Efficacy, safety, and pharmacokinetics by BMI category in Phase 3/3b cabotegravir + rilpivirine long-acting trials
Cabotegravir + rilpivirine (CAB + RPV) is a guideline-recommended long-acting (LA) injectable regimen for the maintenance of HIV-1 virologic suppression. This post hoc analysis summarizes CAB + RPV LA results by baseline body mass index (BMI) category among Phase 3/3b trial participants. Data from C...
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| creator | Elliot, Emilie Polli, Joseph W Patel, Parul Garside, Louise Grove, Richard Barnett, Vince Roberts, Jeremy Byrapuneni, Sri Crauwels, Herta Ford, Susan L Van Solingen-Ristea, Rodica Birmingham, Eileen D'Amico, Ronald Baugh, Bryan van Wyk, Jean |
| description | Cabotegravir + rilpivirine (CAB + RPV) is a guideline-recommended long-acting (LA) injectable regimen for the maintenance of HIV-1 virologic suppression. This post hoc analysis summarizes CAB + RPV LA results by baseline body mass index (BMI) category among Phase 3/3b trial participants.
Data from CAB + RPV-naive participants receiving every 4 or 8 week dosing in FLAIR, ATLAS, and ATLAS-2 M were pooled through Week (W) 48. Data beyond W48 were summarized by study (FLAIR through W96 and ATLAS-2 M through W152). HIV 1 RNA |
| doi_str_mv | 10.1093/infdis/jiad580 |
| format | Article |
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Data from CAB + RPV-naive participants receiving every 4 or 8 week dosing in FLAIR, ATLAS, and ATLAS-2 M were pooled through Week (W) 48. Data beyond W48 were summarized by study (FLAIR through W96 and ATLAS-2 M through W152). HIV 1 RNA <50 and ≥50 copies/mL, confirmed virologic failure (CVF; two consecutive HIV-1 RNA ≥200 copies/mL), safety and tolerability, and plasma CAB and RPV trough concentrations were evaluated by baseline BMI (<30 kg/m2 [lower]; ≥ 30 kg/m2 [higher]).
Among 1245 CAB + RPV LA participants, 213 (17%) had a baseline BMI ≥30 kg/m2. At W48, 92% vs. 93% of participants with lower vs. higher BMI had HIV-1 RNA <50 copies/mL, respectively. Including data beyond W48, 18 participants had CVF; those in the higher BMI group (n = 8) all had at least one other baseline factor associated with CVF (archived RPV resistance-associated mutations or HIV 1 subtype A6/A1). Safety and pharmacokinetic profiles were comparable between BMI categories.
CAB + RPV LA was efficacious and well tolerated, regardless of baseline BMI category.Main point summary: CAB + RPV LA is effective in the maintenance of HIV-1 virologic suppression in adults regardless of BMI category, with longer-length needles (≥2 inches) recommend for those with BMI ≥30 kg/m2 to accommodate individual body habitus and ensure appropriate administration.</description><identifier>ISSN: 1537-6613</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1093/infdis/jiad580</identifier><identifier>PMID: 38134313</identifier><language>eng</language><publisher>United States</publisher><ispartof>The Journal of infectious diseases, 2023-12</ispartof><rights>The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38134313$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Elliot, Emilie</creatorcontrib><creatorcontrib>Polli, Joseph W</creatorcontrib><creatorcontrib>Patel, Parul</creatorcontrib><creatorcontrib>Garside, Louise</creatorcontrib><creatorcontrib>Grove, Richard</creatorcontrib><creatorcontrib>Barnett, Vince</creatorcontrib><creatorcontrib>Roberts, Jeremy</creatorcontrib><creatorcontrib>Byrapuneni, Sri</creatorcontrib><creatorcontrib>Crauwels, Herta</creatorcontrib><creatorcontrib>Ford, Susan L</creatorcontrib><creatorcontrib>Van Solingen-Ristea, Rodica</creatorcontrib><creatorcontrib>Birmingham, Eileen</creatorcontrib><creatorcontrib>D'Amico, Ronald</creatorcontrib><creatorcontrib>Baugh, Bryan</creatorcontrib><creatorcontrib>van Wyk, Jean</creatorcontrib><title>Efficacy, safety, and pharmacokinetics by BMI category in Phase 3/3b cabotegravir + rilpivirine long-acting trials</title><title>The Journal of infectious diseases</title><addtitle>J Infect Dis</addtitle><description>Cabotegravir + rilpivirine (CAB + RPV) is a guideline-recommended long-acting (LA) injectable regimen for the maintenance of HIV-1 virologic suppression. This post hoc analysis summarizes CAB + RPV LA results by baseline body mass index (BMI) category among Phase 3/3b trial participants.
Data from CAB + RPV-naive participants receiving every 4 or 8 week dosing in FLAIR, ATLAS, and ATLAS-2 M were pooled through Week (W) 48. Data beyond W48 were summarized by study (FLAIR through W96 and ATLAS-2 M through W152). HIV 1 RNA <50 and ≥50 copies/mL, confirmed virologic failure (CVF; two consecutive HIV-1 RNA ≥200 copies/mL), safety and tolerability, and plasma CAB and RPV trough concentrations were evaluated by baseline BMI (<30 kg/m2 [lower]; ≥ 30 kg/m2 [higher]).
Among 1245 CAB + RPV LA participants, 213 (17%) had a baseline BMI ≥30 kg/m2. At W48, 92% vs. 93% of participants with lower vs. higher BMI had HIV-1 RNA <50 copies/mL, respectively. Including data beyond W48, 18 participants had CVF; those in the higher BMI group (n = 8) all had at least one other baseline factor associated with CVF (archived RPV resistance-associated mutations or HIV 1 subtype A6/A1). Safety and pharmacokinetic profiles were comparable between BMI categories.
CAB + RPV LA was efficacious and well tolerated, regardless of baseline BMI category.Main point summary: CAB + RPV LA is effective in the maintenance of HIV-1 virologic suppression in adults regardless of BMI category, with longer-length needles (≥2 inches) recommend for those with BMI ≥30 kg/m2 to accommodate individual body habitus and ensure appropriate administration.</description><issn>1537-6613</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNpNkDtPAzEQhC0EIiHQUiKXSHDE9p7vUUIUIFIQFOlPts9OHO6FfYl0HS1_k1-CJYJEsfpmd0ZTLEKXlNxRksPUNqa0frq1ouQZOUJjyiGNkoTC8T89QmfebwkhMSTpKRpBRiEGCmO0nxtjlVDDLfbC6D5QNCXuNsLVQrXvttG9VR7LAT-8LLASvV63bsC2wW8b4TWGKchwlm0wnNhb9_35dRPG2aqzYQ0FuGqbdSRUb5s17p0VlT9HJyZAXxw4QavH-Wr2HC1fnxaz-2XU8QSiRDKiqdAxyyXhOs0ZGE44E0qXaaYhyY2JM6mkVDxOyzKGDFgaZyaTuUipgQm6_q3tXPux074vauuVrirR6HbnC5YTzmnOKAvRq0N0J2tdFp2ztXBD8fcq-AGEgG7f</recordid><startdate>20231222</startdate><enddate>20231222</enddate><creator>Elliot, Emilie</creator><creator>Polli, Joseph W</creator><creator>Patel, Parul</creator><creator>Garside, Louise</creator><creator>Grove, Richard</creator><creator>Barnett, Vince</creator><creator>Roberts, Jeremy</creator><creator>Byrapuneni, Sri</creator><creator>Crauwels, Herta</creator><creator>Ford, Susan L</creator><creator>Van Solingen-Ristea, Rodica</creator><creator>Birmingham, Eileen</creator><creator>D'Amico, Ronald</creator><creator>Baugh, Bryan</creator><creator>van Wyk, Jean</creator><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20231222</creationdate><title>Efficacy, safety, and pharmacokinetics by BMI category in Phase 3/3b cabotegravir + rilpivirine long-acting trials</title><author>Elliot, Emilie ; Polli, Joseph W ; Patel, Parul ; Garside, Louise ; Grove, Richard ; Barnett, Vince ; Roberts, Jeremy ; Byrapuneni, Sri ; Crauwels, Herta ; Ford, Susan L ; Van Solingen-Ristea, Rodica ; Birmingham, Eileen ; D'Amico, Ronald ; Baugh, Bryan ; van Wyk, Jean</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p563-6b20e1ae429b05e7923f5052aced78e369ff48bcbbc547dd43832748f8b9a71f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Elliot, Emilie</creatorcontrib><creatorcontrib>Polli, Joseph W</creatorcontrib><creatorcontrib>Patel, Parul</creatorcontrib><creatorcontrib>Garside, Louise</creatorcontrib><creatorcontrib>Grove, Richard</creatorcontrib><creatorcontrib>Barnett, Vince</creatorcontrib><creatorcontrib>Roberts, Jeremy</creatorcontrib><creatorcontrib>Byrapuneni, Sri</creatorcontrib><creatorcontrib>Crauwels, Herta</creatorcontrib><creatorcontrib>Ford, Susan L</creatorcontrib><creatorcontrib>Van Solingen-Ristea, Rodica</creatorcontrib><creatorcontrib>Birmingham, Eileen</creatorcontrib><creatorcontrib>D'Amico, Ronald</creatorcontrib><creatorcontrib>Baugh, Bryan</creatorcontrib><creatorcontrib>van Wyk, Jean</creatorcontrib><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Elliot, Emilie</au><au>Polli, Joseph W</au><au>Patel, Parul</au><au>Garside, Louise</au><au>Grove, Richard</au><au>Barnett, Vince</au><au>Roberts, Jeremy</au><au>Byrapuneni, Sri</au><au>Crauwels, Herta</au><au>Ford, Susan L</au><au>Van Solingen-Ristea, Rodica</au><au>Birmingham, Eileen</au><au>D'Amico, Ronald</au><au>Baugh, Bryan</au><au>van Wyk, Jean</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy, safety, and pharmacokinetics by BMI category in Phase 3/3b cabotegravir + rilpivirine long-acting trials</atitle><jtitle>The Journal of infectious diseases</jtitle><addtitle>J Infect Dis</addtitle><date>2023-12-22</date><risdate>2023</risdate><issn>1537-6613</issn><eissn>1537-6613</eissn><abstract>Cabotegravir + rilpivirine (CAB + RPV) is a guideline-recommended long-acting (LA) injectable regimen for the maintenance of HIV-1 virologic suppression. This post hoc analysis summarizes CAB + RPV LA results by baseline body mass index (BMI) category among Phase 3/3b trial participants.
Data from CAB + RPV-naive participants receiving every 4 or 8 week dosing in FLAIR, ATLAS, and ATLAS-2 M were pooled through Week (W) 48. Data beyond W48 were summarized by study (FLAIR through W96 and ATLAS-2 M through W152). HIV 1 RNA <50 and ≥50 copies/mL, confirmed virologic failure (CVF; two consecutive HIV-1 RNA ≥200 copies/mL), safety and tolerability, and plasma CAB and RPV trough concentrations were evaluated by baseline BMI (<30 kg/m2 [lower]; ≥ 30 kg/m2 [higher]).
Among 1245 CAB + RPV LA participants, 213 (17%) had a baseline BMI ≥30 kg/m2. At W48, 92% vs. 93% of participants with lower vs. higher BMI had HIV-1 RNA <50 copies/mL, respectively. Including data beyond W48, 18 participants had CVF; those in the higher BMI group (n = 8) all had at least one other baseline factor associated with CVF (archived RPV resistance-associated mutations or HIV 1 subtype A6/A1). Safety and pharmacokinetic profiles were comparable between BMI categories.
CAB + RPV LA was efficacious and well tolerated, regardless of baseline BMI category.Main point summary: CAB + RPV LA is effective in the maintenance of HIV-1 virologic suppression in adults regardless of BMI category, with longer-length needles (≥2 inches) recommend for those with BMI ≥30 kg/m2 to accommodate individual body habitus and ensure appropriate administration.</abstract><cop>United States</cop><pmid>38134313</pmid><doi>10.1093/infdis/jiad580</doi></addata></record> |
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| source | Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| title | Efficacy, safety, and pharmacokinetics by BMI category in Phase 3/3b cabotegravir + rilpivirine long-acting trials |
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