Drug updated on 4/17/2024
| Dosage Form | Tablet (oral; 100 mg glecaprevir and 40 mg pibrentasvir); Pellets (oral; 50 mg glecaprevir and 20 mg pibrentasvir) |
| Drug Class | HCV NS3/4A protease inhibitors and HCV NS5A inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult and pediatric patients 3 years and older with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).
- For the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.
Summary
- Glecaprevir and pibrentasvir (Mavyret) is indicated for the treatment of adult and pediatric patients 3 years and older with chronic Hepatitis C Virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis.
- A total of five systematic reviews/meta-analyses were reviewed to gather information about this drug's effectiveness in treating HCV infections.
- The sustained virologic response rate after a regimen involving glecaprevir/pibrentasvir was found to be higher than other regimens at approximately around an average of over ninety-five percent across various studies.
- In terms of safety profile, some reports suggest that use of glecaprevir/pibrentasvir can cause moderate to severe liver impairment including isolated hyperbilirubinemia; however it remains the primary therapy choice for Chronic Kidney Disease (CKD) and End-Stage Renal Disease (ESRD) patients due its superior safety rate overall.
- Subgroup analysis revealed that glecaprevir/pibrentasvir has high efficacy rates irrespective of factors such as patient's prior treatment experience or presence/absence comorbid conditions like HIV co-infection or severe renal impairment; making it a versatile option in diverse clinical scenarios.
- For those who did not respond optimally to previous direct-acting antiviral treatments especially Asian population with Genotype (GT)-1 & GT-2 HCV infection, retreatment using glecaprevir/pibrentasvir emerged as an effective solution according to one comprehensive review included in our study set.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Mavyret (glecaprevir and pibrentasvir) Prescribing Information. | 2021 | AbbVie Inc., North Chicago, IL |