elbasvir/grazoprevir (Zepatier)
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Indications
- hepatitis C virus genotypes 1 & 4 with or without ribavirin
* effective in illicit drug users enrolled in an opioid-agonist therapy program[3]
Contraindications
Dosage
1 tablet PO QD with or without ribavirin for 12 weeks
Monitor
- serum transaminases prior to initiation, then periodically
Adverse effects
- without ribavirin: fatigue, headache, nausea
- with ribavirin: anemia, headache
- elevations of serum transaminases to > 5X upper limit of normal in 1%[2]
- reactivation of hepatitis B in patients with current or previous hepatitis B infection[4]
- 24% of patients with chronic hepatitis B[5]
- 1.4% with resolved hepatitis B infection[5]
Notes
More general terms
Components
References
- ↑ Sax PE Elbasvir/Grazoprevir Combination Pill for HCV a Welcome New Option - With a Few Buts. HIV and ID Observations. Jan 29, 2016 http://blogs.jwatch.org/hiv-id-observations/index.php/elbasvirgrazoprevir-combination-pill-for-hcv-a-welcome-new-option-with-a-few-buts/2016/01/29/
- ↑ 2.0 2.1 FDA News Release. January 28, 2016 FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483828.htm
- ↑ 3.0 3.1 Dore GJ, Altice F, Litwin AH et al Elbasvir-Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial. Ann Intern Med. Published online 9 August 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27537841 <Internet> http://annals.org/article.aspx?articleid=2542526
- ↑ 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 5.2 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
- ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION ZEPATIER<TM> (elbasvir a& grazoprevir) tablets, for oral use https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208261orig1s000lbl.pdf
- ↑ Department of Veterans Affairs, VA National Formulary