☆ 4.8 Article

Entecavir plus tenofovir combination as rescue therapy in pre-treated chronic hepatitis B patients: An international multicenter cohort study

JOURNAL OF HEPATOLOGY (2012)

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JOURNAL OF HEPATOLOGY

卷 56, 期 3, 页码 520-526

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DOI: 10.1016/j.jhep.2011.09.018

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Hepatitis b; Clinical study; Combination therapy; Drug resistance; Entecavir; Tenofovir

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Gastroenterology & Hepatology

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Background & Aims: Long-term viral, suppression is a major goal to prevent disease progression in patients with HBV. Aim of this study was to investigate the efficacy and safety of entecavir plus tenofovir combination in 57 CHB partial responders or multidrug resistant patients. Methods: Investigator-initiated open-label cohort study. Quantitative HBV-DNA measurement and resistance testing (line-probe-assays and direct-sequencing) at baseline and every 3 months. Results: Fifty seven patients (37 HBeAg+), median age 45 years, previously treated with a median of three lines of antiviral therapy (range 1-6), 24/57 with advanced liver disease, were included. Median ALT at baseline was 1.0 ULN (range 0.3-22) and HBV-DNA 1.5 x 10(4) IU/ml (range 500-1 x 10(11) IU/ml ). Median treatment duration of combination therapy was 21 months. HBV-DNA level dropped 3 logs (median, range, 0-8 log; p<0.0001), 51/57 patients became HBV-DNA undetectable, median after 6 months (95% CI, 4.6-7). The probability for HBV DNA suppression was not reduced in patients with adefovir or entecavir resistance or in patients with advanced liver disease. Viral suppression led to decline in ALT (median 0.7 ULN; range 0.2-2.4; p = 0.001). Five patients lost HBeAg (after 15, 18, 20, 21, and 27 months, respectively), one patient showed HBs-seroconversion. Patients with advanced disease did not show clinical decompensation, two patients with cirrhosis and undetectable HBV DNA developed HCCs. No death, newly induced renal impairment or lactic acidosis were reported. Conclusions: Rescue therapy with entecavir and tenofovir in CHB patients harboring viral resistance patterns or showing only partial antiviral responses to preceding therapies was efficient, safe, and well tolerated in patients with and without advanced liver disease (249). (C) 2011 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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Chronic Hepatitis B Relapse Rates after Cessation of Tenofovir Alafenamide and Entecavir Therapy

Chih-Wen Huang, Chen-Ta Yang, Pei-Yuan Su, Yang-Yuan Chen, Siou-Ping Huang, Hsu-Heng Yen

Summary: This study compared the relapse rates of chronic hepatitis B patients after discontinuation of nucleos(t)ide analogues therapy with tenofovir alafenamide (TAF) and entecavir. The results showed that at 12 weeks after discontinuation, no patients in the entecavir group had relapsed, while three patients (7.9% cumulative rate) in the TAF group had relapsed. At 24 and 48 weeks, the cumulative rates of relapse in the entecavir and TAF groups were significantly different. Therefore, close monitoring of liver function and HBV DNA levels is necessary, especially within 24 weeks after discontinuation of TAF therapy.

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