UNAIDS estimates that almost 40 million people are infected with HIV-1 worldwide. In 2023, there were 1.3 million new infections and 630,000 HIV-related deaths. An estimated 1.2 million persons in the US currently have HIV, and more than 760,000 persons have died of complications related to HIV since the first cases were reported in 1981.
In 2020, there were an estimated 30,635 new diagnoses of HIV in the US, with 80% of new diagnoses occurring among adolescent and adult men and 18% among adolescent and adult women. Men who have sex with men are most affected by HIV, accounting for 68% of new HIV diagnoses.
Pre-exposure prophylaxis (PrEP) for HIV was first approved in 2012 as a daily pill containing emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead Sciences). On October 3, 2019, the FDA approved a second oral drug for PrEP containing emtricitabine and tenofovir alafenamide (Descovy, Gilead Sciences). It is taken once daily. On December 20, 2021, the FDA approved cabotegravir (Vocabria) that is administered by injection every 2 months. Lenacapavir (Sunlenca, Gilead Sciences) received FDA approval on December 22, 2022. It is a twice-yearly injection for treatment of adults with multi-drug resistant HIV-1 infection.
In 2019, the US Preventative Services Task Force (USPSTF) determined their was strong evidence that PrEP prevented HIV transmission from sex. Transmission of HIV to a seronegative partner from a partner with HIV has not been observed when the partner with HIV was being treated with PrEP. Given the US Preventive Services Task Force grade A rating, the Affordable Care Act mandated insurance coverage of PrEP in 2020 and Medicare is considering full coverage under part B.
The CDC has published a clinical testing algorithm to establish HIV status before the initiation of PrEP in persons without recent antiretroviral prophylaxis use. Laboratory HIV antigen/antibody tests are preferred over rapid antigen/antibody tests because they have the highest sensitivity for detecting acute HIV infection. While HIV-1 RNA testing is sensitive, available assays might yield false-positive low viral load results (e.g., <200 copies/ml) among persons without HIV. Without confirmatory tests, such false-positive results can lead to misdiagnosis of HIV infection.
When clinicians prescribe PrEP based solely on the results of point of care rapid tests, a laboratory antigen/antibody test should always be ordered at the time baseline labs are drawn. This will increase the likelihood of detecting unrecognized acute infection so that the patient can be transitioned from PrEP to antiretroviral treatment (ART) in a timely manner.
Patients prescribed PrEP should undergo HIV testing every three months. The current Centers for Disease Control (CDC) HIV testing algorithm recommends an initial 4th generation HIV Antigen/Antibody (Ag/Ab) combination immunoassay; followed by HIV 1/2 differentiation immunoassay if positive and a NAAT if the immunoassay is indeterminate or inconclusive.
HIV antigen/antibody tests can usually detect HIV infection 18 to 45 days after an exposure. Physicians need to be aware that PrEP increases the time to detection of seroconversion. Also, individuals who acquire HIV while taking PrEP may have low or non-detectable HIV-1 RNA levels.
References
US Preventive Services Task Force. Preexposure Prophylaxis to Prevent Acquisition of HIV: US Preventive Services Task Force Recommendation Statement. JAMA. 2023;330(8):736–745.
Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update: A Clinical Practice Guideline. Centers for Disease Control and Prevention, US Public Health Service. Accessed June 28, 2023. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf
Greene M, Mody L. Picking Up PrEP—Role of Clinician Specialty. JAMA Intern Med. Published online August 19, 2024. doi:10.1001/jamainternmed.2024.4004.
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