American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2015
Simeprevir and sofosbuvir for treatment of hepatitis C infection.
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Chopp Shelby, Vanderwall Rebecca, Hult Amanda, Klepser Michael
Аннотация
PURPOSE: The pharmacology, pharmacokinetics, efficacy, safety, costs, and place in therapy of simeprevir and sofosbuvir in the management of hepatitis C virus (HCV) infection are reviewed.
SUMMARY: Sofosbuvir and simeprevir are classified as direct-acting agents because they target specific proteins essential to the replication of HCV. Phase III trials demonstrated that simeprevir in combination with peginterferon alfa and ribavirin was superior to placebo combined with peginterferon alfa and ribavirin in achieving a sustained virological response in both treatment-naive patients and patients who relapsed after treatment with peginterferon alfa-2a or alfa-2b and ribavirin. Q80K polymorphism substantially decreases the efficacy of simeprevir. Clinical trials revealed that sofosbuvir in combination with ribavirin was superior to peginterferon plus ribavirin against HCV genotype 2 infection and as effective as peginterferon plus ribavirin against HCV genotype 3 infection. These findings were significant because they demonstrated the effectiveness of an anti-HCV regimen that did not include peginterferon alfa. Sofosbuvir has much better adverse-effect and drug interaction profiles than previous hepatitis C antiviral agents. Both simeprevir and sofosbuvir are approved for the treatment of chronic hepatitis C in combination with other antiviral medications. Simeprevir has been approved specifically for patients infected with HCV genotype 1 with compensated liver disease (including cirrhosis) in combination with peginterferon alfa-2a or alfa-2b and ribavirin. Sofosbuvir has shown efficacy in HCV genotypes 1-4.
CONCLUSION: Simeprevir and sofasbuvir have advantages in response rates and convenient dosage forms and frequency compared with other HCV treatments; however, they are more expensive than previous HCV therapies.
SUMMARY: Sofosbuvir and simeprevir are classified as direct-acting agents because they target specific proteins essential to the replication of HCV. Phase III trials demonstrated that simeprevir in combination with peginterferon alfa and ribavirin was superior to placebo combined with peginterferon alfa and ribavirin in achieving a sustained virological response in both treatment-naive patients and patients who relapsed after treatment with peginterferon alfa-2a or alfa-2b and ribavirin. Q80K polymorphism substantially decreases the efficacy of simeprevir. Clinical trials revealed that sofosbuvir in combination with ribavirin was superior to peginterferon plus ribavirin against HCV genotype 2 infection and as effective as peginterferon plus ribavirin against HCV genotype 3 infection. These findings were significant because they demonstrated the effectiveness of an anti-HCV regimen that did not include peginterferon alfa. Sofosbuvir has much better adverse-effect and drug interaction profiles than previous hepatitis C antiviral agents. Both simeprevir and sofosbuvir are approved for the treatment of chronic hepatitis C in combination with other antiviral medications. Simeprevir has been approved specifically for patients infected with HCV genotype 1 with compensated liver disease (including cirrhosis) in combination with peginterferon alfa-2a or alfa-2b and ribavirin. Sofosbuvir has shown efficacy in HCV genotypes 1-4.
CONCLUSION: Simeprevir and sofasbuvir have advantages in response rates and convenient dosage forms and frequency compared with other HCV treatments; however, they are more expensive than previous HCV therapies.