{"id":53742,"date":"2026-04-21T18:00:28","date_gmt":"2026-04-21T18:00:28","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=53742"},"modified":"2026-04-21T22:54:41","modified_gmt":"2026-04-21T22:54:41","slug":"us-fda-approves-dual-hiv-combination-of-doravirine-islatravir","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/53742","title":{"rendered":"US FDA approves new once-daily oral HIV combination of doravirine\/islatravir"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 21 April 2026, the US FDA approved a new two-drug fixed combination of doravirine\/islatravir 100 mg\/0.25 mg (DOR\/ISL). [1]<\/strong><\/p>\n<p>This is a once-daily oral pill with an indication as a switch option in people who currently have undetectable viral load (&lt;50 copies\/mL) on current ART.<\/p>\n<p>Other criteria include:<\/p>\n<ul>\n<li>Not having a history of drug resistance to either doravirine or islatravir.<\/li>\n<li>Not using with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers.<\/li>\n<li>Not to use with either lamivudine (3TC) or emtricitabine (FTC).<\/li>\n<\/ul>\n<p>Approval was based on 48-week results from the randomised phase 3 Merck 051 and 052 non-inferiority switch studies.<\/p>\n<p>The open-label 051 study randomised 551 people (2:1) on stable ART to either DOR\/ISL or continuing current ART. \u00a0The double-blind 052 study randomised 513 people (2:1) on stable B\/F\/TAF to either switch to DOR\/ISL or remain on current ART.\u00a0At week-48 viral load was detectable &gt;50 copies\/mL in 1% vs 1% in 051 \u00a0and in 1% vs 5% in 052, in DOR\/ISL vs control arms respectively.<\/p>\n<p>Although these studies reported generally good tolerability with few serious side effects, DOR-ISL doesn&#8217;t provide cover for hepatitis B infection.<\/p>\n<p>DOR\/ISL is manufactured and marketed in the US by Merck\/MSD with the tradname IDVYNSO.<\/p>\n<p>For full details please see the full prescribing information.<\/p>\n<h3><strong>comment<\/strong><\/h3>\n<p><strong>Latest data on DOR\/ISL reported at CROI 2026 in February also included the first results of a randomised phase 3 study in treatment-naive participants.<\/strong><\/p>\n<p><strong>Some of the discussions at the meeting highlighted the importance of monitoring for hepatitis B. [2]<\/strong><\/p>\n<p>References<\/p>\n<ol>\n<li>Merck.MSD press release. FDA Approves Merck\u2019s Once-Daily IDVYNSO (doravirine\/islatravir). 21 April 2026.<br \/>\n<a href=\"https:\/\/www.merck.com\/news\/fda-approves-mercks-once-daily-idvynso-doravirine-islatravir\/\">https:\/\/www.merck.com\/news\/fda-approves-mercks-once-daily-idvynso-doravirine-islatravir\/<\/a><\/li>\n<li>CROI 2026: investigational HIV combinations \u2013 daily, weekly, 4- and 6-monthly\u2026 HTB (15 April 2026).<br \/>\n<a href=\"https:\/\/i-base.info\/htb\/53695\">https:\/\/i-base.info\/htb\/53695<\/a><\/li>\n<\/ol>\n\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 21 April 2026, the US FDA approved a new two-drug fixed combination of doravirine\/islatravir 100 mg\/0.25 mg (DOR\/ISL). [1] This is a once-daily oral pill with an indication as a switch option in people who &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[163,3],"tags":[],"class_list":["post-53742","post","type-post","status-publish","format-standard","hentry","category-early-access","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/53742","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=53742"}],"version-history":[{"count":5,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/53742\/revisions"}],"predecessor-version":[{"id":53748,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/53742\/revisions\/53748"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=53742"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=53742"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=53742"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}