Patients with chronic hepatitis B (CHB) have a lower risk of hepatic events if they achieve normal on-treatment alanine aminotransferase (ALT) in the first 12 months of nucleos(t)ide analogue (NA) treatment, according to a study published in the Journal of Hepatology.

Grace Lai-Hung Wong, MBChB, MD, FRCP, FHKCP, FHKAM, from the Institute of Digestive Disease at the Chinese University of Hong Kong, and colleagues, performed a retrospective territory-wide cohort study to evaluate the impact of normal on-treatment ALT at different time points at the first year of entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment in patients with CHB. The researchers used data from the Clinical Data Analysis and Reporting System (CDARS) of the Hospital Authority (HA), Hong Kong. Patients with CHB who received ETV and/or TDF from January 1, 2005, to December 31, 2016, in Hong Kong were included. Patients were followed until death or last day with dispensed ETV or TDF within 6 years from the baseline visit.

Baseline date was defined as the date of the first prescription of ETV or TDF. Serial on-treatment ALT levels were collected and analyzed. Normal on-treatment ALT (ALT-N) was defined as ALT <30 U/L in males and <19 U/L in females. The primary and secondary outcome were composite hepatic events (including hepatocellular carcinoma) based on diagnosis codes. Patients with hepatic events before or during the first year of antiviral treatment or follow-up <1 year were excluded.

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A total of 46,441 ETV- and/or TDF-treated patients were identified, among whom 21,182 patients with CHB fulfilled the inclusion and exclusion criteria and were included in the analysis. A total of 10,437 patients achieved normal on-treatment ALT within 12 months of NA treatment. The rate of normal on-treatment ALT at 12 months was lower in patients receiving TDF alone (1,119/2,709, 41.3%) than in those receiving ETV alone (9,306/18,447, 50.5%).

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Patients with and without ALT-N differed in baseline ALT (58 vs 61 U/L), HBV DNA (4.9 vs 5.1 log10 IU/mL) and cirrhosis status (8.8% vs 10.5%). A total of 627 (3.0%) patients developed composite hepatic events. Compared with no ALT-N, ALT-N at 3, 6, 9, and 12 months reduced the risk of hepatic events, after adjustment for baseline ALT and other important co-variates, with adjusted hazard ratios (95% CI) of 0.61, 0.55, 0.54, and 0.51, respectively. The cumulative incidence of composite hepatic events at 6 years was 3.51% in ALT-N and 5.70% in no ALT-N group.

“In conclusion, patients with CHB would have a lower risk of hepatic events if they achieve normal on-treatment ALT in the first 12 months of NA treatment,” the authors stated. “The higher the ALT levels during treatment, the higher the risk of hepatic events. The impact of specific NA on normal on-treatment ALT warrants further study.”


Wong GL, Chan HL, Tse YK, et al. Normal on-treatment ALT during antiviral treatment is associated with a lower risk of hepatic events in patients with chronic hepatitis B [published online May 11 2018]. J Hepatol. doi: 10.1016/j.jhep.2018.05.009