Twenty-four treatment-naïve and 19 lamivudine-experienced HBeAg-positive pediatric subjects 2 to less than 18 years of age with compensated CHB and elevated ALT were treated with Entecavir 0.015 mg/kg (up to 0.5 mg) or 0.03 mg/kg (up to 1 mg) once daily. Entecavir is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. These protocol-specified subject management guidelines are not intended as guidance for clinical practice.Among nucleoside-inhibitor-naïve, HBeAg-positive subjects (Study AI463022), 243 (69%) Entecavir-treated subjects and 164 (46%) lamivudine-treated subjects continued blinded treatment for up to 96 weeks. 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. For all patients taking this medicine (entecavir tablets): At study entry, the mean HBV DNA was 8.1 log Entecavir tablets, USP are available in the following strengths and configurations of plastic bottles with child-resistant closures:See FDA-approved patient labeling (Patient Information).Inform patients that discontinuation of anti-hepatitis B therapy, including Entecavir, may result in severe acute exacerbations of hepatitis B. The observed drug accumulation index is approximately 2-fold with once-daily dosing, suggesting an effective accumulation half-life of approximately 24 hours.Entecavir is predominantly eliminated by the kidney with urinary recovery of unchanged drug at steady state ranging from 62% to 73% of the administered dose. Allopurinol reduces the production of uric acid (a compound produced by the body associated with gout and kidney stones), by inhibiting an enzyme called xanthine oxidase. Its molecular formula is C12H15N5O3H2O, which corresponds to a molecular weight of 295.3. Select one or more newsletters to continue. If Entecavir is discontinued without regard to treatment response, the rate of post-treatment flares could be higher.
b Studies …
One percent of Entecavir-treated subjects in these four studies compared with 4% of lamivudine-treated subjects discontinued for adverse events or abnormal laboratory test results.Clinical adverse reactions of moderate-severe intensity and considered at least possibly related to treatment occurring during therapy in four clinical studies in which Entecavir was compared with lamivudine are presented in Table 3.Frequencies of selected treatment-emergent laboratory abnormalities reported during therapy in four clinical trials of Entecavir compared with lamivudine are listed in Table 4.Among Entecavir-treated subjects in these studies, on-treatment ALT elevations greater than 10 times the upper limit of normal (ULN) and greater than 2 times baseline generally resolved with continued treatment.
Lamivudine-resistant strains harboring rtL180M plus rtM204V in combination with the amino acid substitution rtA181C conferred 16- to 122-fold reductions in Entecavir phenotypic susceptibility.HBeAg-positive (n=243) and -negative (n=39) treatment-naïve subjects who failed to achieve the study-defined complete response by 96 weeks were offered continued Entecavir treatment in a rollover study.