Antiviral Therapy Reduces Hepatocellular Carcinoma and Cirrhosis Risk in Chinese Chronic Hepatitis B Patients With Mildly Elevated Alanine Aminotransferase.

[BACKGROUND & AIMS] The long-term benefit of antiviral treatment with nucleos(t)ide analogues (NAs) for non-cirrhotic patients with chronic hepatitis B (CHB) without significant alanine aminotransferase (ALT) elevation remains debatable. We investigated the impact of NA treatment on the long-term risk of hepatocellular carcinoma (HCC) and cirrhosis in these patients.

[METHODS] This retrospective multicenter study included 3734 non-cirrhotic patients with CHB with ALT <2 × the upper limit of normal (ULN). To balance baseline characteristics between treated and untreated patients, inverse probability of treatment weighting (IPTW) and propensity score matching (PSM) were applied. The risk of HCC and cirrhosis development was compared between the treated and untreated patients.

[RESULTS] Of all patients, 37.8% received NA treatment. After IPTW, treated patients had a significantly lower 5-year cumulative incidence of HCC (0.9% vs 4.4%; P < .001) and cirrhosis (4.0% vs 8.9%; P < .001) than untreated patients. In multivariate Cox analyses, NA therapy was associated with a significantly lower risk of developing HCC (adjusted hazard ratio [aHR], 0.14; 95% confidence interval [CI], 0.05-0.37; P < .001) and cirrhosis (aHR, 0.30; 95% CI, 0.18-0.50; P < .001) in the IPTW cohort. The findings were consistent in the subgroup of patients with ALT 1 to 2 × ULN but not in those with ALT ≤1 × ULN. Similar results were obtained in the PSM cohort.

[CONCLUSIONS] NA therapy reduced the risk of HCC and cirrhosis in non-cirrhotic CHB patients with mildly elevated ALT levels (1-2 × ULN). These findings support the expansion of antiviral treatment criteria for the early treatment of these patients.