ArticleInternational journal of clinical pharmacy2015
Efficacy and safety of tenofovir in nucleos(t)ide-naïve patients with genotype C chronic hepatitis B in real-life practice.
Article in International journal of clinical pharmacy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 9 citations in OpenAlex.
- Availability, price, and affordability of anti-hepatitis B virus drugs: a cross-sectional study in China.International journal of clinical pharmacy · 2024Article
- Efficacy of tenofovir disoproxil fumarate switch therapy in chronic hepatitis B patients with suboptimal response to adefovir-based combination therapy.Experimental and therapeutic medicine · 2019Article
- Chronic hepatitis B genotype E in African migrants: response to nucleos(t)ide treatment in real clinical practice.BMC infectious diseases · 2018Observational
- Antiviral Efficacy of Tenofovir Monotherapy in Children with Nucleos(t)ide-naive Chronic Hepatitis B.Journal of Korean medical science · 2018Article
- Adverse effects of oral antiviral therapy in chronic hepatitis B.World journal of hepatology · 2017Review
- Treatment Efficacy and Safety of Tenofovir-Based Therapy in Chronic Hepatitis B: A Real Life Cohort Study in Korea.PloS one · 2017Article
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTenofovir disoproxil fumarate (TDF) has demonstrated potent antiviral activity against hepatitis B virus (HBV) in clinical trials. Although its efficacy has been demonstrated in Caucasian populations, TDF has not previously been studied in Korean patients who present the predominance of HBV genotype C and of vertical or perinatal transmission.
objectiveThe aim of this study was to evaluate the efficacy of TDF in Korean chronic hepatitis B (CHB) patients in real-life practice, and to determine the clinical variables that contribute to virologic response.
settingLarge academic medical center in Korea.
methodWe retrospectively investigated the efficacy of TDF treatment for more than 6 months in 151 nucleos(t)ide-naïve CHB patients.
main outcome measureThe primary endpoint was a virologic response (VR), defined as an HBV DNA level of <12 IU/mL. Secondary endpoints were rates of alanine aminotransaminase (ALT) normalization, hepatitis B e antigen (HBeAg) seroconversion, virologic breakthrough, and safety.
resultsAll patients were the genotype C2. The median duration of TDF treatment was 13 months (range 7-18 months). Ninety-two (61.0 %) patients were HBeAg positive. The mean pre-treatment HBV DNA level was 6.34 ± 1.42 log10 IU/mL. Among the 131 patients with elevated ALT levels at baseline, 128 (97.7 %) patients achieved ALT normalization during TDF treatment. VR was achieved in 97 (64.2 %) patients. The cumulative rates of VR at 6, 9, 12, and 18 months were 47.0, 59.4, 67.9, and 69.3 %, respectively. Among the 92 HBeAg-positive patients, 14 (15.2 %) patients achieved HBeAg seroconversion. In multivariate analysis, absolute HBV DNA levels at baseline (P < 0.001; OR 0.529; 95 % CI 0.560-0.744) and HBeAg positivity (P = 0.015; OR 0.731; 95 % CI 0.615-0.869) were significantly associated with VR. Virologic breakthrough was observed in four patients. These four patients had poor adherence to TDF. Most of the adverse events were mild in severity. No significant changes were observed in serum creatinine and phosphorus levels.
conclusionsTDF was effective and well tolerated in Korean genotype C CHB patients in real life practice, consistent with larger registration trials. The absolute HBV DNA levels at baseline and HBeAg positivity were significantly associated with VR.
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