title: Gastrointestinal tolerability and quality of life in antiretroviral-naive HIV-1-infected patients: data from the CASTLE study.
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.
authors.affiliation: Triple M Research, South Africa. nielm@iafrica.com <nielm@iafrica.com>
authors.forename: Niel
authors.initials: N
authors.lastname: Malan
authors.forename: Jun
authors.initials: J
authors.lastname: Su
authors.forename: Marco
authors.initials: M
authors.lastname: Mancini
authors.forename: Rong
authors.initials: R
authors.lastname: Yang
authors.forename: Victoria
authors.initials: V
authors.lastname: Wirtz
authors.forename: Judith
authors.initials: J
authors.lastname: Absalon
authors.forename: Donnie
authors.initials: D
authors.lastname: McGrath
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives; D000328:Adult; D000368:Aged; D044966:Anti-Retroviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D000069446:Atazanavir Sulfate; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000139:chemically induced; D061466:Lopinavir; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009842:Oligopeptides / Q000009:adverse effects; D063065:Organophosphonates / Q000009:adverse effects; D011446:Prospective Studies; D011725:Pyridines / Q000009:adverse effects; D011744:Pyrimidinones / Q000009:adverse effects; D011788:Quality of Life; D019438:Ritonavir / Q000009:adverse effects; D011795:Surveys and Questionnaires; D000068698:Tenofovir; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents; D009842:Oligopeptides; D063065:Organophosphonates; D011725:Pyridines; D011744:Pyrimidinones; D003841:Deoxycytidine; D061466:Lopinavir; D000069446:Atazanavir Sulfate; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine; D019438:Ritonavir