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glecaprevir/pibrentasvir (Mavyret)

Indications: - treatment of chronic hepatitis C genotypes 1-6 - without cirrhosis, or with mild cirrhosis - useful in patients with renal failure including those on renal dialysis [1] - FDA-approved to treat all genotypes of hepatitis C in children [5] Dosage: - 8 weeks of treatment [1] - 12 weeks of treatment [2] - 8 or 12 weeks of treatment [3,4] - 8 weeks of treatment for treatment naive patients - adults & pediatric patients >= 12 years, >= 99 pounds without cirrhosis or with compensated cirrhosis [6] Contraindications: - not recommended in patients with moderate cirrhosis - contraindicated in patients with severe cirrhosis Adverse effects: - headache, fatigue (70%), nausea Drug interactions: - contraindicated in patients taking atazanavir, rifampin

General

antiviral combination

References

  1. Lowes R FDA OKs 8-Week Mavyret for Hepatitis C Medscape - Aug 03, 2017. http://www.medscape.com/viewarticle/883778 - FDA News Release. August 3, 2017 FDA approves Mavyret for Hepatitis C https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm570038.htm - Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871 - U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
  2. Forns X, Lee SS, Valdes J et al Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial. Lancet. Aug 14, 2017 PMID: 28818546 http://thelancet.com/journals/laninf/article/PIIS1473-3099(17)30496-6/fulltext - Ferenci P New anti-HCV drug combinations: who will benefit? Lancet. Aug 14, 2017 PMID: 28818545 http://thelancet.com/journals/laninf/article/PIIS1473-3099(17)30486-3/fulltext
  3. Kwo PY, Poordad F, Asatryan A et al Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017 Aug;67(2):263-271. Epub 2017 Apr 13. PMID: 28412293
  4. Zeuzem S, Foster GR, Wang S et al Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. N Engl J Med 2018; 378:354-369. Jan 25, 2018 PMID: 29365309 http://www.nejm.org/doi/full/10.1056/NEJMoa1702417
  5. FDA News Release. April 30, 2019 FDA approves first treatment for all genotypes of hepatitis C in pediatric patients. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-all-genotypes-hepatitis-c-pediatric-patients
  6. FDA News Release. Sept 26, 2019 FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks. https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-adults-and-children-all-genotypes-hepatitis-c-and-compensated-cirrhosis
  7. Mavyret (glecaprevir/pibrentasvir) prescribing information. AbbVie Inc. Chicago, IL. August, 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s003lbl.pdf

Components

glecaprevir pibrentasvir