{
  "abstract": "This phase 3, double-blind, randomised trial across North and South America, Thailand and South Africa evaluated the safety and efficacy of subcutaneous lenacapavir. 4634 people reporting no HIV test or pre-exposure prophylaxis (PrEP) use in the previous 3 months underwent HIV screening and contributed to the estimation of background HIV incidence; 3271 were HIV-negative (>14% transgender women, 67% Hispanic) and randomised 2:1 to twice-yearly lenacapavir or daily emtricitabine-tenofovir disoproxil fumarate (F/TDF) plus corresponding matched placebo, and 423 tested HIV-positive, were referred to care and their trial participation ended. Background HIV incidence in the screened population was 2.37/100 person-years (95% CI 1.65 to 3.42). The incidence of HIV in the lenacapavir group was 96% lower than background incidence (incidence rate ratio (IRR)=0.04,0.01–0.18) and was 89% lower than that with F/TDF (IRR=0.11, 0.02–0.51). Among 2179 participants in the lenacapavir group, 2 acquired HIV and had resistance mutations; 9 F/TDF infections resulted from low/non-adherence or discontinuation (1 had a resistance mutation). Incidence of serious adverse events was similar between groups. Twice-yearly lenacapavir is efficacious and may enhance uptake in this population.",
  "authors": [
    {
      "affiliations": [
        "Institute for Global Health, University College London, London, UK"
      ],
      "name": "Marina Daskalopoulou"
    },
    {
      "affiliations": [
        "Infectious Diseases, Burjeel Hospital, Abu Dhabi, UAE"
      ],
      "name": "Rachel Herbert"
    },
    {
      "affiliations": [
        "Lawson Unit, University Hospitals Sussex NHS Foundation Trust, Brighton, East Sussex, UK"
      ],
      "name": "Sonia Raffe"
    },
    {
      "affiliations": [
        "Department of Genitourinary Medicine and Infectious Diseases, St. James's Hospital, Dublin, Ireland"
      ],
      "name": "Giovanni Villa"
    }
  ],
  "title": "Research news in clinical context",
  "uid": "4ac7d058-baeb-5927-88db-d7479c1b4f41"
}