{"id":40142,"date":"2021-03-12T07:37:57","date_gmt":"2021-03-12T07:37:57","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=40142"},"modified":"2021-11-21T12:59:49","modified_gmt":"2021-11-21T12:59:49","slug":"islatravir-dosing-for-once-monthly-and-annual-prep-if-effective-this-will-end-hiv-transmission","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/40142","title":{"rendered":"CROI 2021: Islatravir dosing for once-monthly and annual PrEP: if effective this could end HIV transmission"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/strong><\/p>\n

Two of the first oral abstracts at CROI reported on the next stages of one of the most important pipeline compounds for HIV prevention.<\/span><\/strong><\/p>\n

Munjal Patel from Merck\/MSD presented results of PK\/PD analyses that defined the islatravir exposure threshold for PrEP and the 60 mg oral once monthly dose that will be used in the upcoming phase 3 studies. [1]<\/span><\/p>\n

This was based on intracellular triphosphate (TP) levels derived from macaque studies and phase 1 studies. In a phase 2 study, the 60 mg dose resulted in observed mean islatravir-TP that was still 26-fold higher than the minimum target PK threshold of 0.05 pmol\/million cells and that levels will <\/span><\/p>\n

A second oral presentation is the same session, presented similar results for an islatravir implant that will provide PrEP cover for a year. [2]<\/span><\/p>\n

The technical name for this device – in case it catches on – is a \u201cradiopaque next-generation islatravir-eluting implant\u201d. This was a double-blind phase 1 study and 36 participants (8 active, 4 placebo per dose) at low risk of HIV either had one of three doses of an islatravir implant (48 mg, 52 mg or 56 mg) for 12 weeks or a matched placebo. This is a new formulation of islatravir implant that has a different PK and dose compared to the first dosing studies. This includes\u00a0barium as a safeguard to be able to track the implant if it migrates within the body.<\/span><\/p>\n

Islatravir-TP remained above target levels throughout and PK modelling predicted and at doses of 52 mg and above would maintain target levels for at least 52 weeks.<\/span><\/p>\n

Tolerability was generally good. Common adverse events included haematoma, red skin, tenderness, \u00a0itching and induration, with little difference between the active and placebo groups and no dose-related adverse events.<\/span><\/p>\n

Larger phase 2 studies are now planned.<\/span><\/p>\n

comment<\/span><\/h3>\n

Although the research into islatravir for HIV prevention is still in early stages, this compound has the potential to effectively end HIV transmission.<\/span><\/strong><\/p>\n

If efficacy matches other formulations of PrEP, and there is no concern about drug resistance, these long-acting formulations need to become as accessible as aspirin including as single-dose over-the-counter. A single pill could possibly provide both PEP and PrEP cover for a month.<\/span><\/strong><\/p>\n

Islatravir PrEP could have a larger market than statins and Viagra, probably combined. <\/span><\/strong><\/p>\n

Development and regulatory decisions should understand this urgency and pricing should match affordability for global demand.<\/span><\/strong><\/p>\n

References<\/p>\n

The weblink for this oral abstract session is:
\n<\/span>http:\/\/www.croiwebcasts.org\/s\/2021croi\/Oral-02<\/a><\/p>\n

    \n
  1. Patel <\/span>M et al. islatravir PK threshold & dose selection for monthly oral HIV-1 PrEP. CROI 2021, 6 \u2013 10 March 2021. Oral abstract 87.
    \n<\/span>    https:\/\/www.croiconference.org\/abstract\/islatravir-pk-threshold-dose-selection-for-monthly-oral-hiv-1-prep\/<\/a><\/li>\n
  2. Matthews RP et al. Next-generation islatravir implants projected to provide yearly HIV prophylaxis. CROI 2021, 6 \u2013 10 March 2021. Oral abstract 88.
    \n    https:\/\/www.croiconference.org\/abstract\/next-generation-islatravir-implants-projected-to-provide-yearly-hiv-prophylaxis\/<\/a><\/li>\n<\/ol>\n

    This report was first posted on 8 March 2021.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base Two of the first oral abstracts at CROI reported on the next stages of one of the most important pipeline compounds for HIV prevention. Munjal Patel from Merck\/MSD presented results of PK\/PD analyses that defined the …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,10],"tags":[307],"class_list":["post-40142","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-transmission-and-prevention","tag-croi-2021-virtual"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/40142","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=40142"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/40142\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=40142"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=40142"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=40142"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}