First long-acting injectable treatment for HIV represents an exciting step forward, should be optimized with equity, investment

Dr. Rajesh Gandhi is the Co-Director of the Harvard Center for AIDS Research and the site leader of the MGH Clinical Research Site in the Harvard/Miriam AIDS Clinical Trials Unit and a scientific member of the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents and the International Antiviral Society USA Panel on Antiretroviral Drugs for Treatment and Prevention. The Chair of the HIV Medicine Association (which, with IDSA, produces this blog) Dr. Gandhi has provided HIV care and studied HIV treatment through clinical trials for more than 25 years. Here he discusses the approval of the first long-acting injectable treatment for people living with HIV, announced by the U.S. Food and Drug Administration Jan. 21.

Antiretroviral treatments that control HIV, prevent illness and transmission, and that have turned HIV into a chronic, manageable condition have continued to improve over the last 25 years. Can you explain the significance of the FDA approval of the first long acting injectable treatment, Cabenuva?

Being able to offer some patients the option to replace their daily pill regimen with a monthly injection is an exciting and important step forward. It holds out the promise of simplifying HIV treatment for some patients who want to receive it; by potentially preventing missed doses, long-acting therapy can help treatment to be more consistent – and, therefore, more effective. Not having to take a daily pill can also help to reduce the stigma still experienced by too many people with HIV.

Now that it has been approved, what has to happen next?

Delivery systems and direct resources to ensure that the patients who could benefit most from this new treatment option are able to access it will be critical. This includes making sure this treatment will reach people living with HIV in rural areas, as well as those without consistent housing, and with mental health and substance use conditions. The injections will mainly need to be administered in a clinical setting. Meeting patient needs, including for transportation and scheduling that doesn’t interfere with work and family obligations, will be essential to optimizing this advance as well.

Ensuring equitable access to treatment, particularly for Black and Latinx gay men and women of color -- populations disproportionately affected both by high risks of HIV infection and more limited access to health services -- must be a priority.

How will the cost of the new treatment figure into that?

Cost has the potential to be a barrier as it is for other HIV treatments. The wholesale acquisition cost for the initial dose has been reported to be $5,940 for the initial monthly dose with the monthly cost after the initial dose reportedly being $3,960 per month.  While long-acting injectable therapeutics are of high value to some patients with HIV -- value does not equate to affordability or access. So policy makers and federal and private third-party payers are going to have to consider the cost-effectiveness of long-acting treatment. When people who face barriers to consistent treatment can keep the virus suppressed, with one injection a month, the benefits can include reduced risks of transmitting the virus and of getting sick, as well as improved quality of life. Over the long-term, we need to develop policies that promote reasonable drug pricing without compromising drug development to lower medication prices across the board.

Do we know that access to long-acting HIV treatment can accomplish that?

As this, and, I hope other new long-acting modalities become available, it will be important to monitor their use in real world settings and with different populations through clinical research and data registries.

What else do policy makers and clinicians need to consider, to optimize the success of this advance?

While long-acting injectable treatment options, and possibly soon-to-follow long-acting prevention options, offer a critical new tool to advance efforts to end HIV as an epidemic, we must ensure they reduce rather than widen the existing HIV-related health disparities.