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Gastrointestinal tolerability and quality of life in antiretroviral-naïve HIV-1-infected patients: data from the CASTLE study
Most ritonavir-boosted protease inhibitor (PI)-based antiretroviral regimens offer comparable levels of virological efficacy. Thus, the tolerability of the regimen becomes a distinguishing factor with implications for patient quality of life (QoL), treatment adherence, and clinical outcome. This art...
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| Published in: | AIDS care 2010-06, Vol.22 (6), p.677-686 |
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| Main Authors: | , , , , , , , |
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| container_end_page | 686 |
| container_issue | 6 |
| container_start_page | 677 |
| container_title | AIDS care |
| container_volume | 22 |
| creator | Malan, Niel Su, Jun Mancini, Marco Yang, Rong Wirtz, Victoria Absalon, Judith McGrath, Donnie for the CASTLE Study Team |
| description | Most ritonavir-boosted protease inhibitor (PI)-based antiretroviral regimens offer comparable levels of virological efficacy. Thus, the tolerability of the regimen becomes a distinguishing factor with implications for patient quality of life (QoL), treatment adherence, and clinical outcome. This article describes results from the CASTLE study (comparing once-daily atazanavir/ritonavir [ATV/RTV] with twice-daily lopinavir/ritonavir [LPV/RTV], both in combination with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-infected patients) and an evaluation of the impact of gastrointestinal (GI) complications of treatment on patient QoL, as measured by the irritable bowel syndrome (IBS) QoL questionnaire (IBS-QoL). Changes in IBS-QoL from baseline over time (to week 24) were classified as: "Improvement" (≥2-point positive change from baseline), "No change" ( |
| doi_str_mv | 10.1080/09540120903334641 |
| format | article |
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Thus, the tolerability of the regimen becomes a distinguishing factor with implications for patient quality of life (QoL), treatment adherence, and clinical outcome. This article describes results from the CASTLE study (comparing once-daily atazanavir/ritonavir [ATV/RTV] with twice-daily lopinavir/ritonavir [LPV/RTV], both in combination with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-infected patients) and an evaluation of the impact of gastrointestinal (GI) complications of treatment on patient QoL, as measured by the irritable bowel syndrome (IBS) QoL questionnaire (IBS-QoL). Changes in IBS-QoL from baseline over time (to week 24) were classified as: "Improvement" (≥2-point positive change from baseline), "No change" (<2-point change), or "Worsening" (≥2-point negative change). Data were collected on GI adverse events (AEs) and use of GI medications. Of the 599 patients with IBS-QoL-evaluable data through week 24, fewer patients in the ATV/RTV group than in the LPV/RTV group experienced grade 2-4 treatment-related GI AEs including diarrhea (3% versus 10%), nausea (5% versus 7%), and vomiting (<1% on both arms). Nearly three times as many patients receiving LPV/RTV used GI medications. ATV/RTV was associated with an increase in overall IBS-QoL scores and more patients receiving ATV/RTV than LPV/RTV experienced improvement in IBS-QoL through week 24. In contrast to LPV/RTV, ATV/RTV treatment was associated with earlier and more positive improvements in QoL scores across CD4 sub-groups. Differences in the health-related QoL profile between ATV/RTV and LPV/RTV may be important when selecting PI-based antiretroviral regimens.</description><identifier>ISSN: 0954-0121</identifier><identifier>EISSN: 1360-0451</identifier><identifier>DOI: 10.1080/09540120903334641</identifier><identifier>PMID: 20467943</identifier><identifier>CODEN: AIDCEF</identifier><language>eng</language><publisher>Abingdon: Taylor & Francis Group</publisher><subject>Acquired immune deficiency syndrome ; Adenine - adverse effects ; Adenine - analogs & derivatives ; Adherence ; Adult ; Aged ; AIDS ; AIDS/HIV ; Anti-Retroviral Agents - adverse effects ; Anti-Retroviral Agents - therapeutic use ; Antiretroviral drugs ; Antiretroviral therapy ; Antiretroviral Therapy, Highly Active ; atazanavir ; Atazanavir Sulfate ; Biological and medical sciences ; Clinical outcomes ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Digestive system ; Drug therapy ; Drug Therapy, Combination ; Drug toxicity and drugs side effects treatment ; Emtricitabine ; Female ; Gastrointestinal Diseases - chemically induced ; GI tolerability ; Health ; health-related quality of life ; HIV ; HIV Infections - complications ; HIV Infections - drug therapy ; HIV-1 ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Immune response system ; Infectious diseases ; Irritable bowel syndrome ; Irritable Bowel Syndrome - chemically induced ; Lopinavir ; Male ; Medical care ; Medical sciences ; Medical treatment ; Medication Adherence ; Middle Aged ; Oligopeptides - adverse effects ; Organophosphonates - adverse effects ; Pharmacology. Drug treatments ; Prospective Studies ; Pyridines - adverse effects ; Pyrimidinones - adverse effects ; Quality of Life ; Ritonavir - adverse effects ; Surveys and Questionnaires ; Tenofovir ; Toxicity: digestive system ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Young Adult</subject><ispartof>AIDS care, 2010-06, Vol.22 (6), p.677-686</ispartof><rights>Copyright Taylor & Francis Group, LLC 2010</rights><rights>2015 INIST-CNRS</rights><rights>Copyright Taylor & Francis Ltd. Jun 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c554t-50dda597c4cadfb0796ee0df6b2bdf5227d36fe9ed4ba1f57da19c5cb9d466b83</citedby><cites>FETCH-LOGICAL-c554t-50dda597c4cadfb0796ee0df6b2bdf5227d36fe9ed4ba1f57da19c5cb9d466b83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27926,27927,31001,31002,33225,33226</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22923225$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20467943$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Malan, Niel</creatorcontrib><creatorcontrib>Su, Jun</creatorcontrib><creatorcontrib>Mancini, Marco</creatorcontrib><creatorcontrib>Yang, Rong</creatorcontrib><creatorcontrib>Wirtz, Victoria</creatorcontrib><creatorcontrib>Absalon, Judith</creatorcontrib><creatorcontrib>McGrath, Donnie</creatorcontrib><creatorcontrib>for the CASTLE Study Team</creatorcontrib><creatorcontrib>CASTLE Study Team</creatorcontrib><title>Gastrointestinal tolerability and quality of life in antiretroviral-naïve HIV-1-infected patients: data from the CASTLE study</title><title>AIDS care</title><addtitle>AIDS Care</addtitle><description>Most ritonavir-boosted protease inhibitor (PI)-based antiretroviral regimens offer comparable levels of virological efficacy. Thus, the tolerability of the regimen becomes a distinguishing factor with implications for patient quality of life (QoL), treatment adherence, and clinical outcome. This article describes results from the CASTLE study (comparing once-daily atazanavir/ritonavir [ATV/RTV] with twice-daily lopinavir/ritonavir [LPV/RTV], both in combination with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-infected patients) and an evaluation of the impact of gastrointestinal (GI) complications of treatment on patient QoL, as measured by the irritable bowel syndrome (IBS) QoL questionnaire (IBS-QoL). Changes in IBS-QoL from baseline over time (to week 24) were classified as: "Improvement" (≥2-point positive change from baseline), "No change" (<2-point change), or "Worsening" (≥2-point negative change). Data were collected on GI adverse events (AEs) and use of GI medications. Of the 599 patients with IBS-QoL-evaluable data through week 24, fewer patients in the ATV/RTV group than in the LPV/RTV group experienced grade 2-4 treatment-related GI AEs including diarrhea (3% versus 10%), nausea (5% versus 7%), and vomiting (<1% on both arms). Nearly three times as many patients receiving LPV/RTV used GI medications. ATV/RTV was associated with an increase in overall IBS-QoL scores and more patients receiving ATV/RTV than LPV/RTV experienced improvement in IBS-QoL through week 24. In contrast to LPV/RTV, ATV/RTV treatment was associated with earlier and more positive improvements in QoL scores across CD4 sub-groups. Differences in the health-related QoL profile between ATV/RTV and LPV/RTV may be important when selecting PI-based antiretroviral regimens.</description><subject>Acquired immune deficiency syndrome</subject><subject>Adenine - adverse effects</subject><subject>Adenine - analogs & derivatives</subject><subject>Adherence</subject><subject>Adult</subject><subject>Aged</subject><subject>AIDS</subject><subject>AIDS/HIV</subject><subject>Anti-Retroviral Agents - adverse effects</subject><subject>Anti-Retroviral Agents - therapeutic use</subject><subject>Antiretroviral drugs</subject><subject>Antiretroviral therapy</subject><subject>Antiretroviral Therapy, Highly Active</subject><subject>atazanavir</subject><subject>Atazanavir Sulfate</subject><subject>Biological and medical sciences</subject><subject>Clinical outcomes</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Digestive system</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Drug toxicity and drugs side effects treatment</subject><subject>Emtricitabine</subject><subject>Female</subject><subject>Gastrointestinal Diseases - chemically induced</subject><subject>GI tolerability</subject><subject>Health</subject><subject>health-related quality of life</subject><subject>HIV</subject><subject>HIV Infections - complications</subject><subject>HIV Infections - drug therapy</subject><subject>HIV-1</subject><subject>Human immunodeficiency virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immune response system</subject><subject>Infectious diseases</subject><subject>Irritable bowel syndrome</subject><subject>Irritable Bowel Syndrome - chemically induced</subject><subject>Lopinavir</subject><subject>Male</subject><subject>Medical care</subject><subject>Medical sciences</subject><subject>Medical treatment</subject><subject>Medication Adherence</subject><subject>Middle Aged</subject><subject>Oligopeptides - adverse effects</subject><subject>Organophosphonates - adverse effects</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><subject>Pyridines - adverse effects</subject><subject>Pyrimidinones - adverse effects</subject><subject>Quality of Life</subject><subject>Ritonavir - adverse effects</subject><subject>Surveys and Questionnaires</subject><subject>Tenofovir</subject><subject>Toxicity: digestive system</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Young Adult</subject><issn>0954-0121</issn><issn>1360-0451</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>7QJ</sourceid><sourceid>8BJ</sourceid><recordid>eNqNkt9qFDEUhwdR7Fp9AG8kCOLV6Mnf2UhvylLbwoIXVm-HM5MEU7KTbZKp7o2v5EP4Ys66WwULtlcJyfcdzo9zquo5hTcU5vAWtBRAGWjgnAsl6INqRrmCGoSkD6vZ9r-eAHpQPcn5EgAYKHhcHTAQqtGCz6rvp5hLin4oNhc_YCAlBpuw88GXDcHBkKsRf9-jI8E7S_wwPRef7ORd-4ShHvDnj2tLzs4_17T2g7N9sYassXg7lPyOGCxIXIorUr5Ysjj-eLE8IbmMZvO0euQwZPtsfx5Wn96fXCzO6uWH0_PF8bLupRSllmAMSt30okfjOmi0shaMUx3rjJOMNYYrZ7U1okPqZGOQ6l72nTZCqW7OD6vXu7rrFK_GKWq78rm3IeBg45jbRvK5AC7l3aQQSmuh70OyhjEp7kFyzrTSik_ky3_IyzimaSy5lSCaOcybbRi6g_oUc07WtevkV5g2LYV2uxjtrcWYnBf7wmO3suaPcbMJE_BqD2DuMbiEQ-_zX45pxqc0E3e046Y5x7TCrzEF0xbchJhuJP6_Ppo79VtWW74V_gsG8-Yg</recordid><startdate>201006</startdate><enddate>201006</enddate><creator>Malan, Niel</creator><creator>Su, Jun</creator><creator>Mancini, Marco</creator><creator>Yang, Rong</creator><creator>Wirtz, Victoria</creator><creator>Absalon, Judith</creator><creator>McGrath, Donnie</creator><creator>for the CASTLE Study Team</creator><general>Taylor & Francis Group</general><general>Taylor & Francis</general><general>Taylor & Francis Ltd</general><scope>IQODW</scope><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>7QJ</scope><scope>7QL</scope><scope>7T2</scope><scope>7T7</scope><scope>7U9</scope><scope>8BJ</scope><scope>8FD</scope><scope>C1K</scope><scope>FQK</scope><scope>FR3</scope><scope>H94</scope><scope>JBE</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>201006</creationdate><title>Gastrointestinal tolerability and quality of life in antiretroviral-naïve HIV-1-infected patients: data from the CASTLE study</title><author>Malan, Niel ; Su, Jun ; Mancini, Marco ; Yang, Rong ; Wirtz, Victoria ; Absalon, Judith ; McGrath, Donnie ; for the CASTLE Study Team</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c554t-50dda597c4cadfb0796ee0df6b2bdf5227d36fe9ed4ba1f57da19c5cb9d466b83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>Adenine - adverse effects</topic><topic>Adenine - analogs & derivatives</topic><topic>Adherence</topic><topic>Adult</topic><topic>Aged</topic><topic>AIDS</topic><topic>AIDS/HIV</topic><topic>Anti-Retroviral Agents - adverse effects</topic><topic>Anti-Retroviral Agents - therapeutic use</topic><topic>Antiretroviral drugs</topic><topic>Antiretroviral therapy</topic><topic>Antiretroviral Therapy, Highly Active</topic><topic>atazanavir</topic><topic>Atazanavir Sulfate</topic><topic>Biological and medical sciences</topic><topic>Clinical outcomes</topic><topic>Deoxycytidine - adverse effects</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Digestive system</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Drug toxicity and drugs side effects treatment</topic><topic>Emtricitabine</topic><topic>Female</topic><topic>Gastrointestinal Diseases - chemically induced</topic><topic>GI tolerability</topic><topic>Health</topic><topic>health-related quality of life</topic><topic>HIV</topic><topic>HIV Infections - complications</topic><topic>HIV Infections - drug therapy</topic><topic>HIV-1</topic><topic>Human immunodeficiency virus</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immune response system</topic><topic>Infectious diseases</topic><topic>Irritable bowel syndrome</topic><topic>Irritable Bowel Syndrome - chemically induced</topic><topic>Lopinavir</topic><topic>Male</topic><topic>Medical care</topic><topic>Medical sciences</topic><topic>Medical treatment</topic><topic>Medication Adherence</topic><topic>Middle Aged</topic><topic>Oligopeptides - adverse effects</topic><topic>Organophosphonates - adverse effects</topic><topic>Pharmacology. Drug treatments</topic><topic>Prospective Studies</topic><topic>Pyridines - adverse effects</topic><topic>Pyrimidinones - adverse effects</topic><topic>Quality of Life</topic><topic>Ritonavir - adverse effects</topic><topic>Surveys and Questionnaires</topic><topic>Tenofovir</topic><topic>Toxicity: digestive system</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. 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Thus, the tolerability of the regimen becomes a distinguishing factor with implications for patient quality of life (QoL), treatment adherence, and clinical outcome. This article describes results from the CASTLE study (comparing once-daily atazanavir/ritonavir [ATV/RTV] with twice-daily lopinavir/ritonavir [LPV/RTV], both in combination with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-infected patients) and an evaluation of the impact of gastrointestinal (GI) complications of treatment on patient QoL, as measured by the irritable bowel syndrome (IBS) QoL questionnaire (IBS-QoL). Changes in IBS-QoL from baseline over time (to week 24) were classified as: "Improvement" (≥2-point positive change from baseline), "No change" (<2-point change), or "Worsening" (≥2-point negative change). Data were collected on GI adverse events (AEs) and use of GI medications. Of the 599 patients with IBS-QoL-evaluable data through week 24, fewer patients in the ATV/RTV group than in the LPV/RTV group experienced grade 2-4 treatment-related GI AEs including diarrhea (3% versus 10%), nausea (5% versus 7%), and vomiting (<1% on both arms). Nearly three times as many patients receiving LPV/RTV used GI medications. ATV/RTV was associated with an increase in overall IBS-QoL scores and more patients receiving ATV/RTV than LPV/RTV experienced improvement in IBS-QoL through week 24. In contrast to LPV/RTV, ATV/RTV treatment was associated with earlier and more positive improvements in QoL scores across CD4 sub-groups. Differences in the health-related QoL profile between ATV/RTV and LPV/RTV may be important when selecting PI-based antiretroviral regimens.</abstract><cop>Abingdon</cop><pub>Taylor & Francis Group</pub><pmid>20467943</pmid><doi>10.1080/09540120903334641</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0954-0121 |
| ispartof | AIDS care, 2010-06, Vol.22 (6), p.677-686 |
| issn | 0954-0121 1360-0451 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_744699495 |
| source | Applied Social Sciences Index & Abstracts (ASSIA); International Bibliography of the Social Sciences (IBSS); Taylor and Francis:Jisc Collections:Taylor and Francis Read and Publish Agreement 2024-2025:Medical Collection (Reading list) |
| subjects | Acquired immune deficiency syndrome Adenine - adverse effects Adenine - analogs & derivatives Adherence Adult Aged AIDS AIDS/HIV Anti-Retroviral Agents - adverse effects Anti-Retroviral Agents - therapeutic use Antiretroviral drugs Antiretroviral therapy Antiretroviral Therapy, Highly Active atazanavir Atazanavir Sulfate Biological and medical sciences Clinical outcomes Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Digestive system Drug therapy Drug Therapy, Combination Drug toxicity and drugs side effects treatment Emtricitabine Female Gastrointestinal Diseases - chemically induced GI tolerability Health health-related quality of life HIV HIV Infections - complications HIV Infections - drug therapy HIV-1 Human immunodeficiency virus Human viral diseases Humans Immune response system Infectious diseases Irritable bowel syndrome Irritable Bowel Syndrome - chemically induced Lopinavir Male Medical care Medical sciences Medical treatment Medication Adherence Middle Aged Oligopeptides - adverse effects Organophosphonates - adverse effects Pharmacology. Drug treatments Prospective Studies Pyridines - adverse effects Pyrimidinones - adverse effects Quality of Life Ritonavir - adverse effects Surveys and Questionnaires Tenofovir Toxicity: digestive system Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Young Adult |
| title | Gastrointestinal tolerability and quality of life in antiretroviral-naïve HIV-1-infected patients: data from the CASTLE study |
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