{
  "abstract": "HIV diagnosis can be especially challenging in persons using long-acting cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) due to long-acting early viral inhibition, “LEVI”. 1 New infections are usually clinically silent in this setting and are often missed using routine screening assays due to prolonged viral suppression and delayed/diminished antibody (Ab) production. Tests for HIV antigen (Ag), Ab, RNA and DNA may also revert from reactive/positive to non-reactive/negative.1–3 We evaluated a case where unexpected HIV laboratory results complicated the clinical management of a participant in the HIV Prevention Trials Network (HPTN) 083 trial.4 The results also complicated assessment of the primary study endpoint (incident HIV infection). Laboratory testing was performed in real time at the study site and retrospectively at the HPTN Laboratory Center (LC) and other reference laboratories (online supplemental file 1).",
  "authors": [
    {
      "affiliations": [
        "Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Jessica M Fogel"
    },
    {
      "affiliations": [
        "DNA Reference Laboratory, San Antonio, Texas, USA"
      ],
      "name": "M Ali Salih"
    },
    {
      "affiliations": [
        "Department of Pathology, Johns Hopkins Hospital, Baltimore, Maryland, USA"
      ],
      "name": "Kathy Haddaway"
    },
    {
      "affiliations": [
        "Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA",
        "Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Mark A Marzinke"
    },
    {
      "affiliations": [
        "Department of Pathology, Johns Hopkins Hospital, Baltimore, Maryland, USA"
      ],
      "name": "Christi Marshall"
    },
    {
      "affiliations": [
        "Fred Hutchinson Cancer Center, Seattle, Washington, USA"
      ],
      "name": "Zhe Wang"
    },
    {
      "affiliations": [
        "Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Vanessa Cummings"
    },
    {
      "affiliations": [
        "Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Estelle Piwowar-Manning"
    },
    {
      "affiliations": [
        "Gilead Sciences, Foster City, California, USA"
      ],
      "name": "James F Rooney"
    },
    {
      "affiliations": [
        "FHI 360, Durham, North Carolina, USA"
      ],
      "name": "Marybeth McCauley"
    },
    {
      "affiliations": [
        "Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil"
      ],
      "name": "Beatriz Grinsztejn"
    },
    {
      "affiliations": [
        "Center for Clinical AIDS Research & Education, University of California Los Angeles, Los Angeles, California, USA"
      ],
      "name": "Raphael J Landovitz"
    },
    {
      "affiliations": [
        "Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Susan H Eshleman"
    }
  ],
  "title": "Use of DNA profiling to resolve HIV status in a person using injectable cabotegravir for HIV pre-exposure prophylaxis",
  "uid": "d7fe5cae-31fe-50a2-aed8-66d04244a8f0"
}