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    1. Editors' (re)View

    Editors' (re)View: Gilead inches toward regulatory submission for twice-yearly injectable HIV preventative

    Sept. 13, 2024
    Pharma Manufacturing editors comment on the notable happenings in the pharma industry from the week of Sept 9
    669a6e02ac3ed77511b5e055 Editreview

    Gilead inches toward regulatory submission for twice-yearly injectable HIV preventative

    Gilead's twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, has reduced HIV infections by 96% in a second phase 3 trial, according to an interim analysis.

    Among 2,180 participants, only two HIV cases were reported, with lenacapavir showing superior efficacy over daily Truvada. The trial, involving cisgender men and gender-diverse individuals, highlights the potential of lenacapavir as a more convenient HIV prevention option.

    The PURPOSE 2 trial met its efficacy targets, showing lenacapavir’s ability to reduce infection rates significantly when compared to background HIV incidence and daily Truvada. In response, Gilead halted the blinded phase of the trial early, offering lenacapavir to all participants. With its twice-yearly dosing, lenacapavir addresses key issues like daily pill adherence, offering a simpler, more flexible approach to HIV prevention.

    Lenacapavir’s infrequent dosing is a major advancement, with the potential to significantly improve quality of life for those at risk of HIV. By reducing the need for daily medication, it offers greater convenience and reduces the stigma some individuals face in maintaining daily pill regimens, providing an easier path to sustained prevention.

    As HIV remains a global challenge, particularly in high-risk communities, lenacapavir could become a transformative tool in expanding prevention efforts. Gilead plans regulatory filings to support approval of the first twice-yearly HIV prevention option, with the goal of launching it in 2025. — Andrea Corona

    About the Author

    Andrea Corona | Senior Editor

    Andrea Corona serves as the Senior Editor of Pharma Manufacturing — a leading source of news and insights for pharma professionals — and is responsible for creation of editorial content, moderating webinars, and co-hosting the "Off script" podcast. Her editorial journey started as an as associate editor at Biocompare, an online platform providing product information, industry news, articles, and other resources to support scientists in their work. Before Biocompare, she was a digital producer at Science Friday, focusing on adapting radio segments for the web and social media management. Andrea earned her bachelor's degree in journalism and biology from the State University of New York, at Purchase College.