ledipasvir/sofosbuvir (Harvoni)
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Introduction
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)
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]
More general terms
Components
References
- ↑ 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24209977 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62121-2/abstract
- ↑ 2.0 2.1 2.2 FDA News Release. October 10, 2014 FDA approves first combination pill to treat hepatitis C http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm
- ↑ 3.0 3.1 3.2 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: https://www.ncbi.nlm.nih.gov/pubmed/26704693
- ↑ 4.0 4.1 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
- ↑ 5.0 5.1 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 - ↑ 6.0 6.1 6.2 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
- ↑ 7.0 7.1 7.2 HIGHLIGHTS OF PRESCRIBING INFORMATION HARVONI<TM> (ledipasvir and sofosbuvir) tablets, for oral use https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf