Epclusa

Chronic HCV infection in adults.

1 tab once daily. Patient w/o cirrhosis & patient w/ compensated cirrhosis Sofosbuvir/velpatasvir for 12 wk. Addition of ribavirin may be considered for genotype 3 infected patients w/ compensated cirrhosis. Patient w/ decompensated cirrhosis Sofosbuvir/velpatasvir + ribavirin for 12 wk. Patient who has previously failed therapy w/ NS5A-containing regimen Sofosbuvir/velpatasvir + ribavirin for 24 wk may be considered.

May be taken with or without food: Swallow whole, do not chew/crush.

Hypersensitivity. Co-administration w/ strong P-gp &/or CYP450 inducers eg, carbamazepine, phenobarb, phenytoin, rifampicin, rifabutin, St. John's wort.

Cases of severe bradycardia & heart block in combination w/ amiodarone w/ or w/o other medicinal products that lower heart rate. No clinical data to support efficacy in patients who have failed treatment w/ another NS5A inhibitor. Perform HBV screening in all patients prior to treatment initiation, & monitor & manage HBV/HCV co-infected patients at risk of HBV reactivation. Closely monitor glucose levels of diabetic patients, particularly w/in the 1st 3 mth, & modify their diabetic medication when necessary. Not to be concurrently administered w/ other sofosbuvir-containing medicinal products. Not recommended in co-administration w/ moderate P-gp &/or CYP inducers eg, efavirenz, modafinil, oxcarbazepine or rifapentine. Monitor for tenofovir-associated adverse reactions in patients receiving concomitant elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or w/ tenofovir disoproxil fumarate & boosted HIV PI. Safety data are limited in patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m²) & ESRD requiring haemodialysis. Safety & efficacy have not been assessed in patients w/ CPT class C cirrhosis & in post-liver transplant patients. Not recommended during pregnancy. Not to be used during breast-feeding. Safety & efficacy have not been established in childn & adolescents <18 yr.

Headache, fatigue & nausea. Rash.

Increased exposure of medicinal products that are substrates of P-gp, BCRP, OATP1B1 & OATP1B3 drug transporters. Decreased plasma conc w/ strong inducers of P-gp &/or CYP2B6, CYP2C8, or CYP3A4 eg, carbamazepine, phenobarb, phenytoin, rifampicin, rifabutin & St. John's wort; moderate P-gp &/or CYP inducers eg, efavirenz, modafinil, oxcarbazepine or rifapentine. Increased plasma conc w/ inhibitors of P-gp or BCRP. Close monitoring of INR is recommended in patients treated w/ vit K antagonists. Pharmacokinetics of drugs metabolized by the liver [eg, immunosuppressive agents (eg, calcineurin inhibitors)] may be impacted by changes in liver function during therapy. Increased exposure of dabigatran; tenofovir disoproxil fumarate. Velpatasvir: Increased plasma conc w/ inhibitors of OATP, CYP2B6, CYP2C8, or CYP3A4. Decreased conc w/ acid-reducing agents eg, antacids (eg, Al or Mg hydroxide, Ca carbonate), H₂-receptor antagonists (eg, famotidine, cimetidine, nizatidine, ranitidine), PPIs (eg, omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole); oxcarbazepine; rifapentine; efavirenz/emtricitabine/tenofovir disoproxil fumarate. Increased conc of digoxin; rosuvastatin.

Antivirals

J05AP55 - sofosbuvir and velpatasvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.

Rx