Initiate appropriate patient management for HBV infection as clinically indicated Ledipasvir and sofosbuvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) Table 1 shows the recommended ledipasvir and sofosbuvir treatment regimen and duration based on patient populationThe recommended dosage of ledipasvir and sofosbuvir in pediatric patients 3 years of age and older with genotype 1, 4, 5, or 6 HCV is based on weight (Table 2). Site-directed mutagenesis of the Y93H in both genotypes 1a and 1b, as well as the Q30E substitution in genotype 1a, conferred high levels of reduced susceptibility to ledipasvir (fold change in ECHCV replicons with reduced susceptibility to sofosbuvir have been selected in cell culture for multiple genotypes including 1b, 4a, 5a, and 6a.
P-gp inducers (e.g., rifampin or St. John's wort) may decrease ledipasvir and sofosbuvir plasma concentrations, leading to reduced therapeutic effect of ledipasvir and sofosbuvir, and the use with P-gp inducers is not recommended with ledipasvir and sofosbuvir Ledipasvir is subject to slow oxidative metabolism via an unknown mechanism. Management: Administer H2 receptor antagonist doses less than or comparable to famotidine 40 mg twice daily simultaneously or 12 hours prior to ledipasvir. Study 1119 enrolled 44 treatment-naïve or previously-treated subjects with genotype 4 HCV, with or without cirrhosis. If quantitative HCV viral load is detectable at treatment week 4, repeat testing is recommended after 2 additional weeks of treatment (treatment week 6) (AASLD/IDSA 2018). Management: If combined, administer the P-gp inhibitor simultaneously with, or after, the dose of afatinib. Hemodialysis is unlikely to result in significant removal of ledipasvir since ledipasvir is highly bound to plasma protein. Etoposide Phosphate: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Etoposide Phosphate. OXcarbazepine: May decrease the serum concentration of Sofosbuvir.OXcarbazepine: May decrease the serum concentration of Ledipasvir.Ozanimod: BCRP/ABCG2 Inhibitors may increase serum concentrations of the active metabolite(s) of Ozanimod.
Management: PPI doses equivalent to omeprazole 20 mg or lower may be given with ledipasvir under fasted conditions. Dose adjustments of concomitant medications may be necessary.Table 6 provides a listing of established or potentially clinically significant drug interactions. h�bbd```b``�"�A$�:���L��H�� ��D�>�z�� 9��f,���"�� ��'�20120��30Ҋ��H[�G�H�g`�; � � Post-baseline NS5A and NS5B deep nucleotide sequence analysis data (assay sensitivity of 1%) were available for 37/37 and 36/37 subjects' viruses, respectively.Of the 29 genotype 1a virologic failure subjects, 55% (16/29) of subjects had virus with emergent NS5A resistance-associated substitutions K24R, M28T/V, Q30R/H/K/L, L31M, or Y93H/N at failure. endstream endobj Advise patients to tell their healthcare provider if they have a history of HBV infection Advise patients to seek medical evaluation immediately for symptoms of bradycardia such as near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pain, confusion, or memory problems Inform patients that ledipasvir and sofosbuvir may interact with other drugs. NS5A resistance-associated substitutions for other NS5A inhibitors have been found to persist for >1 year in some patients. 1 Ledipasvir is an inhibitor of P-gp and breast cancer resistance protein and, in theory, may increase intestinal absorption of coadministered substrates for these transporters; however, no documented drug-drug interactions based on this … The clinical significance of these substitutions is currently unknown. Relapse rates among subjects without baseline NS5A polymorphisms at resistance-associated positions were 5% (8/167) after 8 weeks and 1% (3/306) after 12 weeks of treatment with Ledipasvir and Sofosbuvir Tablets.In treatment-experienced subjects in Study ION-2 whose virus had baseline NS5A polymorphisms at resistance-associated positions, relapse rates were 22% (5/23) after 12 weeks and 0% (0/19) after 24 weeks of treatment with Ledipasvir and Sofosbuvir Tablets (90 mg/400 mg).
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