Contents

Search

sofosbuvir/velpatasvir (Epclusa)

Indications: - FDA-approved for treatment of all 6 geneotypes of hepatitis C * for use in combination with ribavirin * for patients both with & without cirrhosis * FDA approved for use in children >= 6 years & 37 lbs mild or no cirrhosis Dosage: - 1 tablet PO QD for 12 weeks [5] - in combination with riboviran (Child-Pugh B & C) Tablets: 400 mg sofosbuvir + 100 mg velpatasvir Adverse effects: - most common: headache, fatigue - symptomatic bradycardia - reactivation of hepatitis B in patients with current or previous hepatitis B infection [2] - 24% of patients with chronic hepatitis B [3] - 1.4% with resolved hepatitis B infection [3] Drug interactions: - use of sofosbuvir in combination with amiodarone may result in symptomatic bradycardia requiring pacemaker

Interactions

drug interactions

General

antiviral combination

References

  1. FDA News Release. June 28, 2016 FDA approves Epclusa for treatment of chronic Hepatitis C virus infection. First regimen to treat all six major HCV genotypes. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm508915.htm
  2. FDA Drug Safety Communication: Oct 4, 2016 FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. http://www.fda.gov/Drugs/DrugSafety/ucm522932.htm
  3. Mucke MM, Backus LI, Mucke VT et al Hepatitis B virus reactivation during direct-acting antiviral therapy for hepatitis C: a systematic review and meta-analysis. Lancet Gastroenterology & Hepatology. Jan 19, 2018 PMID: 29371017 http://www.thelancet.com/journals/langas/article/PIIS2468-1253(18)30002-5/fulltext
  4. FDA Press Release. March 19, 20202 FDA Approves New Treatment for Pediatric Patients with Any Strain of Hepatitis C. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pediatric-patients-any-strain-hepatitis-c
  5. HIGHLIGHTS OF PRESCRIBING INFORMATION EPCLUSA.EPCLUSA (sofosbuvir and velpatasvir) tablets https://www.gilead.com/-/media/files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf

Components

sofosbuvir (Sovaldi) velpatasvir