Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide-naive chronic hepatitis B patients in Korea: data from the clinical practice setting in a single-center cohort.
10.3350/cmh.2014.20.3.261
- Author:
Sung Soo AHN
1
;
Young Eun CHON
;
Beom Kyung KIM
;
Seung Up KIM
;
Do Young KIM
;
Sang Hoon AHN
;
Kwang Hyub HAN
;
Jun Yong PARK
Author Information
1. Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea. DRPJY@yuhs.ac
- Publication Type:Original Article
- Keywords:
Chronic hepatitis B;
Tenofovir;
Korean;
Real-life
- MeSH:
Adenine/adverse effects/*analogs & derivatives/therapeutic use;
Adult;
Aged;
Aged, 80 and over;
Alanine Transaminase/blood;
Antiviral Agents/adverse effects/*therapeutic use;
Cohort Studies;
DNA, Viral/blood;
Female;
Gastrointestinal Diseases/epidemiology/etiology;
Hepatitis B e Antigens/blood;
Hepatitis B virus/genetics;
Hepatitis B, Chronic/complications/*drug therapy/virology;
Humans;
Liver Cirrhosis/etiology;
Male;
Middle Aged;
Organophosphonates/adverse effects/*therapeutic use;
Republic of Korea;
Retrospective Studies;
Treatment Outcome;
Young Adult
- From:Clinical and Molecular Hepatology
2014;20(3):261-266
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND/AIMS: This study assessed the antiviral efficacy and safety of tenofovir disoproxil fumarate (TDF) for up to 12 months in Korean treatment-naive chronic hepatitis B (CHB) patients. METHODS: A total of 411 treatment-naive CHB patients who had been treated with TDF for at least 3 months (median 5.6) were consecutively enrolled. Clinical, biochemical, virological parameters and treatment adherence were routinely assessed every 3 months. RESULTS: The median age was 51.3 years, 63.0% of the patients were male, 49.6% were HBeAg (+), and 210 patients had liver cirrhosis. The median baseline HBV DNA was 5.98 (SD 1.68) log10 IU/mL. Among the patients completing week 48, 83.3% had a complete virologic response (CVR, <12 IU/mL by HBV PCR assay), and 88.2% had normalized levels of alanine aminotransferase (ALT). The cumulative probabilities of CVR at 3, 6, 9 and 12 months were 22.8%, 53.1%, 69.3% and 85.0%. During the follow-up period, 9.8% patients achieved HBeAg loss and 7.8% patients achieved HBeAg seroconversion. There was no virological breakthrough after initiating TDF. The most common TDF-related adverse event was gastrointestinal upset, and three patients discontinued TDF therapy. However, no serious life-threatening side effect was noted. CONCLUSIONS: In a clinical practice setting, TDF was safe and highly effective when administered for 12 months to Korean treatment-naive CHB patients.
