Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide-naïve chronic hepatitis B patients in Korea: data from the clinical practice setting in a singlecenter cohort
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Background/Aims: This study assessed the antiviral efficacy and safety of tenofovir disoproxil fumarate (TDF) for up to12 months in Korean treatment-naïve chronic hepatitis B (CHB) patients. Methods: A total of 411 treatment-naïve CHB patients who had been treated with TDF for at least 3 months (median5.6) were consecutively enrolled. Clinical, biochemical, virological parameters and treatment adherence were routinelyassessed 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 hadliver 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 alanineaminotransferase (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. Therewas no virological breakthrough after initiating TDF. The most common TDF-related adverse event was gastrointestinalupset, 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 Koreantreatment-naïve CHB patients.
Abstract
Background/Aims: This study assessed the antiviral efficacy and safety of tenofovir disoproxil fumarate (TDF) for up to12 months in Korean treatment-naïve chronic hepatitis B (CHB) patients. Methods: A total of 411 treatment-naïve CHB patients who had been treated with TDF for at least 3 months (median5.6) were consecutively enrolled. Clinical, biochemical, virological parameters and treatment adherence were routinelyassessed 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 hadliver 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 alanineaminotransferase (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. Therewas no virological breakthrough after initiating TDF. The most common TDF-related adverse event was gastrointestinalupset, 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 Koreantreatment-naïve CHB patients.
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