Clin Mol Hepatol.  2015 Mar;21(1):24-31. 10.3350/cmh.2015.21.1.24.

Efficacy of prolonged entecavir monotherapy in treatment-naive chronic hepatitis B patients exhibiting a partial virologic response to entecavir

• Choi HN
• Song JE
• Lee HC
• Jo HH
• Lee CH
• Kim BS

• KMID: 2155288
• DOI: http://doi.org/10.3350/cmh.2015.21.1.24

Abstract

BACKGROUND/AIMS
The optimal management of patients exhibiting a partial virologic response (PVR) to entecavir (ETV) has not been determined . The aim of this study was to determine the long-term efficacy of prolonged ETV monotherapy in treatment-naive chronic hepatitis B (CHB) patients exhibiting a PVR to ETV therapy.
METHODS
This study included 364 treatment-naive CHB patients treated with ETV for > or =48 weeks and who received continuous ETV monotherapy for > or =96 weeks. PVR was defined as a decrease in serum hepatitis B virus (HBV) DNA of more than 2 log10 IU/mL from baseline but with detectable HBV DNA by real-time PCR assay at week 48.
RESULTS
Fifty-two of the 364 patients (14.3%) showed a PVR. Among them, 41 patients received continuous ETV monotherapy for > or =96 weeks (median duration 144 weeks, range 96-312 weeks), and 40 of these patients (95%) achieved a virologic response (VR, HBV DNA <20 IU/mL) during prolonged ETV monotherapy (median duration 78 weeks, range 60-288 weeks). The cumulative probabilities of a VR at weeks 96, 144, and 192 from treatment initiation were 78.0%, 92.7%, and 95.1%, respectively. The VR rate was 97.2% (35/36) in HBeAg-positive patients and 100% (5/5) in HBeAg-negative patients. In multivariate analysis, HBeAg positivity (odds ratio [OR], 9.231; 95% confidence interval [CI], 1.03-82.91; P=0.047) and a high baseline HBV DNA level (OR, 0.170; 95% CI, 0.08-0.37; P=0.000) were independently associated with a delayed virologic response. No patient developed genotypic resistance to ETV during follow-up.
CONCLUSIONS
Long-term ETV monotherapy is effective for achieving a VR in treatment-naive CHB patients exhibiting a PVR to ETV. HBeAg positivity and high baseline HBV DNA level were independently associated with a delayed virologic response.

Keyword

Chronic hepatitis B; Entecavir; Partial virologic response

MeSH Terms

Adult
Aged
Antiviral Agents/*therapeutic use
DNA, Viral/blood
Drug Administration Schedule
Female
Genotype
Guanine/*analogs & derivatives/therapeutic use
Hepatitis B e Antigens/blood
Hepatitis B virus/genetics
Hepatitis B, Chronic/*drug therapy/pathology/virology
Humans
Liver Cirrhosis/etiology/radiography/ultrasonography
Magnetic Resonance Imaging
Male
Middle Aged
Multivariate Analysis
Odds Ratio
Real-Time Polymerase Chain Reaction
Retrospective Studies
Tomography, X-Ray Computed
Treatment Outcome
Antiviral Agents
DNA, Viral
Guanine
Hepatitis B e Antigens