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TAG Releases Updated Guide to Hepatitis C Clinical Trials

The Treatment Action Group (TAG) has produced an updated edition of its guide for people considering participating in clinical trials of new therapies for hepatitis C. Written by Matt Sharp and Tracy Swan, the revised Guide to Clinical Trials for People with Hepatitis C provides an overview of the drug development process, along with information about specific types of HCV treatment.

Clinical trials are the process of studying medications intended for treating infections and other diseases. The process includes a complex, systematic protocol intended to provide data that hopefully will show positive safety and effectiveness outcomes. But while the process may be tedious for the investigators and clinic staff, it is even more daunting for the person who is being studied.

New drugs for HCV are flooding the clinical trial pipeline, including some that may completely cure the disease. Older drugs used today may also cure hepatitis C, but they are not friendly at all, and they take such a toll on people that they are imperfect, to say the least. In the meantime, the decision about whether to enter a trial is difficult, and there is little guidance for people who need and want to treat their hepatitis C.

The Treatment Action Group's Hepatitis/HIV Project, under the guidance of Tracy Swan, has issued the second edition of its Guide to Clinical Trials for People with Hepatitis C so that people will have more information about whether or not to participate in a clinical trial, and which trial or trials might be best for them. With the myriad decisions to be made upon entering a trial, especially with a complicated disease such as hepatitis C, this guide will hopefully make it easier.

Eight chapters describe in an easy-to-read format HCV disease, the clinical trial process, hepatitis C therapy -- including drug resistance, treatment adherence, and side effects -- decision-making, and the rights and responsibilities and risks and benefits of trial participation. Also translated into Spanish, the guide is easy to read and understand from a patient point of view, while providing a comprehensive overview of the complexities of hepatitis C treatment.

The revised guide is available through TAG’s website:

• Guide to Clinical Trials for People with Hepatitis C
• Guía sobre ensayos clínicos para personas con hepatitis C

2/1/13

Reference

Treatment Action Group (www.treatmentactiongroup.org). Guide to Clinical Trials for People with Hepatitis C.January 2013.