Optimizing Outcomes by Helping Patients Through Peginterferon/Ribavirin Therapy

Optimizing Outcomes by Helping Patients Through Peginterferon/Ribavirin Therapy

Over the past 5 years, significant advances have been achieved in the treatment of chronic hepatitis C virus (HCV) infection. The current standard of care is combination therapy with Peginterferon/ribavirin (PEG IFN/RBV). The results of recent clinical trials indicate that sustained virologic response (SVR) may be achieved in approximately 54% to 56% of patients treated with PEG IFN/RBV for 48 weeks. More importantly, long-term studies suggest that these SVRs are durable, consistent with HCV eradication, and may lead to regression of HCV-related liver disease among successfully treated patients. Thus, antiviral therapy is now quite effective. The primary factor that now limits treatment outcomes is medication-related toxicity.

To achieve successful outcomes, adherence to HCV treatment is critically important. Not surprisingly, adherence to the recommended doses and duration of therapy, particularly RBV, has been shown to correlate with the likelihood of SVR. Unfortunately, adherence to PEG IFN/RBV may be undermined by treatment-related side effects that prompt physicians to reduce treatment doses or discontinue therapy, and by poor treatment tolerability leading to patient dropout. Common treatment-limiting side effects include hematologic effects (ie, anemia, neutropenia, thrombocytopenia), fatigue, neuropsychiatric effects (eg, depression, insomnia, irritability), and other side effects (eg, rash, cough, dyspnea, weight loss). While psychiatric side effects were the most common reason for treatment discontinuation, hematologic side effects were most frequently the reason for dose modifications of PEG IFN/RBV in large clinical trials.

To optimize outcomes with current therapies for HCV infection, prompt recognition and aggressive management of adverse effects are essential to increase treatment adherence and tolerability. Fortunately, many side effects can be managed, which improves quality of life for the patient. It has not yet been confirmed that the decreased need for treatment discontinuation and dose reduction will improve SVR, but this makes intuitive sense.

Dear Colleague:

PEG IFN/RBV is a highly successful treatment for hepatitis C, producing sustained virologic response (SVR) in more than half of all treated patients. However, virtually all patients experience side effects, most commonly in the early weeks of therapy. These side effects may result in dose reduction or treatment discontinuation, which decreases the likelihood of successful treatment outcome.

In this Tx Reporter, Mark S. Sulkowski, MD, describes evolving strategies for management of PEG IFN/RBV side effects. These strategies minimize the need for dose reduction or treatment discontinuation, and can improve patient motivation. Physicians can thereby make therapy more tolerable, improve treatment adherence, and give each patient the best chance of achieving treatment goals.

I hope you find this newsletter informative, and that the strategies presented herein enhance patient acceptance of treatment and overall care.

Chair John G. McHutchison, MD Director, GI/Hepatology Research Duke Clinical Research Institute Division of Gastroenterology Duke University Medical Center Durham, North Carolina

Faculty Ira M. Jacobson, MD Chief, Division of Gastroenterology and Hepatology Vincent Astor Professor of Clinical Medicine Weill Medical College of Cornell University New York Presbyterian Hospital New York, New York
Mark S. Sulkowski, MD Assistant Professor of Medicine Division of Infectious Diseases Medical Director, Viral Hepatitis Center Johns Hopkins University School of Medicine Baltimore, Maryland

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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 strategies to prevent and manage side effects of antiviral therapy for hepatitis C in order to promote treatment adherence and maximize treatment outcomes.

Learning Objectives
After completing this activity, the physician should be able to:

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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 1 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 1 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).

Ira M. Jacobson, MD, has received grant/research support from InterMune Inc, Isis Pharmaceuticals, Inc, Prometheus Laboratories, Inc, Ribozyme Pharmaceuticals, Inc, and Schering-Plough Corporation; is a consultant for Akros Pharma Inc, Amgen Inc, Centocor, Inc, InterMune Inc, Ortho Biotech Products, LP, Prometheus Laboratories, Inc, and Schering-Plough Corporation; and is on the speakers bureau of Gilead Sciences, Inc, 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.

Mark S. Sulkowski, MD, has received grant/research support from Amgen Inc, Ortho Biotech Products, LP, Roche Pharmaceuticals, and Schering-Plough Corporation; is a consultant for Bristol-Myers Squibb Company; and is on the speakers bureau of Ortho Biotech Products, LP, Roche Pharmaceuticals, and Schering-Plough Corporation.

There will be no discussion of labeled/unapproved uses of drugs or devices in this activity.

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
Amgen Inc.

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