (6%) had minimally raised serum ALT determinations at entry visit of </=1.3 x the upper limit of normal (ULN). By analysis of variance both pretreatment histologic activity index (HAI) scores (P <.0001) and fibrosis scores (P =.003) were significantly lower among patients with baseline ALT levels </=1.3 x ULN. Individuals with lower pretreatment ALT values were younger and weighed less than the ALT >1.3 x ULN cohort. Baseline ALT was not related to gender, race, baseline viral level, or HCV genotype. Using logistic regression analysis, the only demographic feature associated with ALT </=1.3 x ULN was lower baseline weight and lower baseline HAI score. There was no difference in sustained response between patients with baseline ALT levels </=1.3 x ULN and those with >1.3 x ULN, in all treatment groups (26 of 105, 24.8% for ALT </=1.3 x ULN; 440 of 1, 639, 26.8% for ALT >1.3 x ULN). We conclude that HCV patients with minimally raised ALT values (</=1.3 x ULN) weigh less, and have lower histologic inflammatory scores than patients with more conventionally elevated ALT levels. Despite these differences, these patients have a similar sustained response to antiviral therapy.