There were modest increases in HIV PEP prescribing between 2015 and 2023 in the United States, particularly toward bictegravir-based regimens, highlighting the need for dynamic guidelines and expanded community and clinician education.
The number of individuals prescribed HIV post-exposure prophylaxis (PEP) in the United States more than doubled between 2015 and 2023, with a significant shift toward bictegravir-based regimens, according to study findings published in Clinical Infectious Diseases.
Researchers from the Centers for Disease Control and Prevention (CDC) analyzed national prescription data to characterize demographic trends and prescribing patterns among PEP users and to assess the adoption of bictegravir plus emtricitabine and tenofovir alafenamide (BIC/FTC/TAF), a regimen not included in the CDC’s 2016 guidelines but recently added to the 2025 update.
The researchers conducted a retrospective, population-based cohort study using IQVIA Real World Data — Longitudinal Prescriptions, encompassing retail and mail-order pharmacies that capture the majority of prescription activity in the US. Adults aged 16 years and older who were prescribed CDC-recommended PEP regimens or BIC/FTC/TAF between 2015 and 2023 were included.
A total of 44,934 individuals were prescribed PEP in 2023, up from 20,618 in 2015. The annual number of bictegravir-based prescriptions rose sharply after the drug’s 2018 US Food and Drug Administration approval, from 1377 prescriptions (4.1% of total PEP users) in 2018 to 7536 (16.8%) in 2023. Most (88.4%) patients were prescribed a full 28- to 30-day course, consistent with CDC recommendations.
In 2023, 53.8% of PEP users were men and 39.8% were aged 25 to 34 years. Nearly two-thirds of all users were aged between 25 and 44 years, and 42.6% had private health insurance. A higher proportion of bictegravir-based prescriptions were found among men (68.3%) compared with CDC-recommended regimens (50.8%). Conversely, use of assistance programs was more common among bictegravir recipients (17.6%) than among those prescribed guideline-based therapy (2.1%). Full-course completion was also higher among bictegravir users (92.3%) than CDC regimen users (87.6%).
Geographically, the prevalence of PEP prescriptions varied widely. The District of Columbia had the highest PEP prevalence at 68.7 per 100,000 individuals, followed by New York (34.5) and Massachusetts (30.7). The lowest rates were observed in Idaho (4.9). PEP-to-diagnosis ratios, a metric comparing PEP prescriptions with new HIV diagnoses, were highest in Massachusetts (4.2) and New Hampshire (3.5), and lowest in states including Oklahoma (0.5), South Carolina (0.6), and Mississippi (0.6).
The researchers noted that overall PEP prescribing declined briefly in 2020, likely reflecting pandemic-related disruptions in sexual health services and occupational exposures, before rebounding through 2023. The increased use of bictegravir-based PEP regimens may reflect clinician preference for its once-daily dosing, tolerability, and coformulated simplicity.
Study limitations include the inability to distinguish occupational from nonoccupational PEP, incomplete race and ethnicity data, and potential misclassification of short-course HIV treatments as PEP prescriptions.
The researchers concluded, “These findings underscore the need for living PEP guidelines and expanded community and clinician education.”
Disclosure: This research was conducted by the Division of HIV Prevention at the CDC.
By Hibah Khaja, PharmD
References:
Le JN, Zhu W, Huang YA, et al. Trends in persons prescribed HIV postexposure prophylaxis in the United States, 2015-2023. Clin Infect Dis. Published online October 16, 2025. doi:10.1093/cid/ciaf581
Source : Infectious Disease Advisor
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