An HIV breakthrough is here. Let's not let it go to waste

As Congress nears a January deadline to pass a continuing resolution and avert a government shutdown, critical health programs hang in the balance. The now-expired Affordable Care Act subsidies and proposed cuts to the Ryan White HIV/AIDS program could undermine access to lifesaving services and medications, including Lenacapavir, a breakthrough drug offering new hope in the fight against HIV.

Nearly 40 million people worldwide, and more than one million people in the United States, are living with HIV, with more than 30,000 Americans newly infected each year.

A drug like Lenacapavir has the potential to change that trajectory, preventing the global spread of HIV and saving millions of lives.
Lenacapavir is not new. The antiretroviral drug was first approved in 2022 for treating people living with HIV who were highly resistant to other treatments. Subsequent clinical trials demonstrated it was also highly effective (99.9%) in preventing HIV infection, and, in June, the Food and Drug Administration approved its use as a pre-exposure prophylaxis, or PrEP. Unlike other PrEP options, which require oral pills that can be difficult to take consistently, Lenacapavir offers protection through just two injections a year. This simple regimen promises long-lasting, highly effective protection against HIV.

We are encouraged by the strong support of Lenacapavir by numerous federal agencies. In fact, Dr. Jay Bhattacharya, Director of the National Institutes of Health, has made it a priority for funding. The administration is also working with Lenacapavir’s developer, Gilead Sciences, and other key partners to ensure the medication reaches countries most impacted by the disease.

All of this tremendous progress could be lost, though, if we do not confront the critical gaps in U.S. healthcare, from affordability and access to the logistics of drug delivery. Failing to fully utilize this drug wastes the resources invested in its creation and costs us far more in the long run through preventable illness and death from new HIV infections.

Among the many barriers to delivering Lenacapavir to as many people as possible, cost tops the list. Despite requiring only two injections a year, a full course of Lenacapavir currently costs about $28,000 per year, and insurance coverage is currently spotty at best. CVS Caremark, one of the nation’s largest pharmacy benefit managers, doesn’t carry the drug, citing its price among other concerns.

Recently, there have been strong efforts to negotiate lower prices for drugs, such as anticoagulants, rheumatologic and weight loss drugs like GLP-1s. Given the lifesaving potential of Lenacapavir, continued efforts to advocate for price reductions and ensure broad insurance coverage are important. Encouragingly, Gilead is providing the drug at cost for U.S. distribution to select African countries and licensing it to six pharmaceutical manufacturers to produce low-cost generics. Experts estimate that these generics could be made for just $41-$94 per person annually, which could transform global access. Making this a reality in the United States could also increase utilization.

In addition, if people lose the health care safety nets they rely on, they will not be able to access the medication. Programs like the Affordable Care Act, Medicaid, and the Ryan White HIV/AIDS program, all of which are facing substantial cuts, are lifelines that deliver proven, evidence-based HIV treatment and prevention to those most at-risk, many of whom are often underinsured or uninsured. At this critical juncture in the fight to end the epidemic, dismantling these programs and restricting access to prevention drugs would have substantial health and cost implications.

Finally, we need to deal with systems issues to get the drugs to the right people. Currently, Lenacapavir injections must be administered in clinical settings by nurses or other qualified healthcare providers. Our work through the DC Center for AIDS Research, along with lessons learned from the COVID pandemic, underscores the need to reach vulnerable and at-risk populations where they are. For example, mobile health units could bring Lenacapavir directly to underserved neighborhoods or rural communities. Equally important, we could train community health workers or local pharmacists to safely administer Lenacapavir.

While the obstacles we face may be significant, Lenacapavir represents a monumental breakthrough in the fight against HIV/AIDS, one we can not afford to squander. The urgency to develop a robust and equitable strategy to expand access to this drug and curb the spread of HIV has never been clearer.

Dr. Kelly Gebo is the Michael and Lori Milken Dean of the Milken Institute School of Public Health at the George Washington University. Dr. Amanda Castel is a Professor in the Department of Epidemiology at GW. Both Dr. Castel and Dr. Gebo’s research focuses primarily on HIV and related infectious disease.

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