Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide analogue-naive and nucleos(t)ide analogue-experienced chronic hepatitis B patients.
- Author:
Sang Kyung JUNG
1
;
Kyung Ah KIM
;
So Young HA
;
Hyun Kyo LEE
;
Young Doo KIM
;
Bu Hyun LEE
;
Woo Hyun PAIK
;
Jong Wook KIM
;
Won Ki BAE
;
Nam Hoon KIM
;
June Sung LEE
;
Yoon Jung JWA
Author Information
- Publication Type:Original Article
- Keywords: Chronic Hepatitis B; Tenofovir; Nucleos(t)ide analogue-experienced; Lamivudine-resistant
- MeSH: 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
- From:Clinical and Molecular Hepatology 2015;21(1):41-48
- CountryRepublic of Korea
- Language:English
- 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.
