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ledipasvir/sofosbuvir (Harvoni)

FDA-approved Oct 2014 [2] Indications: - treatment of hepatitis C infection (genotypes 1, 4, 5, or 6), overall 90% effective [3] * approved for patients >= 12 years of age [5] * safe & effective in older adults (> 65 years of age) [3] Dosage: - one tablet (90 mg of ledipasvir + 400 mg of sofosbuvir) PO QD for 12 weeks with or without food [7] - in combination with ribovarin genotypes 4,5,6, genotype 1 (Child-Pugh B or C) - riboviran 800-1200 mg PO BID (see riboviran) [7] Adverse effects: - fatigue - headache [2] - reactivation of hepatitis B in patients with current or previous hepatitis B infection [4] - 24% of patients with chronic hepatitis B [6] - 1.4% with resolved hepatitis B infection [6]

Interactions

drug interactions

General

antiviral combination

References

  1. Lawitz E et al Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. The Lancet, Early Online Publication, 5 November 2013 PMID: 24209977 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62121-2/abstract
  2. FDA News Release. October 10, 2014 FDA approves first combination pill to treat hepatitis C http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm
  3. Saab S et al. Safety and efficacy of ledipasvir/sofosbuvir for the treatment of genotype 1 hepatitis C in subjects aged 65 years or older. Hepatology 2016 Apr; 63:1112 PMID: 26704693
  4. 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
  5. Kelley KJ, Sadoughi S, Sofair A FDA Approves Two Antivirals to Treat HCV in Pediatric Patients. Physician's First Watch, April 10, 2017 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org - FDA News Release. April 7, 2017 FDA approves two hepatitis C drugs for pediatric patients. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551407.htm
  6. 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
  7. HIGHLIGHTS OF PRESCRIBING INFORMATION HARVONI (ledipasvir and sofosbuvir) tablets, for oral use https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

Components

ledipasvir sofosbuvir (Sovaldi)