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Elbasvir/Grazoprevir: A Review in Chronic HCV Genotypes 1 and 4
Zaina T Al-Salama1, Emma D Deeks2
1Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.
Insights
Elbasvir/grazoprevir offers a new, effective treatment for chronic hepatitis C virus (HCV) genotypes 1 and 4. This combination therapy shows high sustained virological response rates in diverse patient groups.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Hepatitis C virus (HCV) infection poses a significant global health challenge.
- Chronic HCV genotypes 1 and 4 require effective and well-tolerated treatment options.
Purpose of the Study:
- To evaluate the efficacy and tolerability of elbasvir/grazoprevir for treating chronic HCV genotypes 1 and 4.
- To assess treatment outcomes in various patient populations, including difficult-to-treat groups.
Main Methods:
- Phase III clinical trials were conducted.
- Patients received 12 or 16 weeks of once-daily elbasvir/grazoprevir (fixed-dose combination or individual agents), with or without ribavirin.
- Sustained virological response at 12 weeks (SVR12) was the primary efficacy endpoint.
Main Results:
- High rates of SVR12 were achieved in treatment-naive and -experienced adult patients.
- Efficacy was demonstrated across HCV genotypes 1a, 1b, and 4.
- The treatment was generally well tolerated in diverse populations, including those with compensated cirrhosis, HIV co-infection, and chronic kidney disease.
Conclusions:
- Elbasvir/grazoprevir, with or without ribavirin, is an effective new treatment option for chronic HCV genotypes 1 and 4.
- This regimen provides high SVR12 rates in a broad range of adult patients.
- The combination therapy represents a valuable addition to the HCV treatment armamentarium, particularly for challenging patient cohorts.
Abstract:
A fixed-dose combination tablet comprising the hepatitis C virus (HCV) NS5A inhibitor elbasvir and the HCV NS3/4A protease inhibitor grazoprevir (elbasvir/grazoprevir; Zepatier™) was recently approved for the treatment of chronic HCV genotype 1 and 4 infection in the EU and the USA. In phase III trials, 12 or 16 weeks of treatment with once-daily elbasvir/grazoprevir (fixed-dose tablet or as individual agents), taken with or without ribavirin, generally provided high rates of sustained virological response at 12 weeks (SVR12) in treatment-naive and -experienced adult patients with chronic HCV genotype 1a, 1b or 4 infection, including those with or without compensated cirrhosis, HIV co-infection, inherited blood disorders or chronic kidney disease or patients receiving opioid agonist therapy or of Japanese origin. Elbasvir/grazoprevir was generally well tolerated. Thus, elbasvir/grazoprevir, with or without ribavirin, represents an effective new option for the treatment of adults with chronic HCV genotype 1 and 4 infection, including a number of difficult-to-treat populations.