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https://www.arca.fiocruz.br/handle/icict/30165
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2025-08-30
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- INI - Artigos de Periódicos [3495]
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GASTROINTESTINAL TOLERABILITY AND QUALITY OF LIFE IN ANTIRETROVIRAL-NAIVE HIV-1-INFECTED PATIENTS: DATA FROM THE CASTLE STUDY
Author
Affilliation
Triple M Research. Central, Port Elizabeth, South Africa.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Bristol-Myers Squibb. Research and Development. Wallingford, CT, USA.
Abstract
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-naive 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" (> or =2-point positive change from baseline), "No change" (<2-point change), or "Worsening" (> or =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.
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