sofosbuvir/velpatasvir (Epclusa)
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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
More general terms
Components
References
- ↑ 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
- ↑ 2.0 2.1 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
- ↑ 3.0 3.1 3.2 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/29371017 <Internet> http://www.thelancet.com/journals/langas/article/PIIS2468-1253(18)30002-5/fulltext
- ↑ 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
- ↑ 5.0 5.1 HIGHLIGHTS OF PRESCRIBING INFORMATION EPCLUSA.EPCLUSA (sofosbuvir and velpatasvir) tablets https://www.gilead.com/-/media/files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf