Vosevi

Sofosbuvir 400 mg, velpatasvir 100 mg, voxilaprevir 100 mg

Chronic HCV infection in adults.

Adult 1 tab once daily. Treatment duration for all HCV genotypes: Direct-acting antiviral agent (DAA)-naïve patient w/o cirrhosis 8 wk. DAA-naïve patient w/ compensated cirrhosis 12 wk; 8 wk may be considered in genotype 3 infected patients. DAA-experienced patient w/o cirrhosis or w/ compensated cirrhosis 12 wk.

Should be taken with food: Swallow whole, do not chew/crush.

Hypersensitivity. Concomitant use w/ strong P-gp &/or strong CYP450 inducers (eg, carbamazepine, phenobarb, phenytoin, rifampicin, rifabutin & St. John's wort); rosuvastatin or dabigatran etexilate; ethinylestradiol-containing medicinal products eg, combined OCs or contraceptive vag rings.

Severe bradycardia & heart block during use of sofosbuvir-containing regimens w/ amiodarone w/ or w/o other medicinal products that lower heart rate. HBV reactivation during or after treatment w/ DAAs; risk of HBV reactivation in HCV/HBV co-infected patients. Perform HBV screening in all patients before treatment initiation. Not recommended w/ moderate P-gp &/or moderate CYP inducers (eg, efavirenz, modafinil, oxcarbazepine or rifapentine); strong OATP1B inhibitors (eg, ciclosporin). Monitor for tenofovir-associated adverse reactions in patients receiving Vosevi w/ elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or w/ tenofovir disoproxil fumarate & a boosted HIV PI. Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV DAA treatment; closely monitor glucose levels, particularly w/in the 1st 3 mth. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take Vosevi. Patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m²) & ESRD requiring haemodialysis; liver transplant patients. Not recommended in patients w/ moderate or severe hepatic impairment (CPT Class B or C). Not recommended during pregnancy. Should not be used during breast-feeding. Childn & adolescent <18 yr.

Headache; diarrhoea, nausea. Abdominal pain, decreased appetite, vomiting; rash; myalgia; increased total bilirubin.

Increased exposure of medicinal products that are substrates of P-gp (eg, dabigatran etexilate) &/or BCRP, OATP1B1 & OATP1B3 (eg, rosuvastatin). 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 or rifapentine). Increased sofosbuvir, velpatasvir or voxilaprevir plasma conc w/ P-gp or BCRP inhibitors. Increased velpatasvir or voxilaprevir plasma conc w/ OATP1B, CYP2B6, CYP2C8, or CYP3A4 inhibitors. Close INR monitoring when treated w/ vit K antagonists. Altered pharmacokinetics of drugs metabolized by the liver [eg, immunosuppressive agents (eg, calcineurin inhibitors)]. Increased risk of ALT elevations w/ ethinylestradiol-containing medicinal products. Decreased velpatasvir conc w/ acid reducing agents including antacids (Al or Mg hydroxide, Ca carbonate), H₂-receptor antagonists (famotidine, cimetidine, nizatidine, ranitidine), proton pump inhibitors (omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole). Risk of symptoms of bradycardia & heart block w/ amiodarone. Increased conc of digoxin. Potential increased conc of HMG-CoA reductase inhibitors.

Antivirals

J05AP56 - sofosbuvir, velpatasvir and voxilaprevir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.

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