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elbasvir/grazoprevir (Zepatier)

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: - liver failure 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: - cost: $54,000 for 12 weeks - Department of Veterans Affairs, VA National Formulary

General

antiretroviral combination

References

  1. 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. 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. 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 PMID: 27537841 http://annals.org/article.aspx?articleid=2542526
  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. 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
  6. HIGHLIGHTS OF PRESCRIBING INFORMATION ZEPATIER (elbasvir a& grazoprevir) tablets, for oral use https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208261orig1s000lbl.pdf
  7. Department of Veterans Affairs, VA National Formulary

Components

elbasvir grazoprevir