Clin Mol Hepatol.  2017 Jun;23(2):154-159. 10.3350/cmh.2016.0067.

Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naïve patients with chronic hepatitis B

• Seo HY
• Lee HA
• Ko SY
• Wang JH
• Kim JH
• Choe WH
• Kwon SY

• KMID: 2413119
• DOI: http://doi.org/10.3350/cmh.2016.0067

Abstract

BACKGROUND/AIMS
Little is known about the effect of early flares on response during first-line tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB). The aim of this study was to investigate the incidence and outcome of early alanine aminotransferase (ALT) flare in treatment-naive patients with CHB during long-term TDF monotherapy.
METHODS
One hundred eighty-one treatment-naive CHB patients were treated with a 300-mg once-daily dose of TDF for more than 12 weeks. Virological markers of hepatitis B virus (HBV) and biochemical data were measured at baseline and every 4-12 weeks during the therapy. The proportion of patients with undetectable HBV DNA level (< 100 copies/mL) was noted.
RESULTS
The median age was 48.3 years and 122 patients (67.4%) were men. Hepatitis B envelope antigen (HBeAg) was positive in 101 patients (55.8%). No patient had cirrhosis. The median follow-up duration was 45 weeks (12-155 weeks). ALT flare (>5 × upper limit of the normal range) occurred in seven patients (3%) without viral breakthrough within the first 8 weeks after the start of TDF monotherapy. Among them, six patients were HBeAg-positive and one patient was HBeAg-negative. All cases of early ALT flares resolved within 4 weeks and virologic response was observed in all patients without interruption or discontinuation of treatment.
CONCLUSIONS
Continuous TDF monotherapy was effective and safe in treatment-naive patients with CHB who experienced early ALT flares followed by a decrease in HBV DNA level.

Keyword

Tenofovir; Chronic hepatitis B

MeSH Terms

Adult
Aged
Alanine Transaminase/*blood
Antiviral Agents/*therapeutic use
DNA, Viral/blood/genetics/metabolism
Drug Administration Schedule
Female
Hepatitis B e Antigens/blood
Hepatitis B virus/genetics/isolation & purification
Hepatitis B, Chronic/blood/*drug therapy/virology
Humans
Male
Middle Aged
Real-Time Polymerase Chain Reaction
Tenofovir/*therapeutic use
Treatment Outcome
Young Adult
Antiviral Agents
DNA, Viral
Hepatitis B e Antigens
Tenofovir
Alanine Transaminase