Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance an...
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| Veröffentlicht in: | AIDS research and human retroviruses 2020-01, Vol.36 (1), p.48-57 |
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| creator | Lathouwers, Erkki Wong, Eric Y Brown, Kimberley Baugh, Bryan Ghys, Anne Jezorwski, John Mohsine, El Ghazi Van Landuyt, Erika Opsomer, Magda De Meyer, Sandra |
| description | Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) ≥400 copies/mL at failure/later time points.
analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL |
| doi_str_mv | 10.1089/AID.2019.0111 |
| format | Article |
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analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL <50 copies/mL) in EMERALD. Through week 48 across both studies, no darunavir, primary PI, or tenofovir resistance-associated mutations (RAMs) were observed in HIV-1 viruses of 1,125 participants receiving D/C/F/TAF or 629 receiving boosted darunavir plus emtricitabine/tenofovir-disoproxil-fumarate. In AMBER, the nucleos(t)ide analog reverse transcriptase inhibitor (N(t)RTI) RAM M184I/V was identified in HIV-1 of one participant during D/C/F/TAF treatment. M184V was detected pretreatment as a minority variant (9%). In EMERALD, in participants with prior VF and genoarchive data (
= 140; 98 D/C/F/TAF and 42 control), 4% had viruses with darunavir RAMs, 38% with emtricitabine RAMs, mainly at position 184 (41% not fully susceptible to emtricitabine), 4% with tenofovir RAMs, and 21% ≥ 3 thymidine analog-associated mutations (24% not fully susceptible to tenofovir) detected at screening. All achieved VL <50 copies/mL at week 48 or prior discontinuation. D/C/F/TAF has a high genetic barrier to resistance; no darunavir, primary PI, or tenofovir RAMs were observed through 48 weeks in AMBER and EMERALD. Only one postbaseline M184I/V RAM was observed in HIV-1 of an AMBER participant. In EMERALD, baseline archived RAMs to darunavir, emtricitabine, and tenofovir in participants with prior VF did not preclude virologic response.</description><identifier>ISSN: 0889-2229</identifier><identifier>ISSN: 1931-8405</identifier><identifier>EISSN: 1931-8405</identifier><identifier>DOI: 10.1089/AID.2019.0111</identifier><identifier>PMID: 31516033</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject><![CDATA[Adenine - administration & dosage ; Adenine - analogs & derivatives ; Adult ; Adults ; Alanine ; Anti-HIV Agents - administration & dosage ; Antiretroviral drugs ; Beryl ; Clinical Trials/Clinical Studies ; Cobicistat - administration & dosage ; Darunavir - administration & dosage ; Deoxyribonucleic acid ; DNA ; DNA sequencing ; Drug Administration Schedule ; Drug Combinations ; Drug Resistance, Viral ; Emtricitabine ; Emtricitabine - administration & dosage ; Failure analysis ; Genotyping ; HIV ; HIV Infections - drug therapy ; HIV Infections - epidemiology ; HIV-1 - drug effects ; Human immunodeficiency virus ; Humans ; Life Sciences ; Mutation ; Phenotyping ; Rams ; Reverse Transcriptase Inhibitors - administration & dosage ; RNA-directed DNA polymerase ; Tablets - administration & dosage ; Tenofovir ; Tenofovir - analogs & derivatives ; Thymidine ; Viral Load - drug effects ; Viruses]]></subject><ispartof>AIDS research and human retroviruses, 2020-01, Vol.36 (1), p.48-57</ispartof><rights>Copyright Mary Ann Liebert, Inc. Jan 2020</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><rights>Erkki Lathouwers et al. 2019; Published by Mary Ann Liebert, Inc. 2019 Erkki Lathouwers et al.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c452t-a22a9300b7c4e8bf6d306c690f1780181a780991471e70c487ec0d423c66ada33</citedby><cites>FETCH-LOGICAL-c452t-a22a9300b7c4e8bf6d306c690f1780181a780991471e70c487ec0d423c66ada33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31516033$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://inserm.hal.science/inserm-03335955$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Lathouwers, Erkki</creatorcontrib><creatorcontrib>Wong, Eric Y</creatorcontrib><creatorcontrib>Brown, Kimberley</creatorcontrib><creatorcontrib>Baugh, Bryan</creatorcontrib><creatorcontrib>Ghys, Anne</creatorcontrib><creatorcontrib>Jezorwski, John</creatorcontrib><creatorcontrib>Mohsine, El Ghazi</creatorcontrib><creatorcontrib>Van Landuyt, Erika</creatorcontrib><creatorcontrib>Opsomer, Magda</creatorcontrib><creatorcontrib>De Meyer, Sandra</creatorcontrib><creatorcontrib>AMBER and EMERALD Study Groups</creatorcontrib><creatorcontrib>on behalf of the AMBER and EMERALD Study Groups</creatorcontrib><title>Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials</title><title>AIDS research and human retroviruses</title><addtitle>AIDS Res Hum Retroviruses</addtitle><description>Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) ≥400 copies/mL at failure/later time points.
analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL <50 copies/mL) in EMERALD. Through week 48 across both studies, no darunavir, primary PI, or tenofovir resistance-associated mutations (RAMs) were observed in HIV-1 viruses of 1,125 participants receiving D/C/F/TAF or 629 receiving boosted darunavir plus emtricitabine/tenofovir-disoproxil-fumarate. In AMBER, the nucleos(t)ide analog reverse transcriptase inhibitor (N(t)RTI) RAM M184I/V was identified in HIV-1 of one participant during D/C/F/TAF treatment. M184V was detected pretreatment as a minority variant (9%). In EMERALD, in participants with prior VF and genoarchive data (
= 140; 98 D/C/F/TAF and 42 control), 4% had viruses with darunavir RAMs, 38% with emtricitabine RAMs, mainly at position 184 (41% not fully susceptible to emtricitabine), 4% with tenofovir RAMs, and 21% ≥ 3 thymidine analog-associated mutations (24% not fully susceptible to tenofovir) detected at screening. All achieved VL <50 copies/mL at week 48 or prior discontinuation. D/C/F/TAF has a high genetic barrier to resistance; no darunavir, primary PI, or tenofovir RAMs were observed through 48 weeks in AMBER and EMERALD. Only one postbaseline M184I/V RAM was observed in HIV-1 of an AMBER participant. In EMERALD, baseline archived RAMs to darunavir, emtricitabine, and tenofovir in participants with prior VF did not preclude virologic response.</description><subject>Adenine - administration & dosage</subject><subject>Adenine - analogs & derivatives</subject><subject>Adult</subject><subject>Adults</subject><subject>Alanine</subject><subject>Anti-HIV Agents - administration & dosage</subject><subject>Antiretroviral drugs</subject><subject>Beryl</subject><subject>Clinical Trials/Clinical Studies</subject><subject>Cobicistat - administration & dosage</subject><subject>Darunavir - administration & dosage</subject><subject>Deoxyribonucleic acid</subject><subject>DNA</subject><subject>DNA sequencing</subject><subject>Drug Administration Schedule</subject><subject>Drug Combinations</subject><subject>Drug Resistance, Viral</subject><subject>Emtricitabine</subject><subject>Emtricitabine - administration & dosage</subject><subject>Failure analysis</subject><subject>Genotyping</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - epidemiology</subject><subject>HIV-1 - drug effects</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Life Sciences</subject><subject>Mutation</subject><subject>Phenotyping</subject><subject>Rams</subject><subject>Reverse Transcriptase Inhibitors - administration & dosage</subject><subject>RNA-directed DNA polymerase</subject><subject>Tablets - administration & dosage</subject><subject>Tenofovir</subject><subject>Tenofovir - analogs & derivatives</subject><subject>Thymidine</subject><subject>Viral Load - drug effects</subject><subject>Viruses</subject><issn>0889-2229</issn><issn>1931-8405</issn><issn>1931-8405</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkk2P0zAQhiMEYsvCkSuyxGWRNo0d58uXlULT0khdLSoFjpaTTFovib3YSVH5rfwYXLqsYE9jj595Z6x5Pe81wVOCMxbkZTENMWFTTAh54k0Io8TPIhw_9SY4y5gfhiE7815Ye4sxZmEYP_fOKIlJgimdeL--AnxDUYbWYKUdhKoB5Up0BwsW6RYNO0A3LukXQnaHS_RJqm0H_kZUHQyuaCt7UKgQZlRiL00w05Wsj0JDMO8H486DqKSCYANKt9ohKO9EC0r0sgF0UQSzYBFs8sU7JBXKm7EbLFrJvWuDfshhh5blF5-g1uj-zywfd8ICKssSrYVqdC9_QoPy6_fzNXJ3NL-er_NVgTZGis6-9J61LsCr-3jufV7MN7Olv7r5UM7ylV9HcTj4IgwFoxhXaR1BVrVJQ3FSJwy3JM0wyYhwgTESpQRSXEdZCjVuopDWSSIaQem5d3XSvRurHpoa1GBEx--M7IU5cC0k__9FyR3f6j1PWBQRehS4PAnsHpUt8xWXyoLpuVsXjVkc74nDL-77Gf19BDvwXtoauk4o0KPlbuM4i2NnC4e-fYTe6tG4BTuKUpKlIY2wo_wTVRttrYH2YQiC-dFmXMiGH23GjzZz_Jt_P_xA__UV_Q1RP8vV</recordid><startdate>20200101</startdate><enddate>20200101</enddate><creator>Lathouwers, Erkki</creator><creator>Wong, Eric Y</creator><creator>Brown, Kimberley</creator><creator>Baugh, Bryan</creator><creator>Ghys, Anne</creator><creator>Jezorwski, John</creator><creator>Mohsine, El Ghazi</creator><creator>Van Landuyt, Erika</creator><creator>Opsomer, Magda</creator><creator>De Meyer, Sandra</creator><general>Mary Ann Liebert, Inc</general><general>Mary Ann Liebert</general><general>Mary Ann Liebert, Inc., publishers</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>7QL</scope><scope>7T2</scope><scope>7T5</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>M7N</scope><scope>P64</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><scope>5PM</scope></search><sort><creationdate>20200101</creationdate><title>Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials</title><author>Lathouwers, Erkki ; Wong, Eric Y ; Brown, Kimberley ; Baugh, Bryan ; Ghys, Anne ; Jezorwski, John ; Mohsine, El Ghazi ; Van Landuyt, Erika ; Opsomer, Magda ; De Meyer, Sandra</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c452t-a22a9300b7c4e8bf6d306c690f1780181a780991471e70c487ec0d423c66ada33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adenine - administration & dosage</topic><topic>Adenine - analogs & derivatives</topic><topic>Adult</topic><topic>Adults</topic><topic>Alanine</topic><topic>Anti-HIV Agents - administration & dosage</topic><topic>Antiretroviral drugs</topic><topic>Beryl</topic><topic>Clinical Trials/Clinical Studies</topic><topic>Cobicistat - administration & dosage</topic><topic>Darunavir - administration & dosage</topic><topic>Deoxyribonucleic acid</topic><topic>DNA</topic><topic>DNA sequencing</topic><topic>Drug Administration Schedule</topic><topic>Drug Combinations</topic><topic>Drug Resistance, Viral</topic><topic>Emtricitabine</topic><topic>Emtricitabine - administration & dosage</topic><topic>Failure analysis</topic><topic>Genotyping</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - epidemiology</topic><topic>HIV-1 - drug effects</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Life Sciences</topic><topic>Mutation</topic><topic>Phenotyping</topic><topic>Rams</topic><topic>Reverse Transcriptase Inhibitors - administration & dosage</topic><topic>RNA-directed DNA polymerase</topic><topic>Tablets - administration & dosage</topic><topic>Tenofovir</topic><topic>Tenofovir - analogs & derivatives</topic><topic>Thymidine</topic><topic>Viral Load - drug effects</topic><topic>Viruses</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lathouwers, Erkki</creatorcontrib><creatorcontrib>Wong, Eric Y</creatorcontrib><creatorcontrib>Brown, Kimberley</creatorcontrib><creatorcontrib>Baugh, Bryan</creatorcontrib><creatorcontrib>Ghys, Anne</creatorcontrib><creatorcontrib>Jezorwski, John</creatorcontrib><creatorcontrib>Mohsine, El Ghazi</creatorcontrib><creatorcontrib>Van Landuyt, Erika</creatorcontrib><creatorcontrib>Opsomer, Magda</creatorcontrib><creatorcontrib>De Meyer, Sandra</creatorcontrib><creatorcontrib>AMBER and EMERALD Study Groups</creatorcontrib><creatorcontrib>on behalf of the AMBER and EMERALD Study Groups</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>AIDS research and human retroviruses</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lathouwers, Erkki</au><au>Wong, Eric Y</au><au>Brown, Kimberley</au><au>Baugh, Bryan</au><au>Ghys, Anne</au><au>Jezorwski, John</au><au>Mohsine, El Ghazi</au><au>Van Landuyt, Erika</au><au>Opsomer, Magda</au><au>De Meyer, Sandra</au><aucorp>AMBER and EMERALD Study Groups</aucorp><aucorp>on behalf of the AMBER and EMERALD Study Groups</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials</atitle><jtitle>AIDS research and human retroviruses</jtitle><addtitle>AIDS Res Hum Retroviruses</addtitle><date>2020-01-01</date><risdate>2020</risdate><volume>36</volume><issue>1</issue><spage>48</spage><epage>57</epage><pages>48-57</pages><issn>0889-2229</issn><issn>1931-8405</issn><eissn>1931-8405</eissn><abstract>Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) ≥400 copies/mL at failure/later time points.
analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL <50 copies/mL) in EMERALD. Through week 48 across both studies, no darunavir, primary PI, or tenofovir resistance-associated mutations (RAMs) were observed in HIV-1 viruses of 1,125 participants receiving D/C/F/TAF or 629 receiving boosted darunavir plus emtricitabine/tenofovir-disoproxil-fumarate. In AMBER, the nucleos(t)ide analog reverse transcriptase inhibitor (N(t)RTI) RAM M184I/V was identified in HIV-1 of one participant during D/C/F/TAF treatment. M184V was detected pretreatment as a minority variant (9%). In EMERALD, in participants with prior VF and genoarchive data (
= 140; 98 D/C/F/TAF and 42 control), 4% had viruses with darunavir RAMs, 38% with emtricitabine RAMs, mainly at position 184 (41% not fully susceptible to emtricitabine), 4% with tenofovir RAMs, and 21% ≥ 3 thymidine analog-associated mutations (24% not fully susceptible to tenofovir) detected at screening. All achieved VL <50 copies/mL at week 48 or prior discontinuation. D/C/F/TAF has a high genetic barrier to resistance; no darunavir, primary PI, or tenofovir RAMs were observed through 48 weeks in AMBER and EMERALD. Only one postbaseline M184I/V RAM was observed in HIV-1 of an AMBER participant. In EMERALD, baseline archived RAMs to darunavir, emtricitabine, and tenofovir in participants with prior VF did not preclude virologic response.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>31516033</pmid><doi>10.1089/AID.2019.0111</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0889-2229 |
| ispartof | AIDS research and human retroviruses, 2020-01, Vol.36 (1), p.48-57 |
| issn | 0889-2229 1931-8405 1931-8405 |
| language | eng |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Adenine - administration & dosage Adenine - analogs & derivatives Adult Adults Alanine Anti-HIV Agents - administration & dosage Antiretroviral drugs Beryl Clinical Trials/Clinical Studies Cobicistat - administration & dosage Darunavir - administration & dosage Deoxyribonucleic acid DNA DNA sequencing Drug Administration Schedule Drug Combinations Drug Resistance, Viral Emtricitabine Emtricitabine - administration & dosage Failure analysis Genotyping HIV HIV Infections - drug therapy HIV Infections - epidemiology HIV-1 - drug effects Human immunodeficiency virus Humans Life Sciences Mutation Phenotyping Rams Reverse Transcriptase Inhibitors - administration & dosage RNA-directed DNA polymerase Tablets - administration & dosage Tenofovir Tenofovir - analogs & derivatives Thymidine Viral Load - drug effects Viruses |
| title | Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials |
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