[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-403327-105":59,"doc-detail-403327-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","implementation-april-2023-introduction-and-background","Implementation - April 2023 - Introduction and Background","","April 2023 implementation guidance explains FDA approval of Apretude® (cabotegravir extended-release injectable suspension) for HIV PrEP as a long-acting injectable option for adults and adolescents at risk. It describes how LAI PrEP supports adherence by reducing daily pill burden and related stigma, with benefits for youth, people who use drugs, and individuals facing housing instability. The overview defines long-acting injectables, outlines evidence from HPTN 083 and 084, and summarizes administration schedules, including an optional oral lead-in and next steps for missed doses.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/implementation-april-2023-introduction-and-background/403327/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/implementation-april-2023-introduction-and-background/403327.png","ImageObject",300,407,{"name":92,"@type":93},"Jordan Avery","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-29","2026-09-27",true,{"@type":102,"interactionType":103,"userInteractionCount":44},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is Apretude® and who is it indicated for in the document?","Question",{"text":112,"@type":113},"Apretude® is cabotegravir extended-release injectable suspension approved by the U.S. Food and Drug Administration for HIV PrEP. It is indicated for adults and adolescents weighing at least 77 pounds who are at risk of sexually acquiring HIV.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How does the document describe the benefits of LAI PrEP compared with daily oral pills?",{"text":117,"@type":113},"LAI PrEP provides a prevention option that does not require daily pills, supporting adherence, reducing pill fatigue, and addressing stigma or privacy concerns. It highlights potential advantages for adolescents and people who may have challenges taking daily oral PrEP.",{"name":119,"@type":110,"acceptedAnswer":120},"How should clinicians handle planned missed LAI continuation injections?",{"text":121,"@type":113},"If a person plans to miss a scheduled every-2-month continuation injection visit by more than 7 days, the guidance recommends taking daily oral cabotegravir (Vocabria) for up to 2 months to replace the missed injection, with the first oral PrEP dose taken about 2 months after the last Apretude® injection.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},403327,1791165877,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":44,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},1099523882367,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","Implementation  \nApril 2023  \nIntroduction and Background:  \nOn December 20, 2021, the U.S Food and Drug  \nAdministration approved Apretude® (cabotegravir extended-release injectable suspension) for PrEP, making it the first LAI medication option available for the primary prevention of HIV. Apretude ® is indicated for adults and adolescents weighing at least  \n77 pounds who are at risk of sexually acquiring HIV.  \nThe addition of a long-acting form of PrEP to the biomedical intervention tool-box is exciting as it provides another option for primary HIV prevention that is not a daily pill, creating opportunities for patient choice on what would work best for them.  \nLAI PrEP creates new opportunities to support individuals in maintaining adherence, preventing or alleviating pill fatigue, and reducing stigma or privacy concerns associated with taking oral medications. Adolescents, people who use drugs, individuals experiencing homelessness, and others who experience challenges taking daily oral PrEP could benefit from this new PrEP modality.  \nThe following sections include answers to frequently asked questions about  \nimplementation of LAIs for PrEP.  \nLAI Overview:  \nWhat are long-acting injectables (LAI)?  \nLong-acting antiretroviral injectables refers to an antiretroviral drug that is delivered via an injection and lasts in the body for an extended period of time.1 The goals of injectables are to minimize adherence challenges as daily pills can serve as an adherence challenge. There is now long-acting injectable HIV treatment AND prevention options available. In January 2021 the first long-acting HIV treatment, Cabenuva®, was FDA approved. More long-acting and extended-release HIV prevention products are in the pipeline and currently being evaluated in clinical trials. These include additional injectable methods, vaginal rings, vaginal and rectal gels, and  \n1[https://www.avac.org/sites/default/fi](https://www.avac.org/sites/default/fi)les/infographics/AVAC_Introduction_to_LongActing_Injectables. Dec2016.pdf  \nother oral pills. This graphic ,developed by AVAC in June 2021, details the research pipeline. Since this graphic the FDA is no longer reviewing Dapivirine by manufacturer International Partnership for Microbicides (IPM). In December 2021 IPM pulled their application for FDA approval.2  \nWhat is the effectiveness of LAI?  \nTwo large clinical trials have confirmed the safety and efficacy of long acting cabotegravir. HPTN 083 started in December 2016 and studied cisgender gay men and other men who have sex with men, as well as transgender women. A parallel study, HPTN 084, launched in 2017 and examined the safety and efficacy among cisgender women. Both studies demonstrated the superiority of injectable cabotegravir to oral regimens for PrEP for HIV prevention. Both cabotegravir and oral TDF/FTC have high efficacy for PrEP.3 AVAC developed an Advocates’ Primer on Injectable Cabotegravir for PrEP, which includes additional information on the HPTN 083 and 084 trials.  \nOral PrEP reaches maximum protection from HIV for receptive anal sex at about 7 days of daily use, and receptive vaginal sex at about 21 days of daily use.4 As opposed to oral PrEP, the time from initiation of Apretude® for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown.5  \nHow is LAI administered?  \nApretude ® is administered through a gluteal intramuscular injection given as few as six times per year and is initiated with a single 600 mg (3 mL) injection given one month apart for two consecutive months. After the second initiation injection, the recommended continuation injection dose is a single 600 mg (3 mL) injection given every two months. Apretude ® must be administered by a clinical provider. An initiation dosing infographic has been developed by NASTAD to assist providers and navigators understand the dosing frequency. Access the infographic here.  \nIs there an oral lead in?  \nVocabria® (cabotegravir tablets) is an optional oral","cbCaieJz5rOIs4Hh","https://ap.wps.com/l/cbCaieJz5rOIs4Hh","pdf",443478,11,"English","# Introduction and Background\n## LAI Overview\n## Effectiveness of LAI\n## LAI Administration\n## Oral Lead-In Option\n## Missed Doses (Planned and Unplanned)","[{\"question\":\"What is Apretude® and who is it indicated for in the document?\",\"answer\":\"Apretude® is cabotegravir extended-release injectable suspension approved by the U.S. Food and Drug Administration for HIV PrEP. It is indicated for adults and adolescents weighing at least 77 pounds who are at risk of sexually acquiring HIV.\"},{\"question\":\"How does the document describe the benefits of LAI PrEP compared with daily oral pills?\",\"answer\":\"LAI PrEP provides a prevention option that does not require daily pills, supporting adherence, reducing pill fatigue, and addressing stigma or privacy concerns. It highlights potential advantages for adolescents and people who may have challenges taking daily oral PrEP.\"},{\"question\":\"How should clinicians handle planned missed LAI continuation injections?\",\"answer\":\"If a person plans to miss a scheduled every-2-month continuation injection visit by more than 7 days, the guidance recommends taking daily oral cabotegravir (Vocabria) for up to 2 months to replace the missed injection, with the first oral PrEP dose taken about 2 months after the last Apretude® injection.\"}]","Implementation - April 2023 - Introduction and Background | PDF",1790538903,28]