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
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
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“They bind to cell surface receptors that are upregulated by mutant RAS and exhibit potent antitumor activity, demonstrating their efficacy in targeting undruggable proteins outside the cell.645–649”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [647]
In the citing paper
“They bind to cell surface receptors that are upregulated by mutant RAS and exhibit potent antitumor activity, demonstrating their efficacy in targeting undruggable proteins outside the cell.645–649”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [647]
In the citing paper
“They bind to cell surface receptors that are upregulated by mutant RAS and exhibit potent antitumor activity, demonstrating their efficacy in targeting undruggable proteins outside the cell.645–649”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [647]
Citations
Cites
Forns, X., Lee, S. S., Valdes, J. M., Lens, S., Ghalib, R. H., Aguilar, H. I., Felizarta, F., Hassanein, T., Hinrichsen, H. M., Rincón, D., et al. (2017) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(17)30496-6 · Cited by 349
Kwo, P. Y., Poordad, F. F., Asatryan, A., et al. (2017) · Journal of Hepatology · doi:10.1016/j.jhep.2017.03.039 · Cited by 302
Poordad, F. F., Felizarta, F., Asatryan, A., et al. (2017) · Hepatology · doi:10.1002/hep.29081 · Cited by 204
Rockstroh, J. K., Lacombe, K., Viani, R. M., Orkin, C. M., Wyles, D. L., Luetkemeyer, A. F., Soto-Malave, R., Flisiak, R., Bhagani, S. R., Sherman, K. E., et al. (2018) · Clinical Infectious Diseases · doi:10.1093/cid/ciy220 · Cited by 148
Gane, E. J., Poordad, F. F., Wang, S., Asatryan, A., Kwo, P. Y., Lalezari, J. P., Wyles, D. L., Hassanein, T., Aguilar, H. I., Maliakkal, B. J., et al. (2016) · Gastroenterology · doi:10.1053/j.gastro.2016.07.020 · Cited by 103
Reau, N. S., Kwo, P. Y., Rhee, S. M., et al. (2017) · Journal of Hepatology · doi:10.1016/s0168-8278(17)30444-0 · Cited by 56
Foster, G. R., Gane, E. J., Asatryan, A., et al. (2017) · Journal of Hepatology · doi:10.1016/s0168-8278(17)30326-4 · Cited by 39
Krishnan, P., Schnell, G., Tripathi, R. L., et al. (2017) · Journal of Hepatology · doi:10.1016/s0168-8278(17)31399-5 · Cited by 34
Rockstroh, J., Lacombe, K., Viani, R. M., et al. (2017) · Journal of Hepatology · doi:10.1016/s0168-8278(17)30467-1 · Cited by 24
Poordad, F., Pol, S., Asatryan, A., et al. (2017) · Journal of Hepatology · doi:10.1016/s0168-8278(17)30432-4 · Cited by 19
Research works printed but not linked: 4
- 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/ .
- 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.
- 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.
- 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.
Cited by
Sorted by citations
Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials
Xie, X., Yu, T., Li, X., Zhang, N., Foster, L. J., Peng, C., Huang, W., & He, G. (2023) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-023-01589-z · Cited by 396
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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
