Gilead’s HIV Shot Gains Traction, but Insurance Issues Persist

News desk: Gilead Sciences’ Yeztugo, a twice-yearly HIV prevention shot, is gaining traction in the US market, though insurance gaps and reimbursement issues remain barriers to broader access.

Yeztugo, the brand name for lenacapavir, was approved by the US Food and Drug Administration in June 2025 as the first HIV pre-exposure prophylaxis (PrEP) option offering six months of protection. Administered twice a year, the drug is intended for adults and adolescents at risk of sexually acquired HIV-1 infection.

The approval marked a major scientific milestone. Clinical data from the PURPOSE 1 and PURPOSE 2 trials demonstrated strong protection against HIV infection. The CDC reported that lenacapavir showed 100% efficacy among females and 96% efficacy in a primarily male trial population over 52 weeks.

Early adoption and insurance challenges

Early prescription data indicates growing interest in the drug. According to Reuters, more than 9,000 prescriptions were written for Yeztugo injections in the first quarter of 2026. While this is a promising start, it remains far below established PrEP options, such as Descovy, which recorded around 461,000 prescriptions, and Apretude, a two-month injectable PrEP option, which recorded about 32,000 prescriptions during the same period.

Despite this early interest, the adoption of Yeztugo highlights a significant challenge in the US healthcare system: access largely depends on how insurers and pharmacy benefit managers (PBMs) classify and reimburse the drug.

Gilead has reported that over 90% of insurers cover Yeztugo. However, coverage does not always equate to easy access. Some plans treat the drug as a medical benefit, rather than a pharmacy benefit, meaning clinics may need to buy the drug upfront and seek reimbursement later. This creates financial strain for smaller clinics, who often have limited cash flow.

Cost and coverage complications

Cost remains another major issue. Reuters reported that Yeztugo has a US list price of over $14,000 per injection, totaling more than $28,000 per year. In comparison, daily generic PrEP pills are significantly less expensive. This price disparity has made some insurers and PBMs cautious, despite Yeztugo’s potential for better adherence, especially for patients who struggle with daily medications.

CVS Caremark, one of the largest US pharmacy benefit managers, initially hesitated to cover Yeztugo due to clinical, regulatory, and financial concerns. However, by January 2026, CVS added the drug to its commercial insurance coverage lists, bringing overall insurer coverage to more than 80%.

Even with this progress, patient access remains uneven. Some patients face prior authorization requirements, high co-payments, deductibles, or delays, depending on their insurer. Furthermore, standard no-cost preventive coverage is still uncertain, as the US preventive services recommendation for PrEP has not yet been updated to specifically include Yeztugo.

Patient support and insurance programmes

For uninsured or underinsured patients, Gilead offers support through its Advancing Access program. The company states that eligible commercially insured patients may pay as little as zero dollars through its co-pay savings program. Additionally, qualified patients may receive selected Gilead medications at no cost through patient assistance initiatives.

A difficult balance for insurers

For insurers, Yeztugo presents a difficult balance. The drug could improve adherence and reduce future HIV-related healthcare costs, but its high upfront price and complex administration model create short-term budget and reimbursement concerns.

Public health implications

For public health officials, the stakes are high. A twice-yearly PrEP injection could help reach people who are unable or unwilling to continue daily oral medications. However, unless insurance coverage becomes more consistent and clinics are properly reimbursed, the drug’s real-world impact may not live up to its clinical promise.

Yeztugo may become an important tool in HIV prevention, but its success will depend not only on scientific innovation but also on whether insurers, PBMs, healthcare providers, and public health programs can collaborate to turn this breakthrough into affordable, practical access for at-risk populations.