Dual therapy based on co-formulated darunavir/ritonavir plus lamivudine for initial therapy of HIV infection: The ANDES randomized controlled trial
•The dual therapy strategy was based on co-formulated protease inhibitors plus lamivudine in treatment-naïve people living with human immunodeficiency virus.•This randomized trial shows the non-inferiority of a fixed dose co-formulation of darunavir/ritonavir (DRV/r) combined with lamivudine (3TC) c...
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| Veröffentlicht in: | International journal of antimicrobial agents 2024-10, Vol.64 (4), p.107301, Article 107301 |
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| creator | Figueroa, M.I. Sued, O. Cecchini, D. Sanchez, M. Rolón, M.J. Lopardo, G. Ceschel, M. Mernies, G. De Stefano, M. Patterson, P. Gun, A. Fink, V. Ortiz, Z. Cahn, P. Cahn, Pedro Cecchini, Diego Pryluka, Daniel Sánchez, Marisa Lopardo, Gustavo Altclas, Javier Rolón, María José Multicentric studies unit(UEM) Clinical research Unit (CRS) |
| description | •The dual therapy strategy was based on co-formulated protease inhibitors plus lamivudine in treatment-naïve people living with human immunodeficiency virus.•This randomized trial shows the non-inferiority of a fixed dose co-formulation of darunavir/ritonavir (DRV/r) combined with lamivudine (3TC) compared with a three-drug regimen based on these drugs plus tenofovir.•The combination was well tolerated.•Co-formulated DRV/r plus 3TC is an effective and safe option as initial antiretroviral therapy.
Tenofovir-containing antiretroviral therapy regimens may have long-term toxicity-related side effects. This study aimed to compare the virological efficacy of co-formulated darunavir/ritonavir plus lamivudine with darunavir/ritonavir plus tenofovir and emtricitabine or lamivudine.
The ANDES study was a 48-week, phase 4, randomized, open-label, non-inferiority trial in treatment-naïve adults living with human immunodeficiency virus (HIV). Patients were randomized on a 1:1 basis to receive a daily oral regimen of either dual therapy based on a generic co-formulation of darunavir/ritonavir (800/100 mg) plus a generic lamivudine 300 mg pill, or triple therapy with darunavir/ritonavir plus tenofovir/emtricitabine (300/200 mg) or tenofovir/lamivudine (300/300 mg). The primary endpoint was the proportion of patients with a viral load of |
| doi_str_mv | 10.1016/j.ijantimicag.2024.107301 |
| format | Article |
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Tenofovir-containing antiretroviral therapy regimens may have long-term toxicity-related side effects. This study aimed to compare the virological efficacy of co-formulated darunavir/ritonavir plus lamivudine with darunavir/ritonavir plus tenofovir and emtricitabine or lamivudine.
The ANDES study was a 48-week, phase 4, randomized, open-label, non-inferiority trial in treatment-naïve adults living with human immunodeficiency virus (HIV). Patients were randomized on a 1:1 basis to receive a daily oral regimen of either dual therapy based on a generic co-formulation of darunavir/ritonavir (800/100 mg) plus a generic lamivudine 300 mg pill, or triple therapy with darunavir/ritonavir plus tenofovir/emtricitabine (300/200 mg) or tenofovir/lamivudine (300/300 mg). The primary endpoint was the proportion of patients with a viral load of <50 copies/mL at week 48 in the intention-to-treat population. The US Food and Drug Administration snapshot algorithm and a non-inferiority margin of -12% were used. The secondary objective was to analyse safety in the per-protocol population. This study has been registered at ClinicalTrials.gov (NCT02770508).
Between November 2015 and 31 October 2020, 336 participants were assigned at random to the triple therapy arm (n=165) or the dual therapy arm (n=171). After 48 weeks, 153 patients in the triple therapy group (93%) and 155 patients in the dual therapy group (91%) achieved virological suppression (difference -2.1%, 95% confidence interval -7.0 to 2.9). Drug-related adverse events were more common in the triple therapy group (P=0.04). Two toxicity-related events led to discontinuation in each group.
Co-formulated darunavir/ritonavir plus lamivudine showed non-inferiority and a safer toxicity profile compared with the standard-of-care triple therapy regimen including tenofovir in treatment-naïve patients.
[Display omitted]</description><identifier>ISSN: 0924-8579</identifier><identifier>ISSN: 1872-7913</identifier><identifier>EISSN: 1872-7913</identifier><identifier>DOI: 10.1016/j.ijantimicag.2024.107301</identifier><identifier>PMID: 39151647</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Antiretroviral therapy ; Clinical trial ; Darunavir ; HIV ; Lamivudine</subject><ispartof>International journal of antimicrobial agents, 2024-10, Vol.64 (4), p.107301, Article 107301</ispartof><rights>2024 Elsevier Ltd and International Society of Antimicrobial Chemotherapy</rights><rights>Copyright © 2024 Elsevier Ltd and International Society of Antimicrobial Chemotherapy. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c251t-caef94e9fd8eec4f6ce42721ff50d7822b53ddd3b75b9b554a333949d6a158103</cites><orcidid>0000-0002-0091-5150 ; 0000-0002-8545-6132 ; 0000-0002-9381-1931 ; 0000-0003-3158-8284</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0924857924002176$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39151647$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Figueroa, M.I.</creatorcontrib><creatorcontrib>Sued, O.</creatorcontrib><creatorcontrib>Cecchini, D.</creatorcontrib><creatorcontrib>Sanchez, M.</creatorcontrib><creatorcontrib>Rolón, M.J.</creatorcontrib><creatorcontrib>Lopardo, G.</creatorcontrib><creatorcontrib>Ceschel, M.</creatorcontrib><creatorcontrib>Mernies, G.</creatorcontrib><creatorcontrib>De Stefano, M.</creatorcontrib><creatorcontrib>Patterson, P.</creatorcontrib><creatorcontrib>Gun, A.</creatorcontrib><creatorcontrib>Fink, V.</creatorcontrib><creatorcontrib>Ortiz, Z.</creatorcontrib><creatorcontrib>Cahn, P.</creatorcontrib><creatorcontrib>Cahn, Pedro</creatorcontrib><creatorcontrib>Cecchini, Diego</creatorcontrib><creatorcontrib>Pryluka, Daniel</creatorcontrib><creatorcontrib>Sánchez, Marisa</creatorcontrib><creatorcontrib>Lopardo, Gustavo</creatorcontrib><creatorcontrib>Altclas, Javier</creatorcontrib><creatorcontrib>Rolón, María José</creatorcontrib><creatorcontrib>Multicentric studies unit(UEM)</creatorcontrib><creatorcontrib>Clinical research Unit (CRS)</creatorcontrib><creatorcontrib>ANDES Study Group</creatorcontrib><title>Dual therapy based on co-formulated darunavir/ritonavir plus lamivudine for initial therapy of HIV infection: The ANDES randomized controlled trial</title><title>International journal of antimicrobial agents</title><addtitle>Int J Antimicrob Agents</addtitle><description>•The dual therapy strategy was based on co-formulated protease inhibitors plus lamivudine in treatment-naïve people living with human immunodeficiency virus.•This randomized trial shows the non-inferiority of a fixed dose co-formulation of darunavir/ritonavir (DRV/r) combined with lamivudine (3TC) compared with a three-drug regimen based on these drugs plus tenofovir.•The combination was well tolerated.•Co-formulated DRV/r plus 3TC is an effective and safe option as initial antiretroviral therapy.
Tenofovir-containing antiretroviral therapy regimens may have long-term toxicity-related side effects. This study aimed to compare the virological efficacy of co-formulated darunavir/ritonavir plus lamivudine with darunavir/ritonavir plus tenofovir and emtricitabine or lamivudine.
The ANDES study was a 48-week, phase 4, randomized, open-label, non-inferiority trial in treatment-naïve adults living with human immunodeficiency virus (HIV). Patients were randomized on a 1:1 basis to receive a daily oral regimen of either dual therapy based on a generic co-formulation of darunavir/ritonavir (800/100 mg) plus a generic lamivudine 300 mg pill, or triple therapy with darunavir/ritonavir plus tenofovir/emtricitabine (300/200 mg) or tenofovir/lamivudine (300/300 mg). The primary endpoint was the proportion of patients with a viral load of <50 copies/mL at week 48 in the intention-to-treat population. The US Food and Drug Administration snapshot algorithm and a non-inferiority margin of -12% were used. The secondary objective was to analyse safety in the per-protocol population. This study has been registered at ClinicalTrials.gov (NCT02770508).
Between November 2015 and 31 October 2020, 336 participants were assigned at random to the triple therapy arm (n=165) or the dual therapy arm (n=171). After 48 weeks, 153 patients in the triple therapy group (93%) and 155 patients in the dual therapy group (91%) achieved virological suppression (difference -2.1%, 95% confidence interval -7.0 to 2.9). Drug-related adverse events were more common in the triple therapy group (P=0.04). Two toxicity-related events led to discontinuation in each group.
Co-formulated darunavir/ritonavir plus lamivudine showed non-inferiority and a safer toxicity profile compared with the standard-of-care triple therapy regimen including tenofovir in treatment-naïve patients.
[Display omitted]</description><subject>Antiretroviral therapy</subject><subject>Clinical trial</subject><subject>Darunavir</subject><subject>HIV</subject><subject>Lamivudine</subject><issn>0924-8579</issn><issn>1872-7913</issn><issn>1872-7913</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNqNkVFPHCEUhUnTpq62f6Ghb32ZFQbYGfpmVqsmpn2o7Sth4FLZzMAWmE30b_QPi641PvrEzcl3zs3lIPSZkiUldHW8WfqNDsVP3ug_y5a0vOodI_QNWtC-a5tOUvYWLYhsedOLTh6gw5w3hFDBuHiPDpikgq54t0D_Tmc94nIDSW9v8aAzWBwDNrFxMU3zqEsVrE5z0DufjpMv8XHC23HOeNST383WB8AVxz744l_ERYcvLn9X2YEpPoav-PoG8Mn307OfOOlg4-TvaryJoaQ4jnUsqfo_oHdOjxk-Pr1H6Ne3s-v1RXP14_xyfXLVmFbQ0hgNTnKQzvYAhruVAd52LXVOENv1bTsIZq1lQycGOQjBNWNMcmlXmoqeEnaEvuxztyn-nSEXNflsYBx1gDhnxYjkhLOe9BWVe9SkmHMCp7bJTzrdKkrUQydqo150oh46UftOqvfT05p5mMA-O_-XUIH1HoB67M5DUtl4CAasT_XjlI3-FWvuAR9Fpjw</recordid><startdate>20241001</startdate><enddate>20241001</enddate><creator>Figueroa, M.I.</creator><creator>Sued, O.</creator><creator>Cecchini, D.</creator><creator>Sanchez, M.</creator><creator>Rolón, M.J.</creator><creator>Lopardo, G.</creator><creator>Ceschel, M.</creator><creator>Mernies, G.</creator><creator>De Stefano, M.</creator><creator>Patterson, P.</creator><creator>Gun, A.</creator><creator>Fink, V.</creator><creator>Ortiz, Z.</creator><creator>Cahn, P.</creator><creator>Cahn, Pedro</creator><creator>Cecchini, Diego</creator><creator>Pryluka, Daniel</creator><creator>Sánchez, Marisa</creator><creator>Lopardo, Gustavo</creator><creator>Altclas, Javier</creator><creator>Rolón, María José</creator><creator>Multicentric studies unit(UEM)</creator><creator>Clinical research Unit (CRS)</creator><general>Elsevier Ltd</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-0091-5150</orcidid><orcidid>https://orcid.org/0000-0002-8545-6132</orcidid><orcidid>https://orcid.org/0000-0002-9381-1931</orcidid><orcidid>https://orcid.org/0000-0003-3158-8284</orcidid></search><sort><creationdate>20241001</creationdate><title>Dual therapy based on co-formulated darunavir/ritonavir plus lamivudine for initial therapy of HIV infection: The ANDES randomized controlled trial</title><author>Figueroa, M.I. ; 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Tenofovir-containing antiretroviral therapy regimens may have long-term toxicity-related side effects. This study aimed to compare the virological efficacy of co-formulated darunavir/ritonavir plus lamivudine with darunavir/ritonavir plus tenofovir and emtricitabine or lamivudine.
The ANDES study was a 48-week, phase 4, randomized, open-label, non-inferiority trial in treatment-naïve adults living with human immunodeficiency virus (HIV). Patients were randomized on a 1:1 basis to receive a daily oral regimen of either dual therapy based on a generic co-formulation of darunavir/ritonavir (800/100 mg) plus a generic lamivudine 300 mg pill, or triple therapy with darunavir/ritonavir plus tenofovir/emtricitabine (300/200 mg) or tenofovir/lamivudine (300/300 mg). The primary endpoint was the proportion of patients with a viral load of <50 copies/mL at week 48 in the intention-to-treat population. The US Food and Drug Administration snapshot algorithm and a non-inferiority margin of -12% were used. The secondary objective was to analyse safety in the per-protocol population. This study has been registered at ClinicalTrials.gov (NCT02770508).
Between November 2015 and 31 October 2020, 336 participants were assigned at random to the triple therapy arm (n=165) or the dual therapy arm (n=171). After 48 weeks, 153 patients in the triple therapy group (93%) and 155 patients in the dual therapy group (91%) achieved virological suppression (difference -2.1%, 95% confidence interval -7.0 to 2.9). Drug-related adverse events were more common in the triple therapy group (P=0.04). Two toxicity-related events led to discontinuation in each group.
Co-formulated darunavir/ritonavir plus lamivudine showed non-inferiority and a safer toxicity profile compared with the standard-of-care triple therapy regimen including tenofovir in treatment-naïve patients.
[Display omitted]</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>39151647</pmid><doi>10.1016/j.ijantimicag.2024.107301</doi><orcidid>https://orcid.org/0000-0002-0091-5150</orcidid><orcidid>https://orcid.org/0000-0002-8545-6132</orcidid><orcidid>https://orcid.org/0000-0002-9381-1931</orcidid><orcidid>https://orcid.org/0000-0003-3158-8284</orcidid></addata></record> |
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| issn | 0924-8579 1872-7913 1872-7913 |
| language | eng |
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| source | Elsevier ScienceDirect Journals |
| subjects | Antiretroviral therapy Clinical trial Darunavir HIV Lamivudine |
| title | Dual therapy based on co-formulated darunavir/ritonavir plus lamivudine for initial therapy of HIV infection: The ANDES randomized controlled trial |
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