C형 간염 바이러스 감염 치료를 위한 grazoprevir 및 elbasvir의 유효성 및 안전성에 대한 메타 분석

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.