Release Date
January 30, 2004
Termination Date
January 30, 2005
Estimated time for completion of this
newsletter: .5 hour
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This independent CME activity is supported by an educational grant
from Bayer HealthCare Diagnostics Division.
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HCV RNA Tests: Differences and Dilemmas
Numerous molecular tests (assays), (also termed Nucleic Acid Tests), are now available to determine HCV RNA and genotype. These measurements are critical in making treatment management decisions: HCV RNA levels indicate whether virus is present or has been cleared, and determine when and whether treatment should be stopped or continued in the setting of antiviral therapies. Genotype predicts the likelihood of a response to antiviral therapy and also guides the treatment duration. Thus, accurate measurements are critical at baseline, throughout treatment, and in the posttreatment period. Since assays vary with regard to range of detection, specificity and sensitivity, as well as other features, it is important to optimize our use of available tests.
Dear Colleague:
Recent technologic advances have improved the accuracy of hepatitis C virus (HCV) assays. Determinations of serum levels of HCV RNA and genotype, using these new technologies, allow for more accurate diagnosis and monitoring, and thus, more sophisticated and individualized management. With new, highly sensitive, qualitative and quantitative virologic RNA tests, we can now accurately predict sustained virologic response (SVR) (or lack thereof ) to antiviral therapy by measuring whether a patient has had a 2-log reduction in HCV RNA at week 12 of therapy. Viral clearance can be confirmed at the end of treatment and 6 months posttreatment with newer, highly sensitive qualitative tests.
In this CME newsletter, HCV RNA Tests: Differences and Dilemmas, Dr. Gish explains the strengths, limitations, and best uses of available virologic tests and provides a guideline for a cost-effective management of antiviral therapy. Taken together, these strategies will help increase a patient's chances of successful treatment of hepatitis C viral infection.
I hope you find this informative publication valuable to your patient care.
Sincerely,
Chair
John G. McHutchison, MD
Director, GI/Hepatology Research
Duke Clinical Research Institute
Division of Gastroenterology
Duke University Medical Center
Durham, North Carolina |
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| Faculty
Robert G. Gish, MD
Medical Director
Liver Transplant Program
California Pacific Medical Center
San Francisco, California
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Target Audience
This activity is designed for gastroenterologists and hepatology healthcare professionals who treat patients with hepatitis C.
Activity Goal
The goal of this activity is to discuss recent advances in HCV molecular testing, and to describe advantages, limitations, and best clinical uses of specific HCV RNA and genotyping assays now available.
Learning Objectives
After completing this activity, the physician should be able to:
- Implement management strategies for HCV-infected patients based on results of molecular testing.
- Predict response based on early virologic quantifications.
- Compare the strengths and limitations of available qualitative and quantitative HCV RNA assays and genotyping assays.
- Recognize the importance of the dynamic range of detection of various assays in determining response and confirming viral clearance.
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CME Information
Statement of Accreditation
Projects In Knowledge is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Credit Designation
Projects In Knowledge designates this educational activity for a maximum of .5 category 1 credit toward the AMA Physician's Recognition Award. Each physician should claim only those credits that he/she actually spent in the activity.
This newsletter is planned and implemented as an independent CME activity in accordance with the ACCME Essential Areas and Policies.
Successful completion for .5 hour of CME credit requires a passing score of 70% or higher on the posttest. Full instructions for submission are included on the posttest at the end of this newsletter.
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Disclosure Information
The Disclosure Policy of Projects In Knowledge requires that faculty participating in a CME activity disclose to the audience: any significant relationship they may have with a pharmaceutical or medical equipment company, product, or service that may be mentioned as part of their presentation; any relationship with the commercial supporter of this activity; if discussion includes 1) therapies that are unapproved for use or are investigational; 2) ongoing research; or 3) preliminary data. Faculty will disclose such discussion.
For complete prescribing information on the products discussed during this CME activity, please see your current Physicians' Desk Reference (PDR).
Robert G. Gish, MD, has received grant/research support from, is a consultant for, and is on the speakers bureau of Amgen Inc, Bayer, Bayer Diagnostics, NAD, Ortho Biotech Products, LP, InterMune Inc, Roche Pharmaceuticals, and Schering-Plough Corporation.
John G. McHutchison, MD, has received grant/research support from Akros Pharma Inc, Amgen Inc, Bayer, Biomedicines, Bristol-Myers Squibb Company, Cytel Corporation, Fujisawa Healthcare, Inc, Gen-Probe, Gilead Sciences, Inc, IDUN, Isis Pharmaceuticals, Inc, Ortho Diagnostics, Prometheus Laboratories, Inc, Ribozyme Pharmaceuticals, Inc, Roche Pharmaceuticals, Schering-Plough Corporation, SciClone Pharmaceuticals, Triangle Pharmaceuticals, Inc, and Vertex Pharmaceuticals; is a consultant for Amgen Inc, Anadys Pharmaceuticals, Inc, Centocor, Inc, GlaxoSmithKline, InterMune Inc, Isis Pharmaceuticals, Inc, National Genetics Institute, Novartis Pharmaceuticals Corporation, Pfizer Inc, Prometheus Laboratories, Inc, Ribozyme Pharmaceuticals, Inc, and Schering-Plough Corporation; and is on the speakers bureau of InterMune Inc, Roche Pharmaceuticals, and Schering-Plough Corporation.
The opinions expressed in this activity are those of the faculty and do not necessarily reflect those of Projects In Knowledge.
This CME activity is provided by Projects In Knowledge solely as an educational service. Specific patient care decisions are the responsibility of the physician caring for the patient.
This independent CME activity is supported by an educational grant
from Bayer HealthCare Diagnostics Division.
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