Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study
Post F.A.,Kings College London |
Moyle G.J.,Chelsea and Westminster Hospital |
Stellbrink H.J.,Study Center |
Domingo P.,Hospital de la Santa Creui Sant Pau |
And 10 more authors.
Journal of Acquired Immune Deficiency Syndromes | Year: 2010
Background: Abacavir/lamivudine and tenofovir/emtricitabine fixed-dose combinations are commonly used first-line antiretroviral therapies, yet few studies have comprehensively compared their safety profiles. Methods: Forty-eight-week data are presented from this multicenter, randomized, open-label study comparing the safety profiles of abacavir/lamivudine and tenofovir/emtricitabine, both administered with efavirenz, in HLA-B *5701-negative HIV-1-infected adults. Results: Three hundred eighty-five subjects were enrolled in the study. The overall rate of withdrawal was high (28%). Changes in estimated glomerular filtration rate from baseline were similar between arms [difference 0.953 mL·min -1·1. 73 m -2 (95% confidence interval: -1.445 to 3.351), P = 0.435]. Urinary excretion of retinol-binding protein and β-2 microglobulin increased significantly more in the tenofovir/emtricitabine arm (+50%; +24%) compared with the abacavir/lamivudine arm (no change; -47%) (P < 0.0001). A lower proportion achieved viral load <50 copies per milliliter in the abacavir/lamivudine arm (114 of 192, 59%) compared with the tenofovir/ emtricitabine arm (137 of 193, 71%) [difference 11.6% (95% confidence interval: 2.2 to 21.1)]. The overall virological failure rate was low. The adverse event rate was similar between arms (except drug hypersensitivity, reported more in the abacavir/lamivudine arm). Conclusions: The study showed no difference in estimated glomerular filtration rate between the arms, however, increases in markers of tubular dysfunction were observed in the tenofovir/emtricitabine arm, the long-term consequence of which is unclear. A significant difference in efficacy favoring tenofovir/emtricitabine was observed. Copyright © 2010 by Lippincott Williams & Wilkins.
Delgado J.,Hospital de la Santa Creui Sant Pau |
Aventin A.,Hospital de la Santa Creui Sant Pau |
Briones J.,Hospital de la Santa Creui Sant Pau |
Sanchez J.,Hospital de la Santa Creui Sant Pau |
And 3 more authors.
Genes Chromosomes and Cancer | Year: 2010
Interphase fluorescence in situ hybridization (I-FISH) studies have a remarkable prognostic value in patients with chronic lymphocytic leukemia (CLL). I-FISH studies can be performed either on tetradecanoylphorbol acetate stimulated peripheral blood cells (I-FISH-TPA) or unstimulated peripheral blood mononuclear cells (I-FISH-PBMC). The aim of the study was to evaluate whether this finding was clinically relevant in a group of 235 patients with CLL. Fifty-six patients had both I-FISH-TPA and I-FISH-PBMC results. Compared with uncultured cells, the cytogenetic detection rate rose from 57 to 80% with the use of TPA-stimulated cells (P = 0.014). I-FISH-TPA provided a better prediction of treatment-free survival compared with I-FISH-PBMC (P = 0.031 vs. 0.166). Then, I-FISH-PBMC results from 93 historical patients were compared with 86 recent patients with I-FISH-TPA results. Genomic aberrations were detected in 46 and 67% of patients from the I-FISH-PBMC and I-FISH-TPA cohorts, respectively. The detection rate of 13q deletion as the only aberration increased from 10% with I-FISH-PBMC to 37% with I-FISH-TPA (P = 0.006). In conclusion, I-FISH-TPA increased the detection rate of 13q deletion and had an improved prognostic value compared with I-FISH-PBMC. © 2009 Wiley-Liss, Inc.
Lopez-Delgado J.C.,Hospital Universitari Of Bellvitge |
Lopez-Delgado J.C.,IDIBELL Institute DInvestigacio Biomedica Bellvitge |
Ballus J.,Hospital Universitari Of Bellvitge |
Esteve F.,Hospital Universitari Of Bellvitge |
And 8 more authors.
World Journal of Gastroenterology | Year: 2016
Patients suffering from liver cirrhosis (LC) frequently require non-hepatic abdominal surgery, even before liver transplantation. LC is an important risk factor itself for surgery, due to the higher than average associated morbidity and mortality. This high surgical risk occurs because of the pathophysiology of liver disease itself and to the presence of contributing factors, such as coagulopathy, poor nutritional status, adaptive immune dysfunction, cirrhotic cardiomyopathy, and renal and pulmonary dysfunction, which all lead to poor outcomes. Careful evaluation of these factors and the degree of liver disease can help to reduce the development of complications both during and after abdominal surgery. In the emergency setting, with the presence of decompensated LC, alcoholic hepatitis, severe/advanced LC, and significant extrahepatic organ dysfunction conservative management is preferred. A multidisciplinary, individualized, and specialized approach can improve outcomes; preoperative optimization after risk stratification and careful management are mandatory before surgery. Laparoscopic techniques can also improve outcomes. We review the impact of LC on surgical outcome in non-hepatic abdominal surgeries required in this cirrhotic population before, during, and after surgery. © The Author(s) 2016.