Elbasvir and grazoprevir

(Zepatier®)

Zepatier®

Drug updated on 4/26/2024

Dosage FormTablet (oral; elbasvir/grazoprevir: 50 mg/100 mg)
Drug ClassAntivirals
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for treatment of chronic HCV genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg.
  • Indicated for use with ribavirin in certain patient populations.

Latest News

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Summary
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  • Elbasvir and grazoprevir (Zepatier) is indicated for the treatment of chronic HCV genotype 1 or 4 infection in patients aged 12 years and older, or weighing at least 30 kg. It can also be used with ribavirin in certain populations.
  • Three studies provided information on Zepatier's effectiveness and safety, focusing on patients with chronic kidney disease (CKD) on dialysis, HIV/HCV co-infected patients, as well as those with comorbidities.
  • For CKD patients on dialysis, elbasvir/grazoprevir significantly improved end-of-treatment response compared to placebo. However, data was insufficient regarding sustained virological response (SVR), a critical endpoint for this group.
  • In HIV/HCV co-infected individuals, elbasvir/grazoprevir showed one of the highest SVR rates among various all-oral DAA therapies, making it an optimal choice due to excellent treatment effects and insignificant adverse events.
  • Safety data from clinical trials indicates that the elbasvir/grazoprevir combination is generally safe for adults with HCV infection, including those having challenging comorbidities like CKD stages 4/5 or inherited blood disorders; however, adding ribavirin increases the frequencies of common side effects such as fatigue, headache, and nausea.
  • The studies indicate variations in effectiveness across treatments like standard interferon, pegylated interferon combinations with ribavirin, but overall suggest that Zepatier has a favorable safety profile even in populations with additional health challenges.