Here is a helpful tip for these new hepatitis C virus drugs:
KEY POINTS
- Sofosbuvir/ velpatasvir/ voxilaprevir (Vosevi, SOF/VEL/VOX) is the combination of three direct-acting antivirals that work against hepatitis C virus (HCV)
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- Sofosbuvir is a NS5B-inhibitor. It inhibits HCV NS5B RNA-dependent RNA polymerase, which is an enzyme needed for viral replication.
- Velpatasvir is an NS5A-inhibitor. It inhibits HCV replication by blocking NS5A protein.
- Voxilaprevir is a NS3/4A protease inhibitor. It interferes with proteolytic cleavage of HCV.
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- FDA-approved in July 2017 for:
- Re-treatment of patients with chronic HCV infection in adults due to genotype 1 through 6 previously treated with an NS5A-containing regimen
- Patients with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A-inhibitor
- Single tablet taken once daily
- Sofosbuvir 400 mg + velpatasvir 100 mg + voxilaprevir 100 mg
- Duration and regimen selection for HCV treatment will typically include: genotype (and resistance), cirrhosis status, and treatment history
- Common treatment duration is 12 weeks
- Patients should receive proper screening prior to initiating therapy
- Common side effects to beware include: diarrhea, fatigue, headache, and nausea
- FDA Boxed Warning: beware hepatitis B virus reactivition in patients undergoing HCV therapy with direct-acting antivirals
- Beware drug-drug interactions
- P-gp inducers, CYP-2B6 inducers, CYP-2C8 inducers and CYP-3A4 inducers may reduce sofosbuvir/ velpatasvir/ voxilaprevir concentrations
- Contraindicated with rifampin use
- P-gp inducers, CYP-2B6 inducers, CYP-2C8 inducers and CYP-3A4 inducers may reduce sofosbuvir/ velpatasvir/ voxilaprevir concentrations
- Beware serious bradycardia if administered with amiodarone
- While a cost is not available as of yet, it can be expected that this drug will be very expensive
RESOURCES
- Sofosbuvir/ velpatasvir/ voxilaprevir (Vosevi) Package Insert
- FDA Announcement of Vosevi Approval
- Gilead Press Release on Vosevi Approval
- HCV Treatment Guidelines (American Association For The Study Of Liver Diseases)
- Provision Of Clinical Pharmacist Services For Individuals With Chronic Hepatitis C Viral Infection (Pharmacotherapy 2014)
- Sofosbuvir, Velpatasvir and Voxilaprevir combination for the treatment of hepatitis C (2017)
- Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection (2017)