{"id":87563,"date":"2026-04-30T18:01:53","date_gmt":"2026-04-30T18:01:53","guid":{"rendered":"https:\/\/diyhaven858.wasmer.app\/index.php\/fda-expedites-review-of-new-hiv-treatment-combo\/"},"modified":"2026-04-30T18:01:53","modified_gmt":"2026-04-30T18:01:53","slug":"fda-expedites-review-of-new-hiv-treatment-combo","status":"publish","type":"post","link":"https:\/\/diyhaven858.wasmer.app\/index.php\/fda-expedites-review-of-new-hiv-treatment-combo\/","title":{"rendered":"FDA expedites review of new HIV treatment combo"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div data-component=\"ArticleContent\">\n<div class=\"article__below-title\">\n<div class=\" article__posted-date\">\n<p>April 30, 2026<\/p>\n<p>1 min read<\/p>\n<\/p><\/div>\n<div class=\"mobile-trust-box\">\n<div class=\"row\">\n<div class=\"col-12 col-md-5 d-xl-none\">\n<div class=\"trust-box\">\n<div class=\"trust-box-logo d-none d-md-block\">\n            <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/idn.svg?la=en&amp;h=19&amp;w=171&amp;hash=E5D33CE188190E773BF16C8B389C7AAC\" class=\"logo-img\" height=\"19\" alt=\"infectious disease news logo\" width=\"171\"\/>\n          <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"col-12 col-md-6 offset-md-1 offset-xl-0 col-xl-12\">\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse ua4881e4703db4dc9bdc4a5183843cf2c\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong>  <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<p>The FDA has accepted Gilead Sciences\u2019 new drug application for a single-tablet, once-daily HIV treatment combination and granted the application priority review, according to the drug-maker.<\/p>\n<p>The investigational combination includes two existing Gilead medications: bictegravir (BIC), a guideline-recommended integrase strand transfer inhibitor; and lenacapavir (LEN), a first-in-class capsid inhibitor approved for the treatment of drug-resistant HIV, and also as a long-acting injection for HIV prevention.<\/p>\n<figure class=\"figure article__og-image\">&#13;\n    <picture>&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/infectious-disease\/misc\/infographics\/idn0226meissner_graphic_01_web.webp?w=476\" media=\"(max-width: 768px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/infectious-disease\/misc\/infographics\/idn0226meissner_graphic_01_web.webp?w=800\" media=\"(max-width: 992px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/infectious-disease\/misc\/infographics\/idn0226meissner_graphic_01_web.webp?w=595\" media=\"(max-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/infectious-disease\/misc\/infographics\/idn0226meissner_graphic_01_web.webp?w=476\" media=\"(min-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/infectious-disease\/misc\/infographics\/idn0226meissner_graphic_01_web.webp?w=476\">&#13;<br \/>\n&#13;<br \/>\n      <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/infectious-disease\/misc\/infographics\/idn0226meissner_graphic_01_web.jpg?w=800\" alt=\"IDN0226Meissner_Graphic_01_Web\" class=\"figure-img img-fluid\" width=\"800\"\/>&#13;<br \/>\n    <\/source><\/source><\/source><\/source><\/source><\/picture>&#13;<figcaption class=\"figure-caption\">&#13;<br \/>\n      <span zm=\"\">Data derived from Meissner, et al, and Orkin, et al.<\/span>&#13;<br \/>\n    <\/figcaption>&#13;<br \/>\n  <\/figure>\n<p>Gilead developed the single-tablet regimen for adults who are virologically suppressed on other medication.<\/p>\n<p>\u201cIf approved, BIC\/LEN has the potential to be a single-tablet regimen designed to provide sustained virologic suppression with a high barrier to resistance for people living with HIV who are virologically suppressed, including those who are aging, with comorbidities, seeking to streamline a complex regimen, with prior [antiretroviral] resistance, and those seeking novel treatment options,\u201d <b>Dietmar Berger, MD, PhD,<\/b> Gilead chief medical officer, said in a press release.<\/p>\n<p>Gilead\u2019s application was supported by results from two phase 3 trials \u2014 ARTISTRY-1 and ARTISTRY-2 \u2014 which evaluated BIC\/LEN among people with HIV who were already virologically suppressed, including those switching from complex multi-tablet regimens, and found that participants remained virally suppressed on the single-tablet combo.<\/p>\n<p>Results from the trials were presented at the Conference on Retroviruses and Opportunistic Infections in February and covered here. ARTISTRY-1 results were also published in <i>The Lancet. <\/i>A link to that article can be found below.<\/p>\n<div class=\"article__content--footer\">\n<div class=\"publisher-logo\">\n    <span>Published by:<\/span><br \/>\n    <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/idn.svg?la=en&amp;h=19&amp;w=171&amp;hash=E5D33CE188190E773BF16C8B389C7AAC\" class=\"logo-img\" height=\"19\" alt=\"infectious disease news logo\" width=\"171\"\/>\n  <\/div>\n<div class=\"sources-references-disclosures\">\n<h3>Sources\/Disclosures<\/h3>\n<h2> Source: <\/h2>\n<p class=\"citation\">&#13;<br \/>\n  Press Release&#13;\n<\/p>\n<h2>References:<\/h2>\n<ul class=\"list-unstyled references\">\n<li>Meissner EG, et al. Abstract 513. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 22-25, 2026; Denver.<\/li>\n<li>Orkin C, et al. Abstract 181. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 22-25, 2026; Denver.<\/li>\n<li>      Orkin C, et al. <i>Lancet. <\/i>2026;doi:10.1016\/S0140-6736(26)00307-7.<\/li>\n<\/ul>\n<div class=\"disclosures\">\n<p>&#13;<br \/>\n        <strong> Disclosures: <\/strong>&#13;<br \/>\n        Berger reports being employed by Gilead.&#13;\n      <\/p>\n<\/p><\/div>\n<\/div>\n<p><!-- Healio AI Widget --><\/p>\n<div class=\"healio-ai-component-inline\" data-no-ads=\"true\" data-module-track-category=\"Healio AI\" data-module-track-action=\"Click\" data-module-track-label=\"Access Healio Ai from component - News_AI Component - In-Content (all devices)\">\n<div class=\"healio-ai-content\">\n    <img decoding=\"async\" src=\"https:\/\/m3.healio.com\/~\/media\/images\/healio-ai\/healio-ai_logo.svg\" alt=\"Healio AI\" class=\"healio-ai-logo\"\/><\/p>\n<p><strong>Ask a clinical question<\/strong> and tap into <strong>Healio AI&#8217;s knowledge<\/strong> base.<\/p>\n<ul>&#13;<\/p>\n<li>PubMed, enrolling\/recruiting trials, guidelines<\/li>\n<p>&#13;<\/p>\n<li>Clinical Guidance, Healio CME, FDA news<\/li>\n<p>&#13;<\/p>\n<li>Healio&#8217;s exclusive daily news coverage of clinical data<\/li>\n<p>&#13;\n    <\/ul>\n<p>    <button class=\"healio-ai-button\" onclick=\"window.location.href=\" https:=\"\">Learn more<\/button>\n  <\/div>\n<\/div>\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse ua4881e4703db4dc9bdc4a5183843cf2c\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. 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