Earlier normalization of serum alanine aminotransferase (ALT) levels in patients with chronic hepatitis B (CHB) who initiated treatment with entecavir or tenofovir correlates with a proportionally lower risk of hepatocellular carcinoma (HCC), regardless of fatty liver or cirrhosis at baseline and on-treatment virological response (VR), according to a recent study.
The investigators performed landmark analysis and time-dependent Cox analysis in 4,639 CHB patients treated with entecavir or tenofovir. Normal ALT was defined as ≤35 U/L in men and ≤25 U/L in women; VR was defined as serum hepatitis B virus DNA <15 IU/mL.
Of the patients, 509 (11.0 percent) developed HCC during a median 5.6 years of treatment. ALT normalization occurred in 65.6 percent of patients at 1 year and 81.9 percent at 2 years. It also correlated with a significantly reduced risk of HCC in landmark (p<0.001) and time-dependent Cox analyses (adjusted hazard ratio [AHR], 0.57; p<0.001).
Delayed ALT normalization at 6–12 (AHR, 1.40), 12–24 (AHR, 1.75) and >24 months (AHR, 2.45) correlated with incrementally increasing HCC risk (p<0.001), compared with ALT normalization at 6 months, irrespective of fatty liver or cirrhosis at baseline and VR during treatment.
On the other hand, neither VR (AHR, 0.93; p=0.53) nor earlier hepatitis B e antigen seroclearance (AHR, 0.91; p=0.31) correlated with a significantly reduced HCC risk.
“It was suggested that normalization of serum ALT levels at 1 year of antiviral treatment is associated with a lower risk of hepatic events in patients with CHB,” the investigators noted.