Abstract:

Objective To investigate the efficacy and safety of tenofovir alafenamide fumarate （TAF） in the treatment of patients with decompensated hepatitis B cirrhosis. Methods We retrospective analyzed 41 patients with decompensated hepatitis B cirrhosis receiving TAF antiviral therapy for 24 weeks at Wuwei Tumor Hospital in Gansu province from June 2022 to June 2023. Primary endpoint was proportion of patients achieving virologic response （HBV DNA < 20 IU/mL）. Other endpoints included changes in ALT， AST， TBIL， Child-Pugh score （CTP）， and MELD score from baseline to week 24. In terms of safety， changes in Scr， eGFR and adverse events from baseline to week 24 were observed. Results Of 41 patients， 73.2% were male （n = 30）， with mean age of 53.49 years. 24 weeks after treatment with TAF， HBV DNA was undetectable in 90.2% of the patients. The median levels of ALT， AST and total bilirubin （TBIL） were 50.70 U/L， 48.70 U/L and 26.40 μmol/L respectively at baseline， and reduced significantly to 31.50 U/L， 37.8 U/L and 23.8 μmol/L （P < 0.05） respectively after 24-week therapy with TAF. CTP score was improved in 58.6% of the patients （n = 24）， and so was MELD score in 63.4% of the patients （n = 26） at week 24. The median serum creatinine and eGFR were 58.5 μmol/L and 106.15 mL/（min·1.73 m²） respectively at baseline， and creatinine and eGFR were stable during treatment. No drug-related adverse events or severe adverse events occurred during treatment， neither did creatinine and eGFR liver transplantation， HCC or death. Conclusions Our clinical studies demonstrated better effectiveness and safety of TAF for decompensated CHB patients.

Key words: tenofovir alafenamide, hepatitis B, decompensated cirrhosis, efficacy, safety