Tenofovir alafenamide reduces liver stiffness in CHB patients

Treatment with the nucleos(t)ide analogue (NUC) tenofovir alafenamide (TAF) for 2 years leads to improvements in liver stiffness among patients with chronic hepatitis B (CHB), including those with advanced liver fibrosis, according to a study presented at the IDWeek 2022 in Washington, DC, US.

In addition, baseline liver stiffness and alanine transaminase (ALT) are predictive of liver stiffness reduction in CHB patients treated with TAF.

“This may reflect an overestimation of fibrosis stage in the presence of liver inflammation at NUC initiation,” said the researchers led by Dr Shyam Kottilil, Director Clinical Care and Research, University of Maryland School of Medicine, Baltimore, Maryland, US.

“Repeating FibroScan after initiation of NUC treatment would therefore be useful, especially in people with elevated ALT, for guiding CHB care,” they added.

In the study, Kottilil and colleagues treated patients enrolled at the University of Maryland, Baltimore, with TAF 25 mg daily for 2 years. Liver stiffness was measured using FibroScan at baseline and year 2. Mild (F0/F1) fibrosis was defined as ≤7.4 kPa and advanced fibrosis as ≥7.5 kPa.

The researchers then assessed the correlates of liver stiffness change from baseline to year 2 using multiple linear regression. A p-value of <0.05 was deemed significant.

Sixty patients with CHD completed the study. Of these, 29 switched treatments from another NUC to TAF (switch group), while 31 were not treated with NUC at baseline (No NUC group: 17 treatment-naïve, 14 prior NUC). [IDWeek 2022, abstract 1236]

The no-NUC group showed a higher baseline ALT than the switch group (53.5 vs 30.2 IU/ml; p<0.007). Majority (67.2 percent) of the patients also presented with mild fibrosis at baseline, while 19 had advanced fibrosis. Among patients with advanced fibrosis, 14 had an improvement by at least one disease stage, but five showed no change.

Liver stiffness improved among patients in the no-NUC group (mean change in stiffness ‒1.2161 kPa; p=0.02) but not among those in the switch group. In subgroup analysis, patients with advanced fibrosis in the no-NUC group also had a reduction in liver stiffness, but not those in the switch group.

Of note, higher baseline ALT (rho, ‒0.3; p=0.005) and baseline liver stiffness (rho, ‒0.7; p<0.0001) were robust predictors of improvements in liver stiffness.

“Increased liver stiffness, and therefore fibrosis, at baseline was associated with greater reductions in liver stiffness, and therefore liver stiffness, after 2 years of NUC therapy,” the researchers said.

These findings were consistent with those of an earlier study in Chinese patients with CHB, in which higher liver stiffness values at baseline contributed to a greater decrease in liver stiffness. [Exp Ther Med 2017;13:1169-1175]

“Globally, 296 million people are infected with CHB and at risk for cirrhosis and hepatocellular carcinoma. Suppressive therapy with [an NUC] such as TAF reduces risk of cirrhosis and cancer,” the researchers said.

“Transient elastography measures liver stiffness and is used to monitor liver fibrosis in CHB,” they added.