[Study on the efficacy and safety profile of tenofovir alafenamide fumarate in the treatment of patients with decompensated hepatitis B cirrhosis].

Objective

To explore the efficacy and safety profile of tenofovir alafenamide fumarate (TAF) in the treatment of patients with decompensated hepatitis B cirrhosis.

Methods

A two-way cohort study method was used to enroll patients with decompensated hepatitis B cirrhosis who visited four medical centers, including Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, from April 2021 to April 2024 and were treated with TAF and followed up for 48 weeks. The primary efficacy indicator was hepatitis B virus (HBV) DNA seronegative conversion rate at 48-weeks, and the secondary efficacy indicator was alanine aminotransferase (ALT) return to normal rate at 48-weeks. Relevant safety indicators, adverse drug reactions (ADRs), and clinical adverse outcomes were collected.

Results

A total of 74 cases were included. Of these, 52 were males with an average age of (53.14 ± 9.15) years. Twenty-five and thirty-three cases completed 24 and 48 weeks of follow-up, respectively. The HBV DNA negative conversion rate was 96.97% (32/33), which was higher than the baseline of 58.1% (43/74) following 48 weeks of TAF treatment. The ALT return to normal rate was 72.73% (24/33), which was higher than the baseline of 47.30% (35/74); however, the renal function and blood lipid levels did not change significantly compared with the baseline level after completing 48 weeks of treatment (P>0.05). During the follow-up period, one case developed hepatocellular carcinoma, and no other adverse clinical outcomes, such as liver transplantation or death, were reported.

Conclusion

TAF has a good efficacy and safety profile in the treatment of patients with decompensated hepatitis B cirrhosis.