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Vosevi Generic Name & Formulations
Legal Class
Rx
General Description
Sofosbuvir, velpatasvir, voxilaprevir 400mg/100mg/100mg; tabs.
Pharmacological Class
HCV NS5B polymerase inhibitor + HCV NS5A inhibitor + HCV NS3/4A protease inhibitor.
How Supplied
Tabs—28
Manufacturer
Generic Availability
NO
Vosevi Indications
Indications
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
Adult
Test for HBV infection prior to initiation. Take with food. 1 tab once daily for 12 weeks.
Children
Not established.
Vosevi Contraindications
Contraindications
Concomitant rifampin.
Vosevi Boxed Warnings
Not Applicable
Vosevi Warnings/Precautions
Warnings/Precautions
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.
Vosevi Pharmacokinetics
See Literature
Vosevi Interactions
Interactions
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
Adverse Reactions
Headache, fatigue, diarrhea, nausea, asthenia, insomnia, rash, depression, lab abnormalities.
Vosevi Clinical Trials
See Literature
Vosevi Note
Not Applicable
Vosevi Patient Counseling
See Literature
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