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    Randomised study to assess the efficacy and safety of once-daily etravirine-based regimen as a switching strategy in HIV-infected patients receiving a protease inhibitor-containing regimen. Etraswitch study  Open access

     Echeverria, Patricia; Bonjoch, Anna; Puig Batalla, Jordi; Molto, Jose; Paredes, Roger; Sirera, Guillem; Ornelas, Arelly; Perez Alvarez, Nuria; Clotet, Bonaventura; Negredo, Eugènia
    PLoS one
    Date of publication: 2014-02-04
    Journal article

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    Background: Etravirine (ETR) was approved for patients with virological failure and antiretroviral resistance mutations. It has also shown antiviral efficacy in antiretroviral-naive patients. However, data on the switching from protease inhibitors (PI) to ETR are lacking.; Methods: HIV-1-infected patients with suppressed viral load (VL) during a PI-containing regimen (>12 months) and no previous virological failure were randomized to switch from the PI to ETR (400 mg/day, dissolved in water) (ETR group, n = 22) or to continue with the same regimen (control group, n = 21). Percentage of patients with VL <= 50 copies/mL were assessed at week 48, as well as changes in CD4 T-cell counts and metabolic profile.; Results: We included 43 patients [72.9% male, 46.3 (42.2; 50.6) years]. Two patients receiving ETR (grade-1 diarrhea and voluntary discontinuation) and another in the control group (simplification) discontinued therapy early. No patients presented virological failure (two consecutive VL>50 copies/mL); treatment was successful in 95.2% of the control group and 90.9% of the ETR group (intention-to-treat analysis, missing = failure) (p = 0.58). CD4+ T-cell counts did not significantly vary [+49 cells/mu L in the ETR group (p = 0.25) and -4 cells/mu L in the control group (p = 0.71)]. The ETR group showed significant reductions in cholesterol (p<0.001), triglycerides (p=<0.001), and glycemia (p = 0.03) and higher satisfaction (0-10 scale) (p = 0.04). Trough plasma concentrations of ETR were similar to observed in studies using ETR twice daily.; Conclusion: Switch from a PI-based regimen to a once-daily combination based on ETR maintained undetectable VL during 48 weeks in virologically suppressed HIV-infected patients while lipid profile and patient satisfaction improved significantly.

    Background: Etravirine (ETR) was approved for patients with virological failure and antiretroviral resistance mutations. It has also shown antiviral efficacy in antiretroviral-naive patients. However, data on the switching from protease inhibitors (PI) to ETR are lacking.; Methods: HIV-1-infected patients with suppressed viral load (VL) during a PI-containing regimen (>12 months) and no previous virological failure were randomized to switch from the PI to ETR (400 mg/day, dissolved in water) (ETR group, n = 22) or to continue with the same regimen (control group, n = 21). Percentage of patients with VL <= 50 copies/mL were assessed at week 48, as well as changes in CD4 T-cell counts and metabolic profile.; Results: We included 43 patients [72.9% male, 46.3 (42.2; 50.6) years]. Two patients receiving ETR (grade-1 diarrhea and voluntary discontinuation) and another in the control group (simplification) discontinued therapy early. No patients presented virological failure (two consecutive VL>50 copies/mL); treatment was successful in 95.2% of the control group and 90.9% of the ETR group (intention-to-treat analysis, missing = failure) (p = 0.58). CD4+ T-cell counts did not significantly vary [+49 cells/mu L in the ETR group (p = 0.25) and -4 cells/mu L in the control group (p = 0.71)]. The ETR group showed significant reductions in cholesterol (p<0.001), triglycerides (p=<0.001), and glycemia (p = 0.03) and higher satisfaction (0-10 scale) (p = 0.04). Trough plasma concentrations of ETR were similar to observed in studies using ETR twice daily.; Conclusion: Switch from a PI-based regimen to a once-daily combination based on ETR maintained undetectable VL during 48 weeks in virologically suppressed HIV-infected patients while lipid profile and patient satisfaction improved significantly.

  • Economic evaluation in health research: cohort simultation and applications

     Perez Alvarez, Nuria
    Defense's date: 2014-07-23
    Universitat Politècnica de Catalunya
    Theses

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    Actualment, els recursos destinats a la salut són limitats i es fa necessari racionalitzar-ne el seu consum; cal prioritzar la despesa en opcions que reportin un major benestar i que siguin sostenibles econòmicament. És per aquest motiu, que cada cop hi ha més estudis clínics que inclouen paràmetres econòmics com a instrument per triar entre diferents estratègies terapèutiques.En aquesta tesi, tant el cost com la resposta de salut s¿estudien per separat i conjuntament per a comparar diferents estratègies per al tractament de malalties de diferent àrees de salut. El repte es troba en adaptar i implementar la metodologia necessària per a dur a terme el seguiment d¿aquests problemas de salut.Les anàlisis requereixen dades i la majoria d¿elles provenen d¿estudis clínics, ja siguin prospectius o retrospectius, o bé de models de simulació. L¿ús de dades simulades evita experimentar directament amb el sistema d¿interès, implicant un temps menor, un cost més econòmic i un decreixement del risc d¿experimentació necessaris per a l¿obtenció de resultats. Per contrapartida, la simulació és una aproximació de les dades reals.D¿una banda, l¿avaluació d¿un programa de promoció de l¿adherència al tractament antiretroviral per pacients VIH+ es du a terme amb dades reals recollides en el marc d¿un assaig clínic. El cost per unitat de guany en salut, mesurat amb paràmetres clínics i en qualitat de vida, es representa mitjançant un arbre de decisió.A continuació, la simulació d¿una cohort de dones espanyoles post menopàusiques i les seves possibles fractures òssies permet comparar, en termes de cost-efectivitat, dos tractaments usats en la prevenció de fractures vertebrals i no vertebrals. Els models de Markov permeten simular el curs de la malaltia fent servir un nombre finit d¿esdeveniments que representen els possibles estats de salut i la probabilitat de que un pacient canviï d¿estat amb el L¿adaptació dels models de Markov per permetre que el risc de patir un esdeveniment variï en el temps permet determinar si els tests de co-receptors del VIH són cost-efectius per decidir si un pacient es pot beneficiar del tractament antiretroviral amb maraviroc. Les cadenes de VIH s¿han d¿unir als CD4, com a mínim, en un dels dos co-receptors possibles, CCR5 o CXCR4, per entrar a la cèl¿lula. Alguns virus VIH fan servir els dos co-receptors i alguns individus tenen una mixtura de cadenes de VIH. Els pacients que es poden beneficiar de l¿ús de maraviroc son aquells que estan infectats únicament per virus amb el co-receptor CCR5.Per últim, una anàlisis d¿impacte pressupostari permet quantificar la despesa econòmica d¿introduir eculizumab per a tractar la hemoglobinúria paroxística nocturna. En aquest cas, s¿ha fet una estimació de costos directes i indirectes i es reporten des de la perspectiva del sistema sanitari i des de la perspectiva de la societat.La major part d¿estudis clínics publicats es centren en la mesura de la salut en termes d¿eficàcia i/o de seguretat; però moltes vegades, la salut i el benestar no es poden quantificar de manera directa. En aquest cas, la càrrega de la malaltia de l¿osteoporosi en dones post menopàusiques ha estat quantificada mitjançant anys de vida viscuts amb discapacitat (DALYs) calculats a partir de dades obtingudes a nivell d¿individu. Actualment es disposa de pocs estudis de càrrega de malaltia, i menys encara per a població espanyola i amb dades individuals.Els estudis farmacoeconòmics són d¿utilitat en l¿assignació de recursos, i els estudis d¿impacte pressupostari i la generació de noves mesures per a quantificar la salut i el benestar son eines complementàries. El treball realitzat en aquesta tesis és un bon exemple d¿aplicació i adaptació de l¿estadística per a respondre diferents qüestions de rellevància clínica actualment.

  • Young biostatisticians in Spain: career or race?

     Lorenzo Arribas, Altea; Martínez Silva, Isabel; Gomez Mateu, Moises; Perez Alvarez, Nuria; Perpiñán Fabuel, Hèctor; Valero Coppin, Oliver
    BEIO, Boletín de Estadística e Investigación Operativa
    Date of publication: 2013-10
    Journal article

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    Challenges and new opportunities for the integration of biostatisticians in multidisciplinary teams are a major concern in the field. New forms of broader training in the life sciences, collaborations with other scientists, and strategic partnerships in research, all appear as essential means towards success for young professionals in Biostatistics. This article is novel in that it provides a young biostatisticians perspective on what many experienced colleagues have been discussing for years, i.e., what the future will bring to the profession and how we will be best trained to face it. The vision emerged from a unique forum comprising six authors with completely different backgrounds and work experience in the field, and is complemented by the discussion generated in a roundtable.

    Challenges and new opportunities for the integration of biostatisticians in multidisciplinary teams are a major concern in the field. New forms of broader training in the life sciences, collaborations with other scientists, and strategic partnerships in research, all appear as essential means towards success for young professionals in Biostatistics. This article is novel in that it provides a young biostatisticians perspective on what many experienced colleagues have been discussing for years, i.e., what the future will bring to the profession and how we will be best trained to face it. The vision emerged from a unique forum comprising six authors with completely different backgrounds and work experience in the field, and is complemented by the discussion generated in a roundtable.

  • Early but limited effects of raltegravir intensification on CD4 T cell reconstitution in HIV-infected patients with an immunodiscordant response to antiretroviral therapy

     Negredo, Eugènia; Massanella, Marta; Puertas, Maria C.; Buzón, Maria J.; Puig, Jordi; Perez Alvarez, Nuria; Pérez Santiago, Josué; Bonjoch, Anna; Molto, Jose; Jou, Antoni; Echevarría, Patricia; Llibre, Josep M; Martínez Picado, Javier; Clotet, Bonaventura; Blanco, Julià
    Journal of antimicrobial chemotherapy
    Date of publication: 2013-10
    Journal article

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    Background:Immune hyperactivation in immunodiscordant patients can induce residual HIV replication and limit CD4Tcell recovery. We assessed theimpact of raltegravir intensification onCD4 T cell recoveryandviral persistence.Methods: We performed a randomized, controlled, pilot trial. Patients with CD4 T cell counts <350 cells/mm3 despite suppressive antiretroviral therapy were randomized (2:1) to intensify with raltegravir (intensified arm, n=30) or to continue with the same regimen (control arm, n=14) for 48 weeks. Then, the control individuals intensified their treatment for 24 weeks (delayed-intensification arm). We analysed changes in CD4 T cell counts, total and episomal HIV DNA in peripheral blood mononuclear cells and predictive factors for response.Results: Raltegravir intensification induced a rapid increase in CD4 Tcell counts (week 12) (P=0.007), although this was not sustained over time. Control patients maintained constant but slowincreases in CD4 Tcell counts (present in the pre-study period), reaching CD4 Tcell counts similar to those of patients in the intensificationarmatweek 48. This effectwas confirmed by the analysis of the delayed-intensification arm. Proviral DNA levels remained stable in both arms over time; episomal DNA forms and ultrasensitive plasma viral load were barely detected during the study. Increases in CD4 T cell counts were associated with low baseline CD95 expression in CD4 and CD8 T cells (P=0.020).Conclusions: Raltegravir intensification modestly impacts viral dynamics and induces a rapid but limited gain in CD4 T cell counts in immunodiscordant patients. Residual viral replication does not seem to be the main cause of unsatisfactory CD4 T cell recovery in these patients.

  • A brief and feasible paper-based method to screen for neurocognitive impairment in HIV-infected patients: The NEU screen

     Muñoz Moreno, Jose Antonio; Prats, Anna; Perez Alvarez, Nuria; Rodriguez Fumaz, Carmina; Garolera, Maite; Doval, Eduardo; Negredo, Eugènia; Ferrer, Maria J.; Clotet, Bonaventura
    Journal of acquired immune deficiency syndromes
    Date of publication: 2013-08-15
    Journal article

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    Objective: Practical screening methods are necessary to detect neurocognitive impairment (NCI) in HIV-infected patients. We aimed to find a brief and feasible paper-based tool to facilitate the diagnosis of an HIV-associated neurocognitive disorder. Methods: A total of 106 HIV-infected outpatients with variable clinical characteristics were recruited in a multicenter investigation. NCI was diagnosed using a standardized neuropsychological tests battery (7 areas, 21 measures, ~2 hours). Multiple score combinations were compared to find a paper-based method that took =10 minutes to apply. The presence of NCI was considered the gold standard for comparisons, and the sensitivity and specificity were calculated. Results: Subjects were mostly middle-aged (median, 44 years) men (87%) on antiretroviral treatment. NCI was detected in 51 individuals (48%) and was associated with lower nadir CD4 count (P < 0.001), receiving antiretroviral therapy (P = 0.004), fewer years of education (P = 0.009), and presence of comorbidities (P < 0.001). The score combination that showed the highest sensitivity (74.5%) and specificity (81.8%) detecting NCI included 3 measures of attention/ working memory, executive functioning, and verbal fluency (part A of Trail Making Test, part B of Trail Making Test, and Controlled Oral Word Association Test scores). A broader paperbased selection of measures covering 7 areas indicated a sensitivity of 100% and a specificity of 96.3% (7 measures, ~35 minutes). Conclusions: The combination of the 3 measures presented in this study seems to be a rapid and feasible screening mean for NCI in HIVinfected patients. This approach, combined with screening for potential comorbidities and daily functioning interference, could help in the initial stages of a HIV-associated neurocognitive disorder diagnosis and in settings with limited access to neuropsychological resources.

  • Emotional impact of premature aging symptoms in long-term treated HIV-infected subjects

     Fumaz, Carmina R.; Muñoz Moreno, Jose A.; Ferrer, Maria J.; Gonzalez Garcia, Marian; Negredo, Eugènia; Perez Alvarez, Nuria; Clotet, Bonaventura
    Journal of acquired immune deficiency syndromes
    Date of publication: 2012-01-01
    Journal article

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  • Psychological stress is associated with high levels of IL-6 in HIV-1 infected individuals on effective combined antiretroviral treatment

     Fumaz, Carmina R.; Gonzalez Garcia, Marian; Borrás Pérez, Xavier; Muñoz Moreno, Jose A.; Perez Alvarez, Nuria; Mothe, Beatriz; Brander, C.; Ferrer, MJ; Puig, J.; Llano, Anuska; Fernández Castro, Jordi; Clotet, Bonaventura
    Brain behavior and immunity
    Date of publication: 2012-05
    Journal article

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  • Similarly high prevalence of hypovitaminosis D in HIV-infected subjects with and without low bone mineral density

     Negredo, Eugènia; Puig, Jordi; Bonjoch, Anna; Perez Alvarez, Nuria; Echeverria, Patricia; Estany, Carla; Pastor, María Cruz; Granada, M.L.; Clotet, Bonaventura
    Future virology
    Date of publication: 2012-11
    Journal article

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    Background: Hypovitaminosis D is highly prevalent among HIV-infected patients. Since hypovitaminosis D is a secondary cause of low bone mineral density (BMD), we assessed its prevalence and associated factors in HIV-infected patients with osteopenia/osteoporosis, compared with HIV-infected patients with normal BMD. Materials & methods: Serum 25-hydroxy vitamin D (25[OH]D) concentration were collected from 149 HIV-infected subjects with low BMD and 36 with normal BMD from April to October, 2010. Regression analyses were fitted to predict the probability of hypovitaminosis D in all patients. Results: Of the 149 patients with low BMD (51.8 ±8 years old, 76.5% men), 83% had vitamin D insufficiency (<30 ng/ml) and 7.4% had severe deficiency (<10 ng/ml). In comparison, insufficiency was present in 75% of subjects from the group with normal BMD (p = 0.60) and no subject was severely deficient (p = 0.13). Among subjects with low BMD, 1.8% of men had low levels of testosterone, 5.4% of patients had high levels of thyroid-stimulating hormone, (all with normal free thyroxine levels) and 14.6% had high levels of parathyroid hormone. Univariate analysis showed significant associations between hypovitaminosis D and the current use of non-nucleosides (ß-coefficient: -3.797; standard deviation: 1.538; p = 0.015), whereas protease inhibitors were associated with higher levels of vitamin D (ß-coefficient: 4.640; standard deviation: 1.673; p = 0.006). Conclusion: Hypovitaminosis D was highly prevalent in our patients with low BMD but also in those with normal bone dual x-ray energy absorptionmetry scan. 25(OH)D should be periodically monitored, although the benefit of vitamin D and calcium supplements on bone mineralization has not yet been investigated in this population.

  • High rate of reversibility of renal damage in a cohort of HIV-infected patients receiving tenofovir-containing antiretroviral therapy

     Bonjoch, Anna; Echeverria, Patricia; Perez Alvarez, Nuria; Puig, Jordi; Estany, Carla; Clotet, Bonaventura; Negredo, Eugènia
    Antiviral research
    Date of publication: 2012-10
    Journal article

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    We assessed the progress of renal damage after discontinuation of tenofovir (TDF) in patients who started therapy with normal renal parameters. Normal local reference values were as follows: estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease equation (MDRD), ¿60 mL/min/1.73 m2; creatinine, ¿1.20 mg/dL; serum phosphate: ¿2.69 mg/dL; proteinuria: <30 mg/dL, and glycosuria: <20 mg/dL in nondiabetic patients. A logistic regression analysis was used to evaluate factors related to normalization of renal function.

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    Time of progression to osteopenia/osteoporosis in chronically HIV-infected patients: screening DXA scan  Open access

     Negredo, Eugènia; Bonjoch, Anna; Gomez Mateu, Moises; Estany, Carla; Puig, Jordi; Perez Alvarez, Nuria; Rosales, Joaquim; Di Gregorio, Silvana; del Rio, Luis; Gomez Melis, Guadalupe; Clotet, Bonaventura
    PLoS one
    Date of publication: 2012-10-08
    Journal article

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    Background: Algorithms for bone mineral density (BMD) management in HIV-infected patients are lacking. Our objective was to assess how often a dual-energy x-ray absorptiometry (DXA) scan should be performed by assessing time of progression to osteopenia/osteoporosis. Methods: All DXA scans performed between 2000 and 2009 from HIV-infected patients with at least two DXA were included. Time to an event (osteopenia and osteoporosis) was assessed using the Kaplan¿Meier method. Strata (tertiles) were defined using baseline minimum T scores. Differences between strata in time to an event were compared with the logrank test. Results: Of 391 patients (1,639 DXAs), 49.6% had osteopenia and 21.7% osteoporosis at their first DXA scan. Of the 112 (28.6%) with normal BMD, 35.7% progressed to osteopenia; median progression time was 6.7 years. These patients were stratified: ``low-risk¿¿ (baseline minimum T score .20.2 SD), ``middle-risk¿¿ (between 20.2 and 20.6 SD), and ``high-risk¿¿ (from 20.6 to 21 SD); median progression time to osteopenia was 8.7, .7.2, and 1.7 years, respectively (p,0.0001). Of patients with osteopenia, 23.7% progressed to osteoporosis; median progression time was .8.5 years. Progression time was .8.2 years in ``low-risk¿¿ tertile (T score between 21.1 and 21.6 SD), .8.5 years in ``middle-risk¿¿ (between 21.6 and 22), and 3.2 years in ``high-risk¿¿ (from 22 to 22.4) (p,0.0001). Conclusions: Our results may help to define the BMD testing interval. The lowest T score tertiles would suggest recommending a subsequent DXA in 1¿2 years; in the highest tertiles, $6 years. Early intervention in patients with bone demineralization could reduce fracture¿related morbidity/mortality.

    Algorithms for bone mineral density (BMD) management in HIV-infected patients are lacking. Our objective was to assess how often a dual-energy x-ray absorptiometry (DXA) scan should be performed by assessing time of progression to osteopenia/osteoporosis. Methods: All DXA scans performed between 2000 and 2009 from HIV-infected patients with at least two DXA were included. Time to an event (osteopenia and osteoporosis) was assessed using the Kaplan–Meier method. Strata (tertiles) were defined using baseline minimum T scores. Differences between strata in time to an event were compared with the log-rank test. Results: Of 391 patients (1,639 DXAs), 49.6% had osteopenia and 21.7% osteoporosis at their first DXA scan. Of the 112 (28.6%) with normal BMD, 35.7% progressed to osteopenia; median progression time was 6.7 years. These patients were stratified: “low-risk" (baseline minimum T score >−0.2 SD), “middle-risk" (between −0.2 and −0.6 SD), and “high-risk" (from −0.6 to −1 SD); median progression time to osteopenia was 8.7, >7.2, and 1.7 years, respectively (p<0.0001). Of patients with osteopenia, 23.7% progressed to osteoporosis; median progression time was >8.5 years. Progression time was >8.2 years in “low-risk" tertile (T score between −1.1 and −1.6 SD), >8.5 years in “middle-risk" (between −1.6 and −2), and 3.2 years in “high-risk" (from −2 to −2.4) (p<0.0001). Conclusions: Our results may help to define the BMD testing interval. The lowest T score tertiles would suggest recommending a subsequent DXA in 1–2 years; in the highest tertiles, ≥6 years. Early intervention in patients with bone demineralization could reduce fracture–related morbidity/mortality.

  • Markov models used in a 2-stage outcome cohort simulation for an economic evaluation

     Perez Alvarez, Nuria; Gomez Melis, Guadalupe; Paredes, R.; Clotet, Bonaventura
    International Conference of the ERCIM Working Group on Computing & Statistics
    Presentation's date: 2012-12-02
    Presentation of work at congresses

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  • Effect of an induction period of pegylated interferon-a2a and ribavirin on early virological response in HIV-HCV-coinfected patients: results from the CORAL-2 study

     Tural, Cristina; Solà, Ricard; Perez Alvarez, Nuria; Molto, Jose; Sánchez, Matilde; Moreno Zamora, Ana; Ornelas, Arelly; Laguno, M.; González, Juan; Von Wichmann, Miguel Ángel; Clotet, Bonaventura; Téllez, Maria Jesús; Paredes, Roger
    Antiviral therapy
    Date of publication: 2011
    Journal article

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  • Clustering homogeneous subgroups of HIV-1 patients in accordance with their food intake pattern

     Ornellas, Avelly; Perez Alvarez, Nuria; Estany, Carla; Pérez-Alvarez, Susana; Clotet, Bonaventura
    Conferencia Española y Encuentro Iberoamericano de Biometría
    Presentation's date: 2011-09
    Presentation of work at congresses

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  • Study of the factors related to interleukin-6 production. Modelling an outcome with under detection limit

     Perez Alvarez, Nuria; Fumaz, Carmina R.; Clotet, Bonaventura
    Conferencia Española y Encuentro Iberoamericano de Biometría
    Presentation's date: 2011-09
    Presentation of work at congresses

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  • Use of comprehensive cohort data to identify host genetic and immunological and virological factors associated with relative in vivo control of HIV

     Pérez Alvarez, Susana; Gomez Melis, Guadalupe; Perez Alvarez, Nuria; Christian, Brander
    Date: 2011-04-11
    Report

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  • Prevalence of HIV-related neurocognitive complications in Catalonia: results from a cross-sectional multicenter study

     Muñoz Moreno, Jose A.; Prats, Anna; Fumaz, Carmina R.; Ferrer, Maria J.; Negredo, Eugènia; Gonzalez Garcia, Marian; Olmedo, Lidia; Perez Alvarez, Nuria; Garolera, M; Clotet, Bonaventura
    Journal of neurovirology
    Date of publication: 2010-10
    Journal article

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  • High prevalence of and progression to low bone mineral density in HIV-infected patients: a longitudinal cohort study

     Bonjoch, Anna; Figueras, Marta; Estany, Carla; Perez Alvarez, Nuria; Rosales, Joaquim; del Rio, Luis; Puig, Jordi; Di Gregorio, Silvana; Clotet, Bonaventura; Gomez Melis, Guadalupe; Negredo, Eugènia
    AIDS
    Date of publication: 2010-11-27
    Journal article

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  • IL28B SNP rs8099917 is strongly associated with pegylated interferon-alpha and ribavirin therapy treatment failure in HCV-HIV-1-coinfected patients

     Aparicio, Ester; Parera, M.; Franco, S.; Perez Alvarez, Nuria; Tural, C.; Clotet, Bonaventura; Martinez, M. A.
    Antiviral therapy
    Date of publication: 2010
    Journal article

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  • Interruptions of antiretroviral therapy in human immunodeficiency virus infection: are they detrimental to neurocognitive functioning?

     Muñoz Moreno, Jose A.; Fumaz, Carmina R.; Prats, Anna; Ferrer, Maria J.; Negredo, Eugènia; Perez Alvarez, Nuria; Molto, Jose; Gomez Melis, Guadalupe; Garolera, Maite; Clotet, Bonaventura
    Journal of neurovirology
    Date of publication: 2010-06
    Journal article

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    Because interruptions of antiretroviral treatment may entail clinical risks for human immunodeficiency virus (HIV)-infected individuals, we investigated their impact on neurocognitive functioning. Cross-sectional study was carried out, comparing HIV-infected persons who had interrupted antiretroviral therapy in the past (interruption group, IG) with persons who had never discontinued therapy (noninterruption group, NIG). Interruption was defined as the discontinuation of highly active antiretroviral therapy (HAART) for more than 15 days after previous treatment of at least 15 days. All the participants were on therapy. Demographic, clinical, and neurocognitive variables were assessed. The primary end point was the percentage of people with neurocognitive impairment. The score in different neurocognitive domains was a secondary end point. A total of 83 subjects participated in the study (IG: n = 27; NIG: n = 56). Demographic and clinical characteristics were balanced between the groups, except for years since HIV diagnosis (IG, 13.8; NIG, 10.2 [P = .003]). The percentage of people with neurocognitive impairment was significantly higher in the IG group (IG, 59.25%; NIG, 33.92% [P = 0.02]). As for scores in neurocognitive domains, individuals in the IG showed worse neurocognitive functioning, and significant differences in attention/working memory and information processing speed were found. The adjusted analysis supported the unadjusted analysis. In this study, a higher prevalence of neurocognitive impairment was detected in HIV-infected persons who had interrupted antiretroviral therapy in the past. Additionally, neurocognitive functioning was observed to be more impaired in the same individuals. Further studies should examine the potential negative effects of antiretroviral therapy interruptions on neurocognitive functioning.

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    Nadir CD4 T cell count as predictor and high CD4 T cell intrinsic apoptosis as final mechanism of poor CD4 T cell recovery in virologically suppressed HIV-infected patients: clinical implications  Open access

     Negredo, Eugènia; Massanella, Marta; Puig, Jordi; Perez Alvarez, Nuria; Gallego-Escuredo, Jose Miguel; Villarroya, Joan; Villarroya, Francesc; Molto, Jose; Ramon Santos, Jose; Clotet, Bonaventura; Santos, Julia
    Clinical infectious diseases
    Date of publication: 2010-05-01
    Journal article

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    BACKGROUND: Although antiretroviral therapy improves immune response, some human immunodeficiency virus-infected patients present unsatisfactory CD4 T cell recovery despite achieving viral suppression, resulting in increased morbidity and mortality. METHODS: Cross-sectional, case-control study to characterize the mechanism and to identify predictive factors of poor immune response. We included 230 patients who were receiving highly active antiretroviral therapy and who had a viral load <50 copies/mL for >2 years; 95 were "discordant" (case patients; CD4 T cell count always <350 cells/microL), and 135 were "concordant" (control subjects). Activation markers, CD4 T cell death (necrosis, intrinsic apoptosis, and extrinsic apoptosis), and caspase-3 were measured. Clinical parameters, particularly antiretroviral combinations, were correlated with immune recovery. RESULTS: Discordant patients showed higher levels of activation markers, mainly in CD4 T cells (p < .001), and higher rates of spontaneous cell death (P < .001). Rates of activation and rates of CD4 T cell death (mainly by intrinsic apoptosis) were the best predictive factors for immune recovery, along with nadir CD4 T cell count. Patients who were receiving a protease inhibitor-based regimen were more likely to be discordant and showed higher rates of activation (P= .011), higher rates of CD4 T cell death (P = .033), and a lower nadir CD4 T cell count (P < .001). Multivariate analysis, however, ruled out any effect of protease inhibitors on immune recovery. No differences were observed between the use of tenofovir-emtricitabine (Truvada) and the use of abacavir-lamivudine (Kivexa). CONCLUSIONS: CD4 T cell apoptosis by the intrinsic pathway represents the determinant mechanism of the unsatisfactory immune recovery and should be targeted to manage therapy for discordant patients. The predictive value of low nadir CD4 T cell count for a poor immune recovery led us to consider starting antiretroviral therapy earlier. No differences were observed among antiretrovirals in terms of immune recovery.

  • CD4 T-cell hyperactivation and susceptibility to cell death determine poor CD4 T-cell recovery during suppressive HAART

     Massanella, Marta; Negredo, Eugènia; Perez Alvarez, Nuria; Puig, Jordi; Ruiz Hernandez, Raul; Bofill, Margarita; Clotet, Bonaventura; Blanco, Julia
    AIDS
    Date of publication: 2010-04-24
    Journal article

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  • Four-Year Safety with Polyacrylamide Hydrogel to Correct Antiretroviral-Related Facial Lipoatrophy

     Negredo, Eugènia; Puig, J; Aldea, D; Medina, M; Estany, C; Perez Alvarez, Nuria; Perez-Alvarez, N; Rodriguez-Fumaz, C; Munoz-Moreno, Ja; Higueras, C; Gonzalez-Mestre, V; Clotet, Bonaventura
    AIDS research and human retroviruses
    Date of publication: 2009-04
    Journal article

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  • Increased peripheral proinflammatory cytokines in HIV-1-infected patients with prolonged viral suppression suffering from high psychological stress

     Fumaz, Carmina R.; Gonzalez Garcia, Marian; BORRAS, XAVIER; Muñoz Moreno, Jose A.; Peña, Ruth; Perez Alvarez, Nuria; Puig, Jordi; Paredes, Roger; Fernández Castro, Jordi; Clotet, Bonaventura
    Journal of acquired immune deficiency syndromes
    Date of publication: 2009-11
    Journal article

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    "In summary, patients who reported high levels of stress had significantly higher levels of peripheral proinflammatory cytokines, especially IL-6. The levels in our patients who reported stress averaged more than 6 times the standard cut off of 2.5 pg/mL, which has been determined to be predictive of physical decline.12 TNF-α levels were also significantly higher in patients with stress. Despite the limited sample size in this pilot study, the findings suggest that psychological stress could be a cofactor in the comorbidity of HIV-infected patients. This hypothesis requires further investigation."

  • ANALISIS DE SUPERVIVENCIA PARA MULTIPLES EVENTOS CON PATRONES DE CENSURA COMPLEJOS

     Serrat Pie, Carles; Langohr, Klaus; Perez Alvarez, Nuria; Porta Bleda, Nuria; Gomez Melis, Guadalupe
    Participation in a competitive project

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  • Association between HIV replication and cholesterol in peripheral blood mononuclear cells in HIV-infected patients interrupting HAART

     Negredo, Eugènia; Puigdomenech, I; Marfil, S; Puig, J; Perez-Alvarez, N; Perez Alvarez, Nuria; Ruiz, L; Rey-Joly, C; Clotet, Bonaventura; Blanco, J
    Journal of antimicrobial chemotherapy
    Date of publication: 2008-02
    Journal article

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  • Targeting only reverse transcriptase with zidovudine/lamivudine/abacavir plus tenofovir in HIV-1-infected patients with multidrug-resistant virus: a multicentre pilot study

     Llibre, JM; Bonjoch, A; Iribarren, J; Galindo, Mj; Negredo, Eugènia; Domingo, P; Perez Alvarez, Nuria; Martinez-Picado, J; Schapiro, J; Clotet, Bonaventura
    HIV medicine
    Date of publication: 2008-05
    Journal article

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  • Nadir CD4 Cell Count Predicts Neurocognitive Impairment in HIV-Infected Patients

     Muñoz-Moreno, Ja; Fumaz, Cr; Prats, A; Ferrer, Mj; Negredo, Eugènia; Garolera, M; Perez Alvarez, Nuria; Moltó, J; Gomez Melis, Guadalupe; Clotet, Bonaventura
    AIDS research and human retroviruses
    Date of publication: 2008-10
    Journal article

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  • Darunavir inhibitory quotient predicts the 48-week virological response to darunavir-based salvage therapy in human immunodeficiency virus-infected protease inhibitor-experienced patients

     Moltó, J; Santos, Jr; Pérez-Álvarez, N; Perez Alvarez, Nuria; Cedeño, S; Miranda, C; Khoo, S; Else, L; Llibre, JM; Valle, M; Clotet, Bonaventura
    Antimicrobial agents and chemotherapy
    Date of publication: 2008-08
    Journal article

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  • Efficacy and safety of switching enfuvirtide to raltegravir in patients with viral suppression

     Santos, Jr; Llibre, JM; Moltó, J; Perez Alvarez, Nuria; García, MC; Clotet, Bonaventura
    Ninth International Congress on Drug Therapy in HIV Infection
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  • Saquinavir/ritonavir monotherapy as a new nucleoside-sparing maintenance strategy

     Echeverría, P; Domingo, P; Gutierrez, M; Mateo, G; Puig, J; Moltó, J; Pérez-Álvarez, N; Perez Alvarez, Nuria; Clotet, Bonaventura; Negredo, Eugènia
    Ninth International Congress on Drug Therapy in HIV Infection
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  • ¿ES SOTENIBLE EL TRATAMIENTO HAART EN UN SISTEMA NACIONAL DE SALUD? COSTE-EFECTIVIDAD.

     Perez Alvarez, Nuria
    Participation in a competitive project

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  • Transient therapy with quadruple NRTI provides immune stability in patients with multidrug resistant HIV-1 and no options for suppressive regimens

     Bonjoch, A; Llibre, JM; Negredo, Eugènia; Puig, J; Pérez-Álvarez, N; Perez Alvarez, Nuria; Buzon, MJ; Martinez-Picado, J; Clotet, Bonaventura
    Ninth International Congress on Drug Therapy in HIV Infection
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  • Usefulness of a Dendogram Plot Technique in Clustering Homogeneous Subgroups of Multi-treated HIV-1 Patients in Accordance with their Mutational Pattern

     Perez Alvarez, Nuria
    15th Conference on Retroviruses and Opportunistic Infections
    Presentation's date: 2008-02-03
    Presentation of work at congresses

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  • Long-term Satisfaction and Benefits on Quality of Life in HIV-Infected People after Reparatory Treatment with Aquamid® for Facial Lipoatrophy

     Muñoz-Moreno, Ja; Puig, J; Fumaz, Cr; Negredo, Eugènia; Ferrer, Mj; Pérez-Álvarez, N; Perez Alvarez, Nuria; González-Mestre, V; Clotet, Bonaventura
    Ninth International Congress on Drug Therapy in HIV Infection
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  • Anxiety Predicts Neurocognitive Complaints in HIV-Infected People

     Muñoz Moreno, Jose A.; Fumaz, Carmina R.; Prats, Anna; Perez Alvarez, Nuria; Utzet Sadurní, M; Ferrer, M. J.; Negredo, Eugènia; Garolera, Maite; Clotet, Bonaventura
    17th International AIDS Conference
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  • Mutations in the protease gene associated with virological failure to lopinavir-containing regimens in clinical samples

     Santos, Jr; Llibre, JM; Pérez-Álvarez, N; Perez Alvarez, Nuria; Domingo, P; Miralles, C; Schapiro, J; Clotet, Bonaventura
    Ninth International Congress on Drug Therapy in HIV Infection
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  • Dispositional optimism, perceived health competence and adherence in highly antiretroviral-experienced patients

     Fumaz, Cr; Muñoz-Moreno, Ja; Ferrer, Mj; Perez Alvarez, Nuria; Moltó, J; Clotet, Bonaventura
    Ninth International Congress on Drug Therapy in HIV Infection
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  • Adherence, coping strategies and depression in highly antiretroviral-experienced patients

     Fumaz, Cr; Muñoz-Moreno, Ja; Ferrer, Mj; Perez Alvarez, Nuria; Moltó, J; Clotet, Bonaventura
    Ninth International Congress on Drug Therapy in HIV Infection
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  • Mitochondrial effects of 3 years of CD4-guided HIV treatment interruption

     Garrabou, G; Morén, C; Negredo, Eugènia; Bogarra Rodriguez, Santiago; Nicolàs, M; Miró, Ò; Cardellach, F; Puig, J; Pérez-Álvarez, N; Perez Alvarez, Nuria; López-Blánquez, R; Ruiz, L; Bellido, R; Miranda, C; Clotet, Bonaventura
    Ninth International Congress on Drug Therapy in HIV Infection
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  • Inhibitory Quotient as a Predictor of Virological Response to Darunavir-Based Salvage Regimens

     Perez Alvarez, Nuria
    15th Conference on Retroviruses and Opportunistic Infections
    Presentation's date: 2008-02-03
    Presentation of work at congresses

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  • Analysis of an outcome beyond a detection limit: application to HIV RNA data

     Perez Alvarez, Nuria
    XXIVth International Biometric Conference
    Presentation's date: 2008-07-13
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  • Antiretroviral therapy interruption guided by CD4 cell counts and plasma HIV-1 RNA levels in chronically HIV-1-infected patients

     Ruiz, L; Paredes, R; Gomez Melis, Guadalupe; Romeu Robert, Jordi; Domingo, P; Pérez-Alvarez, N; Perez Alvarez, Nuria; Tambussi, G; Llibre, JM; Martínez-Picado, J; Vidal, F; Fumaz, Cr; Clotet, Bonaventura; Tibet, Study Group
    AIDS
    Date of publication: 2007-01
    Journal article

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  • Influence of the type of pegylated interferon on the onset of depressive and neuropsychiatric symptoms in HIV-HCV coinfected patients

     Fumaz, Cr; Muñoz-Moreno, Ja; Ballesteros, Al; Paredes, R; Ferrer, Mj; Salas, A; Fuster, D; Masmitjà, E; Pérez-Alvarez, N; Perez Alvarez, Nuria; Gomez Melis, Guadalupe; Tural, C; Clotet, Bonaventura
    AIDS care: psychological and socio-medical aspects of AIDS/HIV
    Date of publication: 2007-01
    Journal article

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  • Relative antiviral efficacy of ritonavir-boosted darunavir and ritonavir-boosted tipranavir vs. control protease inhibitor in the POWER and RESIST trials.

     Llibre, J M; Perez-Alvarez, N; Perez Alvarez, Nuria; Moyle, Hill A G
    HIV medicine
    Date of publication: 2007-11
    Journal article

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  • Methodological accuracy in cross-trial comparisons of antiretroviral regimens in multitreated patients

     Llibre, JM; Pérez-Alvarez, N; Perez Alvarez, Nuria; Moyle, Hill A G
    HIV medicine
    Date of publication: 2007-11
    Journal article

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  • Study of the mitochondria function during an HIV interruption treatment

     Perez Alvarez, Nuria; Negredo, Eugènia; Gomez Melis, Guadalupe; Bogarra Rodriguez, Santiago; Miró, O; Clotet, Bonaventura
    XI Conferencia Española y I Encuentro Iberoamericano de Biometria
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  • Study of the CD4 Cell Counts Evolution During the 1st, 2nd and 3rd Period Without Treatment in a HIV Clinical Trial

     Pérez-Álvarez, N; Perez Alvarez, Nuria; Gomez Melis, Guadalupe; Ruiz, L; Clotet, Bonaventura
    4th Conference of the Eastern Mediterranean Region of the International Biometric Society
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  • Classifying adherence to antiretroviral treatment in HIV-Infected patients

     Pérez-Álvarez, N; Perez Alvarez, Nuria; Muñoz-Moreno, Ja; Gomez Melis, Guadalupe; Fumaz, Cr; Ferrer, Mj; Clotet, Bonaventura
    XI Conferencia Española y I Encuentro Iberoamericano de Biometria
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  • Study of the 1st, 2nd and 3d Guided Interruption Periods in an HIV Clinical Trial

     Perez Alvarez, Nuria; Gomez Melis, Guadalupe; Clotet, L Ruiz y B
    22 International Workshop on Statistical Modelling (IWSM'2007)
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