ABSTRACT
Actualmente hay pocos datos sobre los resultados obtenidos con tenofovir y entecavir en la práctica clínica. Objetivo: Valorar la respuesta viral y la seguridad de tenofovir y entecavir en un periodo de 5 años. Material y métodos: Estudio observacional en donde se incluyó a todos los pacientes con hepatitis crónica por virus B que iniciaron tratamiento con tenofovir o entecavir desde enero de 2008 hasta diciembre de 2012. Resultados: De un total de 70 pacientes: 42 (60%) en tratamiento con entecavir y 28 (40%) con tenofovir. Un 75,7% eran hombres, con una edad media de 53 (DE 14) años. Un 70% eran caucásicos. Se realizó biopsia hepática en 46 pacientes (F0 8,7%; F1 6,5%; F2 26,1%; F3 43,5% y F4 15,2%). El 51,4% eran naïve. Del grupo de pacientes previamente tratados, un 17,6% había recibido interferón; un 26,4% interferón inicialmente y luego análogos; y un 55,8% otros análogos de los nucleósidos o de los nucleótidos. El tiempo de seguimiento fue de 36 (DE 12) meses. El DNA del VHB inicial medio era de 31.570.006 UI/mL (rango 24-1.100.000.000 UI/mL).Todos ellos, excepto 3, presentaron un DNA indetectable al año del tratamiento. De los 10 con HBeAg+, 2 de ellos presentaron seroconversión. Los valores de creatinina y la estimación del filtrado glomerular (EFG) fueron de 0,9 (DE 0,3) mg/dL y de 93,92 ml/min/1,73 m² (DE 21,92) al inicio y creatinina 0,93 (DE 0,27) mg/dL y EFG 91,7392 ml/min/1,73 m² (DE 21,38) al año de seguimiento. Conclusiones: Entecavir y tenofovir son eficaces y seguros en la práctica clínica en pacientes con hepatitis crónica por virus B.
The current first line treatment for chronic hepatitis B virus is with entecavir andtenofovir. However, there are few data regarding the results obtained from these treatmentsin clinical practice. Objective: To assess viral response and safety of treatment with entecavir and tenofovir in a5-year follow-up. Material and methods: Observational study on patients with chronic hepatitis B virus who begantreatment with tenofovir or entecavir between January 2008 and December 2012. Results: Seventy patients were included; 42 (60%) were treated with entecavir and 28 (40%)with tenofovir. Of these, 75.7% were men, with an average age of 53 (SD ± 14) years, and mostwere white (70%). A liver biopsy was performed on 46 patients (F0 8.7%; F1 6.5%; F2 26.1%;F3 43.5% and F4 15.2%). Of all the patients, 51.4% were treatment naïve, and of the groupof previously treated patients, 17.6% had received interferon; 26.4% had received interferonfollowed by one or more analogues; and 55.8% had received other nucleoside or nucleotideanalogues.The time of follow-up was 36 (SD ± 12) months. The average initial DNA was 31,570,006UI/mL (range 24-1,100,000,000 UI/mL). All except 3 presented undetectable DNA after oneyear of treatment. Ten patients were HBeAg-positive at the beginning of the treatment and 2seroconverted. At the beginning of the treatment, creatinine was 0.9 (SD ± 0.3) mg/dL and theestimated glomerular filtration rate (eGFR) was 93.92 ml/min/1.73 m²(DE 21.92); both keepingstable after a year of treatment (creatinine levels 0.93 SD ± 0.27 mg/dL, eGFR 91.7392 SD± 21.38 ml/min/1.73 m²). Conclusions: Entecavir and tenofovir are safe and effective in clinical practice for the treatmentof chronic hepatitis B virus, both in treatment-naïve patients and in those previously treated.
Subject(s)
Humans , Antiviral Agents/therapeutic use , Tenofovir , Hepatitis B , Hepatitis, ChronicABSTRACT
BACKGROUND: The treatment goal for patients with chronic hepatitis B infection is to prevent progression of the disease to cirrhosis and hepatocellular carcinoma. Current therapies include standard and pegylated interferon-alfa and nucleoside/nucleotide analogues: lamivudine, adefovir, entecavir, telbivudine, clevudine, and tenofovir. This study aims to analyze changes in the prescribing patterns of chronic hepatitis B (CHB) medications in South Korea between 2013 and 2014. METHODS: A cross-sectional study was conducted using National Patients Sample data compiled by the Health Insurance Review and Assessment Service from 2013 and 2014. Patients with CHB were identified with Korean Standard Classification of Diseases code-6 (B18.0 and B18.1) and those who were maintaining active prescriptions with CHB medications covering the index date (December 1(st), each year) were included. The utilization of antiviral therapy was investigated during 2013 and 2014. RESULTS: A total of 4,204 and 4,552 patients in 2013 and 2014 respectively, were included in the analysis. The proportion of male patients was two of third and the patients 41-60 years old accounted for 60% of all analyzed patients. The most utilized drug was entecavir (55.1% in 2013 and 44.8% in 2014) and the second most utilized drug was tenofovir in both years (18.8% in 2013 and 29.0% in 2014). The percentage of combination therapy was 13.6% and 13.1% in 2013 and 2014, respectively. The proportion of tenofovir prescriptions was increased in 2014 compared with 2013. CONCLUSION: With the development of new drugs and the changes in clinical practice guidelines, the prescription pattern of the antiviral agents for patients with CHB has changed. The rate of utilization of tenofovir has increased.
Subject(s)
Humans , Male , Antiviral Agents , Carcinoma, Hepatocellular , Classification , Cross-Sectional Studies , Drug Utilization , Fibrosis , Hepatitis B, Chronic , Hepatitis, Chronic , Insurance, Health , Korea , Lamivudine , Prescriptions , TenofovirABSTRACT
Transient elastography (TE) has been used as a non-invasive method for liver stiffness measurement (LSM) in patients with chronic liver disease. This study was performed to assess the change of LSM by TE and to assess its clinical usefulness during long-term oral antiviral therapy in patients with chronic hepatitis B (CHB). We retrospectively reviewed 83 CHB patients. The mean interval between two LSM was 411.5 +/- 149.5 days. Initial and follow-up LSM was 16.15 +/- 12.41 kPa and 11.26 +/- 7.36 kPa, respectively (P or = 14.1 kPa (cirrhosis) at 1st LSM, 12 (40%) proved to no longer have cirrhosis (> or = 1 decrease in fibrosis stage) at 2nd LSM. LSM significantly decreased in both baseline high (> upper limit of normal [ULN] x 2) and low (< or = ULN x 2) alanine aminotransferase groups during antiviral therapy (P < 0.001; P = 0.001, respectively). Long-term oral antiviral therapy resulted in the improvement of liver stiffness in a substantial portion of patients with CHB. TE may be used a useful clinical tool to assess disease progression in CHB patients.