Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide analogue-naïve and nucleos(t)ide analogue-experienced chronic hepatitis B patients
2
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
Background/Aims: This study investigated the antiviral effects of tenofovir disoproxil fumarate (TDF) monotherapy in nucleos(t)ide analogue (NA)-naive and NA-experienced chronic hepatitis B (CHB) patients. Methods: CHB patients treated with TDF monotherapy (300 mg/day) for ≥12 weeks between December 2012 and July 2014 at a single center were retrospectively enrolled. Clinical, biochemical, and virological parameters were assessed every 12 weeks. Results: In total, 136 patients (median age 49 years, 96 males, 94 HBeAg positive, and 51 with liver cirrhosis) were included. Sixty-two patients were nucleos(t)ide (NA)-naïve, and 74 patients had prior NA therapy (NA-exp group), and 31 patients in the NA-exp group had lamivudine (LAM)-resistance (LAM-R group). The baseline serum hepatitis B virus (HBV) DNA level was 4.9±2.3 log IU/mL (mean±SD ), and was higher in the NA-naïve group than in the NA-exp and LAM-R groups (5.9±2.0 log IU/mL vs 3.9±2.0 log IU/mL vs 4.2±1.7 log IU/mL, P<0.01). The complete virological response (CVR) rate at week 48 in the NA-naïve group (71.4%) did not differ significantly from those in the NA-exp (71.3%) and LAM-R (66.1%) groups. In multivariate analysis, baseline serum HBV DNA was the only predictive factor for a CVR at week 48 (hazard ratio, 0.809; 95% confidence interval, 0.729–0.898), while the CVR rate did not differ with the NA experience. Conclusions: TDF monotherapy was effective for CHB treatment irrespective of prior NA treatment or LAM resistance. Baseline serum HBV DNA was the independent predictive factor for a CVR. (Clin Mol Hepatol 2015;21:41-48)
Abstract
Background/Aims: This study investigated the antiviral effects of tenofovir disoproxil fumarate (TDF) monotherapy in nucleos(t)ide analogue (NA)-naive and NA-experienced chronic hepatitis B (CHB) patients. Methods: CHB patients treated with TDF monotherapy (300 mg/day) for ≥12 weeks between December 2012 and July 2014 at a single center were retrospectively enrolled. Clinical, biochemical, and virological parameters were assessed every 12 weeks. Results: In total, 136 patients (median age 49 years, 96 males, 94 HBeAg positive, and 51 with liver cirrhosis) were included. Sixty-two patients were nucleos(t)ide (NA)-naïve, and 74 patients had prior NA therapy (NA-exp group), and 31 patients in the NA-exp group had lamivudine (LAM)-resistance (LAM-R group). The baseline serum hepatitis B virus (HBV) DNA level was 4.9±2.3 log IU/mL (mean±SD ), and was higher in the NA-naïve group than in the NA-exp and LAM-R groups (5.9±2.0 log IU/mL vs 3.9±2.0 log IU/mL vs 4.2±1.7 log IU/mL, P<0.01). The complete virological response (CVR) rate at week 48 in the NA-naïve group (71.4%) did not differ significantly from those in the NA-exp (71.3%) and LAM-R (66.1%) groups. In multivariate analysis, baseline serum HBV DNA was the only predictive factor for a CVR at week 48 (hazard ratio, 0.809; 95% confidence interval, 0.729–0.898), while the CVR rate did not differ with the NA experience. Conclusions: TDF monotherapy was effective for CHB treatment irrespective of prior NA treatment or LAM resistance. Baseline serum HBV DNA was the independent predictive factor for a CVR. (Clin Mol Hepatol 2015;21:41-48)
참고문헌 (21)
- Liaw YF, "Hepatitis B virus infection", Lancet, 373, pp.582~592 (2009)
- Chen CJ, "Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level", JAMA, 295, pp.65~73 (2006)
- Iloeje UH, "Predicting cirrhosis risk based on the level of circulating hepatitis B viral load", Gastroenterology, 130, pp.678~686 (2006)
- Mommeja-Marin H, "Serum HBV DNA as a marker of efficacy during therapy for chronic HBV infection : analysis and review of the literature", Hepatology, 37, pp.1309~1319 (2003)
- Liaw YF, "Impact of therapy on the long-term outcome of chronic hepatitis B", Clin Liver Dis, 17, pp.413~423 (2013)
- Woo G, "Tenofovir and entecavir are the most effective antiviral agents for chronic hepatitis B : a systematic review and Bayesian meta-analyses", Gastroenterology 201, 139, pp.1218~1229 (2010)
- Marcellin P, "Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B", N Engl J Med, 359, pp.2442~2455 (2008)
- Marcellin P, "Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B : a 5-year open-label follow-up study", Lancet, 381, pp.468~475 (2013)
- Kitrinos KM, "No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B", Hepatology, 59, pp.434~442 (2014)
- van Bommel F, "Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside", nucleotide analogues, 2010, pp.51, 73~80
- Patterson SJ, "Tenofovir disoproxil fumarate rescue therapy following failure of both lamivudine and adefovir dipivoxil in chronic hepatitis B", Gut w, 60, pp.247~254 (2011)
- Fung S, "Tenofovir disoproxil fumarate in Asian or Pacific Islander chronic hepatitis B patients with high viral load (>", = 9 log copies, Liver Int, pp.2014[DOI]
- Song BC, "Hepatitis B virus genotypes in Korea : an endemic area of hepatitis B virus infection", Intervirology, 48, pp.133~137 (2005)
- 안성수, "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", Clinical and Molecular Hepatology, 20(3), pp.261~266 (2014), 대한간학회[DOI]
- "EASL Clinical Practice Guidelines: management of hepatitis C virus infection", J Hepatol, 55, pp.245~264 (2011)
- van Bommel F, "Tenofovir for patients with lamivudine-resistant hepatitis B virus(HBV)infection and high HBV DNA level during adefovir therapy", Hepatology, 44, pp.318~325 (2006)
- Berg T, "Tenofovir is effective alone or with emtricitabine in adefovir-treated patients with chronic-hepatitis B virus infection", Gastroenterology, 139, pp.1207~1217 (2010)
- Baran B, "Efficacy of tenofovir in patients with Lamivudine failure is not different from that in nucleoside", nucleotide analogue-naive patients with chronic hepatitis B, 2013, pp.57, 1790~1796
- "EASL clinical practice guidelines: Management of chronic hepatitis B virus infection", J Hepatol, 57, pp.167~185 (2012)
- 최강혁, "약제 내성 만성 B형간염 환자에서 테노포비어를 포함한 구원치료의 효과", 대한소화기학회지, 65(1), pp.35~42 (2015), 대한소화기학회
- 이초이, "Efficacy and Safety of Tenofovir-Based Rescue Therapy for Chronic Hepatitis B Patients with Previous Nucleo(s", t)ide Treatment Failure, 2014, pp.8(1), 64~69[DOI]