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1.
Artigo em Inglês | MEDLINE | ID: mdl-31586414

RESUMO

BACKGROUND: Darunavir/cobicistat can be used as mono, dual, triple or more than triple therapy. OBJECTIVES: To assess factors associated with the number of drugs in darunavir/cobicistat regimens. METHODS: A nationwide retrospective cohort study of consecutive HIV-infected patients initiating darunavir/cobicistat in Spain from July 2015 to May 2017. Baseline characteristics, efficacy and safety at 48 weeks were compared according to the number of drugs used. RESULTS: There were 761 patients (75% men, 98% were antiretroviral-experienced, 32% had prior AIDS, 84% had HIV RNA <50 copies/mL and 88% had ≥200 CD4 cells/mm3) who initiated darunavir/cobicistat as mono (n=308, 40%), dual (n=173, 23%), triple (n=253, 33%) or four-drug (n=27, 4%) therapy. Relative to monotherapy, triple therapy was more common in men aged <50 years, with prior AIDS and darunavir plus ritonavir use, and with CD4 cells <200/mm3 and with detectable viral load at initiation of darunavir/cobicistat; dual therapy was more common with previous intravenous drug use, detectable viral load at initiation of darunavir/cobicistat and no prior darunavir plus ritonavir; and four-drug therapy was more common with prior AIDS and detectable viral load at initiation of darunavir/cobicistat. Monotherapy and dual therapy showed a trend to better virological responses than triple therapy. CD4 responses and adverse effects did not differ among regimens. DISCUSSION: Darunavir/cobicistat use in Spain has been tailored according to clinical characteristics of HIV-infected patients. Monotherapy and dual therapy have been common and preferentially addressed to older patients with a better HIV status, suggesting that health issues other than HIV infection may have been strong determinants of its prescription.

2.
BMJ Open ; 9(5): e027245, 2019 May 05.
Artigo em Inglês | MEDLINE | ID: mdl-31061051

RESUMO

OBJECTIVES: Young people are a critical target group for sexually transmitted infections (STI) surveillance due to their particular behavioural and social related vulnerability. The aim of this study was to describe the epidemiological characteristics and trends in the incidence of gonorrhoea, syphilis, HIV and venereal lymphogranuloma (LGV) among 15-24-year-olds in Barcelona, and to determine factors associated with HIV coinfection. DESIGN: We performed a population-based incidence study covering the 2007-2015 period. PARTICIPANTS: All new cases of STI-HIV, gonorrhoea, infectious syphilis and LGV-notified to the epidemiological surveillance system in Barcelona between 2007 and 2015. 1218 cases were studied: 84.6% were men, 19.3% were 15-19 years old and 50.6% were born in Spain. Among men, 73.7% were men who have sex with men (MSM); among women, 85.6% were women that have sex with men. PRIMARY AND SECONDARY OUTCOMES: Incidence of HIV, gonorrhoea, infectious syphilis and LGV. HIV coinfection. RESULTS: There was an increase in the incidence of gonorrhoea, from 1.9 cases per 10 000 people in 2007 to 7.6/10 000 in 2015 (p<0.01), in MSM from 27.1 to 228.8/10 000 (p<0.01). The incidence of syphilis increased from 0.4/10 000 in 2007 to 3.1/10 000 in 2015 (significant in men only, p<0.01), in MSM from 18.1 to 116.9/10 000 (p<0.01). The incidence of HIV showed a non-significant increase in men (p=0.27), and that of LGV remained stable (p=0.59). Factors associated with increased risk of HIV coinfection included being MSM (adjusted OR[ORa]=14.14, 95% CI 3.34 to 59.91) and having >10 sexual partners (ORa=4.11, 95% CI 1.53 to 11.01) or STI diagnosis during the previous 12 months (ORa=2.06; 95% CI 1.13 to 3.77). CONCLUSIONS: The incidence of gonorrhoea and syphilis among 15-24-year-olds increased, while HIV infection remained stable but with a high incidence among MSM. Being MSM, having sex with multiple partners and having a diagnosis of an STI in the previous 12 months were factors associated with HIV coinfection.

3.
Nefrologia ; 39(5): 497-505, 2019.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31027896

RESUMO

BACKGROUND: The use of combination antiretroviral therapy has led to dramatic improvements in the life expectancy of HIV-infected persons. As result, the HIV population is aging and increasingly facing illnesses typically seen in the elderly, such as chronic kidney disease (CKD). METHODS: A retrospective longitudinal study was conducted using data from years 2010 and 2014 in all HIV-infected persons enrolled at the Spanish VACH cohort. We analyzed the prevalence and the predictive factors for developing CKD (estimated glomerular filtration rate, eGFR<60mL/min/1.73m2). RESULTS: The CKD prevalence at baseline was 456/8968, 5.1% [4.6-5.6%]. Of 8512 HIV-positive individuals examined without CKD at baseline (73.7% male, median age 44 years-old), 2.15% developed CKD (eGFR<60mL/min/1.73m2). The odds ratios [95%CI] for the independent predictive factors identified were gender (male) 0.54 [0.39-0.75], age (per year) 1.08 [1.07-1.10], AIDS diagnosis 1.40 [1.03-1.91], protease inhibitor-based regimens 1.49 [1.10-2.02], hypertension 1.37 [0.94-1.99], diabetes 1.84 [1.33-2.55] and history of cardiovascular events 1.66 [0.96-2.86]. CONCLUSION: The prevalence and risk factors for CKD and its progression are high in the VACH cohort. Thus, preventive measures such as control of hypertension, diabetes and obesity, as well as efforts for avoiding exposure to nephrotoxic drugs, including some antiretrovirals, are warranted in this aging HIV population.

4.
Enferm. infecc. microbiol. clín. (Ed. impr.) ; 37(3): 151-159, mar. 2019. graf, tab
Artigo em Inglês | IBECS | ID: ibc-181298

RESUMO

Background: The GESIDA/National AIDS Plan expert panel recommended preferred regimens (PR), alternative regimens (AR) and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2018. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. Methods: Economic assessment of costs and efficiency (cost-effectiveness) based on decision tree analyses. Effectiveness was defined as the probability of reporting a viral load <50 copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug-resistance studies) over the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting was Spain and the costs correspond to those of 2018. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. Results: In the base-case scenario, the cost of initiating treatment ranges from 6788 euros for TAF/FTC/RPV (AR) to 10,649 euros for TAF/FTC + RAL (PR). The effectiveness varies from 0.82 for TAF/FTC + DRV/r (AR) to 0.91 for TAF/FTC+DTG (PR). The efficiency, in terms of cost-effectiveness, ranges from 7814 to 12,412 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TAF/FTC + RAL (PR), respectively. Conclusion: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TAF/FTC/RPV (AR) and TAF/FTC/EVG/COBI (AR)


Introducción El panel de expertos de GESIDA/Plan Nacional del Sida ha recomendado pautas preferentes (PP), pautas alternativas (PA) y otras pautas (OP) para el tratamiento antirretroviral (TAR) como terapia de inicio en pacientes infectados por VIH para 2018. El objetivo de este estudio es evaluar los costes y la eficiencia de iniciar tratamiento con PP y PA. Métodos: Evaluación económica de costes y eficiencia (coste/eficacia) mediante construcción de árboles de decisión. Se definió eficacia como la probabilidad de tener carga viral <50 copias/ml en la semana 48 en análisis por intención de tratar. Se definió coste de iniciar tratamiento con una pauta como los costes del TAR y de todas sus consecuencias (efectos adversos, cambios de pauta y estudio de resistencias) que se producen en las siguientes 48 semanas. Se utilizó la perspectiva del Sistema Nacional de Salud, considerando solo costes directos diferenciales: TAR (a precio oficial), manejo de efectos adversos, estudios de resistencias y determinación de HLA-B*5701. El ámbito es España, con costes de 2018. Se realizó un análisis de sensibilidad determinista construyendo 3 escenarios para cada pauta: basal, más favorable y más desfavorable. Resultados: En el escenario basal, los costes de iniciar tratamiento oscilaron entre 6.788 para TAF/FTC/RPV (PA) y 10.649 para TAF/FTC+RAL (PP). La eficacia osciló entre 0,82 para TAF/FTC+DRV/r (PA) y 0,91 para TAF/FTC+DTG (PP). La eficiencia, en términos de coste/eficacia, osciló entre 7.814 y 12.412 por respondedor a las 48 semanas, para ABC/3TC/DTG (PP) y TAF/FTC+RAL (PP), respectivamente. Conclusión: Considerando el precio oficial del TAR, la pauta más eficiente fue ABC/3TC/DTG (PP), seguida de TAF/FTC/RPV (PA) y AF/FTC/EVG/COBI (PA)


Assuntos
Humanos , Adulto , Antirretrovirais/economia , Antirretrovirais/uso terapêutico , Análise Custo-Benefício , HIV , Fármacos Anti-HIV/uso terapêutico
5.
PLoS One ; 14(1): e0209911, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30689664

RESUMO

BACKGROUND: Comparison of changes in body composition, adipokines and inflammatory markers after initial therapy with a nucleos(t)ide reverse transcriptase inhibitor (N(t)RTI)- sparing or containing regimen are scarce. DESIGN: Randomised Clinical Trial. METHODS: This is the body composition substudy of NEAT 001/ANRS 143, a randomised trial comparing darunavir/ritonavir (DRV/r) plus either raltegravir (RAL) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 805 ART naïve HIV-infected adults. The primary endpoint was percentage change in limb fat at week 96. Secondary endpoints were associations among these changes and metabolic markers (IL-6, insulin, leptin, adiponectin, FGF-23). RESULTS: 126 subjects (61 DRV/r + RAL and 65 DRV/r + TDF/FTC) were included. The rate of change in BMI between groups for RAL versus TDF/FTC at week 96 was 1.5% per 48-week period (p = 0.015). The rate of change in limb fat mass, trunk fat mass, total body fat and total lean mass was for RAL versus TDF/FTC at week 96 was 2.5% (p = 0.38), 7.3% ((p = 0.021), 4.9% (p = 0.061) and 1.3% (p = 0.12) respectively. Baseline insulin and leptin levels were correlated with baseline limb fat and trunk fat mass [r = 0.31 (p = 0.0043)/r = 0.28 (p = 0.0011) for limb fat, and r = 0.63 (p<0.0001)/r = 0.50(p<0.0001) for trunk fat]. After adjustment, a 10% faster increase in leptin between baseline and week 48 was associated with a more rapid increase in limb fat at week 48 (0.5% per 48 weeks, p<0.001), total body fat mass (0.6% per 48 weeks, p<0.001), and trunk fat mass (0.3% per 48 weeks, p = 0.0026). CONCLUSIONS: After week 96 a N(t)RTI sparing regimen of DRV/r + RAL produced a numerically greater percentage increase in body composition variables with only change in trunk fat mass and BMI being significant.


Assuntos
Adipocinas/sangue , Composição Corporal , Índice de Massa Corporal , Combinação Emtricitabina e Fumarato de Tenofovir Desoproxila/administração & dosagem , Raltegravir Potássico/administração & dosagem , Adulto , Combinação Emtricitabina e Fumarato de Tenofovir Desoproxila/efeitos adversos , Feminino , Humanos , Masculino , Raltegravir Potássico/efeitos adversos , Fatores de Tempo
6.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-30389268

RESUMO

BACKGROUND: The life expectancy of HIV-infected individuals has dramatically improved with potent antiretroviral therapies. However, organ-specific toxicities of some antiretrovirals and persistent inflammation and immune activation due to residual virus replication account for a high burden of age-associated comorbidities in the HIV population. METHODS: The prevalence of overt cardiovascular, renal and bone diseases as well as their major risk factors were cross-sectionally examined during the year 2014 in the VACH cohort, a large nationwide population of HIV-infected individuals in Spain. RESULTS: A total of 10,897 HIV-infected patients were examined. Seventy-one point four percent were male and the mean age was 48 years. Mean time since HIV diagnosis was 15.8 years and mean time on antiretroviral therapy was 13.1 years. The proportion of patients with undetectable viral load was 87.1%, whereas 65.7% had CD4 counts>500 cells/mm3. Overall, cardiovascular, renal and bone disease were recorded in 4.7%, 5.9% and 2.8%, respectively. The prevalence of major risk factors was as follows: smoking 51.3%, alcohol abuse 7.8%, overweight/obesity 42.2%, diabetes 19.9%, dyslipidaemia 72.6%, hypertension 25.6%, and osteoporosis 11.1%. In the subset of patients older than 55 years-old (18%), all figures for overt disease and their major risk factors were significantly greater. CONCLUSION: Major age-related medical conditions and most of their risk factors are highly prevalent in HIV-infected individuals on long-term antiretroviral therapy in Spain. Preventive actions, including careful selection of antiretroviral agents, should be prioritized in the ageing HIV population.

7.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-29884455

RESUMO

BACKGROUND: The GESIDA/National AIDS Plan expert panel recommended preferred regimens (PR), alternative regimens (AR) and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2018. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. METHODS: Economic assessment of costs and efficiency (cost-effectiveness) based on decision tree analyses. Effectiveness was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug-resistance studies) over the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting was Spain and the costs correspond to those of 2018. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. RESULTS: In the base-case scenario, the cost of initiating treatment ranges from 6788 euros for TAF/FTC/RPV (AR) to 10,649 euros for TAF/FTC+RAL (PR). The effectiveness varies from 0.82 for TAF/FTC+DRV/r (AR) to 0.91 for TAF/FTC+DTG (PR). The efficiency, in terms of cost-effectiveness, ranges from 7814 to 12,412 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TAF/FTC+RAL (PR), respectively. CONCLUSION: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TAF/FTC/RPV (AR) and TAF/FTC/EVG/COBI (AR).

8.
Artigo em Inglês | IBECS | ID: ibc-176574

RESUMO

Osteoporosis has become an emerging comorbid condition in people living with HIV (PLWH). The increase in survival and the progressive aging of PLWH will make this complication more frequent in the near future. In addition to the traditional risk factors affecting the general population, factors directly or indirectly associated with HIV infection, including antiretroviral therapy, can increase the risk of osteoporosis. The present article is an executive summary of the document that updates the previous recommendations on the prevention and treatment of osteoporosis in PLWH. This document is intended for all professionals who work in clinical practice in the field of HIV infection


La osteoporosis se ha convertido en una situación comórbida emergente en las personas infectadas por VIH. El incremento de la supervivencia y el envejecimiento progresivo de las personas infectadas por VIH harán que esta complicación sea más frecuente en un futuro cercano. Además de los factores de riesgo tradicionales, los factores directa o indirectamente asociados a la infección por VIH, incluyendo el tratamiento antirretroviral, pueden incrementar el riesgo de presentar osteoporosis. El presente artículo constituye un resumen ejecutivo del documento que actualiza las recomendaciones previas sobre la prevención y el tratamiento de la osteoporosis en las personas infectadas por VIH. Este documento va dirigido a todos los profesionales que ejercen la práctica clínica en el campo de la infección por VIH


Assuntos
Humanos , Fármacos Anti-HIV/efeitos adversos , Infecções por HIV/tratamento farmacológico , Osteoporose/induzido quimicamente , Medição de Risco , Fármacos Anti-HIV/uso terapêutico
9.
AIDS ; 32(7): 913-920, 2018 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-29424785

RESUMO

OBJECIVE: Bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) is used to assess bone health in HIV patients. DXA measures the amount of mineral, but not other key aspects of bone strength such as bone microarchitecture or bone quality. Trabecular bone score (TBS) and in-vivo microindentation directly measure trabecular microarchitecture and bone tissue quality, respectively. The aim of this study is to measure bone strength properties using these techniques. RESULTS: Forty naive HIV patients who were going to start antiretroviral therapy (ART), a single pill treatment with elvitegravir/cobicistat, tenofovir disoproxil fumarate (TDF), emtricitavine (FTC) were included. A significant reduction in BMD at spine (-3.25%, P < 0.001) and in femoral neck (-3.82%, P = 0.016) between baseline and 48 weeks of treatment were found. Bone microarchitecture score at the spine, as measured by TBS, also significantly decreased from 1.357 (0.09) to 1.322 (0.09) (-2.5%, P = 0.011) between baseline to 48 weeks of treatment. Microindentation (BMSi) values were significantly higher than at baseline [89.04 (4.2) versus 86.07 (6.1); 3.49%, P < 0.001] after 48 weeks of TDF-based ART treatment, indicating improved bone material properties CONCLUSION:: A significant decrease in BMD and TBS were observed after 1 year of TDF therapy. However, tissue quality significantly improved after 1 year of treatment, suggesting a recovery of bone material properties following the control of the infection despite the significant reduction of BMD. These techniques provide additional and necessary information to DXA about bone health in treated HIV patients, and because of its convenience and feasibility they could be routinely apply to assess bone in clinical practice.

10.
Enferm Infecc Microbiol Clin ; 36(5): 312-314, 2018 05.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-28579014

RESUMO

Osteoporosis has become an emerging comorbid condition in people living with HIV (PLWH). The increase in survival and the progressive aging of PLWH will make this complication more frequent in the near future. In addition to the traditional risk factors affecting the general population, factors directly or indirectly associated with HIV infection, including antiretroviral therapy, can increase the risk of osteoporosis. The present article is an executive summary of the document that updates the previous recommendations on the prevention and treatment of osteoporosis in PLWH. This document is intended for all professionals who work in clinical practice in the field of HIV infection.

11.
Clin Infect Dis ; 65(12): 2112-2118, 2017 Nov 29.
Artigo em Inglês | MEDLINE | ID: mdl-29020293

RESUMO

Background: Our objective was to assess the therapeutic noninferiority of dual therapy with darunavir/ritonavir and lamivudine compared to triple therapy with darunavir/ritonavir plus 2 nucleos(t)ides for maintenance of human immunodeficiency virus type 1 (HIV-1) suppression. Methods: This was a multicenter, open-label, noninferiority trial (margin 12%). Patients with HIV-1 RNA <50 copies/mL for 6 months or longer on triple therapy with darunavir/ritonavir and 2 nucleos(t)ides (tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine) and with no resistance were randomized to continue therapy (n = 128) or switch to darunavir/ritonavir and lamivudine (n = 129). The primary endpoint was the proportion of participants with HIV-RNA <50 copies/mL after 48 weeks of follow-up according to the snapshot algorithm. Results: A total of 249 participants received study drugs (intention-to-treat exposed). The proportion of participants with HIV-RNA <50 copies/mL in the dual- and triple-therapy arms was 88.9% (112/126) and 92.7% (114/123; difference, -3.8%; 95% confidence interval, -11.0 to 3.4), respectively. Four participants in the dual-therapy arm and 2 in the triple-therapy arm developed protocol-defined virological failure. Switching to dual therapy was associated with a significant increase in total, low-density lipoprotein, and high-density lipoprotein (HDL) cholesterol, but not in the total-to-HDL cholesterol ratio. Serious adverse events and study drug discontinuations due to adverse events occurred in 4.8% vs 4.9%P = .97) and in 0.8% (1/126) vs 1.6% P = .55) in dual therapy vs triple therapy, respectively. Conclusions: Dual therapy with darunavir/ritonavir and lamivudine demonstrated noninferior therapeutic efficacy and similar tolerability compared to triple therapy. Clinical Trials Registration: NCT02159599.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Inibidores da Protease de HIV/uso terapêutico , HIV-1/efeitos dos fármacos , Carga Viral/efeitos dos fármacos , Adulto , Fármacos Anti-HIV/administração & dosagem , Contagem de Linfócito CD4 , Darunavir/administração & dosagem , Darunavir/uso terapêutico , Didesoxinucleosídeos/administração & dosagem , Didesoxinucleosídeos/uso terapêutico , Emtricitabina/administração & dosagem , Emtricitabina/uso terapêutico , Feminino , Infecções por HIV/virologia , Inibidores da Protease de HIV/administração & dosagem , Humanos , Lamivudina/administração & dosagem , Lamivudina/uso terapêutico , Masculino , Conduta do Tratamento Medicamentoso , Pessoa de Meia-Idade , RNA Viral/sangue , Ritonavir/administração & dosagem , Ritonavir/uso terapêutico , Tenofovir/administração & dosagem , Tenofovir/uso terapêutico
12.
PLoS One ; 12(4): e0173802, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28388647

RESUMO

Dysbalance in gut microbiota has been linked to increased microbial translocation, leading to chronic inflammation in HIV-patients, even under effective HAART. Moreover, microbial translocation is associated with insufficient reconstitution of CD4+T cells, and contributes to the pathogenesis of immunologic non-response. In a double-blind, randomised, placebo-controlled trial, we recently showed that, compared to placebo, 12 weeks treatment with probiotic Saccharomyces boulardii significantly reduced plasma levels of bacterial translocation (Lipopolysaccharide-binding protein or LBP) and systemic inflammation (IL-6) in 44 HIV virologically suppressed patients, half of whom (n = 22) had immunologic non-response to antiretroviral therapy (<270 CD4+Tcells/µL despite long-term suppressed viral load). The aim of the present study was to investigate if this beneficial effect of the probiotic Saccharomyces boulardii is due to modified gut microbiome composition, with a decrease of some species associated with higher systemic levels of microbial translocation and inflammation. In this study, we used 16S rDNA gene amplification and parallel sequencing to analyze the probiotic impact on the composition of the gut microbiome (faecal samples) in these 44 patients randomized to receive oral supplementation with probiotic or placebo for 12 weeks. Compared to the placebo group, in individuals treated with probiotic we observed lower concentrations of some gut species, such as those of the Clostridiaceae family, which were correlated with systemic levels of bacterial translocation and inflammation markers. In a sub-study of these patients, we observed significantly higher parameters of microbial translocation (LBP, soluble CD14) and systemic inflammation in immunologic non-responders than in immunologic responders, which was correlated with a relative abundance of specific gut bacterial groups (Lachnospiraceae genus and Proteobacteria). Thus, in this work, we propose a new therapeutic strategy using the probiotic yeast S. boulardii to modify gut microbiome composition. Identifying pro-inflammatory species in the gut microbiome could also be a useful new marker of poor immune response and a new therapeutic target.


Assuntos
Infecções por HIV/microbiologia , Intestinos/microbiologia , Microbiota , Probióticos , Saccharomyces boulardii , Adulto , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Placebos
13.
J Acquir Immune Defic Syndr ; 75(3): 322-327, 2017 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-28418990

RESUMO

OBJECTIVES: HIV infection has been associated with reduced bone mineral density (BMD). Antiretroviral therapy (ART) has a deleterious effect on BMD, but its effect on bone fragility is not clear. The objective of this study is to analyze the BMD, microarchitecture, and tissue quality of bone in patients receiving long-term tenofovir- or abacavir-based ART. DESIGN: We conducted a cross-sectional study in patients with HIV undergoing tenofovir or abacavir ART for more than 5 years. METHODS: We measured BMD using dual X-ray absorptiometry ,bone michroarchitecture using trabecular bone score (TBS), and bone tissue quality using microindentation. TBS is a dual X-ray absorptiometry-based software that is more highly correlated with bone fragility than BMD. Microindentation (BMSi) directly assesses bone quality at the tissue level. RESULTS: A total of 63 patients were included in this study, with 36 belonging to the TDF-FTC group and 27 to the ABC-3TC group. Patients receiving TDF-FTC treatment showed lower BMD values than those in the ABC-3TC group. We found no differences in TBS or microindentation between the 2 groups. However, after adjusting for sex, age, body mass index, and 25[OH]vitD we found lower BMSi and thus poorer bone properties in the TDF-FTC group than in the ABC-3TC group [beta coefficient -3.594 (confidence interval: 95% -0.12 to -7.61); P = 0.043]. CONCLUSIONS: Long-term treatment with TDF-FTC leads to impaired bone health, not only in terms of BMD but also in terms of bone quality, another determinant of overall bone strength. To complement BMD-based predictions, these other techniques may also be used to identify patients with excess fracture risk.


Assuntos
Fármacos Anti-HIV/efeitos adversos , Densidade Óssea/efeitos dos fármacos , Didesoxinucleosídeos/efeitos adversos , Emtricitabina/efeitos adversos , Infecções por HIV/fisiopatologia , Lamivudina/efeitos adversos , Tenofovir/efeitos adversos , Absorciometria de Fóton , Fármacos Anti-HIV/administração & dosagem , Remodelação Óssea , Estudos Transversais , Didesoxinucleosídeos/administração & dosagem , Combinação de Medicamentos , Emtricitabina/administração & dosagem , Feminino , Infecções por HIV/tratamento farmacológico , Humanos , Lamivudina/administração & dosagem , Masculino , Pessoa de Meia-Idade , Espanha , Tenofovir/administração & dosagem
15.
Enferm. infecc. microbiol. clín. (Ed. impr.) ; 35(2): 88-99, feb. 2017. graf, tab
Artigo em Inglês | IBECS | ID: ibc-162048

RESUMO

Introduction: GESIDA and the AIDS National Plan panel of experts suggest preferred (PR), alternative (AR), and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for the year 2016. The objective of this study is to evaluate the costs and the efficacy of initiating treatment with these regimens. Methods: Economic assessment of costs and efficiency (cost/efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48 in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and the costs correspond to those of 2016. A sensitivity deterministic analysis was conducted, building three scenarios for each regimen: base case, most favourable, and least favourable. Results: In the base case scenario, the cost of initiating treatment ranges from 4663 Euros for 3TC+LPV/r (OR) to 10,894 Euros for TDF/FTC+RAL (PR). The efficacy varies from 0.66 for ABC/3TC+ATV/r (AR) and ABC/3TC+LPV/r (OR), to 0.89 for TDF/FTC+DTG (PR) and TDF/FTC/EVG/COBI (AR). The efficiency, in terms of cost/efficacy, ranges from 5280 to 12,836 Euros per responder at 48 weeks, for 3TC+LPV/r (OR), and RAL+DRV/r (OR), respectively. Conclusion: Despite the overall most efficient regimen being 3TC+LPV/r (OR), among the PR and AR, the most efficient regimen was ABC/3TC/DTG (PR). Among the AR regimes, the most efficient was TDF/FTC/RPV (AU)


Introducción: El panel de expertos de GESIDA/Plan Nacional del Sida ha recomendado pautas preferentes (PP), pautas alternativas (PA) y otras pautas (OP) para el tratamiento antirretroviral (TARV) como terapia de inicio en pacientes infectados por VIH para 2016. El objetivo de este estudio es evaluar los costes y la eficiencia de iniciar tratamiento con estas pautas. Métodos: Evaluación económica de costes y eficiencia (coste/eficacia) mediante construcción de árboles de decisión. Se definió eficacia como la probabilidad de tener carga viral <50copias/ml en la semana 48 en análisis por intención de tratar. Se definió coste de iniciar tratamiento con una pauta como los costes del TARV y de todas sus consecuencias (efectos adversos, cambios de pauta y estudio de resistencias) que se producen en las siguientes 48 semanas. Se utilizó la perspectiva del Sistema Nacional de Salud, considerando solo costes directos diferenciales: TARV (a precio oficial), manejo de efectos adversos, estudios de resistencias y determinación de HLA B*5701. El ámbito es España, con costes de 2016. Se realizó análisis de sensibilidad determinista construyendo 3 escenarios para cada pauta: basal, más favorable y más desfavorable. Resultados: En el escenario basal, los costes de iniciar tratamiento oscilaron entre 4.663euros para 3TC+LPV/r (OP) y 10.894euros para TDF/FTC+RAL (PP). La eficacia osciló entre 0,66 para ABC/3TC+ATV/r (PA) y ABC/3TC+LPV/r (OP), y 0,89 para TDF/FTC+DTG (PP) y TDF/FTC/EVG/COBI (PA). La eficiencia, en términos de coste/eficacia, osciló entre 5.280 y 12.836euros por respondedor a las 48 semanas, para 3TC+LPV/r (OP) y RAL+DRV/r (OP), respectivamente. Conclusión: Aunque globalmente la pauta más eficiente fue 3TC+LPV/r (OP), considerando solamente las PP y las PA, la pauta más eficiente fue ABC/3TC/DTG (PP). De las PA, la más eficiente fue TDF/FTC/RPV (AU)


Assuntos
Humanos , Infecções por HIV/tratamento farmacológico , Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade/estatística & dados numéricos , Antirretrovirais/uso terapêutico , Análise Custo-Benefício , Custos de Medicamentos/estatística & dados numéricos , Tempo para o Tratamento/estatística & dados numéricos , Síndrome de Imunodeficiência Adquirida/prevenção & controle
16.
AIDS Res Hum Retroviruses ; 33(1): 29-32, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27250802

RESUMO

To assess the efficacy and safety of maraviroc (MVC) administered once-daily in routine clinical practice. A retrospective multicenter study (27 centers in Spain) was conducted. Data were collected from the records of patients starting a regimen with MVC. Laboratory and clinical data were recorded every 3 months the first year and every 6 months thereafter. Data are presented as median and interquartile range. Among 667 patients treated with MVC, 142 (21.3%) received MVC once-daily: 108 (76.1%), 150 mg and 34 (23.9%), and 300 mg. Age was 47 (42-45) years, there were 76.1% men, and 81 (57%) patients had baseline HIV-RNA <50 copies/mL. Viral tropism was R5 in 118 (83.1%) patients. Reasons for prescribing MVC: salvage therapy (36.6%), drug toxicity (31.2%), simplification (16.9%), and immunodiscordant response (7.1%). Median follow-up was 13 (9-16) months. In 95.8%, a PI/r was part of the regimen (67% on dual therapy). At months 12 and 24, 73.3% and 68.2% of patients had HIV-RNA <50 copies/mL, respectively (p = .041 and p < .001 vs. baseline). CD4+ cell count increased by a median of 52 (-36,135) and 84 (-9.5,180) cells/mm3 at 12 and 24 months, respectively (p < .001 and p = .039 vs. baseline). Twenty-five (17.6%) patients discontinued MVC: virologic failure (6), medical decision (5), and other reasons (14). Two patients presented grade 3 adverse events (hypertransaminasemia, hypertriglyceridemia) without the need for MVC withdrawal, whereas MVC was discontinued in two patients due to gastrointestinal toxicity. In routine clinical practice, MVC once-daily combined with at least PI/r was virologically effective and well tolerated in a high percentage of pretreated patients.


Assuntos
Antagonistas dos Receptores CCR5/administração & dosagem , Antagonistas dos Receptores CCR5/efeitos adversos , Cicloexanos/administração & dosagem , Cicloexanos/efeitos adversos , Infecções por HIV/tratamento farmacológico , Triazóis/administração & dosagem , Triazóis/efeitos adversos , Adulto , Contagem de Linfócito CD4 , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , Humanos , Estudos Longitudinais , Masculino , Maraviroc , Pessoa de Meia-Idade , RNA Viral/sangue , Estudos Retrospectivos , Espanha , Resultado do Tratamento , Carga Viral
17.
Enferm Infecc Microbiol Clin ; 35(2): 88-99, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27459919

RESUMO

INTRODUCTION: GESIDA and the AIDS National Plan panel of experts suggest preferred (PR), alternative (AR), and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for the year 2016. The objective of this study is to evaluate the costs and the efficacy of initiating treatment with these regimens. METHODS: Economic assessment of costs and efficiency (cost/efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48 in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and the costs correspond to those of 2016. A sensitivity deterministic analysis was conducted, building three scenarios for each regimen: base case, most favourable, and least favourable. RESULTS: In the base case scenario, the cost of initiating treatment ranges from 4663 Euros for 3TC+LPV/r (OR) to 10,894 Euros for TDF/FTC+RAL (PR). The efficacy varies from 0.66 for ABC/3TC+ATV/r (AR) and ABC/3TC+LPV/r (OR), to 0.89 for TDF/FTC+DTG (PR) and TDF/FTC/EVG/COBI (AR). The efficiency, in terms of cost/efficacy, ranges from 5280 to 12,836 Euros per responder at 48 weeks, for 3TC+LPV/r (OR), and RAL+DRV/r (OR), respectively. CONCLUSION: Despite the overall most efficient regimen being 3TC+LPV/r (OR), among the PR and AR, the most efficient regimen was ABC/3TC/DTG (PR). Among the AR regimes, the most efficient was TDF/FTC/RPV.


Assuntos
Fármacos Anti-HIV/economia , Fármacos Anti-HIV/uso terapêutico , Análise Custo-Benefício , Infecções por HIV/tratamento farmacológico , Infecções por HIV/economia , Humanos , Guias de Prática Clínica como Assunto , Espanha
18.
Enferm. infecc. microbiol. clín. (Ed. impr.) ; 34(10): 620-625, dic. 2016. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-158733

RESUMO

Introducción: El coste incremental que comportan las bacteriemias nosocomiales (BN) se utiliza como medida del impacto de estas infecciones. Los métodos tradicionales de cálculo de coste sobrestiman este incremento al no contemplar variables confusoras. El objetivo de este trabajo es comparar 3 metodologías de cálculo del coste incremental de la BN para corregir los sesgos presentes en análisis previos. Métodos: Se compararon los pacientes que presentaron algún episodio de BN entre 2005 y 2007, con los pacientes con la misma patología sin BN. Los microorganismos causantes se agruparon según la tinción Gram y según si la bacteriemia era monomicrobiana o polimicrobiana, o producida por un hongo. Se compararon 3 métodos de cálculo: 1)estratificación por patología; 2)ajuste econométrico multivariante mediante un modelo lineal generalizado (MLG), y 3)un propensity score matching (PSM) antes del análisis multivariante para controlar los sesgos. Resultados: Se analizaron 640 hospitalizaciones con BN y 28.459 sin BN; el coste medio observado fue de 24.515€ y 4.851,6€, respectivamente. En la estratificación por patología, el coste incremental medio estimado fue de 14.735€; el grupo de microorganismos que ocasionó menor coste incremental fue el de grampositivos, con 10.051€. En el MLG el coste incremental medio estimado fue de 20.922€, mientras que utilizando PSM se estimó un coste incremental medio de 11.916€. En las 3 estimaciones hay diferencias importantes según el grupo de microorganismos. Conclusiones: Utilizar metodologías más elaboradas mejora el ajuste en este tipo de estudios e incrementa el valor de los resultados obtenidos (AU)


Introduction: The excess cost associated with nosocomial bacteraemia (NB) is used as a measurement of the impact of these infections. However, some authors have suggested that traditional methods overestimate the incremental cost due to the presence of various types of bias. The aim of this study was to compare three assessment methods of NB incremental cost to correct biases in previous analyses. Methods: Patients who experienced an episode of NB between 2005 and 2007 were compared with patients grouped within the same All Patient Refined-Diagnosis-Related Group (APR-DRG) without NB. The causative organisms were grouped according to the Gram stain, and whether bacteraemia was caused by a single or multiple microorganisms, or by a fungus. Three assessment methods are compared: stratification by disease; econometric multivariate adjustment using a generalised linear model (GLM); and propensity score matching (PSM) was performed to control for biases in the econometric model. Results: The analysis included 640 admissions with NB and 28,459 without NB. The observed mean cost was €24,515 for admissions with NB and €4,851.6 for controls (without NB). Mean incremental cost was estimated at €14,735 in stratified analysis. Gram positive microorganism had the lowest mean incremental cost, €10,051. In the GLM, mean incremental cost was estimated as €20,922, and adjusting with PSM, the mean incremental cost was €11,916. The three estimates showed important differences between groups of microorganisms. Conclusions: Using enhanced methodologies improves the adjustment in this type of study and increases the value of the results (AU)


Assuntos
Humanos , Infecção Hospitalar/epidemiologia , Bacteriemia/epidemiologia , Custos Diretos de Serviços/estatística & dados numéricos , Economia Hospitalar/tendências
19.
PLoS One ; 11(10): e0164455, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27727331

RESUMO

OBJECTIVES: Based on data from clinical practice, we evaluated the effectiveness and safety of switching to abacavir/lamivudine plus rilpivirine (ABC/3TC+RPV) treatment in virologically suppressed HIV-1-infected patients. METHODS: We performed a multicenter, non-controlled, retrospective study of HIV-1-infected patients who switched treatment to ABC/3TC+RPV. Patients had an HIV-RNA <50 copies/mL for at least 24 weeks prior to changing treatments. The primary objective was HIV-1 RNA <50 copies/mL at week 48. Effectiveness was analyzed by intention-to-treat (ITT), missing = failure and on-treatment (OT) analyses. The secondary objectives analyzed were adverse effects changes in renal, hepatic or lipid profiles, changes in CD4+ cell count and treatment discontinuations. RESULTS: Of the 205 patients included, 75.6% were men and the median age was 49. At baseline, before switching to ABC/3TC+RPV, median time since HIV diagnosis was 13.1 years, median time with undetectable HIV-1 RNA was 6.2 years and median time of previous antiretroviral regimen was 3.1 years (48.3% patients were taking efavirenz and ABC/3TC was the most frequent backbone coformulation in 69.7% of patients). The main reasons for switching were drug toxicity/poor tolerability (60.5%) and simplification (20%). At week 48, the primary objective was achieved by 187 out of 205 (91.2%) patients by ITT analysis, and 187 out of 192 (97.4%) patients by OT analysis. The CD4+ lymphocyte count and CD4+ percentage increased significantly from baseline to week 48 by a median of 48 cells/µL (-50 to 189) and 1.2% (-1.3% to 4.1%), respectively, P<0.001. Thirty-eight adverse events (AE) were detected in 32 patients. Of these, 25 had no clear association with treatment. Three patients interrupted therapy due to AE. We observed a decrease in all lipid parameters, P<0.001, and a slight improvement in the glomerular filtration rate, P<0.01. Therapy was considered to have failed in 18 patients owing to virological failure (5 [2.4%]), toxicity/poor tolerability (4 [2%]), clinical decision (3 [1.5%]), loss to follow-up (3 [1.5%]), death (1 [0.5%]), and no clinical data (2 [1%]). CONCLUSIONS: The results of this study confirms that ABC/3TC+RPV is an effective, safe, and cost-effective option for the treatment of patients with virologically stable HIV-1 infection.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Didesoxinucleosídeos/uso terapêutico , Infecções por HIV/tratamento farmacológico , Lamivudina/uso terapêutico , Rilpivirina/uso terapêutico , Adulto , Fármacos Anti-HIV/efeitos adversos , Contagem de Linfócito CD4 , Depressão/etiologia , Didesoxinucleosídeos/efeitos adversos , Esquema de Medicação , Combinação de Medicamentos , Quimioterapia Combinada , Feminino , Taxa de Filtração Glomerular , Infecções por HIV/virologia , HIV-1/genética , HIV-1/isolamento & purificação , Humanos , Rim/metabolismo , Lamivudina/efeitos adversos , Lipídeos/sangue , Fígado/metabolismo , Masculino , Pessoa de Meia-Idade , RNA Viral/sangue , Estudos Retrospectivos , Rilpivirina/efeitos adversos , Resultado do Tratamento
20.
Enferm. infecc. microbiol. clín. (Ed. impr.) ; 34(8): 516.e1-516.e18, oct. 2016. tab
Artigo em Inglês | IBECS | ID: ibc-156256

RESUMO

Despite the huge advance that antiretroviral therapy represents for the prognosis of infection by the human immunodeficiency virus (HIV), opportunistic infections (OIs) continue to be a cause of morbidity and mortality in HIV-infected patients. OIs often arise because of severe immunosuppression resulting from poor adherence to antiretroviral therapy, failure of antiretroviral therapy, or unawareness of HIV infection by patients whose first clinical manifestation of AIDS is an OI. The present article updates our previous guidelines on the prevention and treatment of various OIs in HIV-infected patients, namely, infections by parasites, fungi, viruses, mycobacteria, and bacteria, as well as imported infections. The article also addresses immune reconstitution inflammatory syndrome (AU)


A pesar del gran avance que ha supuesto el tratamiento antirretroviral (TAR) para el pronóstico de la infección por el VIH, las infecciones oportunistas (IO) continúan siendo causa de morbilidad y mortalidad en estos pacientes. Ello ocurre en muchos casos debido a la inmunodepresión grave, bien ante la falta de adherencia al TAR, el fracaso del mismo o el desconocimiento de la existencia de la infección por el VIH en pacientes que comienzan con una IO. El presente artículo actualiza las recomendaciones de prevención y tratamiento de diferentes infecciones en pacientes con infección por VIH: parasitarias, fúngicas, víricas, micobacterianas, bacterianas e importadas, además del síndrome de reconstitución inmune (AU)


Assuntos
Humanos , Infecções por HIV/complicações , Infecções Oportunistas Relacionadas com a AIDS/prevenção & controle , Antirretrovirais/uso terapêutico , Avaliação de Resultado de Ações Preventivas , Coinfecção/epidemiologia , Síndrome de Imunodeficiência Adquirida/complicações , Síndrome de Imunodeficiência Adquirida/tratamento farmacológico , Padrões de Prática Médica
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