scholarly journals Is it ethical to enroll a patient in a hepatitis C virus clinical trial when current standard of care is highly effective and safe?

2015 ◽  
Vol 6 (5) ◽  
pp. 120-121 ◽  
Author(s):  
Vijaya L. Rao ◽  
Christopher Daugherty
Keyword(s):  
Clinical Trial ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Standard Of Care ◽  
Current Standard ◽  
Highly Effective

scholarly journals Preclinical Characterization of GSK2336805, a Novel Inhibitor of Hepatitis C Virus Replication That Selects for Resistance in NS5A

2013 ◽  
Vol 58 (1) ◽  
pp. 38-47 ◽  
Author(s):  
Jill Walker ◽  
Renae Crosby ◽  
Amy Wang ◽  
Ermias Woldu ◽  
Jessica Vamathevan ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Standard Of Care ◽  
Cross Resistance ◽  
Current Standard ◽  
Dna Viruses ◽  
Consensus Sequences ◽  
Genotype 1A ◽  
Rna And Dna

ABSTRACTGSK2336805 is an inhibitor of hepatitis C virus (HCV) with picomolar activity on the standard genotype 1a, 1b, and 2a subgenomic replicons and exhibits a modest serum shift. GSK2336805 was not active on 22 RNA and DNA viruses that were profiled. We have identified changes in the N-terminal region of NS5A that cause a decrease in the activity of GSK2336805. These mutations in the genotype 1b replicon showed modest shifts in compound activity (<13-fold), while mutations identified in the genotype 1a replicon had a more dramatic impact on potency. GSK2336805 retained activity on chimeric replicons containing NS5A patient sequences from genotype 1 and patient and consensus sequences for genotypes 4 and 5 and part of genotype 6. Combination and cross-resistance studies demonstrated that GSK2336805 could be used as a component of a multidrug HCV regimen either with the current standard of care or in combination with compounds with different mechanisms of action that are still progressing through clinical development.

scholarly journals Structural and Antigenic Definition of Hepatitis C Virus E2 Glycoprotein Epitopes Targeted by Monoclonal Antibodies

2013 ◽  
Vol 2013 ◽  
pp. 1-12 ◽  
Author(s):  
Giuseppe Sautto ◽  
Alexander W. Tarr ◽  
Nicasio Mancini ◽  
Massimo Clementi
Keyword(s):  
Immune Response ◽  
Monoclonal Antibodies ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Structural Characteristics ◽  
Standard Of Care ◽  
Surface Glycoprotein ◽  
Current Standard ◽  
Humoral Immune ◽  
Promising Tool

Hepatitis C virus (HCV) is the major cause of chronic liver disease as well as the major indication for liver transplantation worldwide. Current standard of care is not completely effective, not administrable in grafted patients, and burdened by several side effects. This incomplete effectiveness is mainly due to the high propensity of the virus to continually mutate under the selective pressure exerted by the host immune response as well as currently administered antiviral drugs. The E2 envelope surface glycoprotein of HCV (HCV/E2) is the main target of the host humoral immune response and for this reason one of the major variable viral proteins. However, broadly cross-neutralizing monoclonal antibodies (mAbs) directed against HCV/E2 represent a promising tool for the study of virus-host interplay as well as for the development of effective prophylactic and therapeutic approaches. In the last few years many anti-HCV/E2 mAbs have been evaluated in preclinical and clinical trials as possible candidate antivirals, particularly for administration in pre- and post-transplant settings. In this review we summarize the antigenic and structural characteristics of HCV/E2 determined through the use of anti-HCV/E2 mAbs, which, given the absence of a crystal structure of this glycoprotein, represent currently the best tool available.

Trends in the Treatment of Chronic Hepatitis C Virus Infection

2009 ◽  
Vol 22 (4) ◽  
pp. 405-418 ◽  
Author(s):  
Jennifer J. Kiser
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C Virus ◽  
Liver Disease ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Standard Of Care ◽  
New Drugs ◽  
Current Standard ◽  
Course Of Illness ◽  
Chronic Hepatitis C Virus

Despite reductions in the incidence of new hepatitis C virus infections, infections from previous decades continue to place a substantial burden on our health care system. Although the course of the disease is highly variable, approximately 20% to 30% of patients develop cirrhosis, end-stage liver disease, or hepatocellular carcinoma. Fortunately, treatment with our current standard of care, peginterferon a and ribavirin, can reduce the complications of chronic liver disease. However, these drugs are associated with significant adverse effects, many patients are ineligible for treatment, and only 50% are cured. Thus, there is a tremendous need to improve our current therapies and develop new compounds for this disease. This review highlights the transmission, pathophysiology, and course of illness; the pharmacokinetics, proposed mechanisms of action, adverse events, and potential drug interactions with peginterferon a and ribavirin; current treatment trends; the role of the pharmacist in the treatment of this disease; and investigational drugs in later stages of clinical development. Despite the initial hope that these new drugs would replace our current standard of care, it has become clear that ribavirin and peginterferon a will continue to play an important role in the treatment of chronic hepatitis C virus in the years to come.

scholarly journals Pro: Use of Hepatitis C Virus-Positive Donors Should Be Considered Standard of Care

2018 ◽  
Vol 12 (4) ◽  
pp. 100-104 ◽  
Author(s):  
William A. Werbel ◽  
Christine M. Durand
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Standard Of Care

scholarly journals Promising Anti-Hepatitis C Virus Compounds from Natural Resources

2016 ◽  
Vol 11 (8) ◽  
pp. 1934578X1601100 ◽  
Author(s):  
Tutik Sri Wahyuni ◽  
Chie Aoki Utsubo ◽  
Hak Hotta
Keyword(s):  
Hepatocellular Carcinoma ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Natural Resources ◽  
Antiviral Agents ◽  
High Morbidity ◽  
Current Standard ◽  
Treatment Regimens ◽  
Medicinal Plant Extracts ◽  
Ns3 Protease

Hepatitis C virus (HCV) infection is a major worldwide problem, which involves approximately 170 million people. High morbidity of patients is caused by chronic infection, which leads to liver cirrhosis, hepatocellular carcinoma and other HCV-related diseases. The sustained virological response (SVR) has been markedly improved to be >90% by the current standard interferon (IFN)-free treatment regimens with a combination of direct-acting antiviral agents (DAAs) targeting the viral NS3 protease, NS5A multi-function protein and NS5B RNA-dependent RNA polymerase, compared with 50–70% of SVR rates achieved by the previous standard IFN-based treatment regimens with or without an NS3 protease inhibitor. However, the emergence of DAA-resistant HCV strains and the limited access to the DAAs due to their high cost could be major concerns. Also, the long-term prognosis of patients treated with DAAs, such as the possible development of hepatocellular carcinoma, still needs to be further evaluated. Natural resources are considered to be good candidates to develop anti-HCV agents. Here, we summarize anti-HCV compounds obtained from natural resources, including medicinal plant extracts, their isolated compounds and some of their derivatives that possess high antiviral potency against HCV.

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