In the last decade, the significant expenditure and consumption increase of vitamin D in Italy led some regions to adopt strategies to improve prescribing appropriateness and contain expenditure.
...Using the statistical analysis method of interrupted time series for consumption and expenditure of cholecalciferol, different types of interventions adopted in four Italian regions and their efficacy were evaluated.
Molise achieved the best results by adopting a health professionals' education program in addition to a prescriber-sanction system. Emilia-Romagna also opted for a medical education strategy, but the results were less relevant due to the lack of penalties. Lazio obtained a slowdown in consumption growth by targeting on the utilization of lower-cost per defined daily dose (DDD) packs and adopting a therapeutic plan. Sardinia showed a decrease in expenditure by adopting a target threshold of lower-cost formulation.
The reimbursement of the lowest-cost packs within the National Health Service (NHS) undoubtedly influences spending trend, but it does not solve prescriptive inappropriateness.
Knowledge of factors associated with medication adherence could help HIV clinicians to target persons in need of intervention, design these interventions, and help researchers to plan studies of ...adherence. This review summarizes the results of 20 studies investigating the issue of barriers to optimal highly active antiretroviral therapy (HAART) adherence. Only a few determinants were consistently associated with nonadherence. Symptoms and adverse drug effects, psychologic distress, lack of social or family support, complexity of the HAART regimen, low patient self-efficacy, and inconvenience of treatment were the factors most consistently associated with nonadherence. There were inconsistent findings regarding the relationship of adherence and the following variablessociodemographic characteristics, substance abuse, depressive symptoms, quality of life, CD4 cell count, knowledge and beliefs about treatment, patientsʼ satisfaction with health care, and patient-provider relationship. A synthesis of findings relating various factors to adherence to HAART is difficult to reach because of several limitations of the existing body of research. These limitations concern the measurement of adherence, the assessment of correlates and predictors of adherence, the study population, and the study design.
Background. Although the kinetics of CD4+ cell counts have been extensively studied in antiretroviral-naive HIV-infected patients, data on individuals who have failed combination antiretroviral ...therapy (cART) are lacking. Methods. This analysis was based on the ICONA Foundation Study. Subjects with ≥1 episode of viral suppression after starting first-line cART were included (n = 3537). Following a viral rebound, patients who achieved another episode of viral suppression could reenter the analysis. The percentage of patients with an increase in CD4+ cell count >300 cells/mm3 was estimated using Kaplan-Meier techniques; the rate of CD4+ cell count increase per year was estimated using a multivariable, multilevel linear model with fixed effects of intercept and slope. Multivariable models were also fitted to include several covariates. Results. The median time to reach a CD4+ cell count increase >300 cells/mm3 from baseline was significantly associated with the number of failed regimens: 34 months, 41 months, 51 months, and 45 months in subjects without evidence of previous virological failure, or 1, 2, or ≥3 previous virologically failed regimens, respectively (P < .001, by log-rank test). The annual estimated increases in CD4+ cell count were 36 cells/mm3 (95% confidence interval CI, 34–38 cells/mm3), 28 cells/mm3 (95% CI, 11–21 cells/mm3), 31 cells/mm3 (95% CI, 26–36 cells/ mm3), and 26 cells/mm3 (95% CI, 18–33 cells/mm3), respectively. Differences in the annual CD4+ cell count increase were observed between specific antiretrovirals. Conclusions. Subjects with ≥1 virological failure took a longer time to reach a CD4+ cell count >300 cell/ mm3 and had a slower annual increase than those without virological failure. Efforts should be made to optimize first-line cART, because this represents the best chance of achieving an effective CD4+ response.
Adipose tissue alterations (ATA), which are common among persons treated with highly active antiretroviral therapy (HAART), can have substantial psychologic repercussions, with a subsequent negative ...impact on the patientʼs quality of life and on HAART adherence. However, the cross-sectional nature of the studies precludes establishing the direction and causality of the relationship. The authors evaluated the longitudinal relationship between ATA and adherence to HAART. The analysis included all participants in the AdICoNA and the LipoICoNA substudies of the Italian Cohort Naive Antiretrovirals (ICoNA). Adherence was assessed using a 16-item self-administered questionnaire, which also included a question on self-perceived fat accumulation experienced during the past 4 weeks. ATA was diagnosed by physicians at enrollment and evaluated every 6 months thereafter. There were 207 patients, with a median age of 35 years; 73% were men; and 34% acquired HIV through injection drug use. At baseline, nonadherence was reported by 63% of participants, and ATA was self-perceived by 15% and clinically diagnosed in 25%. Using Cox regression analysis, patients with good adherence at baseline were more likely to develop ATA (RH = 2.58; 95% CI, 1.09-6.11) and developed it sooner. Self-perceived ATA at baseline was independently related to subsequent nonadherence (OR, 4.67; 95% CI, 1.01-22.4), but clinically diagnosed ATA was not (OR, 0.77; 95% CI, 0.37-1.61). Patientsʼ adherence to HAART is a dynamic process that interacts with ATA. Better adherence is associated with a higher risk of subsequent occurrence of ATA, while patient-perceived onset of morphologic alterations can reduce adherence to antiretroviral therapy.
Background. Consensus on the interpretation of mutations in the human immunodeficiency virus (HIV)-1 reverse transcriptase (RT) gene that predict the response to didanosine treatment is needed. ...Methods. Baseline HIV-1 RT genotypes and 12-week virological outcomes for patients undergoing didanosine-containing salvage regimens were extracted from prospective studies. Existing didanosine genotypic-resistance interpretation rules were validated in the entire-patient data set. Mutations were given weighted positive or negative scores according to their coefficient of correlation with virological response in a derivation set. The score resulting from the algebraic sum of the mutations was then validated in an independent data set. Results. A total of 485 patients were analyzed. The didanosine-resistance scores derived from the Jaguar and Gesca studies predicted virological outcome. The best correlation with response was found with the derived score (M41L × 2) + E44D/A/G + T69D/S/N/A + (L210W × 2) + T215Y or revertants + L228H/R — D123E/N/G/S, by use of which viruses were categorized as being susceptible (score ⩽0), as having intermediate resistance (1–3), and as being resistant (⩾4) to didanosine. In the validation set, the adjusted mean difference in 12-week virological response was +0.34 log10 copies/mL (95% confidence interval, +0.11 to +0.57; P = .004) per higher resistance category. Correlation with virological response constantly outperformed that obtained with the previous interpretation. Conclusion. The improved genotypic-resistance interpretation score can be applied to better guide the use of didanosine in treatment-experienced individuals.
OBJECTIVES: To evaluate the rate of discordance between patients and physicians on adherence to highly active antiretroviral therapy (HAART) and identify factors related to discordance in these two ...assessments.
DESIGN: Prospective, multicenter, cohort study (AdICONA) nested within the Italian Cohort Naïve Antiretrovirals (ICONA) study.
SETTING: Tertiary clinical centers.
PARTICIPANTS: The patients filled out a 16‐item self‐administered questionnaire on adherence to HAART. At the same time, physicians estimated the current HAART adherence of their patient.
MAIN OUTCOME MEASURE: Discordance between patient and physician on adherence to antiretroviral therapy.
RESULTS: From May 1999 to March 2000, 320 paired patient‐physician assessments were obtained. Patients had a mean plasma HIV RNA of 315 copies/ml (64% had undetectable HIV RNA) and a mean CD4+ cell count of 577 cells × 106/L. Nonadherence was reported by 30.9% of patients and estimated by physicians in 45.0% cases. In 111 cases (34.7%), patients and physicians were discordant on adherence to HAART. Kappa statistics was 0.27. Using patient‐assessed adherence as reference, sensitivity, specificity, positive predictive value, and negative predictive value of physician‐estimated adherence were 64.7%, 66.6%, 81.2%, and 45.8%, respectively. On multivariable analysis, low education level, unemployment, absence of a social worker in the clinical center, and unavailability of afternoon visits were significantly correlated with patient‐physician discordance on adherence to antiretrovirals.
CONCLUSIONS: Physicians did not correctly estimate patient‐reported adherence to HAART in more than one third of patients. Both social variables and factors related to the clinical center were important predictors of discordance between patients and physicians. Interventions to enhance adherence should include strategies addressed to improve patient‐physician relationship.
This cross-sectional study compares demand for drugs for treatment of coronavirus disease 2019 (COVID-19) between the period directly before the COVID-19 outbreak in Italy and the early period of the ...outbreak.