The second meeting under FDA's Patient-Focused Drug Development initiative has raised a conundrum for the agency and HIV companies. As the HIV population grows older and has more age-related co-morbidities, the need for drugs that eradicate the virus and offer a cure has increased. Yet patients who have managed their disease often are unwilling to risk going off their standard antiretroviral regimens to enroll in trials testing HIV cure strategies.

FDA did not say how it plans to address patient concerns with HIV cure research. However, two biotechs told BioCentury they have trial designs in place to reduce the perceived risk of participating.