Efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir-based three-drug regimens in people with HIV with varying adherence to antiretroviral therapy
Five Phase 3 bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) clinical studies demonstrated that the efficacy of B/F/TAF was non-inferior to dolutegravir (DTG) + 2 NRTIs. We retrospectively assessed drug adherence and effect on virologic outcomes. Studies (NCT02607930, NCT02607956, NCT03547...
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| Veröffentlicht in: | Journal of antimicrobial chemotherapy 2025-01, Vol.80 (1), p.281-291 |
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| creator | Andreatta, Kristen Sax, Paul E Wohl, David D'Antoni, Michelle L Liu, Hui Hindman, Jason T Callebaut, Christian |
| description | Five Phase 3 bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) clinical studies demonstrated that the efficacy of B/F/TAF was non-inferior to dolutegravir (DTG) + 2 NRTIs. We retrospectively assessed drug adherence and effect on virologic outcomes.
Studies (NCT02607930, NCT02607956, NCT03547908, NCT02603120 and NCT03110380) were double-blind, placebo-controlled and enrolled treatment-naïve or virologically suppressed adults. Adherence was calculated by pill count from returned pill bottles; virologic outcome was assessed by last on-treatment HIV-1 RNA.
Altogether, 2622 participants (B/F/TAF: n = 1306; DTG + 2 NRTIs: n = 1316) were categorized as having high (≥95%), intermediate (≥85% to |
| doi_str_mv | 10.1093/jac/dkae407 |
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Studies (NCT02607930, NCT02607956, NCT03547908, NCT02603120 and NCT03110380) were double-blind, placebo-controlled and enrolled treatment-naïve or virologically suppressed adults. Adherence was calculated by pill count from returned pill bottles; virologic outcome was assessed by last on-treatment HIV-1 RNA.
Altogether, 2622 participants (B/F/TAF: n = 1306; DTG + 2 NRTIs: n = 1316) were categorized as having high (≥95%), intermediate (≥85% to <95%) or low (<85%) adherence. Through Week 48, low adherence was observed in 46 (3.5%) participants in the B/F/TAF group (78% median adherence) and 69 (5.2%) in the DTG + 2 NRTI group (80% median adherence). Overall, 1287 (98.5%) participants in the B/F/TAF group and 1292 (98.2%) in the DTG + 2 NRTI group had virologic suppression (VS; HIV-1 RNA < 50 copies/mL) through Week 48. VS in participants with low adherence versus high or intermediate adherence was similar in the B/F/TAF group, but lower in the DTG + 2 NRTI group (P ≤ 0.002). Similar results were observed at Weeks 96 and 144. Two participants (<95% adherence) in the DTG + 2 NRTI group receiving DTG and abacavir/lamivudine developed M184V; there was no treatment-emergent resistance to B/F/TAF.
Participants with suboptimal (<85%) adherence to B/F/TAF maintained high levels of VS, whereas suboptimal DTG + 2 NRTI adherence was associated with lower VS.</description><identifier>ISSN: 0305-7453</identifier><identifier>ISSN: 1460-2091</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkae407</identifier><identifier>PMID: 39556192</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject><![CDATA[Adenine - administration & dosage ; Adenine - analogs & derivatives ; Adenine - therapeutic use ; Adult ; Alanine - therapeutic use ; Amides - therapeutic use ; Anti-HIV Agents - administration & dosage ; Anti-HIV Agents - therapeutic use ; Antiretroviral Therapy, Highly Active ; Double-Blind Method ; Drug Combinations ; Emtricitabine - therapeutic use ; Female ; Heterocyclic Compounds, 3-Ring - administration & dosage ; Heterocyclic Compounds, 3-Ring - therapeutic use ; Heterocyclic Compounds, 4 or More Rings - administration & dosage ; Heterocyclic Compounds, 4 or More Rings - therapeutic use ; HIV Infections - drug therapy ; HIV Infections - virology ; HIV-1 - drug effects ; HIV-1 - genetics ; Humans ; Male ; Medication Adherence ; Middle Aged ; Original Research ; Oxazines - therapeutic use ; Piperazines ; Pyridones ; Retrospective Studies ; RNA, Viral - blood ; Tenofovir - analogs & derivatives ; Tenofovir - therapeutic use ; Treatment Outcome ; Viral Load - drug effects]]></subject><ispartof>Journal of antimicrobial chemotherapy, 2025-01, Vol.80 (1), p.281-291</ispartof><rights>The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy.</rights><rights>The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c270t-d726a565e407fe3aa5ee9bc2ea70978433353dca4d679b416f4504aec9e07ad83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39556192$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Andreatta, Kristen</creatorcontrib><creatorcontrib>Sax, Paul E</creatorcontrib><creatorcontrib>Wohl, David</creatorcontrib><creatorcontrib>D'Antoni, Michelle L</creatorcontrib><creatorcontrib>Liu, Hui</creatorcontrib><creatorcontrib>Hindman, Jason T</creatorcontrib><creatorcontrib>Callebaut, Christian</creatorcontrib><title>Efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir-based three-drug regimens in people with HIV with varying adherence to antiretroviral therapy</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>Five Phase 3 bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) clinical studies demonstrated that the efficacy of B/F/TAF was non-inferior to dolutegravir (DTG) + 2 NRTIs. We retrospectively assessed drug adherence and effect on virologic outcomes.
Studies (NCT02607930, NCT02607956, NCT03547908, NCT02603120 and NCT03110380) were double-blind, placebo-controlled and enrolled treatment-naïve or virologically suppressed adults. Adherence was calculated by pill count from returned pill bottles; virologic outcome was assessed by last on-treatment HIV-1 RNA.
Altogether, 2622 participants (B/F/TAF: n = 1306; DTG + 2 NRTIs: n = 1316) were categorized as having high (≥95%), intermediate (≥85% to <95%) or low (<85%) adherence. Through Week 48, low adherence was observed in 46 (3.5%) participants in the B/F/TAF group (78% median adherence) and 69 (5.2%) in the DTG + 2 NRTI group (80% median adherence). Overall, 1287 (98.5%) participants in the B/F/TAF group and 1292 (98.2%) in the DTG + 2 NRTI group had virologic suppression (VS; HIV-1 RNA < 50 copies/mL) through Week 48. VS in participants with low adherence versus high or intermediate adherence was similar in the B/F/TAF group, but lower in the DTG + 2 NRTI group (P ≤ 0.002). Similar results were observed at Weeks 96 and 144. Two participants (<95% adherence) in the DTG + 2 NRTI group receiving DTG and abacavir/lamivudine developed M184V; there was no treatment-emergent resistance to B/F/TAF.
Participants with suboptimal (<85%) adherence to B/F/TAF maintained high levels of VS, whereas suboptimal DTG + 2 NRTI adherence was associated with lower VS.</description><subject>Adenine - administration & dosage</subject><subject>Adenine - analogs & derivatives</subject><subject>Adenine - therapeutic use</subject><subject>Adult</subject><subject>Alanine - therapeutic use</subject><subject>Amides - therapeutic use</subject><subject>Anti-HIV Agents - administration & dosage</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretroviral Therapy, Highly Active</subject><subject>Double-Blind Method</subject><subject>Drug Combinations</subject><subject>Emtricitabine - therapeutic use</subject><subject>Female</subject><subject>Heterocyclic Compounds, 3-Ring - administration & dosage</subject><subject>Heterocyclic Compounds, 3-Ring - therapeutic use</subject><subject>Heterocyclic Compounds, 4 or More Rings - administration & dosage</subject><subject>Heterocyclic Compounds, 4 or More Rings - therapeutic use</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - virology</subject><subject>HIV-1 - drug effects</subject><subject>HIV-1 - genetics</subject><subject>Humans</subject><subject>Male</subject><subject>Medication Adherence</subject><subject>Middle Aged</subject><subject>Original Research</subject><subject>Oxazines - therapeutic use</subject><subject>Piperazines</subject><subject>Pyridones</subject><subject>Retrospective Studies</subject><subject>RNA, Viral - blood</subject><subject>Tenofovir - analogs & derivatives</subject><subject>Tenofovir - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Viral Load - drug effects</subject><issn>0305-7453</issn><issn>1460-2091</issn><issn>1460-2091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2025</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUcFu1DAQtRCILoUTd-QjEgprx7GzPiFUFVqpEhfgak3sSdYlsRfb2Wo_in8kq91WcJrRzJv3nuYR8pazj5xpsb4Hu3a_ABvWPiMr3ihW1Uzz52TFBJNV20hxQV7lfM8YU1JtXpILoaVUXNcr8ue6770Fe6Cxp523BYcEe5_WOJXkrS_Q-YDrgiH2cZlTGKHHAJN3SPeY8pypi-P8eFd1kNHRsk2IlUvzQBMOfsKQqQ90h3E3In3wZUtvbn-emj2kgw8DBbfFhMEiLZFCKD5hSUdNGBc-TLA7vCYvehgzvjnXS_Ljy_X3q5vq7tvX26vPd5WtW1Yq19YKpJLHl_QoACSi7myN0DLdbhohhBTOQuNUq7uGq76RrAG0GlkLbiMuyacT727uJnQWQ1lcmF3y02LWRPDm_03wWzPEveFcaanZkeH9mSHF3zPmYiafLY4jBIxzNoLXWm3aVrEF-uEEtSnmnLB_0uHMHBM2S8LmnPCCfvevtSfsY6TiLxq1qfU</recordid><startdate>20250103</startdate><enddate>20250103</enddate><creator>Andreatta, Kristen</creator><creator>Sax, Paul E</creator><creator>Wohl, David</creator><creator>D'Antoni, Michelle L</creator><creator>Liu, Hui</creator><creator>Hindman, Jason T</creator><creator>Callebaut, Christian</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20250103</creationdate><title>Efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir-based three-drug regimens in people with HIV with varying adherence to antiretroviral therapy</title><author>Andreatta, Kristen ; Sax, Paul E ; Wohl, David ; D'Antoni, Michelle L ; Liu, Hui ; Hindman, Jason T ; Callebaut, Christian</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c270t-d726a565e407fe3aa5ee9bc2ea70978433353dca4d679b416f4504aec9e07ad83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2025</creationdate><topic>Adenine - administration & dosage</topic><topic>Adenine - analogs & derivatives</topic><topic>Adenine - therapeutic use</topic><topic>Adult</topic><topic>Alanine - therapeutic use</topic><topic>Amides - therapeutic use</topic><topic>Anti-HIV Agents - administration & dosage</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antiretroviral Therapy, Highly Active</topic><topic>Double-Blind Method</topic><topic>Drug Combinations</topic><topic>Emtricitabine - therapeutic use</topic><topic>Female</topic><topic>Heterocyclic Compounds, 3-Ring - administration & dosage</topic><topic>Heterocyclic Compounds, 3-Ring - therapeutic use</topic><topic>Heterocyclic Compounds, 4 or More Rings - administration & dosage</topic><topic>Heterocyclic Compounds, 4 or More Rings - therapeutic use</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - virology</topic><topic>HIV-1 - drug effects</topic><topic>HIV-1 - genetics</topic><topic>Humans</topic><topic>Male</topic><topic>Medication Adherence</topic><topic>Middle Aged</topic><topic>Original Research</topic><topic>Oxazines - therapeutic use</topic><topic>Piperazines</topic><topic>Pyridones</topic><topic>Retrospective Studies</topic><topic>RNA, Viral - blood</topic><topic>Tenofovir - analogs & derivatives</topic><topic>Tenofovir - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Viral Load - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Andreatta, Kristen</creatorcontrib><creatorcontrib>Sax, Paul E</creatorcontrib><creatorcontrib>Wohl, David</creatorcontrib><creatorcontrib>D'Antoni, Michelle L</creatorcontrib><creatorcontrib>Liu, Hui</creatorcontrib><creatorcontrib>Hindman, Jason T</creatorcontrib><creatorcontrib>Callebaut, Christian</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Andreatta, Kristen</au><au>Sax, Paul E</au><au>Wohl, David</au><au>D'Antoni, Michelle L</au><au>Liu, Hui</au><au>Hindman, Jason T</au><au>Callebaut, Christian</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir-based three-drug regimens in people with HIV with varying adherence to antiretroviral therapy</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2025-01-03</date><risdate>2025</risdate><volume>80</volume><issue>1</issue><spage>281</spage><epage>291</epage><pages>281-291</pages><issn>0305-7453</issn><issn>1460-2091</issn><eissn>1460-2091</eissn><abstract>Five Phase 3 bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) clinical studies demonstrated that the efficacy of B/F/TAF was non-inferior to dolutegravir (DTG) + 2 NRTIs. We retrospectively assessed drug adherence and effect on virologic outcomes.
Studies (NCT02607930, NCT02607956, NCT03547908, NCT02603120 and NCT03110380) were double-blind, placebo-controlled and enrolled treatment-naïve or virologically suppressed adults. Adherence was calculated by pill count from returned pill bottles; virologic outcome was assessed by last on-treatment HIV-1 RNA.
Altogether, 2622 participants (B/F/TAF: n = 1306; DTG + 2 NRTIs: n = 1316) were categorized as having high (≥95%), intermediate (≥85% to <95%) or low (<85%) adherence. Through Week 48, low adherence was observed in 46 (3.5%) participants in the B/F/TAF group (78% median adherence) and 69 (5.2%) in the DTG + 2 NRTI group (80% median adherence). Overall, 1287 (98.5%) participants in the B/F/TAF group and 1292 (98.2%) in the DTG + 2 NRTI group had virologic suppression (VS; HIV-1 RNA < 50 copies/mL) through Week 48. VS in participants with low adherence versus high or intermediate adherence was similar in the B/F/TAF group, but lower in the DTG + 2 NRTI group (P ≤ 0.002). Similar results were observed at Weeks 96 and 144. Two participants (<95% adherence) in the DTG + 2 NRTI group receiving DTG and abacavir/lamivudine developed M184V; there was no treatment-emergent resistance to B/F/TAF.
Participants with suboptimal (<85%) adherence to B/F/TAF maintained high levels of VS, whereas suboptimal DTG + 2 NRTI adherence was associated with lower VS.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>39556192</pmid><doi>10.1093/jac/dkae407</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of antimicrobial chemotherapy, 2025-01, Vol.80 (1), p.281-291 |
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| subjects | Adenine - administration & dosage Adenine - analogs & derivatives Adenine - therapeutic use Adult Alanine - therapeutic use Amides - therapeutic use Anti-HIV Agents - administration & dosage Anti-HIV Agents - therapeutic use Antiretroviral Therapy, Highly Active Double-Blind Method Drug Combinations Emtricitabine - therapeutic use Female Heterocyclic Compounds, 3-Ring - administration & dosage Heterocyclic Compounds, 3-Ring - therapeutic use Heterocyclic Compounds, 4 or More Rings - administration & dosage Heterocyclic Compounds, 4 or More Rings - therapeutic use HIV Infections - drug therapy HIV Infections - virology HIV-1 - drug effects HIV-1 - genetics Humans Male Medication Adherence Middle Aged Original Research Oxazines - therapeutic use Piperazines Pyridones Retrospective Studies RNA, Viral - blood Tenofovir - analogs & derivatives Tenofovir - therapeutic use Treatment Outcome Viral Load - drug effects |
| title | Efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir-based three-drug regimens in people with HIV with varying adherence to antiretroviral therapy |
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