Clin Mol Hepatol.  2014 Sep;20(3):261-266. 10.3350/cmh.2014.20.3.261.

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

• Ahn SS
• Chon YE
• Kim BK
• Kim SU
• Kim DY
• Ahn SH
• Han KH
• Park JY

• KMID: 2069762
• DOI: http://doi.org/10.3350/cmh.2014.20.3.261

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.

Keyword

Chronic hepatitis B; Tenofovir; Korean; Real-life

MeSH Terms

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
Adenine
Alanine Transaminase
Antiviral Agents
DNA, Viral
Hepatitis B e Antigens
Organophosphonates