BACKGROUND: We assessed annual out-of-pocket (OOP) costs for HIV preexposure prophylaxis (PrEP)-related services among commercially insured individuals in the U.S. before and after the Affordable Care Act (ACA) mandated no cost-sharing in 2021. METHODS: Using data from a large commercial database, we identified persons aged ≥18 years who were prescribed PrEP from 2017-2022. Medical claims for PrEP-related services submitted within one week before each PrEP prescription were extracted using CPT codes. For each service, we calculated the annual proportion of persons incurring OOP costs and associated annual amounts, adjusted to 2022 U.S. dollars. We assessed trends in the proportion of persons with OOP costs for each service from 2019-2022. We also examined the association between OOP cost occurrence and patient demographic characteristics. RESULTS: Among 141,300 PrEP users, we observed decreasing trends in the proportion incurring OOP costs for PrEP ancillary services over the study period. In 2022, OOP costs were incurred by 65.6% for provider visits, 14.3% for HIV testing, and 32.5% for creatinine testing, with mean OOP costs of $54.18, $26.06, and $6.07, respectively. Rural users were more likely to incur costs than urban users. CONCLUSIONS: Despite ACA mandates, many persons received cost-sharing bills for PrEP services. Standardized billing and coding, along with enhanced monitoring and enforcement, could help protect access to evidence-based preventive care.

Preexposure prophylaxis (PrEP) is highly effective in preventing HIV infections and is recommended for people without HIV who are at ongoing risk of HIV acquisition. In 2019, the U.S. launched the "Ending the HIV Epidemic in the U.S." initiative, which aims to reduce by 90 % the number of annual new HIV infections. To monitor progress towards this goal, several national indicators have been established, one of which is PrEP coverage. Several ways to monitor PrEP use have been developed, each with its own advantages and disadvantages. We developed a method to estimate PrEP "need" in the U.S. that could be used as a denominator to estimate PrEP coverage. The "population need for PrEP" (PPN) is estimated based on the number of people needed to treat (NNT) with PrEP to prevent an additional HIV infection in subpopulations whose annual HIV incidence is ≥ 1 %. This is done in three steps: 1) calculating NNT for each transmission group using 1 % incidence threshold and clinical trial-and cohort-generated evidence of the degree of PrEP effectiveness in each transmission group, 2) estimating the proportion of new HIV infections in subpopulations with incidence at least 1 % from epidemiologic data, 3) multiplying estimates from steps 1 and 2 with the number of new HIV infections for each transmission group from Surveillance. The estimates for each transmission group are then added together, and the number of current PrEP users is finally added to this estimate to produce PPN. This method is relatively easy to calculate and can provide public health authorities at the national, state, or local level with pragmatic estimates of PrEP "need" among different demographic or transmission groups, which can help with planning, resource allocation, and monitoring progress.

BACKGROUND: The 2021 update of the CDC clinical guidelines for HIV preexposure prophylaxis (PrEP) recommended both antigen/antibody (Ag/Ab) and RNA testing at PrEP initiation and routine follow-up. We assessed real-world utilization and performance of HIV tests among oral PrEP users. METHODS: An oral PrEP user cohort was constructed using the HealthVerity database that included linked diagnoses, laboratory tests, and prescriptions from December 2018 to August 2023. Data was stratified by guideline pre- (2019-2021) and post-update (2022-2023) periods. For each period, we assessed the agreement between same-day HIV Ag/Ab and RNA results and calculated the false positive rate (FPR) and positive predictive values (PPV) of HIV Ag/Ab and RNA tests compared with adjudicated HIV status. RESULTS: The HIV RNA testing rate for follow-up increased from 16 per 100 person-years (PY) to 123 per 100 PYs after the guideline update. The positivity rate of HIV RNA tests decreased from 1.39% to 0.22%. Overall agreement between Ag/Ab and RNA results remained high. The FPRs of HIV Ag/Ab and RNA testing remained similar, but the PPV of HIV RNA testing for PrEP follow-up decreased from 100% to 67%. We estimated that 8,226 to 9,900 RNA tests would be needed for one HIV diagnosis earlier than would be detected with Ag/Ab testing alone. DISCUSSION: HIV RNA testing did not provide additional value to Ag/Ab testing during routine follow-up of oral PrEP users. Considering the cost and logistical complexity of HIV RNA testing, its use as a routine test during follow-up of oral PrEP users warrants reconsideration.

BACKGROUND: People who use long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) can have ambiguous HIV test results if HIV is acquired during its use. The 2021 CDC PrEP guidelines recommend both HIV antigen/antibody (Ag/Ab) and RNA testing at CAB-LA initiation and follow-up. METHODS: We conducted a cohort study using the HealthVerity database to evaluate the utilization of HIV testing among people who use CAB-LA PrEP. We identified and adjudicated HIV Ag/Ab and RNA tests with a positive result, and estimated the incidence of breakthrough HIV infection or long-acting early viral inhibition (LEVI) syndrome. Testing agreement, false positive test rates, and positive predictive value were explored. RESULTS: Among 384 people who use CAB-LA PrEP with both HIV Ag/Ab and RNA testing with a median follow-up time of 4.2 months, we found one discordant pair with Ag/Ab(-) and RNA(+), and one with Ag/Ab(+) and RNA(-). Among four users with a positive Ag/Ab or RNA test, we identified one who acquired HIV before CAB-LA initiation with both Ag/Ab(+) and RNA(+), one likely false RNA(+), one likely false Ag/Ab(+), and one inconclusive Ag/Ab(+) due to insufficient follow-up. We identified no persons with confirmed breakthrough HIV infection or LEVI syndrome, or with RNA testing resulting in an earlier HIV diagnosis compared with Ag/Ab testing alone. INTERPRETATION: The frequency of breakthrough HIV infection or LEVI syndrome in this real-world cohort was low during initial three to seven months of injectable PrEP use. Ongoing assessment of the added value of HIV RNA testing for monitoring during CAB-LA PrEP use is warranted.

PURPOSE OF REVIEW: Injectable cabotegravir for HIV preexposure prophylaxis (PrEP) is effective, yet global implementation has been slow. We review factors which have contributed to the delayed roll-out of this medication. RECENT FINDINGS: Fifty-three countries have approved cabotegravir for HIV prevention yet roll-out has been slow. Cabotegravir made up 2.5% of all U.S. PrEP prescriptions in 2023 and is very slowly increasing after FDA approval in 2021. Medication has not been available outside of implementation science studies in Africa and Asia. There is a lengthy process for generic medication production despite agreements signed in 2021; the first available generic dose is not anticipated until 2027. In the United States, where some of the cabotegravir medication costs can be covered under individual insurance plans, high costs and medication acquisition pathways for health centers have been complex, contributing to national implementation delays. The intensity of the staffing required for medication acquisition, insurance paperwork filing, process documentation, billing, injection administration, appointment scheduling, missed appointment monitoring and client follow up has burdened healthcare organizations. SUMMARY: Injectable cabotegravir PrEP has not reaped its potential to be an alternative in those for whom adherence to a daily PrEP pill is challenging. Lessons learned regarding cabotegravir medication acquisition pathways and clinical delivery strategies can inform the rollout of future HIV prevention long-acting agents.

Pre-exposure prophylaxis (PrEP) is highly effective in reducing HIV transmission but remains underutilised globally. Same-day PrEP prescribing and medication provision is an emerging implementation approach. The experiences of the three same-day PrEP programmes support the feasibility of the approach. Key elements of safe and effective same-day PrEP programmes include the ability to order laboratory tests at the time of the clinical visit and the ability to contact patients when laboratory results are available. Same-day PrEP has the potential to alleviate the attrition seen in usual care between initial evaluation and receipt of a PrEP prescription. A widespread application of same-day prescribing will be needed to assess its effect on PrEP usage.

Sunscreen use is well recognized as an effective strategy for reducing risk of sunburn, photoaging, and skin cancer.1–3 The US Food and Drug Administration regulates sunscreen as an over-the-counter drug product. In some states, students’ ability to carry or use US Food and Drug Administration–regulated over-the-counter drug products of any kind while on school property is restricted, unintentionally creating barriers to adequate sun protection for students. Realizing this concern, major medical associations have called on schools to allow sunscreen use,4 and some states have passed legislation granting students the ability to carry and self-apply sunscreen while at school. We conducted a content analysis of this state legislation.