PMID- 20467943 OWN - NLM STAT- MEDLINE DCOM- 20101129 LR - 20151119 IS - 1360-0451 (Electronic) IS - 0954-0121 (Linking) VI - 22 IP - 6 DP - 2010 Jun TI - Gastrointestinal tolerability and quality of life in antiretroviral-naive HIV-1-infected patients: data from the CASTLE study. PG - 677-86 LID - 10.1080/09540120903334641 [doi] AB - 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. FAU - Malan, Niel AU - Malan N AD - Triple M Research, South Africa. nielm@iafrica.com FAU - Su, Jun AU - Su J FAU - Mancini, Marco AU - Mancini M FAU - Yang, Rong AU - Yang R FAU - Wirtz, Victoria AU - Wirtz V FAU - Absalon, Judith AU - Absalon J FAU - McGrath, Donnie AU - McGrath D CN - CASTLE Study Team LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - AIDS Care JT - AIDS care JID - 8915313 RN - 0 (Anti-Retroviral Agents) RN - 0 (Oligopeptides) RN - 0 (Organophosphonates) RN - 0 (Pyridines) RN - 0 (Pyrimidinones) RN - 0W860991D6 (Deoxycytidine) RN - 2494G1JF75 (Lopinavir) RN - 4MT4VIE29P (Atazanavir Sulfate) RN - 99YXE507IL (Tenofovir) RN - G70B4ETF4S (Emtricitabine) RN - JAC85A2161 (Adenine) RN - O3J8G9O825 (Ritonavir) SB - IM MH - Adenine/adverse effects/analogs & derivatives MH - Adult MH - Aged MH - Anti-Retroviral Agents/*adverse effects/therapeutic use MH - Antiretroviral Therapy, Highly Active MH - Atazanavir Sulfate MH - Deoxycytidine/adverse effects/analogs & derivatives MH - Drug Therapy, Combination MH - Emtricitabine MH - Female MH - Gastrointestinal Diseases/*chemically induced MH - HIV Infections/complications/*drug therapy MH - HIV-1 MH - Humans MH - Irritable Bowel Syndrome/chemically induced MH - Lopinavir MH - Male MH - Medication Adherence MH - Middle Aged MH - Oligopeptides/adverse effects MH - Organophosphonates/adverse effects MH - Prospective Studies MH - Pyridines/adverse effects MH - Pyrimidinones/adverse effects MH - *Quality of Life MH - Ritonavir/adverse effects MH - Surveys and Questionnaires MH - Tenofovir MH - Young Adult FIR - Benetucci, J IR - Benetucci J FIR - Casiro, A IR - Casiro A FIR - Cassetti, I IR - Cassetti I FIR - Corral, J IR - Corral J FIR - Galindez, J IR - Galindez J FIR - Luna, N IR - Luna N FIR - Lupo, S IR - Lupo S FIR - Pallone, E IR - Pallone E FIR - Rodriguez, C IR - Rodriguez C FIR - Baker, D IR - Baker D FIR - Roth, N IR - Roth N FIR - Workman, C IR - Workman C FIR - Vetter, N IR - Vetter N FIR - Pelgrom, J IR - Pelgrom J FIR - Andrade, J L IR - Andrade JL FIR - Da Eira, M IR - Da Eira M FIR - Grinsztejn, B IR - Grinsztejn B FIR - De Jesus Pedro, R IR - De Jesus Pedro R FIR - Rangel, F IR - Rangel F FIR - Zajdenverg, R IR - Zajdenverg R FIR - Baril, J-G IR - Baril JG FIR - Crouzat, F IR - Crouzat F FIR - LeBlanc, R IR - LeBlanc R FIR - Tremblay, C IR - Tremblay C FIR - Fernandez, L Bavestrello IR - Fernandez LB FIR - Gutierrez, P Gaete IR - Gutierrez PG FIR - Noriega, L IR - Noriega L FIR - Perez, C IR - Perez C FIR - Sussmann, O IR - Sussmann O FIR - Herrera, G IR - Herrera G FIR - Koenig, E IR - Koenig E FIR - Bergmann, J-F IR - Bergmann JF FIR - Dellamonica, P IR - Dellamonica P FIR - Katlama, C IR - Katlama C FIR - Molina, J-M IR - Molina JM FIR - Vittecoq, D IR - Vittecoq D FIR - Weiss, L IR - Weiss L FIR - Arasteh, K IR - Arasteh K FIR - Faetkenheuer, G IR - Faetkenheuer G FIR - Rockstroh, J IR - Rockstroh J FIR - Stoehr, A IR - Stoehr A FIR - Arathoon, E IR - Arathoon E FIR - Garcia, J-F IR - Garcia JF FIR - Mejia-Villatoro, C IR - Mejia-Villatoro C FIR - Li, P IR - Li P FIR - Djauzi, S IR - Djauzi S FIR - Antinori, A IR - Antinori A FIR - Lazzarin, A IR - Lazzarin A FIR - Monforte, A D'Arminio IR - Monforte AD FIR - Penco, G IR - Penco G FIR - Vullo, V IR - Vullo V FIR - Aquino, M Magana IR - Aquino MM FIR - Amaya, G IR - Amaya G FIR - Andrade-Villanueva, J IR - Andrade-Villanueva J FIR - Jorge, D IR - Jorge D FIR - Sierra, J IR - Sierra J FIR - Tinoco, J Carlos IR - Tinoco JC FIR - Zavala, I IR - Zavala I FIR - Hoepelman, I M IR - Hoepelman IM FIR - Van Der Geest, S IR - Van Der Geest S FIR - Alfredo, C IR - Alfredo C FIR - Sosa, N IR - Sosa N FIR - Cabello, R IR - Cabello R FIR - Echevarria, J IR - Echevarria J FIR - La Rosa, A IR - La Rosa A FIR - Salazar, R IR - Salazar R FIR - Antunes, F IR - Antunes F FIR - Saavedra, S IR - Saavedra S FIR - Sepulveda, G IR - Sepulveda G FIR - Lin, L IR - Lin L FIR - Arribas, J IR - Arribas J FIR - Clotet, B IR - Clotet B FIR - Gatell, J IR - Gatell J FIR - Miralles, P IR - Miralles P FIR - Ortega, F Pulido IR - Ortega FP FIR - Rivero, A IR - Rivero A FIR - Gil, I Santos IR - Gil IS FIR - Gonzalez, J Santos IR - Gonzalez JS FIR - David, N IR - David N FIR - Firnhaber, C IR - Firnhaber C FIR - Johnson, D IR - Johnson D FIR - Krantz, E IR - Krantz E FIR - Latiff, G IR - Latiff G FIR - Malan, D IR - Malan D FIR - Martin, D IR - Martin D FIR - Pitt, J IR - Pitt J FIR - Zeier, M IR - Zeier M FIR - Chetchotisakd, P IR - Chetchotisakd P FIR - Supparatpinyo, K IR - Supparatpinyo K FIR - Hsieh, S-M IR - Hsieh SM FIR - Liu, Y-C IR - Liu YC FIR - Wong, W W IR - Wong WW FIR - Ainsworth, J IR - Ainsworth J FIR - Johnson, M IR - Johnson M FIR - Moyle, G IR - Moyle G FIR - Scullard, G IR - Scullard G FIR - Williams, I IR - Williams I FIR - Brand, D IR - Brand D FIR - Cruickshank, F IR - Cruickshank F FIR - DeJesus, E IR - DeJesus E FIR - McDonald, C IR - McDonald C FIR - Myers, R IR - Myers R FIR - Reddy, S IR - Reddy S FIR - Sension, M IR - Sension M FIR - Ward, D IR - Ward D EDAT- 2010/05/15 06:00 MHDA- 2010/12/14 06:00 CRDT- 2010/05/15 06:00 PHST- 2010/05/15 06:00 [entrez] PHST- 2010/05/15 06:00 [pubmed] PHST- 2010/12/14 06:00 [medline] AID - 922194568 [pii] AID - 10.1080/09540120903334641 [doi] PST - ppublish SO - AIDS Care. 2010 Jun;22(6):677-86. doi: 10.1080/09540120903334641.