In recent years, phylogenetic analysis of HIV sequence data has been used in research studies to investigate transmission patterns between individuals and groups, including analysis of data from HIV prevention clinical trials, in molecular epidemiology, and in public health surveillance programs. Phylogenetic analysis can provide valuable information to inform HIV prevention efforts, but it also has risks, including stigma and marginalization of groups, or potential identification of HIV transmission between individuals. In response to these concerns, an interdisciplinary working group was assembled to address ethical challenges in US-based HIV phylogenetic research. The working group developed recommendations regarding (1) study design; (2) data security, access, and sharing; (3) legal issues; (4) community engagement; and (5) communication and dissemination. The working group also identified areas for future research and scholarship to promote ethical conduct of HIV phylogenetic research.

IMPORTANCE With the goal of ending the HIV epidemic in the United States, access to HIV pre-exposure prophylaxis (PrEP) is essential to help curb new HIV infections. There has been differential uptake of PrEP by region, with the South lagging behind other regions. Discriminatory benefit design (benefit design that prevents or delays people with complex or expensive conditions from obtaining appropriate treatment) through prior authorization requirements could be a systemic barrier that contributes to the decreased PrEP uptake in the South.OBJECTIVES To investigate whether there are regional disparities in prior authorization requirements for combined tenofovir disoproxil fumarate and emtricitabine for qualified health plans (QHPs) and to assess whether any QHP characteristics explain the disparities. DESIGN, SETTING, AND PARTICIPANTSThis design was a cross-sectional study of QHPs offered in the 2019 Affordable Care Act Marketplace. The QHPs studied included all Affordable Care Act-compliant individual and small-group market plans in the United States. EXPOSURES The primary exposure was the 4 census regions (Northeast, West, Midwest, and South). Additional covariates included other plan characteristics. MAIN OUTCOMES AND MEASURES Prior authorization requirement for combined tenofovir disoproxil fumarate and emtricitabine at the QHP level. RESULTSIn total, 16 853 QHPs were analyzed (18.2% in the Northeast, 19.5% in the West, 25.0% in the Midwest, and 37.3% in the South). Overall, 18.9% of QHPs required prior authorization for combined tenofovir disoproxil fumarate and emtricitabine. This percentage varied by region, with 2.3%, 6.2%, 13.3%, and 37.3% of plans requiring prior authorization in the Northeast, West, Midwest, and South, respectively. Compared with QHPs in the Northeast, QHPs in the South were 15.89 (95% CI, 12.57-20.09) times as likely to require prior authorization, whereas the Midwest and West were 5.69 (95% CI, 4.45-7.27) and 2.65 (95% CI, 2.02-3.47) times as likely, respectively. Other plan characteristics did not account for the regional variation. CONCLUSIONS AND RELEVANCECompared with QHPs in the Northeast, QHPs in the South were almost 16 times as likely to require prior authorization for PrEP, and the reasons for these disparities are unknown. The prior authorization requirement is a possible barrier to PrEP access in the South, which is the region of the United States with the most annual new HIV diagnoses. There is limited regulation of QHPs' prior authorization requirements. Federal-or state-level health policy laws may be necessary to remove this system-level barrier to ending the HIV epidemic in the United States.

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The U.S. has the tools to end the HIV epidemic, but progress has stagnated. A major gap in U.S. efforts to address HIV is the under-utilization of medications that can virtually eliminate acquisition of the virus, known as pre-exposure prophylaxis (PrEP). This document proposes a financing and delivery system to unlock broad access to PrEP for those most vulnerable to HIV acquisition and bring an end to the HIV epidemic.

On December 20, 2021, the US Food and Drug Administration (FDA) approved long-acting cabotegravir, the first injectable medication to prevent HIV. Two randomized clinical trials that together included 7790 study participants demonstrated that long-acting cabotegravir was more likely to prevent HIV acquisition than daily oral medication for people at risk of sexually acquiring HIV, including men who have sex with men, heterosexual women, and transwomen. 1 The advantage of the medication was attributed partly to the high efficacy of this and other integrase inhibitors and, in part, to better adherence for an injection compared with a once-daily pill regimen; whether this advantage remains outside of clinical trials remains unknown. It is hoped that this new tool for HIV prevention will accelerate progress toward the US goal of reducing new infections by 90% by 2030. However, the potential for public health benefit is jeopardized by the cost and complexity of the US health care system.The manufacturer of cabotegravir (ViiV Healthcare) set the initial list price for the long-acting drug at $3700 per dose. 2 Therefore, the required 2 doses in the first month and subsequent dosing every other month will cost $22 200 per year. At this price, public and private Policy innovation is necessary for the US to realize the promise of long-acting cabotegravir and future medical advances for HIV prevention.