Public FDA Meeting to Address Antiretroviral Therapy for Patients With ‘Limited’ Treatment Options
The public is invited to attend a Jan. 11 FDA Antiviral Drugs Advisory Committee meeting discussing clinical trial design issues pertaining to the development of antiretroviral treatment for patients with "limited treatment options." The meeting will address the challenges of evaluating the safety and effectiveness of new antiretroviral therapies in "heavily pretreated patients" -- patients who have experienced a "loss or lack of virologic response with at least two previous antiretroviral regimens that consisted of drugs from the approved drug classes nucleoside and non-nucleoside reverse transcriptase inhibitors and protease inhibitors." The forum intends to explore "practical" methods of facilitating and promoting development of new therapies for patients "most in need of additional treatment options." The meeting aims to identify appropriate trial designs, control arms and study endpoints for developing new therapies intended for this group of patients. The meeting will be held in the Versailles Ballroom of the Holiday Inn in Bethesda, Md. For more general information on the event, please contact Richard Klein at the Office of Special Health Issues (e-mail Rklein@oc.fda.gov) ( HIV and Hepatitis.com, 12/11).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.