Document Detail


Phase III results of Boceprevir in treatment naïve patients with chronic hepatitis C genotype 1.
MedLine Citation:
PMID:  22212568     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
INTRODUCTION: Chronic hepatitis C virus infection affects approximately 2% of the world population and can result in cirrhosis and hepatocellular carcinoma. Until 2011, the standard of care (SOC) has been therapy with pegylated interferon alfa and ribavirin (PEG-IFN/RBV). Sustained virologic response rates (SVR) after SOC in patients infected with genotype 1 have been 40-50%. The development of new direct antiviral agents (DAA) is vital. The first drugs that specifically target the HCV protease have been approved in 2011. This review summarizes the results of SPRINT-2, a phase III double blind, placebo controlled study in which the efficacy and safety of Boceprevir, a new HCV protease inhibitor, was compared to SOC.
DESIGN: A total of 1097 treatment-naïve, genotype 1, chronic hepatitis C patients were randomized into three different groups. All patients received a 4-week lead in phase with peginterferon alfa-2b and ribavirin. A total of 363 patients were randomized to the control group and received 44 additional weeks of PEG-IFN/RBV; of the 368 patients randomized to group 2, the response-guided treatment regimen (RGT), patients with undetectable HCV RNA through week 8 and 24 received 24 weeks of triple therapy (PEG-IFN/RBV/Boceprevir); patients whose HCV-RNA was detectable between weeks 8 and 24 but undetectable at week 24 received subsequently 20 weeks of (PEG-IFN/RBV); 366 patients in group 3 were treated with lead-in followed by triple therapy through week 48.
RESULTS: Treatment with Boceprevir triple therapy increased SVR to 63-66% compared to 38% receiving PEG-IFN/RBV therapy. Non-Black patients achieved higher SVR rates compared to Black patients. Responsiveness to interferon in the lead-in phase was predictive for SVR. SVR rates did not differ between patients randomized to RGT with Boceprevir and those treated with a fixed duration. Anaemia was the most important adverse event leading to dose reduction of RBV in 13% of controls and 21% of Boceprevir recipients.
CONCLUSION: Triple therapy of Boceprevir in combination with PEG-IFN 2b/RBV is more effective than SOC alone. RGT is possible without reducing the SVR rates. Management of anaemia has to be considered.
Authors:
Michael P Manns; Antoaneta A Markova; Beatriz Calle Serrano; Markus Cornberg
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Liver international : official journal of the International Association for the Study of the Liver     Volume:  32 Suppl 1     ISSN:  1478-3231     ISO Abbreviation:  Liver Int.     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-01-03     Completed Date:  2012-05-15     Revised Date:  2012-11-09    
Medline Journal Info:
Nlm Unique ID:  101160857     Medline TA:  Liver Int     Country:  England    
Other Details:
Languages:  eng     Pagination:  27-31     Citation Subset:  IM    
Copyright Information:
© 2012 John Wiley & Sons A/S.
Affiliation:
Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. manns.michael@mh-hannover.de
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MeSH Terms
Descriptor/Qualifier:
Anemia / chemically induced
Antiviral Agents / adverse effects,  pharmacology,  therapeutic use*
Clinical Trials, Phase III as Topic*
Drug Delivery Systems
Drug Therapy, Combination
Genotype
Hepacivirus / drug effects*,  genetics,  isolation & purification
Hepatitis C, Chronic / drug therapy*
Humans
Interferon-alpha / therapeutic use
Polyethylene Glycols / therapeutic use
Proline / adverse effects,  analogs & derivatives*,  pharmacology,  therapeutic use
RNA, Viral / analysis
Randomized Controlled Trials as Topic
Recombinant Proteins / therapeutic use
Ribavirin / therapeutic use
Serine Proteinase Inhibitors / adverse effects,  pharmacology,  therapeutic use*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antiviral Agents; 0/Interferon-alpha; 0/N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; 0/Polyethylene Glycols; 0/RNA, Viral; 0/Recombinant Proteins; 0/Serine Proteinase Inhibitors; 0/peginterferon alfa-2a; 147-85-3/Proline; 36791-04-5/Ribavirin

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