Pan-genotypic regimen for HCV effective in eight weeks for the majority of patients1
1. Puoti M. High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy: an integrated analysis of HCV genotype 1–6 patients without cirrhosis. J Hepatol. 2018 Aug;69(2):293-300
Mechanism of action and antiviral activity1
GLECAPREVIR
is a new generation protease inhibitor with potent pan-genotypic activity and high barrier against the development of resistance2.
Glecaprevir, when compared with paritaprevir and grazoprevir, two recent HCV protease inhibitors, has shown to have improved activity against the principal replicons tested2.
PIBRENTASVIR
has an improved resistance profile if compared with the profiles of other NS5A inhibitors3.
NS5A is a multifunctional protein required for the replication of RNA and the assemblage of HCV virions and a new target for the most effective anti-HCV treatments4..
From Phase 2/3 studies on 2,256 patients with genotype 1-6 HCV who received treatment for 8, 12 or 16 weeks, independent of the patient's viral characteristics.
* mITT, modified intention to treat, excluding non-virologic failures. The data includes naive or previously treated patients with or without compensated cirrhosis2
Activity of Glecaprevir and Pibrentasvir toward cell lines of the replicon of genotypes 1-6 of HCV1
NA = not available.
The in vitro activity of glecaprevir was also studied in a biochemical test, with CI 50 values that were similarly low between the genotypes1
The inhibitors of the NS5A replication complex are a new class of DAA with an exceptional in vitro potency against different genotypes of HCV, which makes them essential components for effective combination treatment with anti-HCV DAA4
Glecaprevir and Pibrentasvir in vitro have shown to be active against replicons of HCV containing amino acids that provide resistance to first-generation protease inhibitors (NS3/4A) and NS5A inhibitors3.
Pibrentasvir
Achieved the highest level of effectiveness against mutations; viruses with RAS in position 28, 30 or 31 demonstrated no apparent resistance to pibrentasvir and the HCV virus with RAS in position 93 showed a low level of resistance5
Mechanism of action for Maviret
Reference the most recent version of the SmPC, scanning the QR Code.
The continually updated version of the SmPC is also available on the website https://rcpabbvie.it/mav
Ex-factory price (VAT EXCLUDED): € 14,000
Retail price (VAT EXCLUDED): € 23,105.60
Reimbursement class: A
Classification for supply: medicinal products subject to limited medical prescription, with single refills, sold to the public by prescription from hospital centers or specialists: infectious disease specialists, gastroenterologists, internists (RNRL)
Stored at AIFA on 09/25/2019 - Code IT-MAVI-190076
Translated from the Italian local content. Global approved content coming soon.
Bibliografia:
1. MAVIRET Riassunto delle
Caratteristiche del Prodotto (RCP)
2. Ng TI, et
al. “In Vitro Antiviral Activity and Resistance Profile of the
Next Generation Hepatitis C Virus NS3/4A Protease Inhibitor
Glecaprevir.” Antimicrob Agents Chemother. 2017 Oct 30
3. Ng
TI, et al. “In Vitro Antiviral Activity and Resistance Profile
of the Next Generation Hepatitis C Virus NS5A Inhibitor Pibrentasvir.”
Antimicrob Agents Chemother. 2017 Apr 24;61(5)
4. Gao M.
“Antiviral activity and resistance of HCV NS5A replication complex
inhibitors”. Curr Opin Virol. 2013 Oct;3(5):514- 20. Epub 2013 Jul
27
5. Judith M. Gottwein Efficacy of NS5A Inhibitors
Against Hepatitis C Virus Genotypes 1–7 and Escape Variants