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Normal ALT levels during HBV therapy improves outcomes

Normal on-treatment alanine aminotransferase levels correlated with improved clinical outcomes in patients with chronic hepatitis B during nucleo(s)tide analogue treatment, according to a recently published study.

“[Chronic HBV] patients would have a lower risk of hepatic events if they achieve normal on-treatment ALT in the first 12 months of [nucleo(s)tide analogue (NA)] treatment,” Grace Lai-Hung Wong, MD, from the Chinese University of Hong Kong, and colleagues wrote. “The higher the ALT levels during treatment, the higher the risk of hepatic events.”

The study comprised 21,182 patients with chronic HBV, 10,437 of whom achieved normalized ALT within 1 year of NA treatment. Patients who received Baraclude (entecavir, Bristol-Myers Squibb) alone were more likely to achieve normalized ALT compared with those who received Viread (tenofovir disoproxil fumarate, Gilead Sciences) alone (50.5% vs. 41.3%; P < .001).

Patients who achieved normalized ALT had lower ALT (58 vs. 61 U/L; P < .001) and HBV DNA levels at baseline (4.9 vs. 5.1 log 10 IU/mL; P < .001), and were more likely to be men (76.9% vs. 58.4%; P < .001), less likely to be hepatitis B e-antigen positive (31.5% vs. 37.1%; P < .001), and less likely to have cirrhosis (8.8% vs. 10.5%; P < .001), diabetes (12.6% vs. 15.8%; P < .001) and coexisting fatty liver disease (76.7% vs. 85.6%; P < .001).

During a mean follow-up of 4 years, 627 patients experienced a composite hepatic event, most of which were the development of hepatocellular carcinoma (n = 509).

The cumulative incidence rates of composite events in patients who had normal vs. elevated on-treatment ALT were as follows: 4.27 (95% CI, 3.54-5.15) vs. 4.76 (95% CI, 4.34-5.21) at 3 months; 3.6 (95% CI, 3.07-4.21) vs. 5.24 (95% CI, 4.76-5.77 at 6 months; 3.44 (95% CI, 2.98-3.97) vs. 5.57 (95% CI, 5.04-6.16) at 9 months; and 3.51 (95% CI, 3.06-4.02) vs. 5.7 (95% CI, 5.15-6.32) at 1 year.

Among patients who had normal on-treatment ALT, the adjusted hazard ratios for composite hepatic events were 0.61 (95% CI, 0.49-0.77) at 3 months; 0.55 (95% CI, 0.45-0.67) at 6 months; 0.54 (95% CI, 0.44-0.65) at 9 months; and 0.51 (95% CI, 0.42-0.61) at 1 year.

“We should keep our vigilance for disease progression and HCC in patients with persistent ALT elevation even if they are receiving potent NAs with complete viral suppression,” Wong and colleagues concluded. “We may consider further intervention to reduce risk of hepatic events. Recent studies demonstrated the beneficial effect of statins on CHB patients as it reduces the risk of HCC, liver decompensation and death in patients with chronic viral hepatitis.” – by Talitha Bennett

Disclosure: Wong reports she served as an advisory committee member for Gilead Sciences, and as a speaker for Abbott, AbbVie, Bristol-Myers Squibb, Echosens, Furui, Gilead Sciences, Janssen and Roche. Please see the full study for the other authors’ relevant financial disclosures.