Digestive Diseases and Sciences

, Volume 59, Issue 1, pp 168–173

Similar Response to Entecavir 0.5 and 1.0 Mg in Treatment-Naïve Chronic Hepatitis B Patients: A Case-Control Study

  • Nghiem B. Ha
  • Nghi B. Ha
  • Kevin T. Chaung
  • Huy N. Trinh
  • Huy A. Nguyen
  • Khanh K. Nguyen
  • Mindie H. Nguyen
Original Article

DOI: 10.1007/s10620-013-2940-2

Cite this article as:
Ha, N.B., Ha, N.B., Chaung, K.T. et al. Dig Dis Sci (2014) 59: 168. doi:10.1007/s10620-013-2940-2

Abstract

Background and Aims

The dose recommendation for entecavir (ETV) is 0.5 mg daily for treatment-naïve chronic hepatitis B (CHB) patients and 1.0 mg daily for lamivudine-refractory patients; however, few data are available for the efficacy of a 1.0-mg daily dose in treatment-naïve CHB patients. Our goal is to examine the treatment outcome of treatment-naïve patients placed on ETV 0.5 mg or ETV 1.0 mg daily through week 48.

Methods

Cases were 40 consecutive hepatitis B e antigen (HBeAg)-positive CHB patients treated with ETV 1.0 mg daily between January 2005 and September 2010, and controls were 40 consecutive CHB patients treated with ETV 0.5 mg daily between January 2005 and September 2010 at three US gastroenterology/liver clinics. Controls were matched for age (±5 years), sex, HBeAg, and baseline hepatitis B virus (HBV) DNA (±0.5 log10 IU/ml). Complete viral suppression was defined as undetectable HBV DNA by polymerase chain reaction (<100 IU/ml).

Results

Both groups had similar distributions of age (38 ± 11 years), male patients (55 %), and mean HBV DNA (7.7 ± 1.1 log10 IU/ml). The complete viral suppression rate was similar in both cases and controls through week 24 (15 vs. 15 %, p = 1.00) and week 48 (22 vs. 36 %, p = 0.17). Non-adherence was reported in three patients in the ETV 1.0 mg daily cohort at week 48.

Conclusions

There were no significant differences in the proportion of patients with complete viral suppression in patients treated with ETV 0.5 mg daily or the higher daily dose of 1.0 mg.

Keywords

Hepatitis BTreatmentDoseOutcome

Abbreviations

ADV

Adefovir dipivoxil

Anti-HBe

Hepatitis B e antibody

ALT

Alanine aminotransferase

AST

Aspartate aminotransferase

CHB

Chronic hepatitis B

DNA

Deoxyribonucleic acid

ETV

Entecavir

HBeAg

Hepatitis B e antigen

HBsAg

Hepatitis B surface antigen

HBV

Hepatitis B virus

HCC

Hepatocellular carcinoma

ICD-9

International Classification of Disease, 9th revision

IU

International unit

LAM

Lamivudine

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • Nghiem B. Ha
    • 1
    • 2
  • Nghi B. Ha
    • 3
  • Kevin T. Chaung
    • 4
  • Huy N. Trinh
    • 5
    • 4
  • Huy A. Nguyen
    • 5
  • Khanh K. Nguyen
    • 5
  • Mindie H. Nguyen
    • 2
  1. 1.School of MedicineUniversity of California, DavisSacramentoUSA
  2. 2.Division of Gastroenterology and HepatologyStanford University Medical CenterPalo AltoUSA
  3. 3.School of PharmacyUniversity of California, San FranciscoSan FranciscoUSA
  4. 4.Pacific Health FoundationSan JoseUSA
  5. 5.San Jose GastroenterologySan JoseUSA