TAF may reduce liver inflammation and fibrosis in CHB patients

Results of small study in Taiwan suggest that tenofovir alafenamide (TAF) may reduce liver inflammation and fibrosis in treatment-naïve chronic hepatitis B (CHB) patients with mildly elevated alanine transaminase (ALT) and significantly liver injury.

The phase IV study, presented at the Asian Pacific Association for the Study of the Liver (APASL) 2023 Annual Meeting, included 20 treatment-naïve patients (mean age, 57.2 years; male, n=10) with CHB (hepatitis B e antigen [HBeAg]–negative with hepatitis B virus [HBV] DNA level >2,000 IU/mL, or HBeAg-positive with HBV DNA level >20,000 IU/mL), who had ALT level 1–2 times upper limit of normal and had undergone liver biopsy within 1 year before enrolment. The patients also had histology activity index (HAI) score of ≥4 on the Knodell necroinflammation scoring system or fibrosis of stage 2 or 3 on the Metavir scoring system. Treatment with TAF 25 mg/day was given. Liver stiffness measurement (LSM) by FibroScan was undertaken on the same day of liver biopsy and repeated at study week 48. [Cheng PN, et al, APASL 2023, abstract PPB-037]

At baseline, the patients’ HBV DNA level was 5.7 ± 1.5 log₁₀ IU/mL. Among 15 patients who completed 48 weeks of TAF treatment, 14 (93.3 percent) had undetectable HBV DNA. ALT level decreased significantly from 50.2 ± 22.5 U/L at baseline to 28.1 ± 10.8 U/L at 48 weeks (p<0.001), with ALT normalization achieved in 11 patients (73.3 percent) at 48 weeks.

Liver stiffness also improved following 48 weeks of TAF treatment, with FibroScan LSM values improving from 7.9 ± 3.5 kPa at baseline to 5.9 ± 1.9 kPa at 48 weeks (p=0.003) and Fibrosis-4 score improving from 1.9 ± 1.3 at baseline to 1.7 ± 1.2 at 48 weeks (p=0.003).

“For CHB patients with mildly elevated ALT and significant liver injury, 48-week treatment with TAF resulted in decline of ALT levels, ALT normalization in a large proportion of patients, and improvement of liver stiffness and Fibrosis-4 score. These results indicated that 48-week TAF treatment may improve liver inflammation and fibrosis,” the researchers concluded.