Abstract
BACKGROUND: The prevalence of precore (PC) and core promoter (CP) mutations in patients with chronic hepatitis B virus (HBV) infection (CHB) and their impact on liver disease is incompletely defined in the United States. METHODS: A retrospective chart review using a cross-sectional approach of 1,186 CHB patients was conducted. RESULTS: Of 926 patients tested for HBV e antigen (HBeAg), 37% were HBeAg+. Of 194 patients tested for mutations, 80% had PC or CP mutations or both; 89% of HBeAg-negative and 56% of HBeAg+ patients had PC or CP mutations or both (p < 0.001). The mean log10 ALT was significantly lower in patients with both mutations compared to patients without mutations. The mean log10 HBV DNA was significantly lower in patients with only PC mutations (4.82) compared to patients without mutations (5.71, p = 0.019). With the study population divided into four subgroups based on ALT level at time of diagnosis, cirrhosis incidence was significantly higher in patients with ALT 1-2 × ULN and ALT > 2 × ULN compared to patients with ALT ≤ 0.5 × ULN. CONCLUSIONS: Our finding that PC and CP mutations may be associated with milder liver disease in some patients could serve as the basis for longitudinal studies to help delineate treatment need and duration in patients with these mutations. If confirmed, the finding of an association between ALT 1-2 × ULN and increased incidence of cirrhosis could call into question guidelines which only recommend treatment with ALT > 2 × ULN.