{"id":53288,"date":"2026-02-24T05:39:34","date_gmt":"2026-02-24T05:39:34","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=53288"},"modified":"2026-03-16T23:44:41","modified_gmt":"2026-03-16T23:44:41","slug":"11-mg-dose-selected-for-once-monthly-mk-8527-for-phase-3-prep-studies","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/53288","title":{"rendered":"CROI 2026: 11 mg dose selected for once-monthly MK-8527 for phase 3 PrEP studies"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-53259\" src=\"https:\/\/i-base.info\/htb\/wp-content\/uploads\/2026\/02\/CROI-page-banner-300x58.png\" alt=\"\" width=\"620\" height=\"120\" srcset=\"https:\/\/i-base.info\/htb\/wp-content\/uploads\/2026\/02\/CROI-page-banner-300x58.png 300w, https:\/\/i-base.info\/htb\/wp-content\/uploads\/2026\/02\/CROI-page-banner-1024x198.png 1024w, https:\/\/i-base.info\/htb\/wp-content\/uploads\/2026\/02\/CROI-page-banner-768x149.png 768w, https:\/\/i-base.info\/htb\/wp-content\/uploads\/2026\/02\/CROI-page-banner.png 1240w\" sizes=\"auto, (max-width: 620px) 100vw, 620px\" \/><\/p>\n<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>A second study presented at CROI 2026 reported on the studies that led to selecting the 11 mg dose of MK-8527 (the successor compound to islatravir) that will be used in a once-monthly oral formulation in phase 3 PrEP studies. [1]<\/strong><\/p>\n<p>This was decided based on PK results using doses from 6 mg to 12 mg from five phase 1 studies and one phase 2 study.<\/p>\n<p>These studies predicted that an 11 mg dose would exceed the efficacy threshold in more than 95% of participants at four time points: 30 minutes after the 1st dose, 31 days after the 1st dose, 31 days at steady state, and 38 days at steady state. Protective levels are also achieved within an hour.<\/p>\n<p>This dose is predicted to also cover exposure during pregnancy (when levels are predicted to be 10% to 30% lower), in people with mild renal impairment (eGFR &gt;60 mL\/min) and in people weighing &gt;35 kg (increased weight reduces exposure). Protection extends for an additional week if the monthly dose is late.<\/p>\n<h3>comment<\/h3>\n<p><strong>Although the 11 mg dose was already reported in HTB in July 2025mr it is good to see the research that supported this decision. [2]<\/strong><\/p>\n<p><strong>CROI 2026 also included a PrEP study showing that islatravir did not protect macaques against virus with the M184V mutation. This is important becasue islatravir is very similar to MK-8527. [3]<\/strong><\/p>\n<p><strong>Although important to report, this is not expected to change the approach to the development as PrEP.\u00a0<\/strong><\/p>\n<p>Reference<\/p>\n<ol>\n<li>Kapoor Y et al. MK-8527 Phase III Dose Selection for Monthly Oral HIV-1 Preexposure Prophylaxis. CROI 2026, Denver. Oral abstract 126.<\/li>\n<li>IAS 2025: Once-monthly oral PrEP using MK-8527: the drug that could stop HIV. HTB (23 February 2025).<br \/>\n<a href=\"https:\/\/i-base.info\/htb\/51874\">https:\/\/i-base.info\/htb\/51874<\/a><\/li>\n<li>Islatravir PrEP doesn&#8217;t protect against M184V mutation in macaque study. HTB (23 February 2025).<br \/>\n<a href=\"https:\/\/i-base.info\/htb\/53297\">https:\/\/i-base.info\/htb\/53297<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base A second study presented at CROI 2026 reported on the studies that led to selecting the 11 mg dose of MK-8527 (the successor compound to islatravir) that will be used in a once-monthly oral formulation in &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,10],"tags":[346],"class_list":["post-53288","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-transmission-and-prevention","tag-croi-2026"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/53288","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=53288"}],"version-history":[{"count":1,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/53288\/revisions"}],"predecessor-version":[{"id":53573,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/53288\/revisions\/53573"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=53288"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=53288"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=53288"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}