Efficacy and resistance to telbivudine treatment in chronic hepatitis B patients with favorable predictors: a multicenter study in Taiwan
Journal
Hepatology International
Journal Volume
10
Journal Issue
2
Pages
294-301
Date Issued
2016
Author(s)
Wang C.-C.
Lin C.-L.
Hsieh T.-Y.
Tseng K.-C.
Peng C.-Y.
Yang S.-S.
Hsu Y.-C.
Chen T.-M.
Abstract
Background/purpose: A subgroup analysis of a GLOBE study identified subgroups of chronic hepatitis B (CHB) patients with excellent outcomes to telbivudine (LdT) treatment. The aim of this study was to validate this concept using a real-world clinical population. Methods: This prospective, retrospective, and multicenter study examined both HBeAg-positive and HBeAg-negative CHB patients treated with LdT for 2?years. Results: A total of 116 CHB patients were recruited. Of the 64 HBeAg-positive patients, 35 had favorable baseline characteristics [hepatitis B virus (HBV) DNA???9 log10 copies/mL and alanine aminotransferase ? 2×?the upper limit of normal (ULN)], but only 40?% (14/35) achieved polymerase chain reaction (PCR) negativity at week 24. Among the 14 patients with favorable baseline characteristics and on-treatment response, the rates of virologic, biochemical, and serologic response and genotypic resistance were 78.6?% (11/14), 64.3?% (9/14), 50?% (7/14), and 7.1?% (1/14), respectively, at week 104 of therapy. Of the 52 HBeAg-negative patients, 34 met the criteria of a baseline serum HBV-DNA level less than 7?log10?copies/mL, and 29 (85.3?%) achieved PCR negativity at week 24. Among the 29 patients with favorable baseline characteristics and on-treatment response, the rates of virologic and biochemical response and genotypic resistance were 96.6?% (28/29), 72.4?% (21/29), and 6.9?% (2/29), respectively. In addition, the PCR negativity at week 24 was the only factor associated with the virologic response and genotypic resistance to LdT treatment. Conclusion: The efficacy and resistance to LdT treatment in CHB patients with favorable predictors were comparable between a real-world clinical population and the GLOBE study. In addition, PCR negativity at week 24 could predict virologic response and genotypic resistance to LdT treatment. ? 2015, Asian Pacific Association for the Study of the Liver.
SDGs
Other Subjects
adefovir; alanine aminotransferase; entecavir; hepatitis B(e) antigen; telbivudine; tenofovir; virus DNA; antivirus agent; hepatitis B(e) antigen; telbivudine; thymidine; virus DNA; add on therapy; adult; aged; Article; biochemical analysis; chronic hepatitis B; clinical trial; dizziness; drug efficacy; drug substitution; drug withdrawal; dysgeusia; female; genotype; Hepatitis B virus; human; insomnia; major clinical study; male; multicenter study; muscle weakness; myalgia; open study; polymerase chain reaction; population research; priority journal; prospective study; retrospective study; serology; treatment duration; treatment response; virology; analogs and derivatives; antiviral resistance; blood; genetics; Hepatitis B, Chronic; isolation and purification; middle aged; Taiwan; treatment outcome; young adult; Adult; Aged; Antiviral Agents; DNA, Viral; Drug Resistance, Viral; Female; Hepatitis B e Antigens; Hepatitis B virus; Hepatitis B, Chronic; Humans; Male; Middle Aged; Prospective Studies; Retrospective Studies; Taiwan; Thymidine; Treatment Outcome; Young Adult
Publisher
Springer
Type
journal article