Therapy with Entecavir is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) a of Moderate-Severe Intensity (Grades 2 to 4) Reported in Four Entecavir Clinical Trials Through 2 Yearsa Laboratory Abnormalities Reported in Four Entecavir Clinical Trials Through 2 YearsExacerbations of Hepatitis After Discontinuation of TreatmentTable 6: Principal Analyses of Time to Adjudicated Events - Randomized Treated SubjectsAdverse Reactions from Postmarketing Spontaneous ReportsTable 7: Pharmacokinetic Parameters in Pediatric SubjectsNucleoside-inhibitor-naïve Subjects with Compensated Liver DiseaseHBeAg-negative (anti-HBe-positive/HBV DNA-positive)Table 9: Histologic Improvement and Change in Ishak Fibrosis Score at Week 48, Nucleoside-Inhibitor-Naïve Subjects in Studies AI463022 and AI463027Table 10: Selected Virologic, Biochemical, and Serologic Endpoints at Week 48, Nucleoside-Inhibitor-Naïve Subjects in Studies AI463022 and AI463027Lamivudine-refractory Subjects with Compensated Liver DiseaseTable 11: Histologic Improvement and Change in Ishak Fibrosis Score at Week 48, Lamivudine-Refractory Subjects in Study AI463026Table 12: Selected Virologic, Biochemical, and Serologic Endpoints at Week 48, Lamivudine-Refractory Subjects in Study AI463026Table 13: Selected Endpoints at Week 48, Subjects with Decompensated Liver Disease, Study AI463048Table 14: Virologic and Biochemical Endpoints at Week 24, Study AI463038Severe Acute Exacerbation of Hepatitis after Discontinuation of TreatmentRisk of Development of HIV-1 Resistance in Patients with HIV-1 CoinfectionWhat is the most important information I should know about Entecavir Tablets?1. Entecavir (ETV), sold under the brand name Baraclude, is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection.
By competing with the natural substrate deoxyguanosine triphosphate, Entecavir triphosphate functionally inhibits all three activities of the HBV reverse transcriptase: (1) base priming, (2) reverse transcription of the negative strand from the pregenomic messenger RNA, and (3) synthesis of the positive strand of HBV DNA. Obesity and prolonged nucleoside inhibitor exposure may be risk factors. A majority of these exacerbations were associated with a ≥2 log An exacerbation of hepatitis or ALT flare was defined as ALT greater than 10 times ULN and greater than 2 times the subject’s reference level (minimum of the baseline or last measurement at end of dosing). Your doctor will order certain tests to check your body's response to entecavir during this time. The data also showed that long-term Entecavir use was not associated with a lower occurrence of HBV disease progression or a lower rate of death overall compared to other HBV disease progression or a lower rate of death overall compared to other HBV nucleos(t)ides.
This study was aimed to compare the long-term efficacy between them in treatment-naïve chronic hepatitis B (CHB). All patients underwent liver biopsy before treatment commencement because this is required by the state insurance body to start antiviral treatment in CHB or CHD. Entecavir is taken by mouth as a tablet or solution. Complete response for HBeAg-positive was <0.7 MEq/mL (approximately 7 x 10 Lamivudine-refractory subjects (n=157) who failed to achieve the study-defined complete response by Week 96 were offered continued Entecavir treatment. Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.Entecavir tablets should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).The recommended dose of Entecavir tablets for chronic hepatitis B virus infection in nucleoside-inhibitor-treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily.The recommended dose of Entecavir tablets in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.The recommended dose of Entecavir tablets for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.Table 1 describes the recommended dose of Entecavir tablets for pediatric patients 2 years of age or older and weighing at least 10 kg. Patients with decompensated liver disease may be at higher risk for lactic acidosis. However, you should not flush this medication down the toilet. Abbreviations: ALT, alanine aminotransferase; HDV, hepatitis D virus; RNA, ribonucleic acid.Alanine aminotransferase levels in the 3 patients who cleared hepatitis D virus RNA at the end of entecavir treatment.
In the U.S. general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15 to 20%.In animal reproduction studies, no adverse developmental effects were observed with Entecavir at clinically relevant exposures. Common side effects include headache, nausea, high blood sugar, and decreased kidney function.