[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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 < 140/90mm 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 ≥25kg/m(2), 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.
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.
Full-text · Article · Sep 2013 · American Journal of Hypertension
[Show abstract][Hide abstract] ABSTRACT: The main objective is to evaluate the efficacy and durability of Lopinavir-ritonavir monotherapy (LPV/r-MT) in virologically-controlled HIV-positive individuals switching from combination antiretroviral therapy (cART).
Criteria to be included in this observational study were to have initiated for the first time LPV/r-MT after >=2 consecutive HIV-RNA ≤50 copies/mL achieved on a >=3 drugs-including regimen. The main end-points were time to virological rebound (VR, defined in two ways: time of first of two consecutive viral load (VL)>50 and >200 copies/ml); time to discontinuation/intensification and time to experience either a single VL >200 copies/ml or discontinuation/intensification (=treatment failure-TF). Individuals' follow-up accrued from the date of starting LPV/r-MT to event or last available VL. Kaplan-Meier curves and Cox regression analysis were used.
228 individuals were included; median age: 46 (IQR: 40-50) years, 36% females, 36% IDU, 25% HCV-co-infected. Median CD4 at nadir: 215 cell/mm3 (IQR:116-336); at baseline: 615 cell/mm3 (IQR: 436-768). By 36 months from switching to LPV/r-MT, the proportion of individuals with VR (confirmed VL>200 cp/ml) was 11% and with TF was 35%. In the multivariable Cox model the factors associated with a lower risk of TF was the duration of viral suppression <50 copies/mL prior to baseline (ARH=0.92, 95% CI:0.85-0.99, p=0.024, per 6 months longer) and having LPV/r as part of last cART (ARH=0.45, 95% CI:0.21-0.95, p=0.037) .
In daily clinical practice, we confirm a relatively safe approach of simplification to LPV-MT in selected population with long-lasting virological control.
No preview · Article · Sep 2013 · Antiviral therapy
[Show abstract][Hide abstract] ABSTRACT: Background: In recent years, Highly-Active Anti-Retroviral Therapies (HAARTs) have modified the Human Immunodeficiency Virus (HIV) life-cycle and the disease is now considered chronic. Consequently, a longitudinal and complex follow-up is now required for HIV positive patients during their lifetime. Moreover, patients often encounter various complications due to comorbidities, related to the immunodeficiency state and HAARTs' side effects. Thus, HIV positive patients are involved in multicenter clinical trials (MCTs) to improve treatments and discover a preventive vaccine. Therefore, physicians require proper instruments to access comprehensive patient data for managing patients during follow-ups, and tools for data collection and analysis in MCTs. Objective: The Ligurian HIV Clinical Network aims to provide physicians with a Web-tool to administrate HIV positive patients' data within primary-care and to reuse the collected clinical information to perform MCTs in Northern Italy. Methods: The key aspect of the system is a relational database which allows the storage of various types of clinical information (eg, related to HIV, cardiovascular, or hepatic diseases) in multiple formats. The modular design of the database permits a rapid insertion of new parameters without requiring any changes in the database structure. Furthermore, codes from biomedical ontologies controlled vocabularies ("Logical Observation Identifier Names and Codes", and "International Classification of Diseases 9") and ontologies ("Systematized Nomenclature of Medicine Clinical Terms"), units and normality ranges used by all partners participating in the project were collected to achieve a complete semantic interoperability. Accordingly, data can be automatically normalized through the z score formula and physicians can extract and correctly compare information with external statistical tools. Moreover, to respect patients' privacy and legal issues, a local identifier, determined through an HASH cryptography algorithm, is assigned to each patient during the registration process. The database is managed by a user-friendly Web-platform which allows quick access to information during medical examinations and the reusing of the collected data for present and future MCTs. Furthermore, a bidirectional middleware was created in order to import/export information through HL7 messaging. Hence, data can be manually entered by physicians or automatically collected within HL7-compliant Hospital Information systems. Results: Presently, the direct storage of patients' information from the San Paolo Hospital (Savona, Italy), and San Martino and Galliera hospitals in Genoa is in a test phase. Currently, 8 centers of Infectious Diseases (located in Liguria and Piedmont) are participating in the project and almost 400 HIV positive patients have been recorded in the system. Patient data has been used for primary care and research purposes. Currently, there are 4 on-going MCTs and preliminary results have already been presented at International HIV congresses. Conclusions: The Web-platform allows effective management, sharing and reuse of information within primary care and clinical research. In the future it is planned to share the clinical information from this network with other HL7-compliant workgroups and to extend the platform to other infective diseases (eg, hepatitis).
[Show abstract][Hide abstract] ABSTRACT: Control of HIV replication in elite controller (EC) and long-term nonprogressor (LTNP) patients has been associated with efficient CD8(+)cytotoxic T-lymphocyte function. However, innate immunity may play a role in HIV control. We studied the expression of natural cytotoxicity receptors (NKp46, NKp30, and NKp44) and their induction over a short time frame (2-4 d) on activation of natural killer (NK) cells in 31 HIV controller patients (15 ECs, 16 LTNPs). In EC/LTNP, induction of NKp46 expression was normal but short (2 d), and NKp30 was induced to lower levels vs. healthy donors. Notably, in antiretroviral-treated aviremic progressor patients (TAPPs), no induction of NKp46 or NKp30 expression occurred. More importantly, EC/LTNP failed to induce expression of NKp44, a receptor efficiently induced in activated NK cells in TAPPs. The specific lack of NKp44 expression resulted in sharply decreased capability of killing target cells by NKp44, whereas TAPPs had conserved NKp44-mediated lysis. Importantly, conserved NK cell responses, accompanied by a selective defect in the NKp44-activating pathway, may result in lack of killing of uninfected CD4(+)NKp44Ligand(+) cells when induced by HIVgp41 peptide-S3, representing a relevant mechanism of CD4(+) depletion. In addition, peripheral NK cells from EC/LTNP had increased NKG2D expression, significant HLA-DR up-regulation, and a mature (NKG2A-CD57(+)killer cell Ig-like receptor(+)CD85j(+)) phenotype, with cytolytic function also against immature dendritic cells. Thus, NK cells in EC/LTNP can maintain substantially unchanged functional capabilities, whereas the lack of NKp44 induction may be related to CD4 maintenance, representing a hallmark of these patients.
Full-text · Article · Jul 2013 · Proceedings of the National Academy of Sciences
[Show abstract][Hide abstract] ABSTRACT: 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 term 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 trials.
Full-text · Article · Feb 2013 · Current HIV research
[Show abstract][Hide abstract] ABSTRACT: 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.
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 48 ± 10 years, BP 142/91 ± 12/7 mmHg) and 325 HIV-negative individuals with comparable age, sex distribution, and office BP (68% men, age 48 ± 10 years, BP 141/90 ± 11/8 mmHg) underwent 24-h ambulatory BP monitoring.
Despite having similar office BP, HIV-infected individuals had higher 24-h SBP (130.6 ± 14 vs. 126.4 ± 10 mmHg) and pulse pressure (49.1 ± 9 vs. 45.9 ± 7 mmHg, both P < 0.001), and a lower day-night reduction of mean arterial pressure (14.3 ± 9 vs. 16.3 ± 7%, P = 0.025). Both s-AASI and AASI were significantly higher in HIV patients (s-AASI, 0.22 ± 0.18 vs. 0.11 ± 0.15; AASI, 0.46 ± 0.22 vs. 0.29 ± 0.17; both P <0.001). In a multivariate regression, s-AASI was independently predicted by HIV infection (β = 0.252, P <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, P = 0.027).
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.
No preview · Article · Dec 2012 · Journal of Hypertension
[Show abstract][Hide abstract] ABSTRACT: 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 which 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.
No preview · Article · Oct 2012 · AIDS (London, England)
[Show abstract][Hide abstract] ABSTRACT: Metabolic Syndrome (MS) is a common disorder combining obesity, dyslipidemia, hypertension, and insulin resistance. Its prevalence among HIV-infected people is still debated. Besides, how antiretroviral therapy and HIV infection per se are related to MS is still unclear. All treatment-naïve patients attending scheduled visits at CISAI group hospitals between January and December 2007 were eligible for the study. Patients without MS at enrolment were followed-up for 3 years or until they developed MS, diagnosed according to the National Cholesterol Education Program (NCEP) definition. The main objective was to assess the 3-years incidence of MS. MS was evaluated for 188 subjects. Out of them, 62 (33.0%) had started HAART at enrolment, whereas 67 (35.6%) more started during the observation. 59 (31.4%) were still treatment-naive at the study end. MS was newly diagnosed in 14 patients. The incidence was 2.60 cases/100 person-years (95% CI 1.47-4.51), 2.75 (1.11-5.72) among HAART-naïve patients and 2.65 (1.23-5.03) in subjects on HAART. Blood pressure did not change in the study period, whereas in naive patients the HDL level significantly lowered (median -6.0 vs. 4.0, P<0.0001) compared to HAART-treated patients. Triglicerides increased significantly in HAART subjects (median 12.0 vs. 1.0, P=0.02), as well as blood glucose (median 6.0 vs. 1.0, P=0.01). In our population, the overall MS incidence was low and largely similar in patients who started HAART or remained naive. However, the feature of MS was different in the two groups, suggesting that in untreated and treated patients MS developed through different metabolic pathways.
[Show abstract][Hide abstract] ABSTRACT: The aim of the ADONE (ADherence to ONE pill) study was to verify the effect of a reduced number of pills on adherence and quality of life (QoL) in HIV-infected patients on highly active antiretroviral therapy (HAART).
Prospective, multicenter, study.
Patients chronically treated with emtricitabine (FTC) + tenofovir (TDF) + efavirenz (EFV) or lamivudine (3TC) +TDF +EFV and with a HIV-RNA < 50 copies/mL were switched to the single-pill fixed-dose regimen (FDR) of FTC +TDF +EFV. Data were collected with SF-36 using visual analog scales. Results of the final (6 months) primary as-treated analysis are reported.
212 patients (77.4% males) of mean age 45.8 years were enrolled; 202 completed the study. One month post switch to FDR the adherence rate increased significantly to 96.1% from a baseline value of 93.8% (P < 0.01). The increase was steadily maintained throughout the study (96.2% at 6 months). QoL improved over time from 68.8% to 72.7% (P = 0.042) as well, and was significantly associated with the perception of health status, presence of adverse events (AEs) and number of reported AEs (P < 0.0001). QoL significantly influenced adherence (P < 0.0001). During FDR use the mean CD4 count increased from 556 to 605 cells/muL (P < 0.0001). At the end of follow-up 98% of patients maintained HIV-RNA level < 50 copies/mL and 100% <400 copies/mL. Four patients stopped therapy because they were lost to follow-up and 6 because of AEs (insomnia/nervousness 4, allergy 1, difficulties swallowing pills 1).
By substituting a one-pill once-a-day HAART, we observed an improvement of both adherence and QoL while maintaining high virologic and immunologic efficacy. HAART simplicity is an added value that favors adherence and may improve long-term success.
Full-text · Article · May 2010 · Patient Preference and Adherence
[Show abstract][Hide abstract] ABSTRACT: HERMES is a prospective study, including all treatment-naïve patients attending scheduled visits at hospitals in the CISAI group in 2007. The present cross-sectional analysis aims to assess the baseline prevalence and characteristics of Metabolic Syndrome (MS) in a population of HIV-positive treatment-naïve patients. MS was diagnosed using the National Cholesterol Education Program (NCEP) definitions. A total of 292 subjects were enrolled, median age was 37 years, 75% of them were males. The prevalence of MS was 12.3%. The most frequent trio of abnormalities that led to the diagnosis of MS was high blood pressure, triglycerides and HDL. Univariate analysis showed that MS was associated with the following variables: age, education, physical activity, advanced HIV disease (CDC stage C or HIV-RNA >100,000 copies + CD4 <100 cells/mm(3)). Higher educational levels remained protectively associated with MS in multivariate analysis. A higher risk of MS was also associated with advanced HIV disease. Actually, treatment-naïve HIV-positive patients in an advanced stage of the disease have a higher prevalence of abnormal levels of triglycerides, HDL cholesterol and blood glucose than those at a less advanced stage. These findings of the HERMES study suggest, therefore, that HIV infection per se is associated to MS.
No preview · Article · Feb 2010 · Current HIV research
[Show abstract][Hide abstract] ABSTRACT: Adherence to highly active antiretroviral treatment (HAART) is critical to long-term treatment success in patients infected with human immunodeficiency virus (HIV). However, the relationship between psychological variables and medication adherence is still poorly understood. The aim of this study was to investigate how anger dimensions in subjects with HIV affect adherence to antiretroviral drugs.
One hundred and thirty outpatients with HIV who were nondepressed and receiving HAART were administered the State-Trait Anger Inventory and a compliance self-report questionnaire. They also underwent clinical laboratory tests aimed at investigating immune function and disease stage.
Forty-three patients (33%) reported suboptimal adherence. Full compliance with HAART was related to higher age, lower HIV RNA level, lower trait anger, lower outside-directed anger and greater anger control. In a multiple regression analysis, low trait anger (p = 0.02) and high anger control (p = 0.03) were significantly associated with full adherence to HAART.
Anger dimensions are linked with, and may affect, adherence to HAART. A better understanding of the psychological determinants of compliance might allow for the identification of patients who are at higher risk of nonadherence. To sustain adherence to HAART, these patients may benefit from increased clinical attention or intervention.
Full-text · Article · Feb 2009 · Psychotherapy and Psychosomatics
[Show abstract][Hide abstract] ABSTRACT: It is not known whether antiretroviral therapy (ART) including lopinavir/r has a different effect on the lipid metabolism in HIV patients co-infected with HCV. This study investigated changes in lipid levels, comparing patients with HIV infection alone and those with HCV too, in the lopinavir/r cohort of the SCOLTA project.
We analyzed the data for the lopinavir/r nationwide cohort from 25 Italian infectious disease departments, which comprises 743 HIV-infected patients followed prospectively, comparing subjects with HIV-HCV co-infection and those with single-infection.
At enrolment, co-infected patients had significantly lower mean cholesterol than HCV negative cases (162+/-43mg/dL vs. 185+/-52mg/dL, p=0.0009). Total and non-HDL cholesterol and triglycerides rose significantly from baseline in HIV single-infection patients, but not in those with co-infection. The patients with dual HIV-HCV infection, treated with an ART regimen including lopinavir/r, have only limited increases in total and non-HDL cholesterol and triglycerides.
Changes in serum lipids in co-infected patients differed significantly from those in patients without HCV. It remains to be seen whether this is associated with a lower risk of progression of atherosclerotic disease.
No preview · Article · Feb 2008 · Biomedecine [?] Pharmacotherapy
[Show abstract][Hide abstract] ABSTRACT: We describe the hepatotoxicity encountered in a cohort of HIV-positive patients treated with lopinavir/ritonavir. We used the database from the SCOLTA project, an on-line pharmacovigilance programme involving 25 Italian infectious disease centres. A total of 755 patients were followed, over a mean observation period of 16 months. The incidence of severe events was low despite the high prevalence of patients co-infected with hepatitis virus at enrollment.
[Show abstract][Hide abstract] ABSTRACT: Physicians estimate their patients' adherence to medications, and base decisions about treatment on these estimates. In HIV, misjudgment of patient adherence can have adverse consequences, including withholding of therapy, unnecessary changes in therapy, or unnecessary laboratory testing. A review of the literature demonstrates that physicians are often inaccurate in estimating patient adherence with antiretroviral therapy. These findings have implications for practice. Standardized methods for adherence assessment are currently available that can be used to enhance physicians' ability to understand adherence behavior and barriers. The patient-physician relationship presents a unique setting for improving adherence. The authors propose interventions to improve adherence within the context of the patient-physician relationship at the physician level, interpersonal level, and organizational level. Improved communication, including discussion about patient lifestyle and preferences, can facilitate a frank exchange of information, negotiation, and a spirit of cooperation. Active patient participation in the decision-making process is crucial.
No preview · Article · Jan 2003 · JAIDS Journal of Acquired Immune Deficiency Syndromes