The FDA has approved Gilead’s new HIV prevention drug, lenacapavir, which is a twice-a-year injectable medication proven to prevent new infections in clinical trials. Marketed under the name Yeztugo, the drug will be sold for an annual price of $28,218, or $14,109 per injection. Gilead assures that this pricing is comparable to existing HIV prevention drugs, and the company will collaborate with insurers to ensure broad coverage for the drug.
Advocates view the long-acting medication as promising due to its convenience compared to daily HIV prevention drugs. Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, described the option of a twice-a-year injectable as a “game changer” not just for the U.S., but globally.
Gilead officials are excited about the FDA’s approval of lenacapavir, a product that has been researched and developed over almost two decades. Daniel O’Day, chairman and CEO of Gilead Sciences, sees this as a significant opportunity to combat the HIV epidemic, emphasizing the drug’s effectiveness and the new approach it offers in HIV prevention.
Compared to other HIV prevention drugs like Truvada, Descovy, and Apretude, which require daily or bi-monthly doses, lenacapavir’s twice-a-year injection may improve adherence rates among users, according to Gilead’s chief commercial officer, Johanna Mercier. Dr. Paul Sax of Brigham and Women’s Hospital noted that the convenience of the new drug may appeal to those who struggle with adherence to daily pills.
Studies have shown that lenacapavir is highly effective in preventing HIV infections, with a 100% success rate in women and adolescent girls in sub-Saharan Africa and Uganda, and a 96% reduction in infection rates among cisgender men and gender-diverse individuals across various countries.
Gilead aims to work with insurers and payers to ensure broad coverage for Yeztugo, acknowledging the importance of making the drug accessible to those who need it.
The U.S. Preventive Services Task Force has given an “A” rating to PrEP medications when prescribed to adolescents and adults at higher risk of HIV. This rating means that under the Affordable Care Act, insurers are required to fully cover the costs of the medication as a preventive measure. However, activists have pointed out that some insurers have still imposed copays and other expenses for necessary lab tests and medical visits. Individuals must test negative for HIV before starting PrEP and continue with routine testing for HIV, other sexually transmitted infections, and kidney health while on the treatment.
Insurance coverage for medications like lenacapavir is crucial for ensuring access to these drugs. Some insurance companies may be more inclined to cover generic versions of the daily PrEP pills, which can be more affordable compared to the brand-name options.
It’s important to note that the Supreme Court’s decisions may impact access to this HIV prevention medication for individuals engaging in gay sex. Globally, over 1 million new HIV cases occur each year, with an estimated 10 million individuals worldwide needing to take PrEP to align with global HIV prevention targets. Despite this, only around 2.5 million people are currently using PrEP.
In the U.S., the Centers for Disease Control and Prevention reported over 39,000 new HIV diagnoses in 2023, resulting in more than 4,700 deaths attributed to the virus. Research indicates that as many as 2.2 million Americans could benefit from HIV prevention medications, with the majority of new cases affecting men, particularly gay or bisexual men. Disparities exist in PrEP uptake, with White patients being more likely to use it compared to Black or Latino patients, despite lower infection rates among White individuals. The Southern region of the U.S. sees more than half of new HIV cases.
Efforts are being made to reduce these numbers and work towards a future where zero infections are reported. The FDA’s approval of a new twice-yearly HIV shot aims to contribute to the end of the HIV epidemic.
