Cited by 93Hepatitis C virus researchAnimal Virus Infections StudiesHIV/AIDS drug development and treatment

The DOI matches its Crossref record; 18 of the 18 references it cites were found in a registry or an index.

Glecaprevir/Pibrentasvir: First Global Approval

Lamb, Yvette N.·2017·Drugs

Abstract

A fixed-dose combination tablet of the hepatitis C virus (HCV) NS3/4A protease inhibitor (PI) glecaprevir and the HCV NS5A inhibitor pibrentasvir [glecaprevir/pibrentasvir; MAVIRET™ (EU); MAVYRET™ (USA)] has been developed by AbbVie. Oral glecaprevir/pibrentasvir 300 mg/120 mg (three 100 mg/40 mg tablets) taken once daily has been approved by the EMA for the treatment of all major genotypes (genotypes 1-6) of chronic HCV infection in adults. It has also been approved by the US FDA for the treatment of adult patients with chronic HCV genotype 1-6 infection without cirrhosis and with compensated cirrhosis, and for the treatment of adult patients with HCV genotype 1 infection who previously have been treated with a regimen containing either an HCV NS5A inhibitor or an NS3/4A PI, but not both. This article summarizes the milestones in the development of glecaprevir/pibrentasvir leading to its first global approval in the EU and subsequent approval in the USA for chronic HCV infection.

Overview

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Registry

Crossref · 10.1007/s40265-017-0817-y

Cites

18 of 18 references verified0 citation errors · 0 not checkable

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Citations

Cites

Research works printed but not linked: 4

  1. Enanta Pharmaceuticals. Enanta announces Japanese Ministry of Health, Labour and Welfare grants priority review for AbbVies investigational HCV regimen of glecaprevir/ pibrentasvir (G/P) for the treatment of all major genotypes of chronic hepatitis C [media release]. 2017. http://www.enanta.com/ .
  2. Gane E, Lawitz EJ, Pugatch D, et al. EXPEDITION-IV: safety and efficacy of GLE/PIB in adults with renal impairment and chronic hepatitis C virus genotype 1–6 infection [abstract and poster no. LB-11]. Hepatology. 2016;64(6 Suppl.):1125A.
  3. Kowdley KV, Colombo M, Zadeikis N, et al. ENDURANCE-2: safety and efficacy of ABT-493/ABT-530 in hepatitis C virus genotype 2-infected patients without cirrhosis, a randomized, double-blind, placebo-controlled study [abstract and poster no. 73]. Hepatology. 2016;64(1 Suppl.):39A.
  4. Zeuzem S, Feld JJ, Wang S, et al. ENDURANCE-1: efficacy and safety of 8- versus 12-week treatment with ABT-493/ABT-530 in patients with chronic HCV genotype 1 infection [abstract and poster no. 253]. Hepatology. 2016;64(1 Suppl.):132A–3A.

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Metadata

Authors
Lamb, Y. N.
Corresponding author
Lamb, Yvette N.
Venue
Drugs
Published
2017-09-19
Volume
77
Issue
16
Pages
1797-1804
ISSN
  • 0012-6667 (ISSN-L)
  • 1179-1950
OpenAlex
W2754868188
Cited by
93
References
18
Citations by year
2026: 5 · 2025: 12 · 2024: 9 · 2023: 19 · 2022: 8 · 2021: 8 · 2020: 12 · 2019: 12 · 2018: 7 · 2017: 1
FWCI
1.26
Type
journal article
Language
en
Open access
closed
Locations
  • Drugs (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Hepatology › Hepatitis C virus research
  • Life Sciences › Agricultural and Biological Sciences › Animal Science and Zoology › Animal Virus Infections Studies
  • Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
Keywords
glecaprevir/pibrentasvir, hepatitis C virus, chronic hepatitis C, NS3/4A protease inhibitors, NS5A inhibitors, fixed-dose combination, drug approval, HCV genotype 1-6, liver cirrhosis, AbbVie, drug development milestones
MeSH terms
Viral Proteases, Aminoisobutyric Acids, Antiviral Agents, Benzimidazoles, Cyclopropanes, Drug Combinations, Genotype, Humans, Leucine, Liver Cirrhosis, Proline, Pyrrolidines, Quinoxalines, RNA-Dependent RNA Polymerase, Serine Endopeptidases, Sulfonamides, United States, United States Food and Drug Administration, Hepacivirus, Drug Approval, Viral Nonstructural Proteins, Hepatitis C, Chronic, Nucleoside-Triphosphatase, Lactams, Macrocyclic, DEAD-box RNA Helicases

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