Greetings,
As we know the FDA Panel will be reviewing the two experimental hepatitis C virus protease inhibitors ; Merck-Boceprevir, Vertex-Telaprevir in late April. Today on the blog boceprevir is in the spotlight with the help of NATAP, EASL and HIV and hepatitis.
Just as a side note; Merck has registered the name Victrelis® as their trademark and has used it in the press release to announce their posters/abstracts which will be presented at the EASL meeting this month.
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As noted previously on the blog, because the EASL has a media embargo in place until all data is presented and reviewed by attendees/physicians, I have provided my readers with a few direct links to some of the "Boceprevir" posters available to the public through the EASL website.
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Today, with the wealth of information on the internet the HCV patient is educated and has become their own advocate. However, the majority of journals provided online are not "peer reviewed" and these patients hunger for substantial credible information. Although the liver meeting provides the HCV community with clinical data, this data presented at the EASL should be considered preliminary until it has been reviewed and published in a peer-reviewed publication. ( See below for a list of peer-reviewed journals.)
These links will help you navigate your way through the EASL website.
Upcoming Oral Presentations
Abstracts/Poster Sessions
Boceprevir;
P3.08D: Category 08d: Viral Hepatitis C: Clinical (new compounds, resistance)
http://www1.easl.eu/easl2011/program/Posters/Abstract4.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract216.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract225.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract229.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract235.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract240.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract255.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract256.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract259.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract273.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract283.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract288.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract291.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract1072.htm
http://www1.easl.eu/easl2011/program/Posters/Abstract1118.htm
NATAP has put together this great information on Boceprevir that you'll find easy to understand;
Simplified Explanation of the Phase 3 Studies of HCV Protease Inhibitor Boceprevir
Boceprevir is a HCV protease inhibitor for patients with genotype 1, the more difficult to treat type of patients, that is expected to be publicly reviewed at an FDA hearing in April, approved and in the pharmacy by June this year 2011 and will be added to pegylated interferon/ribavirin as part of a 3 drug combination therapy; up until now standard-of-care therapy has been only peginterferon+ribavirin.
With triple-drug therapy response rates are greatly increased.
Early responses (called Response Guided Therapy) will allow many patients to be able to cut the duration of therapy significantly by a number of months from the current 48 weeks to 28 or 36 weeks.
A new pill developed by Merck for chronic hepatitis C virus (HCV) genotype 1, the hardest to treat form, significantly improves virologic cure rates when added to standard therapy and shortens treatment time for up to half of patients by three to five months.
The pill, called boceprevir, is to be used in combination with standard therapy. The combination has been shown in two major studies to be significantly more effective than standard therapy for people undergoing HCV treatment for the first time as well as for people who previously did not attain a virologic cure by standard therapy alone (nonresponders).
The combination of boceprevir and standard therapy also offers patients the opportunity to individually tailor how long they undergo treatment based on early responses to the drugs. This represents an approach to treating HCV, called response-guided therapy (RGT)....continue reading.............
Also from NATAP & HIV and Hepatitis ; Conference on Retroviruses and Opportunistic Infections - CROI 2011
Boceprevir Improves SVR With PegIFN/RBV After Failure or Relapse With HCV-1
Mark Mascolini
Adding the HCV-NS3 protease inhibitor boceprevir to pegylated interferon plus ribavirin (PegIFN/RBV) significantly improved sustained virologic response (SVR) rates in HCV genotype 1-infected people with a history of nonresponse or relapse with PegIFN/RBV [1]. SVR rates were higher among relapsers than nonresponders, though 40% to 50% of nonresponders attained SVR with boceprevir plus PegIFN/RBV...continue reading.....
From HIV and Hepatitis
HCV Protease Inhibitor Boceprevir Improves Response for Treatment-Naive and Non-responders
SUMMARY: Merck's investigational hepatitis C virus (HCV) protease inhibitor boceprevir improved sustained response rates when combined with pegylated interferon plus ribavirin in both previously untreated patients and those who were non-responders or relapsers after prior therapy, according to 2 Phase 3 studies presented at the 18th Conference on Retroviruses and Opportunistic Infections (CROI 2011) this month in Boston...continue reading.....
Looking For HCV Information Online
Hint;
Look for web sites that end in .gov or .org rather than .com
From HCV Advocate
The Internet as a Source for information
The Internet is a valuable tool. However, like any tool, one needs to know how to use it well. The following are some suggestions for how to use the Internet more effectively:
Find out if the information comes from independent and not-for-profit sources, particularly from the U.S. federal government (e.g., National Institutes of Health (NIH), FDA), a general medical society (e.g., American Medical Association) or specialty or disease society (e.g., American Association for the Study of Liver Diseases) is likely to be reliable.
Commercial sources (e.g.,pharmaceutical companies) may be scientifically accurate, but may emphasize the positive aspects of a drug for marketing purposes...continue reading......
A Few Of My Favorite Peer Reviewed Medical Journals
The Lancet
You are able to search for articles on hepatitis C and are able to view the abstracts free of charge; full text articles can be viewed for a fee.
The New England Journal of Medicine
Many abstracts and full text articles to view without a fee.
Specialties & Topics ;
Infectious Disease
Gastroenterology
The World Journal of Gastroenterology
Abstracts, and full text articles to view, again without a fee.
List Of All Peer-Reviewed Journals
ACS Publications
Accounts of Chemical Research
ACS Chemical Biology
Analytical Chemistry
Biochemistry
Bioconjugate Chemistry
Biomacromolecules
Chemical Research in Toxicology
Chemical Reviews
Chemistry of Materials
Crystal Growth & Design
Energy & Fuels
Environmental Science & Technology
Industrial & Engineering Chemistry Research Inorganic Chemistry
Journal of Agriculture and Food Chemistry
Journal of the American Chemical Society
Journal of Chemical & Engineering Data
Journal of Chemical Information and Modeling
Journal of Chemical Theory and Computation
Journal of Combinatorial Chemistry
Journal of Medicinal Chemistry
Journal of Natural Products
The Journal of Organic Chemistry
The Journal of Physical Chemistry A
Journal of Proteome Research
Langmuir
Macromolecules
Molecular Pharmaceutics
Nano Letters
Organic Letters
Organic Process Research & Development
Organometallics
Alcohol
Acupuncture in Medicine
Alcoholism: Clinical and Experimental Research
American Association of Pharmaceutical Scientists Journals
Pharmaceutical
Research
PharmSci Tech
AHA Scientific Publishing
Arteriosclerosis, Thrombosis, and Vascular Biology
Circulation
Circulation Research
Hypertension
Stroke
AMA Publications
Archives of Internal Medicine
Archives of Neurology
Archives of Ophthalmology
Archives of Otolaryngology-Head & Neck Surgery
Archives of Pediatrics & Adolescent Medicine
Archives of Surgery
JAMA
The American Institute of Physics Online Journal Service
The American Journal of Clinical Nutrition
American Journal on Mental Retardation
American Physical Society Journals
Physical Review Letters
Other APS Research Journals
American Society of Nephrology Journals
Journal of the American Society of Nephrology
Clinical Journal of the American Society of Nephrology
Annals of Emergency Medicine
Annals of Internal Medicine The Annals of Thoracic
Surgery -->
Annual Review of Biochemistry
Arthritis Research
BioScience
BMJ
Breast Cancer Research
Canadian Association of Radiologists Journal
Canadian Journal of Rural Medicine
Canadian Journal of Surgery
Canadian Medical Association Journal (CMAJ)
Cancer
Catheterization and Cardiovascular Interventions
Chinese Science Bulletin
Cell Press
Cancer Cell
Cell
Chemistry & Biology
Current Biology
Developmental Cell
Molecular Cell
Structure
Immunity
Neuron
CHEST
Cold Spring Harbor Laboratory Press
Genes and Development
Genome Research
Learning & Memory
Conservation Biology
Critical Care
Current Research in Social Psychology
Drug and Alcohol Dependence
Deutsches Ă„rzteblatt International
Electronic Journal of Biotechnology
Endocrine-Related Cancer
European Journal of Enocrinology
Federation of American Societies for Experimental Biology
Frontline Gastroenterology
Gastroenterology
Hand Surgery
IEEE Intelligent Systems
Intellectual and Developmental Disabilities
International Journal of Modern Physics A Internet Archaeology
Investigative Ophthalmology & Visual Science
JAMA
The Journal of Biological Chemistry
Journal of Biological Systems
Journal of Clinical Investigation
Journal of Clinical Oncology
Journal of Endocrinology
The Journal of Intelligent Systems
Journal of Molecular Endocrinology
Journal of Neurosciencee
Journal of Psychiatry & Neuroscience
Journal of the National Cancer Institute Journal of International
Wildlife Law & Policy
Journal of Rehabilitation Research and Development
Journal of Vascular and Interventional Radiology
Journal of Vision
Journal of Young Investigators
The Lancet
Liebert Publications
AIDS Patient Care and STDs
AIDS Research and Human Retroviruses
Alternative & Complementary Therapies
Antioxidants & Redox Signaling
ASSAY and Drug Development Technologies
Astrobiology
Bariatric Nursing and Surgical Patient Care
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science
Biotechnology Law Report
Breastfeeding Medicine
Cancer Biotherapy & Radiopharmaceuticals
Cell Preservation Technology
Cloning and Stem Cells
CyberPsychology & Behavior
Diabetes Technology & Therapeutics
Disease Management
DNA and Cell Biology
Election Law Journal
Environmental Engineering Science
Foodborne Pathogens and Disease
Gaming Law Review
Genetic Testing
Genetic Engineering & Biotechnology News
High Altitude Medicine & Biology
Human Gene Therapy
Hybridoma
Industrial Biotechnology
Journal of Aerosol Medicine
Journal of Alternative and Complementary Medicine
Journal of Child and Adolescent Psychopharmacology
Journal of Computational Biology
Journal of Endourology
Journal of Gynecologic Surgery
Journal of Interferon & Cytokine Research
Journal of Laparoendoscopic & Advanced Surgical Techniques
Journal of Medicinal Food
Journal of Neurotrauma
Journal of Ocular Pharmacology and Therapeutics
Journal of Palliative Medicine
Journal of Women's Health
Lymphatic Research and Biology
Medical Acupuncture
Metabolic Syndrome and Related Disorders
Microbial Drug Resistance
Obesity Management
Oligonucleotides
OMICS: A Journal of Integrative Biology
Pediatric Asthma, Allergy & Immunology
Photomedicine and Laser Surgery
Rejuvenation Research
Stem Cells and Development
Surgical Infections
Sustainability: The Journal of Record
Telemedicine and e-Health
Thyroid
Tissue Engineering, Parts A, B, C
Vector-Borne and Zoonotic Diseases
Viral Immunology
Zebrafish
Planned Giving Mentor
Planned Giving Today
Molecular Biology of the Cell
Modern Physics Letters A
Modern Physics Letters B
Nature
Neurology
New England Journal of Medicine
NRC Research Press
Canadian Journal of Forest Research
Canadian Journal of Physics
The Ohio Academy
of Science -->
Physiological Genomics
Population Council
Population and Development Review
Studies in Family Planning
Proceedings of the National Academy of Sciences
Reproduction
Respiratory Research
Science
World Journal of Gastroenterology
List can be found at; http://www.eurekalert.org/links.php?jrnl=A
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