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

<b>Objective:</b> To explore the efficacy and safety profile of tenofovir alafenamide fumarate (TAF) in the treatment of patients with decompensated hepatitis B cirrhosis. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusion:</b> TAF has a good efficacy and safety profile in the treatment of patients with decompensated hepatitis B cirrhosis.

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Publication Details

Journal
PubMed
Published
2024-12-30
DOI
https://doi.org/10.3760/cma.j.cn501113-20240905-00479
Primary Topic
Hepatitis B Virus Studies
Type
article
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article

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

Yue Ying, Z G Wang, X Z Wang, Xuan Wu et al.
PubMed
Hepatitis B Virus Studies
article

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

Yue Ying, Z G Wang, X Z Wang, Xuan Wu, Fanpu Ji, Jun Dou, Haifang Wang, Shan Zeng, Z H Ning, Qiang Fu, Feng Guo, Qiang Xu, S S Dang, X B Wang, Weize Zuo
article en

Abstract

<b>Objective:</b> To explore the efficacy and safety profile of tenofovir alafenamide fumarate (TAF) in the treatment of patients with decompensated hepatitis B cirrhosis. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusion:</b> TAF has a good efficacy and safety profile in the treatment of patients with decompensated hepatitis B cirrhosis.

PubMedVol. 32(S2)
Xinjiang Medical University (CN), Yili Friendship Hospital (CN), Second Affiliated Hospital of Xi'an Jiaotong University (CN), First Affiliated Hospital of Shihezi University Medical College (CN)
Hepatitis B Virus Studies
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