Epclusa

Sofosbuvir 400 mg, velpatasvir 100 mg

Chronic HCV infection in patients ≥12 yr & weighing at least 30 kg.

1 tab once daily. Adult w/o cirrhosis & adult w/ compensated cirrhosis Epclusa for 12 wk. Addition of ribavirin may be considered for genotype 3-infected patients w/ compensated cirrhosis. Adult w/ decompensated cirrhosis Epclusa + ribavirin for 12 wk. Adult who have previously failed therapy w/ an NS5A-containing regimen Epclusa + ribavirin for 24 wk may be considered. Paed patient 12 to <18 yr & weighing at least 30 kg Epclusa for 12 wk. Elderly No dose adjustment. Renal impairment No dose adjustment required for patients w/ mild or moderate renal impairment. Epclusa can be used w/ no dose adjustment in patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m²) & ESRD requiring haemodialysis when no other relevant treatment options are available. Hepatic impairment No dose adjustment required for patients w/ mild, moderate, or severe hepatic impairment (CPT Class A, B, or C).

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

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

Risk of severe bradycardia & heart block when sofosbuvir-containing regimens are used in combination w/ amiodarone. Risk of HBV reactivation in HBV/HCV co-infected patients. Perform HBV screening in all patients before treatment initiation. Do not administer w/ other sofosbuvir-containing medicinal products. Not recommended w/ moderate P-gp &/or moderate 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 tenofovir disoproxil fumarate & a boosted HIV PI. Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after treatment initiation. 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. Should not be used during breast-feeding. Safety & efficacy have not been established in childn <12 yr or weighing <30 kg.

Rash.

Increased exposure of P-gp (eg, digoxin, dabigatran etexilate), BCRP (eg, rosuvastatin), OATP1B1 & OATP1B3 substrates. Decreased plasma conc w/ strong P-gp &/or strong CYP2B6, CYP2C8, or CYP3A4 inducers (eg, carbamazepine, phenobarb, phenytoin, rifampicin, rifabutin, St. John's wort); moderate P-gp &/or moderate CYP inducers (eg, efavirenz, modafinil, oxcarbazepine, rifapentine). Close monitoring of INR is recommended in patients treated w/ vit K antagonists. Altered pharmacokinetics of drugs metabolized by the liver eg, immunosuppressive agents (eg, ciclosporin & tacrolimus). Decreased velpatasvir conc w/ acid-reducing agents including antacids (Al or Mg hydroxide, Ca carbonate), H₂-receptor antagonists (famotidine, cimetidine, nizatidine, ranitidine), PPIs (omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole). Co-administration of amiodarone w/ a sofosbuvir-containing regimen may result in serious symptomatic bradycardia. Increased exposure of tenofovir disoproxil fumarate. Decreased velpatasvir conc w/ efavirenz/emtricitabine/tenofovir disoproxil fumarate. Potential increased conc of statins other than atorvastatin & pravastatin.

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.

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