Long-Acting HIV Treatment and Prevention Are Coming
Preparing for Potential Game Changers
While treatment for HIV infection has become more effective and less complicated in recent years, it still involves taking a pill or pills each day for life. But innovative new products could revolutionize HIV treatment and prevention. Sometimes called long-acting agents, these products may take different forms, ranging from injections to implants to oral medications, and they would not require daily dosing. Some might require a monthly dose, while others could be administered a few times a year.
Taking an idea and turning it into a desirable, effective, affordable, and accessible product is a long and difficult process. To facilitate the analysis and policy decisions needed to advance the process, amfAR has produced a series of reports that describe the critical issues that must be navigated to make these potentially game-changing new products available for people living with HIV or vulnerable to infection.
A summary of the complex issues policy makers must assess and navigate, such as FDA approval, defining the intended market, and payer coverage and access.
From Laboratory to Marketplace
The FDA will have to determine that these new products are safe and effective, but the complexity of issues related to long-acting products creates substantial obstacles to efficient FDA review.
Policy makers will need to assess a range of critical issues that will influence whether and when individuals can and will choose to use these new products.
To achieve the benefits of innovative products, payers (Medicaid, Medicare, private insurers, the Ryan White HIV/AIDS Program, and others) must be engaged with clinicians, researchers, and consumers to consider how to deploy them.