The US Food and Drug Administration (FDA) has approved Gilead Science’s Yeztugo for the prevention of human immunodeficiency virus (HIV) infection. This is the first and only FDA-approved HIV pre-exposure prophylaxis (PrEP) option offering six months of protection. The approval was based on the Phase III PURPOSE 1 and PURPOSE 2 trials, which showed that more than 99% of participants remained HIV-negative on the twice-yearly injectable therapy. Yetzugo is a long-acting HIV-1 capsid inhibitor that reduces the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. Yeztugo will compete with Gilead’s own oral PrEP therapies Truvada and Descovy, as well as ViiV Healthcare’s Apretude, the only other injectable PrEP therapy available in the US. However, Apretude requires more frequent dosing than Yetzugo, as it is typically administered once every two months.
The approval of Yeztugo is a momentous step in improving PrEP options available for people vulnerable to contracting HIV. Currently, the majority of PrEP therapies require daily oral administration. Key opinion leaders (KOLs) previously interviewed by leading data and analytics company GlobalData noted that there is often a psychosocial burden when taking daily PrEP due to stigma, and patients have concerns about others discovering their medication or adherence challenges. Yeztugo could address these key issues. However, KOLs noted that the cost of the drug could be a major barrier to uptake. Gilead has announced the US price of Yeztugo for PrEP at $28,218 per year for each patient. KOLs expressed doubts about whether insurance companies will cover the cost of this drug since generic versions of oral PrEP medications are widely available and much less expensive. Additionally, this situation may be exacerbated by the HIV funding cuts that have been proposed by US President Donald Trump’s administration.
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Furthermore, PrEP usage has not been maximised across the US thus far. According to GlobalData epidemiologists, 437,425 people were on PrEP in the US in 2022, but this figure had the potential to be much higher. In the same year, only 36% of people in the US who met the Centers for Disease Control and Prevention’s (CDC) eligibility criteria for PrEP were prescribed a form of PrEP. CDC data shows that vulnerable populations in the US are not yet using PrEP at rates that could end the transmission of the virus at the population level, with particular gaps for women, Black/African American, and Hispanic/Latino people. Increasing awareness and access will be an important element of reducing HIV through PrEP use and maximising Yetzugo’s sales.
Yeztugo is likely to be approved in other countries shortly, as Gilead has filed for regulatory approval in several markets, including the European Medicines Agency, where it is under accelerated review.
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