Meta-analysis of the Efficacy and Safety of Grazoprevir and Elbasvir for the Treatment of Hepatitis C Virus Infection
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Background: Recently, a fixed combination of grazoprevir and elbasvir (GE) has been introduced to the arsenal ofchemotherapeutics to fight against this virus. The study aimed to provide information on the efficacy and safety of GE for thetreatment of HCV infection by performing a meta-analysis of literature data. Methods: PubMed and EMBASE database searcheswere conducted. Among the literature retrieved, pivotal Phase III clinical studies were analyzed. Statistical analysis of the data wasperformed by RevMan. Results: Four pivotal Phase III clinical studies compared the efficacy and safety of GE. When HCV patientswere treated with GE for 12 weeks, the sustained virologic response, defined as the viral RNA level below the lower limit ofquantification at 12 weeks after the cessation of therapy (SVR12), was 94.7%. The clinical advantage of GE involves its use bypatients with cirrhosis and/or renal failure without dose adjustment. If the genotype (GT) of the causative virus was GT1a with NS5Apolymorphism or GT4 with resistance to peginterferon/ribavirin, treatment with GE plus ribavirin for 16 weeks resulted in a betteroutcome compared to treatment with GE alone for 12 weeks. Adverse events reported during the four clinical studies were 71.09%in the GE arms and it was 76.61% in the non-GE arms, with the most frequent events being mild central nervous system symptoms. Conclusion: GE was generally safe and effective for the treatment of HCV infection. However, since HCV mutates very rapidly andbecomes resistant to antiviral agents, long-term monitoring should be mandatory.
Abstract
Background: Recently, a fixed combination of grazoprevir and elbasvir (GE) has been introduced to the arsenal ofchemotherapeutics to fight against this virus. The study aimed to provide information on the efficacy and safety of GE for thetreatment of HCV infection by performing a meta-analysis of literature data. Methods: PubMed and EMBASE database searcheswere conducted. Among the literature retrieved, pivotal Phase III clinical studies were analyzed. Statistical analysis of the data wasperformed by RevMan. Results: Four pivotal Phase III clinical studies compared the efficacy and safety of GE. When HCV patientswere treated with GE for 12 weeks, the sustained virologic response, defined as the viral RNA level below the lower limit ofquantification at 12 weeks after the cessation of therapy (SVR12), was 94.7%. The clinical advantage of GE involves its use bypatients with cirrhosis and/or renal failure without dose adjustment. If the genotype (GT) of the causative virus was GT1a with NS5Apolymorphism or GT4 with resistance to peginterferon/ribavirin, treatment with GE plus ribavirin for 16 weeks resulted in a betteroutcome compared to treatment with GE alone for 12 weeks. Adverse events reported during the four clinical studies were 71.09%in the GE arms and it was 76.61% in the non-GE arms, with the most frequent events being mild central nervous system symptoms. Conclusion: GE was generally safe and effective for the treatment of HCV infection. However, since HCV mutates very rapidly andbecomes resistant to antiviral agents, long-term monitoring should be mandatory.
참고문헌 (38)
- Mohd Hanafiah K, "Global epidemiology of hepatitis C virus infection : New estimates of age-specific antibody to hepatitis C virus seroprevalence", Hepatology, 57, pp.1333~1342 (2013)
- "Guidelines for the screening care and treatment of persons with chronic hepatitis C infection: Updated version April 2016"[URL]
- Manns MP, "Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C : a randomised trial", Lancet, 358, pp.958~965 (2001)
- Nicot F, "Influence of HCV genotype 1 subtypes on the virus response to PEG interferon alpha-2a plus ribavirin therapy", J Med Virol, 83, pp.437~444 (2011)
- Fried MW, "Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection", N Engl J Med, 347, pp.975~982 (2002)
- AASLD and IDSA HCV Guidance Panel, "Hepatitis C guidance:AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus", Hepatology, 62, pp.932~954 (2015)
- Keating GM, "Elbasvir", grazoprevir : First global approval, 2016, pp.76, 617~624
- Suraweera D, "Spotlight on grazoprevir-elbasvir once-daily combination and its potential in the treatment of hepatitis C", Drug Des Devel Ther, 10, pp.2119~2127 (2016)
- Landaverde C, "Dual therapy of grazoprevir and elbasvir for the treatment of hepatitis C infection", Expert Rev Gastroenterol Hepatol, 10, pp.419~429 (2016)
- "Prescribing information (Zepatier:Elbasvir and Grazoprevir)"[URL]
- Banerjee D, "Review article: safety and tolerability of directacting anti-viral agents in the new era of hepatitis C therapy", Aliment Pharmacol Ther, 43, pp.674~696 (2016)
- Ward RP, "Using pegylated interferon and ribavirin to treat patients with chronic hepatitis C", Am Fam Physician, 72, pp.655~662 (2005)
- Carrion AF, "Safety and efficacy of elbasvir and grazoprevir for treatment of hepatitis C", Expert Opin Drug Saf, 15, pp.883~890 (2016)
- Alric L, "Grazoprevir + elbasvir for the treatment of hepatitis C virus infection", Expert Opin Pharmacother, 17, pp.735~742 (2016)
- "Pharmacology review"[URL]
- "Medical review"[URL]
- Zeuzem S, "Grazoprevir-elbasvir combination therapy for treatment-naive cirrhotic and noncirrhotic patients with chronic hepatitis C virus genotype 1, 4, or 6 infection: a randomized trial", Ann Intern Med, 163, pp.1~13 (2015)
- Rockstroh JK, "Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial", Lancet HIV, 2, pp.319~327 (2015)
- Roth D, "Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease(the CSURFER study) : a combination phase 3study", Lancet, 386, pp.1537~1545 (2015)
- Kwo P, "Effectiveness of elbasvir and grazoprevir combination, with or without ribavirin, for treatment-experienced patients with chronic hepatitis C infection", Gastroenterology, 152, pp.164~175 (2017)
- Nakamoto S, "Antiviral therapies for chronic hepatitis C virus infection with cirrhosis", World J Hepatol, 7, pp.1133~1141 (2015)
- Pár A, "IL28B CC genotype: a protective factor and predictor of the response to interferon treatment in chronic hepatitis C virus infection", Orv Hetil, 154, pp.1261~1268 (2013)
- Cacoub P, "Extrahepatic manifestations of chronic hepatitis C. MULTIVIRC Group. Multidepartment Virus C", Arthritis Rheum, 42, pp.2204~2212 (1999)
- Tang L, "Systemic manifestations of hepatitis C infection", Infect Agent Cancer, 11, pp.29~ (2016)
- Lavanchy D, "Evolving epidemiology of hepatitis C virus", Clin Microbiol Infect, 17, pp.107~115 (2011)
- Nkontchou G, "HCV genotype 3 is associated with a higher hepatocellular carcinoma incidence in patients with ongoing viral C cirrhosis", J Viral Hepat, 18, pp.516~522 (2011)
- Yang HJ, "Meta-analysis of the efficacy and safety of sofosbuvir for the treatment of hepatitis C virus infection", Int J Clin Pharm, 37, pp.698~708 (2015)
- Dugum M, "Hepatitis C virus : here comes all-oral treatment", Cleve Clin J Med, 81, pp.159~172 (2014)
- Bell AM, "Elbasvir", grazoprevir : A review of the latest agent in the fight against hepatitis C, 2016, pp.2016, 3852126~
- Messina JP, "Global distribution and prevalence of hepatitis C virus genotypes", Hepatology, 61, pp.77~87 (2015)
- Deming P, "Therapeutic advances in HCV genotype 1 infection : insights from the society of infectious diseases pharmacists", Pharmacotherapy, 36, pp.203~217 (2016)
- Zhu Y, "Antiviral treatment of hepatitis C virus infection and factors affecting efficacy", World J Gastroenterol, 19, pp.8960~8973 (2013)
- Smolders EJ, "Pharmacokinetics, efficacy, and safety of hepatitis C virus drugs in patients with liver and", or renal impairment, 2016, pp.39, 589~611
- "Clinical pharmacology and biopharmaceutics review"[URL]
- Ferreira VL, "Safety of interferon-free therapies for chronic hepatitis C : a network meta-analysis", J Clin Pharm Ther, 41, pp.478~485 (2016)
- "Merck Helps™"[URL]