[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-403330-105":59,"doc-detail-403330-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","effect-of-dosing-concentrations-interruptions-on-apretude","Effect of Dosing Concentrations - Interruptions on Apretude","","Effect of dosing concentration interruptions on Apretude (long-acting cabotegravir; CAB LA) dosing for PrEP summarizes adherence guidance and pharmacokinetic evidence. Population pharmacokinetic modeling indicates minimal impact for delays up to 1 week, while delays exceeding 1 week show greater changes in the proportion maintaining target CAB concentrations. The HPTN 084 pharmacologic evaluation reports CAB concentrations remain above protein-adjusted inhibitory thresholds for delayed administration in cisgender women, with explicit limits on extrapolation to cisgender men and transgender women. Detailed missed-dose management and injection-or-oral bridging recommendations are provided, supported by simulation and study tables.",{"@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/effect-of-dosing-concentrations-interruptions-on-apretude/403330/",{"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/effect-of-dosing-concentrations-interruptions-on-apretude/403330.png","ImageObject",300,407,{"name":92,"@type":93},"Taylor Morgan","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-29","2026-09-27",true,{"@type":102,"interactionType":103,"userInteractionCount":34},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"How should missed Apretude CAB LA injections be managed?","Question",{"text":112,"@type":113},"Adherence to the injection schedule is strongly recommended. If an injection visit is missed, individuals should be clinically reassessed and receive an HIV test, and dosing should follow the missed-dose table guidance.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What is the expected pharmacokinetic impact of CAB LA dosing delays?",{"text":117,"@type":113},"Modeling shows minimal effect on the proportion of subjects maintaining target CAB concentrations (≥0.65 µg/mL) after 1-week delays. Delays longer than 1 week produce a more profound effect, with results summarized for second (and similar patterns for third and fourth) injections.",{"name":119,"@type":110,"acceptedAnswer":120},"Can results from HPTN 084 delayed dosing be applied to cisgender men and transgender women?",{"text":121,"@type":113},"No. The document states that the pharmacokinetic data described for cisgender women with delayed dosing should not be extrapolated to cisgender men and transgender women.","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},403330,1790920932,{"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":34,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":81,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":39,"preview_page_count":4},1099523885336,"https://ap-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","Effect of Dosing Concentrations  \nInterruptions on Apretude  \nSummary  \n• Adherence to the Apretude ( long-acting cabotegravir [CAB LA]) dosing schedule for preexposure prophylaxis (PrEP) is strongly recommended.~~1~~ Missed doses should be managed in accordance with the local label.  \n• Population pharmacokinetic modeling data shows minimal effect on the percentage of subjects maintaining target CAB concentrations (≥ 0.65 µg/mL) after dosing delays of 1 week.2 Dosing delays > 1 week resulted in a more profound effect.  \no Results were consistent for delays ofthe second, third, and fourth CAB LA doses.2  \n• A pharmacokinetic analysis of the HPTN 084 study described CAB concentrations incisgender women with delayed dosing; most patients maintained CAB concentrations above 4x protein-adjusted 90% inhibitory concentration (PA-IC90) after delays up to 18 weeks.3  \no This data should not be extrapolated to cisgender men and transgender women.  \n• Important Safety Information and Boxed Warning can be found in the Prescribing Information and can also be accessed from Our HIV Medicines.  \nTo access additional scientific information related to ViiV Healthcare medicines, visit the ViiV US Medical Portal [at](at viivhcmedinfo.com)[ ](at viivhcmedinfo.com)[viivhcmedinfo.com](at viivhcmedinfo.com).  \nMANAGEMENT OF CAB LA MISSED DOSES  \nAdherence to the injection dosing schedule is strongly recommended.~~1~~ Individuals who miss a scheduled injection visit should be clinically reassessed and an HIV test performed to ensure resumption of PrEP remains appropriate. Table 1 summarizes dosing recommendations after a missed injection.  \nIf a delay of > 7 days from a scheduled injection visit cannot be avoided, daily oral CAB (one 30-mg tablet once daily) can be used for up to two months to replace one scheduled injection visit.~~1~~ For oral PrEP durations > 2 months, an alternative to oral CAB is recommended.  \nThe first dose of oral CAB (or alternative oral PrEP regimen) should be taken 2 months (± 7 days) after the last injection dose of CAB LA.~~1~~ Injection dosing should be planned to resume on the last day of oral CAB (PrEP) or within 3 days thereafter.  \nTable 1. Injection Dosing Recommendations After Missed Injection or Following Oral Regimento Replace an Injection 1  \n\n| Time Since the Missed Injection | Recommendation |\n| --- | --- |\n| ≤ 1 month | Administer one 600 mg/3 mL injection as soon as possible and continue with the every-2-month injection dosing schedule. |\n| > 1 month | Restart the individual on one 600 mg/3 mL initiation injection, followed by a second 600 mg/3 mL initiation injection one month later. Then follow the every-2-month injection dosing schedule. |\n\nPOPULATION PHARMACOKINETIC SIMULATION  \nA population pharmacokinetic model was used to assess CAB concentration-versus-time profiles after injection delays of 1–12 weeks at different injection visits to provide data on how to manage CAB LAdosing interruptions.2  \nDosing delays of 1–12 weeks of the second, third, and fourth injections, based on the CAB LA 600mg every 2 month (Q2M) dosing schedule, were simulated.2 The target was for approximately ≥ 95% of simulated subjects to maintain CAB concentrations of ≥ 0.65 µg/mL (4x PA-IC90 [phase 3 benchmark]) . Results for a delay of the second CAB LA injection are summarized in Table 2.  \nTable 2. Percentage of Subjects with CAB Concentrations > 0.65 µg/mL After Delay of Second Injection2  \n\n| Proportion of Subjects with CAB Concentrations > 0.65 µg/mL |  |  |\n| --- | --- | --- |\n| Trough Prior to Resuming Delayed Injection (%) |  | Trough After Resuming Delayed\u003Cbr>Injection (%)a |\n| Length of delay of\u003Cbr>second Injection |  |  |\n| No Delay | 95.0 | 95.6 |\n| 1 Week | 93.6 | 94.8 |\n| 2–4 Weeks | 77.4–91.4 | 92.8–94.2 |\n| 4–12 Weeks | 9.6–77.4 | 91.2–92.8b |\n| a Injections continue Q2M without re-initiating the Q2M regimen. b After re-initiation: 96.0–96.2% . CAB = cabotegravir; Q2M = every 2 months |  |  |\n\nFor delays ofthe t","cbCaim6ihGKJfiA0","https://ap.wps.com/l/cbCaim6ihGKJfiA0","pdf",172773,"English","# Summary\n## Management of CAB LA missed doses\n## Population pharmacokinetic simulation\n## HPTN 084: Pharmacologic evaluation of delayed CAB LA administration","[{\"question\":\"How should missed Apretude CAB LA injections be managed?\",\"answer\":\"Adherence to the injection schedule is strongly recommended. If an injection visit is missed, individuals should be clinically reassessed and receive an HIV test, and dosing should follow the missed-dose table guidance.\"},{\"question\":\"What is the expected pharmacokinetic impact of CAB LA dosing delays?\",\"answer\":\"Modeling shows minimal effect on the proportion of subjects maintaining target CAB concentrations (≥0.65 µg/mL) after 1-week delays. Delays longer than 1 week produce a more profound effect, with results summarized for second (and similar patterns for third and fourth) injections.\"},{\"question\":\"Can results from HPTN 084 delayed dosing be applied to cisgender men and transgender women?\",\"answer\":\"No. The document states that the pharmacokinetic data described for cisgender women with delayed dosing should not be extrapolated to cisgender men and transgender women.\"}]","Effect of Dosing Concentrations - Interruptions on Apretude | PDF",1790538908]