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Randomised clinical trial: safety, efficacy and pharmacokinetics of HS-10234 versus tenofovir for the treatment of chronic hepatitis B infection.

Abstract：

BACKGROUND:HS-10234 is a novel prodrug of tenofovir developed to increase anti-viral potency and to reduce systemic toxicities. AIMS:To evaluate the tolerability, pharmacokinetics and anti-viral efficacy of HS-10234 in patients with chronic hepatitis B (CHB) infection METHODS: Treatment-naïve subjects with non-cirrhotic CHB were divided into three groups (n = 12/group) and randomised within each group to receive 10, 25 or 40 mg of HS-10234, or 300 mg of tenofovir disoproxil fumarate (TDF) once a day for 28 days. RESULTS:Among 36 enrolled subjects, 33.3% were hepatitis B e antigen-negative with a mean hepatitis B virus (HBV) DNA level of 6.32-7.42 log10  IU/mL. Nephrotoxicity and serious adverse events were not observed; all adverse events were mild or moderate and non-specific. The mean reductions in serum HBV DNA after 28 days were -2.70, -2.89, -2.72 and -3.04 log10  IU/mL for treatment with 10, 25 or 40 mg HS-10234, and 300 mg TDF, respectively. HS-10234 and its metabolite TFV showed linear, dose-proportional pharmacokinetics. The concentrations of active TFV-DP in peripheral blood mononuclear cells were higher (approximately 2- to 11-fold increase) and TFV in plasma were lower (approximately 4.5- to 25-fold reduction) in subjects taking HS-10234 than those in the TDF group. CONCLUSIONS:HS-10234 was well tolerated during a 4-week course. TDF and HS-10234 had comparable potency in inhibiting HBV replication. A daily dose of 10-25 mg of HS-10234 is recommended for CHB treatment. (Chinese Drug Trial Identifier: CTR20161077).

journal_name

Aliment Pharmacol Ther

journal_title

Alimentary pharmacology & therapeutics

authors

Zhang H,Hu Y,Wu M,Liu J,Zhu X,Li X,Chen H,Li C,Liu C,Niu J,Ding Y

doi

10.1111/apt.16196

subject

Has Abstract

pub_date

2021-01-01 00:00:00

pages

243-252

issue

2

eissn

0269-2813

issn

1365-2036

journal_volume

53

pub_type

杂志文章

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