Efficacy and safety of switching to tenofovir alafenamide in poor responsive/low-level viremia hepatitis B patients with decompensated cirrhosis to nucleos(t)ide analogs therapy

Abstract

Abstract: Objective Real-world efficacy and safety of switching to TAF in decompensated hepatitis B-related cirrhotic patients poor responsive or with low-level viremia (LLV) to nucleos(t)ide analogue (NA) therapy are unclear. The purpose of this study was to investigate the efficacy and safety of the sequential therapy in order to optimize antiviral treatment. Methods In this prospective cohort study 56 patients with decompensated hepatitis B cirrhosis were enrolled who had been switched to TAF monotherapy due to poor response to NA therapy or LLV for at least 6 mooths. According to the baseline HBV DNA level, they were divided into LLV group (HBVDNA<2000 IU/mL) and poor response group (HBV-DNA≥2000 IU/mL). All patients were followed up every 12 weeks. Their virological/biochemical responses were evaluated after switchover. Results (1) Complete virological response (CVR) at 48 weeks [32.14%(18/56)] after swithing to TAF was significantly increased than that at 12 weeks [80.00%(16/20)](P<0.05). (2)Subgroup analysis of LLV group and poor response group showed that the former achieved favours CVR at 12 weeks [61.54%(16/26) vs 6.67%(2/30)]. However, there was no statistical difference between the two groups at 24 weeks, 36 weeks and 48 weeks. (3) Additionally, the mean changes in HBsAg and HBV DNA levels were significant at 48 weeks (-0.44 and -3.38 logIU/mL, respectively) (P<0.05).(4) The normalization rate of ALT at 48 week was 95.00%(19/20), which were significantly higher than that of 66.07%(37/56) at the baseline (P<0.05). (5) The mean Child-Pugh score and the proportion of Child-pugh A at 48 weeks was 5.45±0.76 and 85%(17/20), respectively, which were significantly improved than those of 8.66±2.30 and 21.43% (12/56) at the baseline (P<0.05). (6) During the 48-weeks’ treatment period, there were no significant changes in serum creatinine, phosphorus, and eGFR (P>0.05), However, the median urinary β2-microglobulin (β2-MG) at 24-weeks was 0.98, compared to 1.14 at the baseline, however, the difference was not statistically significant. Conclusion (1) Switching to TAF monotherapy is effective in patients with decompensated hepatitis B-related cirrhosis due to poor response to NA therapy /LLV, regarding both CVR and the liver function benefits. (2) TAF has a good renal safety in the treatment of decompensated hepatitis B-related cirrhosis.

Key words: Low-level viremia, Antiviral treatment, Heaptitis B decompensated cirrhosis, tenofovir alafenamide(TAF), renal impairment

ZENG A-juan, LI Lei, DING Hui-guo. Efficacy and safety of switching to tenofovir alafenamide in poor responsive/low-level viremia hepatitis B patients with decompensated cirrhosis to nucleos(t)ide analogs therapy[J]. Chinese Hepatolgy, 2024, 29(5): 504-507.

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