Clin Mol Hepatol.  2015 Mar;21(1):41-48. 10.3350/cmh.2015.21.1.41.

Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide analogue-naive and nucleos(t)ide analogue-experienced chronic hepatitis B patients

• Jung SK
• Kim KA
• Ha SY
• Lee HK
• Kim YD
• Lee BH
• Paik WH
• Kim JW
• Bae WK
• Kim NH
• Lee JS
• Jwa YJ

• KMID: 2155290
• DOI: http://doi.org/10.3350/cmh.2015.21.1.41

Abstract

BACKGROUND/AIMS
This study investigated the antiviral effects of tenofovir disoproxil fumarate (TDF) monotherapy in nucleos(t)ide analogue (NA)-naive and NA-experienced chronic hepatitis B (CHB) patients.
METHODS
CHB patients treated with TDF monotherapy (300 mg/day) for > or =12 weeks between December 2012 and July 2014 at a single center were retrospectively enrolled. Clinical, biochemical, and virological parameters were assessed every 12 weeks.
RESULTS
In total, 136 patients (median age 49 years, 96 males, 94 HBeAg positive, and 51 with liver cirrhosis) were included. Sixty-two patients were nucleos(t)ide (NA)-naive, and 74 patients had prior NA therapy (NA-exp group), and 31 patients in the NA-exp group had lamivudine (LAM)-resistance (LAM-R group). The baseline serum hepatitis B virus (HBV) DNA level was 4.9+/-2.3 log IU/mL (mean+/-SD), and was higher in the NA-naive group than in the NA-exp and LAM-R groups (5.9+/-2.0 log IU/mL vs 3.9+/-2.0 log IU/mL vs 4.2+/-1.7 log IU/mL, P<0.01). The complete virological response (CVR) rate at week 48 in the NA-naive group (71.4%) did not differ significantly from those in the NA-exp (71.3%) and LAM-R (66.1%) groups. In multivariate analysis, baseline serum HBV DNA was the only predictive factor for a CVR at week 48 (hazard ratio, 0.809; 95% confidence interval, 0.729-0.898), while the CVR rate did not differ with the NA experience.
CONCLUSIONS
TDF monotherapy was effective for CHB treatment irrespective of prior NA treatment or LAM resistance. Baseline serum HBV DNA was the independent predictive factor for a CVR.

Keyword

Chronic Hepatitis B; Tenofovir; Nucleos(t)ide analogue-experienced; Lamivudine-resistant

MeSH Terms

Adult
Aged
Aged, 80 and over
Antiviral Agents/*therapeutic use
DNA, Viral/blood
Drug Resistance, Viral
Female
Hepatitis B e Antigens/blood
Hepatitis B virus/genetics
Hepatitis B, Chronic/complications/*drug therapy
Humans
Lamivudine/therapeutic use
Liver Cirrhosis/etiology
Male
Middle Aged
Nucleotides/*chemistry/therapeutic use
Retrospective Studies
Tenofovir/*therapeutic use
Treatment Outcome
Antiviral Agents
DNA, Viral
Hepatitis B e Antigens
Lamivudine
Nucleotides
Tenofovir