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OBJECTIVES: To investigate the use of statins and acetylsalicylic acid (ASA) in HIV people in clinical practice. DESIGN: A multicenter, nationwide, prospective cohort study, including 1182 consecutive HIV patients was conducted. METHODS: Statin and ASA prescription was evaluated in primary and secondary cardiovascular disease prevention, according to the European AIDS Clinical Society (EACS) guidelines. RESULTS: Followed-up patients (998) were mostly males (70.9 %) with a mean age at enrolment of 46.5 years (SD 9.5). The mean time of follow-up was 3.3 years (SD 0.8). At the last follow-up visit, statins would have been recommended for 31.2 % and ASA for 16 % by EACS guidelines. Conversely, only 15.6 and 7.6 % of patients were on statin and ASA treatment, respectively; only 50.3 % of patients treated with statins achieved recommended low-density lipoprotein cholesterol (LDL-c) levels. At the last follow-up visit, agreement between statin therapy and EACS recommendation was 0.58 (95 % CI 0.52-0.63). The corresponding figure for ASA therapy was 0.50 (95 % CI 0.42-0.58), whereas the agreement for ASA therapy in secondary prevention was 0.59 (95 % CI 0.50-0.68). CONCLUSIONS: The prescription of statins and ASA in HIV-infected patients remains largely suboptimal, as only about 50 % of patients requiring statins and ASA are properly treated. Higher attention on this relevant issue and further investigation are warranted in this at risk population.
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Antiinflamatorios no Esteroideos/uso terapéutico , Aspirina/uso terapéutico , Enfermedades Cardiovasculares/tratamiento farmacológico , Adhesión a Directriz , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Guías de Práctica Clínica como Asunto , Prevención Secundaria , Adolescente , Adulto , Anciano , Femenino , Adhesión a Directriz/estadística & datos numéricos , VIH/fisiología , Infecciones por VIH/virología , Humanos , Italia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Prevención Secundaria/estadística & datos numéricos , Adulto JovenRESUMEN
BACKGROUND AND AIM: Dysgeusia is an altered or damaged tasting perception of a multifactorial etiology, from polypharmacy, infections to chemotherapy and radiotherapy. Approximately 5% of the population suffer from a diminished taste sensation, which unfortunately remains underestimated by the affected person, creating the conditions for a dramatic underestimation of the incidence of the symptom. The aim of this study is to summarize the evidences present in literature on the relations between Dysgeusia and alterations of the nutritional status Methods: an integrative review with metanarrative analysis of the articles included was carried out in August 2020. PubMed, Scopus, Embase and CINAHL databases were examined with keywords and methodological strings. PRISMA flow-chart along with a qualitative evaluation grid (JBI-QARI) were applied in the selection of the studies with a time limitation to the last ten years. RESULTS: 10 articles resulted from the literature review process were divided into two macro-categories. Eight articles reported dysgeusia linked to weight loss. The second macro-category showed two studies relating to dysgeusia in patients with altered nutritional status associated with body weight gain. CONCLUSIONS: this review represents an initial contribution to summarize the best evidence and knowledge in relation to dysgeusia, with the aim of enabling the identification and treatment of this symptom and facilitating targeted educational interventions.
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Disgeusia , Estado Nutricional , Disgeusia/etiología , Humanos , Polifarmacia , Pérdida de PesoRESUMEN
We report the surprising yet sought impact that an antiretroviral (ARV) regimen containing maraviroc had on an HIV-infected and heavily highly active antiretroviral therapy (HAART)-experienced patient with chronic polymyositis. The patient had elevated creatine kinase (CK) levels in serum for 6 years, reaching peaks over 900 U/L and showing only partial response to high-dose steroids, not responding to HAART withdrawal. The disease started while on second-line HAART and gradually impaired his muscular function, leading to the absolute loss of the ability to stand on his legs. Atherosclerosis and hypertension contributed to the development of myocardial infarction. The association of unboosted atazanavir (ATV) plus maraviroc was designed hoping in a protective role on the cardiovascular system and in an anti-inflammatory effect that some authors have hypothesized. After only 3 months the patient's CK levels had normalized and with the help of rehabilitation he recovered the ability to walk, which he still maintains at the one year of observation.
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Antiinflamatorios/uso terapéutico , Ciclohexanos/uso terapéutico , Inhibidores de Fusión de VIH/uso terapéutico , Infecciones por VIH/complicaciones , Miositis/complicaciones , Miositis/tratamiento farmacológico , Triazoles/uso terapéutico , Anciano , Antiinflamatorios/administración & dosificación , Terapia Antirretroviral Altamente Activa , Enfermedad Crónica , Creatina Quinasa/sangre , Ciclohexanos/administración & dosificación , Inhibidores de Fusión de VIH/administración & dosificación , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/virología , Humanos , Masculino , Maraviroc , Resultado del Tratamiento , Triazoles/administración & dosificaciónRESUMEN
Rilpivirine is associated with a good efficacy and safety profile. However, data from real-life settings are scarce. METHODS: We investigated the durability, safety and efficacy of Rilpivirine-based antiretroviral therapy in a prospective, observational, multicenter study. RESULTS: We enrolled 499 HIV-infected patients, 360 (72.1%) males, mean age 43.4 ± 10.5 years, mean CD4 600 ± 327 cell/µL, mean HIV-RNA 3.80 ± 1.15 log10 cp/mL. After a median follow up of 16 months, 81 (16.2%) interruptions were reported, 36 (7.2%) of which for adverse events (16 of grade ≥3), most commonly neurological and gastrointestinal. We observed virological failures in only 8 (1.6%) patients. Naive patients showed a significant reduction in eGFR at week 24, 48 and 72 and in total cholesterol (TC)/HDL ratio at week 48 (p=0.007). In patients switching from PI we found a significant decrease at week 24 and 48 in TC and triglycerides at week 24, 48 and 72. eGFR showed a significant decrease at week 48 and 72. TC/HDL ratio showed a statistically significant decrease at week 24 (p=0.0008) and 72 (p=0.04). A significant increase at week 24 and 48 in AST and ALT values was observed. Patients switching from TDF/FTC/EFV showed a reduction in HDL, total cholesterol and triglycerides at week 24 and 48 and in eGFR at all follow up times. TC/HDL ratio showed a significant decrease at week 48 (p=0.01). CDC stage C and antiretroviral-experience (especially Protease Inhibitors) were associated with RPV discontinuation. CONCLUSION: In conclusion, our data confirm Rilpivirine efficacy, safety and tolerability with improvement in lipid profile. Although hepatic and renal events rarely caused discontinuation, liver and kidney parameters should be monitored.
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In view of the forthcoming long-acting antiretrovirals, measures should be taken to prevent the selection of HIV drug resistance mutations. All subjects who had been switched to boosted protease inhibitors plus maraviroc (bPIs/MVC) with baseline HIV-1 RNA >50âcopies/mL between June, 2014, and April, 2015, were retrospectively evaluated. HIV-1 RNA, CD4+ T-cells, serum glucose, creatinine, ALT, and adverse events were controlled every 3 to 4 months. We retrospectively analyzed 44 patients: 18 were taking darunavir/ritonavir (DRV/r) and 26âatazanavir/ritonavir (ATV/r) once daily, plus MVC 300âmg once daily. Seven subjects were in CDC stage C. All had a follow-up of at least 24 weeks, 28 exceeded 48 weeks, and 21 exceeded 72 weeks. All had experienced at least 1 viral failure and had selected at least 1 resistance-associated mutation (RAM). At baseline, 38 had plasma HIV-1 RNA 50-499âcopies/mL and 6 had ≥500. At week 24, none had viremia >500 and 30 (68.2%) had suppressed HIV-1 RNA below 50âcopies/mL. Of the subgroup with 48 weeks' follow-up, 23 had HIV-1 RNA 50-499âcopies/mL, 5 had ≥500, and 20/28 suppressed to <50âcopies/mL. Of the longest observed subgroup (72 weeks), 17 had HIV-1 RNA 50-499âcopies/mL, and 4 had ≥500âcopies/mL and 15/21 (71.4%) suppressed to <50âcopies/mL. This combination allowed fair suppression of viral replication, with minor genotypic evolution in 6 subjects, and seems to be a feasible strategy to prevent damaging future options.
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Ciclohexanos/uso terapéutico , Inhibidores de Fusión de VIH/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Inhibidores de Proteasas/uso terapéutico , Triazoles/uso terapéutico , Adulto , Quimioterapia Combinada , Femenino , Humanos , Masculino , Maraviroc , Cumplimiento de la Medicación , Persona de Mediana Edad , Estudios Retrospectivos , Adulto JovenRESUMEN
OBJECTIVES: The study aim was to evaluate the impact on Liver and Kidney toxicity of the single tablet regimen Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF) on Antiretroviral Therapy (ART) experienced or naïve patients. METHODS: Patients initiating EVG/COBI/FTC/TDF were enrolled in the SCOLTA project, a multicenter observational study reporting grade 3-4 Adverse Events in subjects beginning new antiretroviral drug regimens. In this analysis, patients were evaluated at T0 (baseline), T1 (six months) and at T2 (twelve months). RESULTS: A total of 329 patients were enrolled, and 280 (85.1%) of these had at least one follow-up visit. Median observation time was 11 months (IQR 7.0-15.5). Two hundred and two patients (72.1%) were ART experienced and 78 (27.9%) ART naive. Prevalence of HCV-co-infection was 21.4%. At T1, we observed a significant decline in estimated glomerular filtration rate (eGFR), both in experienced and naive patients (mean change from T0-7.5 ± 12.8 ml/min, -15.5 ± 17.8 ml/min, respectively, p = 0.0005), which was confirmed at T2 (mean change from T0-8.2 ± 15.8 ml/min, -17.6 ± 19.4 ml/min, respectively, p = 0.001). Regarding aspartate aminotransferase (AST) and alanine transaminase (ALT) grade 1-2 modifications, no significant differences were observed between experienced and naïve subjects, but an increased prevalence of abnormal liver function test was observed in patients with chronic HCV infection (p<0.001). CONCLUSIONS: A significant decline in eGFR was observed in patients initiating EVG/COBI/FTC/TDF in the first 6 months, with no significant worsening occurring at 12 months vs. 6 months of therapy. Patients with chronic HCV infection were at higher risk to develop abnormal liver tests.
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Fármacos Anti-VIH/uso terapéutico , Cobicistat/uso terapéutico , Emtricitabina/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , VIH-1/efectos de los fármacos , Quinolonas/uso terapéutico , Tenofovir/uso terapéutico , Adulto , Combinación de Medicamentos , Femenino , Infecciones por VIH/virología , Humanos , Masculino , Dosis Máxima Tolerada , Persona de Mediana Edad , SeguridadRESUMEN
Muscle alterations ranging from asymptomatic creatine phosphokinase (CPK) increases to rhabdomyolysis and central nervous system (CNS) symptoms have been reported in patients receiving raltegravir. Muscle symptoms and CPK increases were investigated in a cohort of HIV-infected patients receiving raltegravir-based antiretroviral therapy, and possible associated predictors were evaluated. The SCOLTA Project is a prospective, observational, multicentre study created to assess the incidence of adverse events in patients receiving new antiretroviral drugs in clinical practice. In total, 496 HIV-infected patients were enrolled [333 (67.1%) male]. CDC stage was C in 196 patients (39.5%). Mean age at enrolment was 45.9 ± 9.3 years. Median follow-up was 21 months. Twenty-six patients (5.2%) reported muscle symptoms (16 muscle pain and 17 weakness; 7 had both). Of 342 patients with normal baseline CPK values, 72 (21.1%) had a CPK increase. Seven patients (1.4%) discontinued raltegravir because of muscular events (three for muscle pain/weakness and four CPK increases). No cases of rhabdomyolysis were observed. Patients with muscle symptoms were more frequently receiving in their regimen than those not receiving atazanavir (P=0.04) and were more likely to also report CNS symptoms (P<0.0001). Significant predictors of muscle symptoms were CNS symptoms and use of atazanavir. Female sex was associated with a reduced risk of CPK increase. In conclusion, muscle symptoms and CPK elevations occurred frequently and caused most discontinuations due to adverse events. Their monitoring in patients receiving raltegravir should be considered, especially when co-administered with atazanavir or when CNS symptoms are also present.
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Fármacos Anti-VIH/efectos adversos , Creatina Quinasa/sangre , Infecciones por VIH/tratamiento farmacológico , Debilidad Muscular/inducido químicamente , Mialgia/inducido químicamente , Pirrolidinonas/efectos adversos , Adulto , Fármacos Anti-VIH/uso terapéutico , Sulfato de Atazanavir , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/patología , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Debilidad Muscular/epidemiología , Mialgia/epidemiología , Oligopéptidos/uso terapéutico , Estudios Prospectivos , Piridinas/uso terapéutico , Pirrolidinonas/uso terapéutico , Raltegravir PotásicoRESUMEN
BACKGROUND: We aimed to assess the prevalence of hypertension in an unselected human immunodeficiency virus (HIV)-infected population and to identify factors associated with hypertension prevalence, treatment, and control. METHODS: We used a multicenter, cross-sectional, nationwide study that sampled 1,182 unselected, consecutive, HIV-infected patients. Office blood pressure was accurately measured with standard procedures. RESULTS: Patients were 71% men and 92% white, with a median age of 47 years (range = 18-78); 6% were antiretroviral treatment naive. The overall prevalence of hypertension was 29.3%; high-normal pressure accounted for an additional 12.3%. Among hypertensive subjects, 64.9% were aware of their hypertensive condition, 52.9% were treated, and 33.0% were controlled (blood pressure < 140/90 mm Hg). Blood pressure-lowering medications were used in monotherapy in 54.3% of the subjects. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers were the most frequently used drugs (76.1%: monotherapy = 39.1%, combination treatment = 37.0%). In multivariable regression models, hypertension was independently predicted by traditional risk factors, including age ≥50 years, male sex, family history of cardiovascular disease, body mass index ≥25 kg/m2, previous cardiovascular events, diabetes, central obesity, and metabolic syndrome, as well as by duration of HIV infection, duration of antiretroviral therapy, and nadir CD4+ T-cell count <200/µl. The choice of protease inhibitors vs. nonnucleoside reverse transcriptase inhibitors as a third antiretroviral drug was irrelevant. CONCLUSIONS: Hypertension affects nearly 30% of HIV adult outpatients in Italy. More than one-third of the hypertensive subjects are unaware of their condition, and more than two-thirds are uncontrolled. A higher level of attention to the diagnosis and treatment of hypertension is mandatory in this setting.
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Antihipertensivos/uso terapéutico , Infecciones por VIH/epidemiología , Hipertensión/tratamiento farmacológico , Hipertensión/epidemiología , Adulto , Anciano , Estudios Transversales , Femenino , Infecciones por VIH/complicaciones , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , PrevalenciaRESUMEN
Apart from the BENCHMRK study, there are no large observational experiences describing the long-term efficacy and safety of rescue regimens for human immunodeficiency virus type 1 (HIV-1) infection. Antiretroviral-experienced patients with detectable viraemia starting a raltegravir (RAL)-based regimen between March 2007 and June 2009 were consecutively enrolled and followed for ≥4 years. Data were censored at Week 206 for homogeneity. Of 333 patients, 258 (77.5%) were still on RAL-based therapy at Week 206, and 241 had undetectable HIV-1 RNA (73% in intention-to-treat analysis). Of the 75 subjects who discontinued RAL therapy, 36 were lost to follow-up, 15 changed their regimen due to virological failure, 2 simplified their regimen stopping RAL, 9 stopped all antiretrovirals and 13 died. Overall, 100 subjects (30.0%) had at least one detectable viraemia, but only 32 (9.6%) had true viral failure. Seventeen patients continued their failing regimen. 'Blips' were experienced by 53 patients (15.9%), whilst 15 (4.5%) had confirmed viral rebound due to adherence issues and were re-suppressed upon treatment re-introduction. In a multivariate analysis of predictors of interruption or failure, each baseline HIV-1 RNA log10 increase was associated with an adjusted hazard ratio for failure of 1.6; having more than 13 previous treatment courses also emerged as a predictor. Overall, adverse events were rare (n=64), with 13 deaths. Tumours were mainly early events, often fatal (7/15), mainly non-Hodgkin's lymphomas (8), followed by hepatocarcinoma (2). RAL proved effective and well tolerated in this cohort, and few patients experienced viral failure after 4 years.
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Fármacos Anti-VIH/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Pirrolidinonas/uso terapéutico , Terapia Recuperativa/métodos , Fármacos Anti-VIH/efectos adversos , Femenino , Infecciones por VIH/virología , VIH-1/aislamiento & purificación , Humanos , Masculino , Pirrolidinonas/efectos adversos , ARN Viral/sangre , Raltegravir Potásico , Terapia Recuperativa/efectos adversos , Resultado del Tratamiento , Carga ViralRESUMEN
We report an interventional, non-randomized experience of OM-85 BV immunization in a group of 104 HIV-infected subjects presenting recurrent seasonal respiratory bacterial infections. We compared the number of respiratory events, the use of antibiotics and the cost related to antibiotics before (2005-2006) and after (2008-2011) the introduction of such intervention. The year 2007 was excluded from the analysis since half of the patients were immunized in that year in an exploratory approach. Respiratory infections dropped in all groups but in subjects with recurrent otitis, leading to a reduction in the use of antibiotics. This is the first report of the effect of OM-85 BV in vivo in HIV-infected subjects.
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Infecciones Bacterianas/prevención & control , Extractos Celulares/administración & dosificación , Extractos Celulares/inmunología , Infecciones por VIH/complicaciones , Infecciones del Sistema Respiratorio/prevención & control , Adulto , Anciano , Antibacterianos/economía , Antibacterianos/uso terapéutico , Infecciones Bacterianas/tratamiento farmacológico , Infecciones Bacterianas/epidemiología , Utilización de Medicamentos/economía , Utilización de Medicamentos/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infecciones del Sistema Respiratorio/tratamiento farmacológico , Infecciones del Sistema Respiratorio/epidemiologíaRESUMEN
Despite the relative lack of data, nucleoside/nucleotide reverse transcriptase inhibitor (NRTI)-sparing regimens are increasingly prescribed in clinical practice in treatment-experienced HIV-1 infected patients. We aimed to assess the frequency of NRTI-sparing regimens among these subjects, and to evaluate and compare their safety and tolerability. Patients were included if enrolled in the currently ongoing cohorts (raltegravir and darunavir) of the Surveillance Cohort Long-Term Toxicity Antiretrovirals (SCOLTA) Project. The duration of treatment with antiretroviral therapy was evaluated using the Kaplan-Meier curve and NRTI-sparing and NRTI-based regimens were compared using the log-rank test. From 2006 to 2011, 689 experienced patients were analyzed, of whom 210 (30.5%) were on NRTI-sparing regimens. Patients on NRTI-sparing regimens were older (p=0.004) and had higher median CD4+ cell counts (p=0.002) than patients on NRTI-based regimens. The most frequent combination regimens were raltegravir plus darunavir/ritonavir (n=65; 30.95%) among patients on NRTI-sparing regimen and tenofovir DF/emtricitabine plus darunavir/ritonavir in the NRTI-containing group (n=102; 21.3%). There was no difference between groups in terms of total withdrawal, treatment discontinuation was more likely due to therapeutic failure in NRTI-sparing regimen. NRTI-sparing regimens should be evaluated in a prospective randomized trial.
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Terapia Antirretroviral Altamente Activa/métodos , Infecciones por VIH/tratamiento farmacológico , Nucleósidos/uso terapéutico , Inhibidores de la Transcriptasa Inversa/uso terapéutico , Adulto , Anciano , Terapia Antirretroviral Altamente Activa/efectos adversos , Femenino , Infecciones por VIH/virología , VIH-1/aislamiento & purificación , Humanos , Masculino , Persona de Mediana Edad , Nucleósidos/efectos adversos , Estudios Prospectivos , Inhibidores de la Transcriptasa Inversa/efectos adversos , Insuficiencia del Tratamiento , Privación de TratamientoRESUMEN
OBJECTIVE: HIV infection has been associated with increased cardiovascular risk. Twenty-four-hour ambulatory blood pressure (BP) is a more accurate and prognostically relevant measure of an individual's BP load than office BP, and the ambulatory BP-derived ambulatory arterial stiffness index (AASI) and symmetric AASI (s-AASI) are established cardiovascular risk factors. METHODS: In the setting of the HIV and HYpertension (HIV-HY) study, an Italian nationwide survey on high BP in HIV infection, 100 HIV-infected patients with high-normal BP or untreated hypertension (72% men, age 48â±â10 years, BP 142/91â±â12/7âmmHg) and 325 HIV-negative individuals with comparable age, sex distribution, and office BP (68% men, age 48â±â10 years, BP 141/90â±â11/8âmmHg) underwent 24-h ambulatory BP monitoring. RESULTS: Despite having similar office BP, HIV-infected individuals had higher 24-h SBP (130.6â±â14 vs. 126.4â±â10âmmHg) and pulse pressure (49.1â±â9 vs. 45.9â±â7âmmHg, both Pâ<â0.001), and a lower day-night reduction of mean arterial pressure (14.3â±â9 vs. 16.3â±â7%, Pâ=â0.025). Both s-AASI and AASI were significantly higher in HIV patients (s-AASI, 0.22â±â0.18 vs. 0.11â±â0.15; AASI, 0.46â±â0.22 vs. 0.29â±â0.17; both Pâ<0.001). In a multivariate regression, s-AASI was independently predicted by HIV infection (ßâ=â0.252, Pâ<0.001), age, female sex, and 24-h SBP. In HIV patients, s-AASI had an inverse relation with CD4 cell count (Spearman's ρ -0.24, Pâ=â0.027). CONCLUSION: Individuals with HIV infection and borderline or definite hypertension have higher symmetric AASI and 24-h systolic and pulse pressures than HIV-uninfected controls matched by office BP. High ambulatory BP may play a role in the HIV-related increase in cardiovascular risk.
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Presión Sanguínea , Infecciones por VIH/fisiopatología , Rigidez Vascular , Adulto , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVE: To evaluate safety and durability of once-daily and twice-daily darunavir/ritonavir (DRV/r)-based treatment in HIV patients in clinical practice. METHODS: The Surveillance Cohort Long-Term Toxicity Antiretrovirals (SCOLTA) project is a prospective, observational, multicenter cohort created to assess the incidence of adverse events in patients receiving new antiretroviral drugs. Twenty-five Italian infectious diseases centers enroll patients and collect their data through this on-line system. Periodical evaluations of these patients, including physical examination and laboratory tests, were performed at baseline and every 6 months. RESULTS: Four hundred and twenty-nine patients were enrolled since May 2006. Eighty-five patients (19.8%) were prescribed once-daily DRV/r; 31 of them were treatment-naïve (36.5%). Among 54 (63.5%) treatment-experienced patients, 21 (38.9%) had undetectable viral load and started once-daily DRV/r as a simplification regimen. Patients on twice-daily regimen were older, more frequently lipodystrophic, HCV-coinfected, and in CDC stage C. In the following 24 months of follow-up, the viral load steadily decreased as well as the CD4 cell count rose. The reason for discontinuation did not significantly differ between groups. Mean blood glucose (BG) change from baseline did not show significant difference between groups, as well as high density lipoprotein cholesterol (HDL-C), triglycerides (TGL) and alanine transaminase (ALT). The survival curve shows that patients in the once-daily regimen withdrew treatment more frequently than those on twice-daily regimen (Log Rank Chi(2)P=0.009). CONCLUSION: Our study showed that DRV/r administrated both once daily or twice daily was safe and well tolerated with few discontinuations due to adverse events.
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Infecciones por VIH/tratamiento farmacológico , Inhibidores de la Proteasa del VIH/uso terapéutico , Ritonavir/uso terapéutico , Sulfonamidas/uso terapéutico , Adulto , Factores de Edad , Estudios de Cohortes , Darunavir , Esquema de Medicación , Combinación de Medicamentos , Femenino , Estudios de Seguimiento , Infecciones por VIH/virología , Inhibidores de la Proteasa del VIH/administración & dosificación , Inhibidores de la Proteasa del VIH/efectos adversos , VIH-1/aislamiento & purificación , Humanos , Internet , Italia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Ritonavir/administración & dosificación , Ritonavir/efectos adversos , Sulfonamidas/administración & dosificación , Sulfonamidas/efectos adversos , Análisis de Supervivencia , Factores de Tiempo , Carga Viral/efectos de los fármacosRESUMEN
Central nervous system (CNS) symptoms have been reported in clinical trials and case reports in patients receiving raltegravir. We investigated CNS symptoms in 453 HIV-infected patients. Of these 47 (10.4%) developed at least one drug-related CNS symptom. Predictors of CNS symptoms were concomitant therapy with tenofovir or with proton pump inhibitors that can increase raltegravir concentration. Thus, our data suggest a possible correlation between high raltegravir plasma concentrations and CNS symptoms, and therefore their monitoring in clinical practice.
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Fármacos Anti-VIH/efectos adversos , Fármacos Anti-VIH/sangre , Sistema Nervioso Central/efectos de los fármacos , Infecciones por VIH/tratamiento farmacológico , Pirrolidinonas/efectos adversos , Pirrolidinonas/sangre , Adenina/efectos adversos , Adenina/análogos & derivados , Adenina/sangre , Fármacos Anti-VIH/administración & dosificación , Sistema Nervioso Central/fisiopatología , Esquema de Medicación , Interacciones Farmacológicas , Femenino , Infecciones por VIH/sangre , Infecciones por VIH/fisiopatología , Humanos , Masculino , Organofosfonatos/efectos adversos , Organofosfonatos/sangre , Pirrolidinonas/administración & dosificación , Raltegravir Potásico , Tenofovir , Resultado del Tratamiento , Carga ViralRESUMEN
BACKGROUND: In recent years, the increased efficacy and effectiveness of antiretroviral treatment has led to longer survival of patients infected with human immunodeficiency virus (HIV), but has also raised the question of what happens to consumption of resources. Early highly active antiretroviral treatment (HAART), management of hepatitis C virus (HCV) coinfection, and expensive newly marketed drugs may affect the economic sustainability of treatment from the point of view of the National Healthcare Services. The present study aimed to provide information on the economic burden of HIV-positive patients resident in the Lombardy region using a three-year time horizon. METHODS: This was a retrospective, observational, budget impact study, based on information collected for the period 2007-2009, including hospitalizations, outpatient services, and HAART and non-HAART drug utilization. Patients with confirmed HIV infection, aged ≥ 18 years, resident in the Lombardy region, and followed at the "L Sacco" Hospital in Milan from 2007 to 2009 were eligible. RESULTS: A total of 483 patients (mean age 44.1 years) were included in the study. The mean CD4+ cell count increased over the study period from 462 ± 242 cells/mm(3) in 2007, to 513 ± 267 cells/mm(3) in 2008, to 547 ± 262 cells/mm(3) in 2009. In total, 162 subjects (33.5%) were coinfected with HCV. Hospitalizations and HAART costs increased from 2007 to 2009, whereas outpatient visits and non-HAART drug costs decreased slightly over time. The total cost increase was also significant when limiting the analysis to experienced patients, HCV-negative patients, and experienced HCV-negative patients. CONCLUSION: CD4+ cell count, a major predictor of costs, increased over the study period. However, immunological improvement was achieved by greater expense in the short term. Whether this may be compensated by a long-term decrease in opportunistic infections and in the costs of management of HIV-related events is an area still to be investigated.
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INTRODUCTION: We carried out an economic analysis to assess the cost-effectiveness of highly active antiretroviral therapy (HAART) regimens in Italy for the management of human immunodeficiency virus (HIV)-infected patients according to clinical practice in the Infectious Diseases Department of "L. Sacco" Hospital, Milan, Italy. PATIENTS AND METHODS: The incremental cost-effectiveness analysis was completed by means of a Markov model. Through a decision-analytic approach, this enabled us to compare the studied antiretroviral regimens. The model considered a population of adult HIV subjects who received HAART therapy for the first time according to clinical practice in the Infectious Diseases Department of "L. Sacco" Hospital, Milan. Data were investigated from the standpoint of the Lombardy Regional Health Service. We considered the following outcome measures: quality-adjusted life-years (QALYs), and direct health costs calculated for the years 2008 and 2009. The time horizon adopted in the model was 2 years. RESULTS: The model revealed that, in terms of cost per gained QALY, the tenofovir disoproxil fumarate + emtricitabine + efavirenz (TDF+FTC+EFV) once-a-day treatment strategy seems to be the most cost-effective therapeutic choice (34,965); the incremental cost-effectiveness ratio (ICER) values for the remaining strategies ranged from 53,000 to around 62,000 per QALY. The validity of the base case scenario was then confirmed by means of a sensitivity analysis on the main variables. CONCLUSION: The TDF+FTC+EFV treatment strategy (TDF/FTC+EFV fixed-dose combination then switched to single-tablet regimen [STR]) in this setting is the most cost-effective treatment strategy compared with the other therapeutic regimens. The ICER value for the TDF+FTC+EFV once-a-day then switched to STR treatment was lower than the internationally generally accepted threshold value of 50,000. The developed model is a tool for policy makers and health care professionals for creating short- and long-term cost projections, with the aim of assessing their impact on the available budgets for HIV patients.
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Secondary hyperparathyroidism may develop in the presence of hypovitaminosis D in order to maintain calcium homeostasis. We conducted a cross-sectional analysis in a cohort of 371 patients, identifying secondary hyperparathyroidism in 65 patients. This high prevalence (17.5%) was in part justified by the high prevalence of hypovitaminosis D (77.4%) in the whole sample, but we also identified an independent association with the use of tenofovir.
Asunto(s)
Densidad Ósea/efectos de los fármacos , Infecciones por VIH/tratamiento farmacológico , Hiperparatiroidismo Secundario/inducido químicamente , Absorciometría de Fotón , Adulto , Anciano , Terapia Antirretroviral Altamente Activa/efectos adversos , Biomarcadores , Femenino , Infecciones por VIH/complicaciones , Humanos , Hiperparatiroidismo Secundario/epidemiología , Hiperparatiroidismo Secundario/metabolismo , Masculino , Persona de Mediana Edad , PrevalenciaRESUMEN
BACKGROUND: Healthcare expenditures incurred by the Health Service for HIV-infected patients have not been reported in Italy. OBJECTIVE: To present health care costs for HIV-infected patients in the Lombardy Region, in 2004-2007, to determine the clinical characteristics of HIV infection associated with costs. METHODS: Retrospective, observational, budget impact study, based on information collected for the period 2004-2007, including hospitalizations, outpatient services, highly active antiretroviral therapy (HAART) and non-HAART drug utilization. Inclusion criteria includes: confirmed HIV infection, age ≥18 years, resident in Lombardy Region, and followed at the "L. Sacco" Hospital in Milan from 2004 to 2007. RESULTS: The mean total cost per year to provide healthcare to HIV-positive patients was rather stable ( 9658.36 in 2004 and 9745.65 in 2007 (+0.90%)); HAART represented more than 60% of the total cost. We found that hepatitis C virus coinfection was related to higher costs ( 11,003.45 vs. 8896.06), as well as CD4 cell count <200 cells/mm ( 12,681.36 vs. 9594.11 and 9450.36 in 200-499 and ≥500 cells/mm, respectively). The mean total cost of HIV health care was higher in patients who initiated antiretroviral treatment before 1997 than in those who started after 1996. CONCLUSIONS: The mean total cost per year to provide health care to HIV-positive patients was stable during the period 2004-2007, with an increase of HAART percentage impact on the total cost. Several clinical characteristics of HIV-infected patients were significantly associated with cost variation.
Asunto(s)
Fármacos Anti-VIH/uso terapéutico , Terapia Antirretroviral Altamente Activa/economía , Infecciones por VIH/economía , Infecciones por VIH/terapia , Costos de la Atención en Salud/estadística & datos numéricos , Adulto , Fármacos Anti-VIH/economía , Femenino , Infecciones por VIH/epidemiología , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
Many infections favor or are directly implicated with lipid metabolism perturbations and/or increased risk of coronary heart disease (CHD). HIV itself has been shown to increase lipogenesis in the liver and to alter the lipid profile, while the presence of unsafe habits, addiction, comorbidities, and AIDS-related diseases increases substantially the risk of cardiovascular disease (CVD) in the HIV-infected population. Antiretroviral therapy reduces such stimuli but many drugs have intrinsic toxicity profiles impacting on metabolism or potential direct cardiotoxicity. In a moment when the main guidelines of HIV therapy are predating the point when to start treating, we mean to highlight the contribution of HIV-1 to lipid alteration and inflammation, the impact of antiretroviral therapy, the decisions on what drugs to use to reduce the probability of having a cardiovascular event, the increasing use of statins and fibrates in HIV-1 infected subjects, and finally the switch strategies, that balance effectiveness and toxicity to move the decision to change HIV drugs. Early treatment might reduce the negative effect of HIV on overall cardiovascular risk but may also evidence the impact of drugs, and the final balance (reduction or increase in CHD and lipid abnormalities) is not known up to date.