On June 14, 2013 The U.S. Food and Drug Administration (FDA) held a public meeting on HIV (human immunodeficiency virus) patient-focused drug development and cure research, in Silver Spring, Maryland. The FDA sees to it that drugs are safe and used effectively by enforcing the Food, Drug, and Cosmetic Act as well as the Public Health Service Act.
Patients affected with the virus drove the discussion. The FDA was interested in getting the patient’s perspective in terms of how HIV impacts their daily life, current available therapies to treat the virus, and cure research.
Topics and Questions
The panelist started off the discussion to begin a facilitated dialogue between the guests and audience members upon the presentation of each subject. Topic 1 was patients’ perspective on current approaches to managing HIV and on symptoms experienced because of HIV or its treatment. The questions included:
- What are you currently doing to help manage your HIV and any symptoms you experience because of your condition or other therapies?
- How well does your current treatment regimen treat any significant symptoms of your condition?
- What are the most significant downsides to your current therapies or treatments, and how do they affect your daily life?
- Of all the symptoms that you experience because of your condition, or because of your therapy or treatment, which 1-3 symptoms have the most significant impact on your life?
- Assuming there is currently no complete cure for your condition, what specific things would you look for in an ideal therapy or treatment to manage your condition?
Topic 2 was patients’ perspectives on HIV cure research. The questions included:
- What do you believe are the benefits of participating in an HIV cure research study?
- What would motivate you to participate or to not participate in an HIV cure research study?
- What risks would you find unacceptable for participating in an HIV cure research study, and why?
- In certain HIV cure research studies, you would be asked to stop any other HIV medications that you are currently taking. How would this affect your decision whether to participate in an HIV cure research study?
- What else do you want FDA to know about HIV Cure Research from your perspective?
Members of the public were invited to submit their own responses to the questions via written format or electronically.