Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study)
We evaluated whether maintenance therapy with atazanavir/ritonavir plus lamivudine (ATV/r + 3TC) was non-inferior to ATV/r plus two nucleosides (ATV/r + 2NUCs) at 96 weeks of follow-up. SALT is a multicentre, open-label, non-inferiority clinical trial in HIV-1-infected virologically suppressed patie...
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| Veröffentlicht in: | Journal of antimicrobial chemotherapy 2017-01, Vol.72 (1), p.246-253 |
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| creator | Perez-Molina, J A Rubio, R Rivero, A Pasquau, J Suárez-Lozano, I Riera, M Estébanez, M Palacios, R Sanz-Moreno, J Troya, J Mariño, A Antela, A Navarro, J Esteban, H Moreno, S |
| description | We evaluated whether maintenance therapy with atazanavir/ritonavir plus lamivudine (ATV/r + 3TC) was non-inferior to ATV/r plus two nucleosides (ATV/r + 2NUCs) at 96 weeks of follow-up.
SALT is a multicentre, open-label, non-inferiority clinical trial in HIV-1-infected virologically suppressed patients. Hepatitis B virus surface antigen-negative subjects with no previous treatment failure/resistance mutations and HIV-1-RNA |
| doi_str_mv | 10.1093/jac/dkw379 |
| format | Article |
| fullrecord | <record><control><sourceid>pubmed_cross</sourceid><recordid>TN_cdi_crossref_primary_10_1093_jac_dkw379</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>27629070</sourcerecordid><originalsourceid>FETCH-LOGICAL-c323t-5fb2b84af9d07407169c6600049dc9c9529fc32a212648dffc50cb2230d72993</originalsourceid><addsrcrecordid>eNp9kU1v0zAchw0CsTK48AGQj-1YqGMnTr3bNDGGVInDekMocvwC3hw7sp1W2YnzPuY-CS5l48bBL4dHv_9j_wB4V6KPJWJkecPFUt7uSMOeg1lZUVRgxMoXYIYIqoumqskReB3jDUKI1nT1ChzhhmKGGjR7VlybfrBGG8GT8Q4mD-XILUw_VeDDBOc88Tvu-NaEZTDJ_7k9_Lr_kJflvdmO0ji1gFsV4hhhTNxJHiRMwQxWPcV8-09M2nnoRmGVj_O0MFLF79A4mAFv_Y8sZu20D-5y3pAtlUsRZlXukgkqBZ_Jf8ZnkFG4U-oWBhVHm1EdfJ9h6AflCss7ZU-h864wTqtgfNaZTmHI3r43d0pCYY3bT92_Ie_z6_P1Js8f5bR4A15qbqN6-_c8BpvLT5uLq2L99fOXi_N1IQgmqah1h7tVxTWTqKlQU1ImKM3fXzEpmGA1ZjqTHJeYViuptaiR6DAmSDaYMXIMTg6xIvgYg9LtEEzPw9SWqN1X3ubK20PlGX5_gIex65V8Qh87Jr8B_o-0yw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study)</title><source>MEDLINE</source><source>Oxford University Press Journals All Titles (1996-Current)</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><source>Free Full-Text Journals in Chemistry</source><creator>Perez-Molina, J A ; Rubio, R ; Rivero, A ; Pasquau, J ; Suárez-Lozano, I ; Riera, M ; Estébanez, M ; Palacios, R ; Sanz-Moreno, J ; Troya, J ; Mariño, A ; Antela, A ; Navarro, J ; Esteban, H ; Moreno, S</creator><creatorcontrib>Perez-Molina, J A ; Rubio, R ; Rivero, A ; Pasquau, J ; Suárez-Lozano, I ; Riera, M ; Estébanez, M ; Palacios, R ; Sanz-Moreno, J ; Troya, J ; Mariño, A ; Antela, A ; Navarro, J ; Esteban, H ; Moreno, S ; GeSIDA 7011 Study Group</creatorcontrib><description>We evaluated whether maintenance therapy with atazanavir/ritonavir plus lamivudine (ATV/r + 3TC) was non-inferior to ATV/r plus two nucleosides (ATV/r + 2NUCs) at 96 weeks of follow-up.
SALT is a multicentre, open-label, non-inferiority clinical trial in HIV-1-infected virologically suppressed patients. Hepatitis B virus surface antigen-negative subjects with no previous treatment failure/resistance mutations and HIV-1-RNA <50 copies/mL for ≥6 months were randomized (1 : 1) to ATV/r + 3TC or ATV/r + 2NUCs. The primary endpoint was HIV-1-RNA <50 copies/mL in the PP population. Non-inferiority was demonstrated if the lower bound of the 95% CI for the difference was not below -12%.
Some 286 patients were analysed. At week 96, 74.4% had HIV-1-RNA <50 copies/mL in the ATV/r + 3TC arm versus 73.9% in the ATV/r + 2NUCs arm (95% CI for the difference, -9.9%-11.0%). In both groups, similar values were observed for patients with confirmed virological failure in ATV/r + 3TC versus ATV/r + 2NUCs (9 versus 5), death (1 versus 0), discontinuation due to ART-related toxicity (7 versus 11), withdrawal from the study (7 versus 9) and loss to follow-up (6 versus 6). One patient taking ATV/r + 2NUCs developed resistance mutations (M184V and L63P). Similar values were obtained for change in mean CD4 count [19 versus 18 cells/mm
(95% CI for the difference, -49.3-50.7), grade 3-4 adverse events (70.7% versus 70.2%) and changes in the global deficit score, -0.3 (95% CI, -0.5 to -0.1) for ATV/r + 3TC, versus -0.2 (95% CI, -0.4 to -0.1) for ATV/r + 2NUCs].
The long-term results of switching to ATV/r + 3TC show that this strategy is effective, safe and non-inferior to ATV + 2NUCs in virologically suppressed HIV-infected patients.</description><identifier>ISSN: 0305-7453</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkw379</identifier><identifier>PMID: 27629070</identifier><language>eng</language><publisher>England</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - therapeutic use ; Antiretroviral Therapy, Highly Active - adverse effects ; Antiretroviral Therapy, Highly Active - methods ; Female ; Humans ; Maintenance Chemotherapy - adverse effects ; Maintenance Chemotherapy - methods ; Male ; Middle Aged ; Treatment Outcome ; Viral Load ; Young Adult</subject><ispartof>Journal of antimicrobial chemotherapy, 2017-01, Vol.72 (1), p.246-253</ispartof><rights>The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c323t-5fb2b84af9d07407169c6600049dc9c9529fc32a212648dffc50cb2230d72993</citedby><cites>FETCH-LOGICAL-c323t-5fb2b84af9d07407169c6600049dc9c9529fc32a212648dffc50cb2230d72993</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27629070$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Perez-Molina, J A</creatorcontrib><creatorcontrib>Rubio, R</creatorcontrib><creatorcontrib>Rivero, A</creatorcontrib><creatorcontrib>Pasquau, J</creatorcontrib><creatorcontrib>Suárez-Lozano, I</creatorcontrib><creatorcontrib>Riera, M</creatorcontrib><creatorcontrib>Estébanez, M</creatorcontrib><creatorcontrib>Palacios, R</creatorcontrib><creatorcontrib>Sanz-Moreno, J</creatorcontrib><creatorcontrib>Troya, J</creatorcontrib><creatorcontrib>Mariño, A</creatorcontrib><creatorcontrib>Antela, A</creatorcontrib><creatorcontrib>Navarro, J</creatorcontrib><creatorcontrib>Esteban, H</creatorcontrib><creatorcontrib>Moreno, S</creatorcontrib><creatorcontrib>GeSIDA 7011 Study Group</creatorcontrib><title>Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study)</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>We evaluated whether maintenance therapy with atazanavir/ritonavir plus lamivudine (ATV/r + 3TC) was non-inferior to ATV/r plus two nucleosides (ATV/r + 2NUCs) at 96 weeks of follow-up.
SALT is a multicentre, open-label, non-inferiority clinical trial in HIV-1-infected virologically suppressed patients. Hepatitis B virus surface antigen-negative subjects with no previous treatment failure/resistance mutations and HIV-1-RNA <50 copies/mL for ≥6 months were randomized (1 : 1) to ATV/r + 3TC or ATV/r + 2NUCs. The primary endpoint was HIV-1-RNA <50 copies/mL in the PP population. Non-inferiority was demonstrated if the lower bound of the 95% CI for the difference was not below -12%.
Some 286 patients were analysed. At week 96, 74.4% had HIV-1-RNA <50 copies/mL in the ATV/r + 3TC arm versus 73.9% in the ATV/r + 2NUCs arm (95% CI for the difference, -9.9%-11.0%). In both groups, similar values were observed for patients with confirmed virological failure in ATV/r + 3TC versus ATV/r + 2NUCs (9 versus 5), death (1 versus 0), discontinuation due to ART-related toxicity (7 versus 11), withdrawal from the study (7 versus 9) and loss to follow-up (6 versus 6). One patient taking ATV/r + 2NUCs developed resistance mutations (M184V and L63P). Similar values were obtained for change in mean CD4 count [19 versus 18 cells/mm
(95% CI for the difference, -49.3-50.7), grade 3-4 adverse events (70.7% versus 70.2%) and changes in the global deficit score, -0.3 (95% CI, -0.5 to -0.1) for ATV/r + 3TC, versus -0.2 (95% CI, -0.4 to -0.1) for ATV/r + 2NUCs].
The long-term results of switching to ATV/r + 3TC show that this strategy is effective, safe and non-inferior to ATV + 2NUCs in virologically suppressed HIV-infected patients.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretroviral Therapy, Highly Active - adverse effects</subject><subject>Antiretroviral Therapy, Highly Active - methods</subject><subject>Female</subject><subject>Humans</subject><subject>Maintenance Chemotherapy - adverse effects</subject><subject>Maintenance Chemotherapy - methods</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Treatment Outcome</subject><subject>Viral Load</subject><subject>Young Adult</subject><issn>0305-7453</issn><issn>1460-2091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU1v0zAchw0CsTK48AGQj-1YqGMnTr3bNDGGVInDekMocvwC3hw7sp1W2YnzPuY-CS5l48bBL4dHv_9j_wB4V6KPJWJkecPFUt7uSMOeg1lZUVRgxMoXYIYIqoumqskReB3jDUKI1nT1ChzhhmKGGjR7VlybfrBGG8GT8Q4mD-XILUw_VeDDBOc88Tvu-NaEZTDJ_7k9_Lr_kJflvdmO0ji1gFsV4hhhTNxJHiRMwQxWPcV8-09M2nnoRmGVj_O0MFLF79A4mAFv_Y8sZu20D-5y3pAtlUsRZlXukgkqBZ_Jf8ZnkFG4U-oWBhVHm1EdfJ9h6AflCss7ZU-h864wTqtgfNaZTmHI3r43d0pCYY3bT92_Ie_z6_P1Js8f5bR4A15qbqN6-_c8BpvLT5uLq2L99fOXi_N1IQgmqah1h7tVxTWTqKlQU1ImKM3fXzEpmGA1ZjqTHJeYViuptaiR6DAmSDaYMXIMTg6xIvgYg9LtEEzPw9SWqN1X3ubK20PlGX5_gIex65V8Qh87Jr8B_o-0yw</recordid><startdate>201701</startdate><enddate>201701</enddate><creator>Perez-Molina, J A</creator><creator>Rubio, R</creator><creator>Rivero, A</creator><creator>Pasquau, J</creator><creator>Suárez-Lozano, I</creator><creator>Riera, M</creator><creator>Estébanez, M</creator><creator>Palacios, R</creator><creator>Sanz-Moreno, J</creator><creator>Troya, J</creator><creator>Mariño, A</creator><creator>Antela, A</creator><creator>Navarro, J</creator><creator>Esteban, H</creator><creator>Moreno, S</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>201701</creationdate><title>Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study)</title><author>Perez-Molina, J A ; Rubio, R ; Rivero, A ; Pasquau, J ; Suárez-Lozano, I ; Riera, M ; Estébanez, M ; Palacios, R ; Sanz-Moreno, J ; Troya, J ; Mariño, A ; Antela, A ; Navarro, J ; Esteban, H ; Moreno, S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c323t-5fb2b84af9d07407169c6600049dc9c9529fc32a212648dffc50cb2230d72993</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anti-HIV Agents - adverse effects</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antiretroviral Therapy, Highly Active - adverse effects</topic><topic>Antiretroviral Therapy, Highly Active - methods</topic><topic>Female</topic><topic>Humans</topic><topic>Maintenance Chemotherapy - adverse effects</topic><topic>Maintenance Chemotherapy - methods</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Treatment Outcome</topic><topic>Viral Load</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Perez-Molina, J A</creatorcontrib><creatorcontrib>Rubio, R</creatorcontrib><creatorcontrib>Rivero, A</creatorcontrib><creatorcontrib>Pasquau, J</creatorcontrib><creatorcontrib>Suárez-Lozano, I</creatorcontrib><creatorcontrib>Riera, M</creatorcontrib><creatorcontrib>Estébanez, M</creatorcontrib><creatorcontrib>Palacios, R</creatorcontrib><creatorcontrib>Sanz-Moreno, J</creatorcontrib><creatorcontrib>Troya, J</creatorcontrib><creatorcontrib>Mariño, A</creatorcontrib><creatorcontrib>Antela, A</creatorcontrib><creatorcontrib>Navarro, J</creatorcontrib><creatorcontrib>Esteban, H</creatorcontrib><creatorcontrib>Moreno, S</creatorcontrib><creatorcontrib>GeSIDA 7011 Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Perez-Molina, J A</au><au>Rubio, R</au><au>Rivero, A</au><au>Pasquau, J</au><au>Suárez-Lozano, I</au><au>Riera, M</au><au>Estébanez, M</au><au>Palacios, R</au><au>Sanz-Moreno, J</au><au>Troya, J</au><au>Mariño, A</au><au>Antela, A</au><au>Navarro, J</au><au>Esteban, H</au><au>Moreno, S</au><aucorp>GeSIDA 7011 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study)</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2017-01</date><risdate>2017</risdate><volume>72</volume><issue>1</issue><spage>246</spage><epage>253</epage><pages>246-253</pages><issn>0305-7453</issn><eissn>1460-2091</eissn><abstract>We evaluated whether maintenance therapy with atazanavir/ritonavir plus lamivudine (ATV/r + 3TC) was non-inferior to ATV/r plus two nucleosides (ATV/r + 2NUCs) at 96 weeks of follow-up.
SALT is a multicentre, open-label, non-inferiority clinical trial in HIV-1-infected virologically suppressed patients. Hepatitis B virus surface antigen-negative subjects with no previous treatment failure/resistance mutations and HIV-1-RNA <50 copies/mL for ≥6 months were randomized (1 : 1) to ATV/r + 3TC or ATV/r + 2NUCs. The primary endpoint was HIV-1-RNA <50 copies/mL in the PP population. Non-inferiority was demonstrated if the lower bound of the 95% CI for the difference was not below -12%.
Some 286 patients were analysed. At week 96, 74.4% had HIV-1-RNA <50 copies/mL in the ATV/r + 3TC arm versus 73.9% in the ATV/r + 2NUCs arm (95% CI for the difference, -9.9%-11.0%). In both groups, similar values were observed for patients with confirmed virological failure in ATV/r + 3TC versus ATV/r + 2NUCs (9 versus 5), death (1 versus 0), discontinuation due to ART-related toxicity (7 versus 11), withdrawal from the study (7 versus 9) and loss to follow-up (6 versus 6). One patient taking ATV/r + 2NUCs developed resistance mutations (M184V and L63P). Similar values were obtained for change in mean CD4 count [19 versus 18 cells/mm
(95% CI for the difference, -49.3-50.7), grade 3-4 adverse events (70.7% versus 70.2%) and changes in the global deficit score, -0.3 (95% CI, -0.5 to -0.1) for ATV/r + 3TC, versus -0.2 (95% CI, -0.4 to -0.1) for ATV/r + 2NUCs].
The long-term results of switching to ATV/r + 3TC show that this strategy is effective, safe and non-inferior to ATV + 2NUCs in virologically suppressed HIV-infected patients.</abstract><cop>England</cop><pmid>27629070</pmid><doi>10.1093/jac/dkw379</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of antimicrobial chemotherapy, 2017-01, Vol.72 (1), p.246-253 |
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| language | eng |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection; Free Full-Text Journals in Chemistry |
| subjects | Adult Aged Aged, 80 and over Anti-HIV Agents - adverse effects Anti-HIV Agents - therapeutic use Antiretroviral Therapy, Highly Active - adverse effects Antiretroviral Therapy, Highly Active - methods Female Humans Maintenance Chemotherapy - adverse effects Maintenance Chemotherapy - methods Male Middle Aged Treatment Outcome Viral Load Young Adult |
| title | Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study) |
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