Vosevi Generic Name & Formulations
Sofosbuvir, velpatasvir, voxilaprevir 400mg/100mg/100mg; tabs.
HCV NS5B polymerase inhibitor + HCV NS5A inhibitor + HCV NS3/4A protease inhibitor.
Chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have genotype 1, 2, 3, 4, 5, or 6 and were previously treated with an NS5A inhibitor-containing regimen or have genotype 1a or 3 and were previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.
Vosevi Dosage and Administration
Test for HBV infection prior to initiation. Take with food. 1 tab once daily for 12 weeks.
Vosevi Boxed Warnings
Risk of HBV reactivation in patients coinfected with HCV/HBV. Test all patients for HBV infection by measuring HBsAg and anti-HBc; if positive serologic evidence, monitor for hepatitis flare or HBV reactivation during and at post-treatment follow-up; treat if clinically indicated. Increased risk of symptomatic bradycardia when concomitant amiodarone esp. patients also taking beta-blockers or with cardiac comorbidities and/or advanced liver disease. Discontinue if evidence of hepatic decompensation/failure develops. Moderate or severe hepatic impairment, history of prior hepatic decompensation: not recommended. Pregnancy. Nursing mothers.
Concomitant amiodarone: not recommended; if no alternatives, monitor cardiac function (see full labeling). Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. May potentiate P-gp, BCRP, OATP1B1, OATP1B3, or OATP2B1 substrates. Concomitant BCRP substrates (eg, methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan): not recommended. Concomitant P-gp and/or moderate to potent CYP2B6, CYP2C8, CYP3A4 inducers (eg, St. John’s wort, carbamazepine), anticonvulsants (eg, phenytoin, phenobarbital, oxcarbazepine), rifabutin, rifapentine, tipranavir/ritonavir, atazanavir-, lopinavir-, or efavirenz-containing regimens, OATP inhibitors (eg, cyclosporine): not recommended. Separate dosing of antacids by 4hrs. May give H2-antagonists simultaneously or staggered from Vosevi (at a dose that does not exceed doses comparable with famotidine 40mg twice daily). May coadminister with omeprazole 20mg. May potentiate digoxin, dabigatran etexilate; monitor. Concomitant tenofovir DF regimens; monitor. May potentiate pravastatin (do not exceed 40mg dose), pitavastatin (not recommended), atorvastatin, fluvastatin, lovastatin, simvastatin; use lowest approved dose. Monitor INR with warfarin.
Vosevi Adverse Reactions
Headache, fatigue, diarrhea, nausea, asthenia, insomnia, rash, depression, lab abnormalities.
Vosevi Clinical Trials
Vosevi Patient Counseling