{"id":222840,"date":"2025-06-29T02:20:31","date_gmt":"2025-06-29T02:20:31","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/222840\/"},"modified":"2025-06-29T02:20:31","modified_gmt":"2025-06-29T02:20:31","slug":"fda-approves-highly-effective-twice-yearly-shot-for-prevention","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/222840\/","title":{"rendered":"FDA Approves Highly Effective, Twice-Yearly Shot for Prevention"},"content":{"rendered":"<p><img decoding=\"async\" src=\"https:\/\/www.europesays.com\/uk\/wp-content\/uploads\/2025\/06\/HIV-prep-medication-1296x728-header.jpg\" alt=\"Person receives PrEP injection in arm\" class=\"css-1jytyml\"\/><a class=\"icon-hl-pinterest css-1dn5h5\" target=\"_blank\" rel=\"noopener noreferrer nofollow\" data-event=\"Any Page|Image Pinterest Click|Icon Clicked\" data-element-event=\"OPEN|CONTENTBLOCK|Any Page|Article Body|BUTTON|Image Widget Pinterest Click|\" href=\"https:\/\/www.pinterest.com\/pin\/create\/button\/?url=https%3A%2F%2Fwww.healthline.com%2Fhealth-news%2Ffda-approves-twice-yearly-injection-hiv-prevention&amp;media=https%3A%2F%2Fmedia.post.rvohealth.io%2Fwp-content%2Fuploads%2F2025%2F06%2FHIV-prep-medication-1296x728-header.jpg&amp;description=HIV%3A%20FDA%20Approves%20Highly%20Effective%2C%20Twice-Yearly%20Shot%20for%20Prevention\" title=\"Share on Pinterest\" data-pin-custom=\"true\" data-share-url=\"https:\/\/www.europesays.com\/uk\/wp-content\/uploads\/2025\/06\/HIV-prep-medication-1296x728-header.jpg\">Share on Pinterest<\/a>Yeztugo is a twice-yearly injection to prevent HIV that could improve adherence rates compared to other PrEP medications. d3sign\/Getty Images<\/p>\n<ul>\n<li><strong>The FDA has approved lenacapvir, a twice-yearly injection to prevent HIV infection that could improve adherence rates compared to other PrEP medications.<\/strong><\/li>\n<li><strong>The drug, which will be sold under the brand name Yeztugo, showed near-total effectiveness in clinical trials with minimal side effects.<\/strong><\/li>\n<li><strong>Experts are excited about using lenacapvir for HIV prevention, but remain cautious about the drug\u2019s affordability and accessibility.<\/strong><\/li>\n<\/ul>\n<p>A drug used to treat some HIV infections can now be used to help prevent HIV, the virus that causes <a href=\"https:\/\/www.healthline.com\/health\/hiv-aids\" class=\"content-link css-1c2ok3c\" target=\"_blank\" rel=\"noopener\">AIDS<\/a>. <\/p>\n<p>On June 18, lenacapavir, a twice-yearly injection from <a href=\"https:\/\/www.gilead.com\/\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">Gilead Sciences<\/a>, gained <a href=\"https:\/\/www.gilead.com\/news\/news-details\/2025\/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">approval<\/a> from the Food and Drug Administration (FDA) for HIV prevention in adults and adolescents.<\/p>\n<p>The drug, which will be sold under the brand name Yeztugo, significantly reduced the risk of HIV infection in two phase 3 clinical trials that were funded by Gilead. <\/p>\n<p>The <a href=\"https:\/\/www.gilead.com\/news\/news-details\/2024\/full-efficacy-and-safety-results-for-gilead-investigational-twice-yearly-lenacapavir-for-hiv-prevention-presented-at-aids-2024\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">PURPOSE 1<\/a> and <a href=\"https:\/\/www.gilead.com\/news\/news-details\/2024\/gilead-presents-full-purpose-2-data-results-for-twice-yearly-lenacapavir-for-hiv-prevention-at-hiv-glasgow\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">PURPOSE 2<\/a> trials, which were highly inclusive by design, showed that 99.9% of participants who received lenacapavir remained HIV negative. The side effects were also minimal, mostly pain or swelling at the injection site.<\/p>\n<p>PrEP treatments have been used in the United States to prevent HIV since 2012. These therapies generally involve daily oral medication (Truvada) or injections every two months (Apretude). <\/p>\n<p>Now, a biannual injection option offers an effective and appealing alternative for HIV prevention with less commitment. Yeztugo is the first and only twice-yearly option for HIV prevention available in the United States for those who may need or want PrEP. <\/p>\n<p>The FDA approval of this prevention therapy marks a silver lining amid uncertainty in HIV treatment and research. The Trump administration had recently announced federal cuts to <a href=\"https:\/\/www.healthline.com\/health-news\/federal-cuts-hiv-vaccine-program-other-treatment-options\" class=\"content-link css-1c2ok3c\" target=\"_blank\" rel=\"noopener\">funding for an HIV vaccine program<\/a> and the <a href=\"https:\/\/www.upi.com\/Health_News\/2025\/06\/21\/national-institutes-health-HIV-AIDS\/5581750530039\/\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">elimination of federal support<\/a> for clinical practice guidelines that advise doctors on how to diagnose and treat HIV.<\/p>\n<p>\u201cYeztugo could be the transformative PrEP option we\u2019ve been waiting for \u2014 offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,\u201d <a href=\"https:\/\/vaccines.emory.edu\/faculty\/primary-faculty\/delrio-carlos.html\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">Carlos del Rio<\/a>, MD, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and co-director of the Emory Center for AIDS Research in Atlanta, said in a <a href=\"https:\/\/www.gilead.com\/news\/news-details\/2025\/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">news release<\/a>. <\/p>\n<p>\u201cA twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing,\u201d del Rio continued.<\/p>\n<p>Despite advancements in HIV treatment and prevention, in 2023, <a href=\"https:\/\/www.cdc.gov\/hiv-data\/nhss\/hiv-diagnoses-deaths-and-prevalence-2025.html\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">more than 100 people<\/a> were diagnosed with HIV every day in the United States.<\/p>\n<p>A recent <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/abs\/pii\/S1047279725000900?via%3Dihub\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">CDC analysis<\/a> shows that up to 2.5 million U.S. adults need PrEP to prevent HIV infection. However, <a href=\"https:\/\/www.cdc.gov\/nchhstp\/director-letters\/expanding-prep-coverage.html\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">just over one-third<\/a> of those who would benefit from the medication are prescribed it. <\/p>\n<p>PrEP therapies are widely available in the United States, but the medication <a href=\"https:\/\/www.cdc.gov\/nchhstp\/director-letters\/expanding-prep-coverage.html\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">remains underutilized<\/a> due to stigma or lack of affordability, insurance, and access. Black people, African Americans, and Latin or Hispanic populations are most impacted by this disparity, as are those who reside in the <a href=\"https:\/\/www.ajpmonline.org\/article\/S0749-3797(21)00359-7\/fulltext\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">Southern U.S.<\/a><\/p>\n<p>Experts say having a highly effective, twice-yearly PrEP option for HIV prevention could improve access for people with and without insurance and bolster adherence rates.<\/p>\n<p>\u201cProviders are excited about the approval of long-acting lenacapavir for HIV prevention since this once-every-six-month injection has been shown to have high efficacy in preventing HIV in both women and men in two large trials,\u201d said <a href=\"https:\/\/profiles.ucsf.edu\/monica.gandhi\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">Monica Gandhi<\/a>, MD, MPH, a professor of medicine at the University of California, San Francisco. Gandhi wasn\u2019t involved in the clinical trials.<\/p>\n<p>\u201cData from <a href=\"https:\/\/academic.oup.com\/cid\/article-abstract\/80\/5\/1139\/7861053?redirectedFrom=fulltext&amp;login=true#google_vignette\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">our clinic<\/a> in San Francisco, which serves low income people with or at risk of HIV, and others have shown that long-acting PrEP works well for people living with HIV who have high rates of concomitant challenges such as housing insecurity and substance use where it can be difficult to take a daily oral pill for PrEP,\u201d Gandhi told Healthline.<\/p>\n<p>Gandhi further noted that higher retention rates have been <a href=\"https:\/\/academic.oup.com\/cid\/article-abstract\/80\/5\/1139\/7861053?redirectedFrom=fulltext&amp;login=true#google_vignette\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">observed<\/a> among those on long-acting PrEP with another long-acting agent, Apretude (cabotegravir), compared to oral PrEP alone.<\/p>\n<p>She anticipates similar improved adherence rates for those on long-acting Yeztugo (lenacapavir), both for those who have difficulty taking an oral pill or those who might prefer the convenience of a twice-yearly injection. <\/p>\n<p>Within the United States, <a href=\"https:\/\/www.healthline.com\/health\/hiv-aids\/hiv-risk-in-gay-men\" class=\"content-link css-1c2ok3c\" target=\"_blank\" rel=\"noopener\">men who have sex with men<\/a>, as well as heterosexual individuals with multiple partners, are considered high risk for HIV transmission. <\/p>\n<p>But the need for accessible HIV prevention therapies like PrEP spans the globe.<\/p>\n<p><a href=\"https:\/\/www.gilead.com\/news\/news-details\/2025\/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">According to Gilead<\/a>, regulators around the world are reviewing Yeztugo for HIV prevention. For now, the United States is the only country to approve the drug.<\/p>\n<p>\u201cIt\u2019s very exciting and we have a great deal of confidence in it,\u201d <a href=\"https:\/\/wag.app.vanderbilt.edu\/PublicPage\/Faculty\/Details\/27990\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">William Schaffner<\/a>, MD, professor of preventive medicine and infectious diseases in the Department of Health Policy at Vanderbilt University Medical Center in Nashville, said of the drug. Schaffner wasn\u2019t involved in the clinical trials.<\/p>\n<p>\u201cIt could be a game-changer,\u201d he told Healthline. \u201cShort of a vaccine, this is a way to efficiently prevent HIV infection in large populations that are at high risk, not only in the developed world, but potentially in the developing world also. If we have the determination, followed by the allocation of resources to reach out to populations at high risk, we can make this available,\u201d Schaffer noted.<\/p>\n<p>It\u2019s unclear when Yeztugo will become available to the general U.S. population and how much it might cost out of pocket, particularly for those without health insurance.<\/p>\n<p>\u201cI don\u2019t know how quickly the company can make this available and educate practitioners about its utility, but certainly both in the public health sector \u2014 and we\u2019ll see where the resources extend to \u2014 and in private medical circumstances, we may have to wait a little while before medical insurance programs include Yeztugo in their benefits packages,\u201d Schaffer said.<\/p>\n<p>Gandhi expressed concern over the drug\u2019s high cost and whether it would be covered by large health insurance companies. <\/p>\n<p>A corporate spokesperson for Gilead said lenacapavir could cost around $28,218 annually per person in the United States.<\/p>\n<p>\u201cWe are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage,\u201d the spokesperson said by email. <\/p>\n<p>\u201cWe\u2019ve seen high insurance coverage for existing prevention options \u2014 for example, the vast majority of consumers have a $0 copay for Descovy for PrEP in the U.S. \u2014 and we are working to ensure broad coverage for lenacapavir.\u201d<\/p>\n<p>Gandhi agreed that the estimated total cost per year is similar to the total cost of other long-acting PrEP therapies, such as Apretude (cabotegravir), but noted the medication may still be out of reach for those with low socioeconomic status who rely on federal subsidies.<\/p>\n<p>\u201cThese are days of austerity in healthcare, including the concerning possibility of a $700 billion cut to Medicaid which will be determined in an upcoming Senate vote, leaving the health insurance program for low-income individuals in the U.S. <a href=\"https:\/\/www.pih.org\/article\/largest-medicaid-cut-us-history-would-leave-millions-vulnerable\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"content-link css-1c2ok3c\">severely underfunded<\/a>. I urge the company to reconsider their price to improve access for Americans,\u201d Gandhi said.<\/p>\n","protected":false},"excerpt":{"rendered":"Share on PinterestYeztugo is a twice-yearly injection to prevent HIV that could improve adherence rates compared to other&hellip;\n","protected":false},"author":2,"featured_media":222841,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4315],"tags":[105,4326,87957,16,15],"class_list":{"0":"post-222840","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-medication","10":"tag-twice-yearly-injection-hiv-prevention-fda","11":"tag-uk","12":"tag-united-kingdom"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/114764265815089396","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/222840","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=222840"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/222840\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/222841"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=222840"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=222840"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=222840"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}