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New treatments for genotype 1 chronic hepatitis C - focus on simeprevir.

Kanda T, Nakamoto S, Wu S, Yokosuka O - Ther Clin Risk Manag (2014)

Bottom Line: Chronic hepatitis C virus (HCV) infection causes end-stage liver diseases and hepato cellular carcinoma.In the USA, Canada, and Japan, simeprevir - one of the second-generation HCV NS3/4A protease inhibitors - in combination with peginterferon α-2a or 2b plus ribavirin has recently been approved for HCV genotype 1-infected patients and is now used in daily clinical practice.In the near future, the development of interferon-free regimens with simeprevir is expected.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University, Chiba, Japan.

ABSTRACT
Chronic hepatitis C virus (HCV) infection causes end-stage liver diseases and hepato cellular carcinoma. In the USA, Canada, and Japan, simeprevir - one of the second-generation HCV NS3/4A protease inhibitors - in combination with peginterferon α-2a or 2b plus ribavirin has recently been approved for HCV genotype 1-infected patients and is now used in daily clinical practice. This review summarizes the mechanism of action of simeprevir and the results of clinical trials of simeprevir and peginterferon plus ribavirin for HCV genotype 1 patients. In general, the simeprevir and peginterferon plus ribavirin treatment is highly effective and its adverse events are similar to those of peginterferon plus ribavirin only, the exception being milder, reversible jaundice. In the near future, the development of interferon-free regimens with simeprevir is expected. Careful attention should be paid to new results of clinical trials with simeprevir.

No MeSH data available.


Related in: MedlinePlus

DRAGON study designs and results.Notes: SVR rates were measured at 24 weeks after the end of treatment. RGT criteria: all therapy of the SMV group was completed at week 24 if hepatitis C virus RNA was <1.4 log10 IU/mL at week 4 and undetectable at weeks 12, 16, and 20; otherwise PR (180 µg/week peginterferon α-2a; 600–1,000 mg/day ribavirin) was continued to week 48. In the control group, patients received PR for 48 weeks. Data from Hayashi et al.22Abbreviations: DRAGON, A Phase II Study of TMC435 in Patients with Chronic Hepatitis C; PR, peginterferon plus ribavirin; RGT, response-guided therapy; SMV, simeprevir; SVR, sustained virologic response.
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f3-tcrm-10-387: DRAGON study designs and results.Notes: SVR rates were measured at 24 weeks after the end of treatment. RGT criteria: all therapy of the SMV group was completed at week 24 if hepatitis C virus RNA was <1.4 log10 IU/mL at week 4 and undetectable at weeks 12, 16, and 20; otherwise PR (180 µg/week peginterferon α-2a; 600–1,000 mg/day ribavirin) was continued to week 48. In the control group, patients received PR for 48 weeks. Data from Hayashi et al.22Abbreviations: DRAGON, A Phase II Study of TMC435 in Patients with Chronic Hepatitis C; PR, peginterferon plus ribavirin; RGT, response-guided therapy; SMV, simeprevir; SVR, sustained virologic response.

Mentions: The Phase II, multicenter, double-blind, DRAGON study (A Phase II Study of TMC435 in Patients with Chronic Hepatitis C; NCT00996476) examined the efficacy and safety of two different doses of simeprevir administered QD for two different durations in combination with peginterferon plus ribavirin in treatment-naïve HCV genotype 1b patients.22 A total of 92 patients were randomly assigned to one of five groups (Figure 3): simeprevir (50 mg or 100 mg QD) for 12 or 24 weeks, and peginterferon plus ribavirin. Patients in the simeprevir arms were treated for 24 or 48 weeks according to RGT criteria.


New treatments for genotype 1 chronic hepatitis C - focus on simeprevir.

Kanda T, Nakamoto S, Wu S, Yokosuka O - Ther Clin Risk Manag (2014)

DRAGON study designs and results.Notes: SVR rates were measured at 24 weeks after the end of treatment. RGT criteria: all therapy of the SMV group was completed at week 24 if hepatitis C virus RNA was <1.4 log10 IU/mL at week 4 and undetectable at weeks 12, 16, and 20; otherwise PR (180 µg/week peginterferon α-2a; 600–1,000 mg/day ribavirin) was continued to week 48. In the control group, patients received PR for 48 weeks. Data from Hayashi et al.22Abbreviations: DRAGON, A Phase II Study of TMC435 in Patients with Chronic Hepatitis C; PR, peginterferon plus ribavirin; RGT, response-guided therapy; SMV, simeprevir; SVR, sustained virologic response.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4043814&req=5

f3-tcrm-10-387: DRAGON study designs and results.Notes: SVR rates were measured at 24 weeks after the end of treatment. RGT criteria: all therapy of the SMV group was completed at week 24 if hepatitis C virus RNA was <1.4 log10 IU/mL at week 4 and undetectable at weeks 12, 16, and 20; otherwise PR (180 µg/week peginterferon α-2a; 600–1,000 mg/day ribavirin) was continued to week 48. In the control group, patients received PR for 48 weeks. Data from Hayashi et al.22Abbreviations: DRAGON, A Phase II Study of TMC435 in Patients with Chronic Hepatitis C; PR, peginterferon plus ribavirin; RGT, response-guided therapy; SMV, simeprevir; SVR, sustained virologic response.
Mentions: The Phase II, multicenter, double-blind, DRAGON study (A Phase II Study of TMC435 in Patients with Chronic Hepatitis C; NCT00996476) examined the efficacy and safety of two different doses of simeprevir administered QD for two different durations in combination with peginterferon plus ribavirin in treatment-naïve HCV genotype 1b patients.22 A total of 92 patients were randomly assigned to one of five groups (Figure 3): simeprevir (50 mg or 100 mg QD) for 12 or 24 weeks, and peginterferon plus ribavirin. Patients in the simeprevir arms were treated for 24 or 48 weeks according to RGT criteria.

Bottom Line: Chronic hepatitis C virus (HCV) infection causes end-stage liver diseases and hepato cellular carcinoma.In the USA, Canada, and Japan, simeprevir - one of the second-generation HCV NS3/4A protease inhibitors - in combination with peginterferon α-2a or 2b plus ribavirin has recently been approved for HCV genotype 1-infected patients and is now used in daily clinical practice.In the near future, the development of interferon-free regimens with simeprevir is expected.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University, Chiba, Japan.

ABSTRACT
Chronic hepatitis C virus (HCV) infection causes end-stage liver diseases and hepato cellular carcinoma. In the USA, Canada, and Japan, simeprevir - one of the second-generation HCV NS3/4A protease inhibitors - in combination with peginterferon α-2a or 2b plus ribavirin has recently been approved for HCV genotype 1-infected patients and is now used in daily clinical practice. This review summarizes the mechanism of action of simeprevir and the results of clinical trials of simeprevir and peginterferon plus ribavirin for HCV genotype 1 patients. In general, the simeprevir and peginterferon plus ribavirin treatment is highly effective and its adverse events are similar to those of peginterferon plus ribavirin only, the exception being milder, reversible jaundice. In the near future, the development of interferon-free regimens with simeprevir is expected. Careful attention should be paid to new results of clinical trials with simeprevir.

No MeSH data available.


Related in: MedlinePlus