Suchergebnisse

In the Lazio region, about 10.000 HIV+subjects receive combination antiretroviral therapy (cART) with a medication expense of 78.177.632,28. In 2011, in order to standardize prescriptions, to monitor appropriateness, and to decrease drug costs, the Protocol for Regional Therapeutics (PTR) for cART was developed. Aim was to describe prescription patterns and costs of first‐line cART in 2010 and to estimate the theoretical impact of PTR application on medication costs. A cross‐sectional evaluation of first‐line cART prescribed during 2010 at the National Institute for Infectious Diseases was carried out. Data collected: age, date of HIV diagnosis, CD4, HIV‐RNA, antiretroviral drugs. cART were classified based on the PTR ranks as follows: a) recommended regimen (rank A1/A1); b) alternative regimens (ranks A1/B1; B1/A1; B1/B1); c) not recommended regimens. A descriptive analysis of prescription patterns together with their economic impact was carried out. A multivariate analysis was performed to identify predictive factors of higher regimen costs. The hypothetical transition of not recommended regimens to recommended or alternative regimens was assessed. 370 naïve patients were evaluated: mean age 42 y (range, 1–84), mean duration of HIV 41 months (range, 1–84); median CD4 269/mmc (135–349), log10HIV RNA 4.91 (4.4–5.4). A1/A1 regimens were prescribed in 62.2% (€163.789,28); A1/B1‐B1/A1‐B1/B1 in 22.8% (€73.831,75); not recommended cART in 15% (€54.929,95). Among A1/A1 regimes the most frequent were: TDF/FTC+EFV/(TDF+ FTC+EFV) in 39.4% and TDF+FTC+atazanavir/ritonavir in 22.7%. Up to 30 different cART (79% of all prescribed regimens) were used, each with a prescription prevalence lower than 1%. Mean patient‐month cART expense was €790,68. At multivariate analysis, higher plasma HIV RNA was associated with significantly higher first‐line regimen costs (coeff. B 48.64; 95% CI 22.78–74.50; P<0.0001). When applying the simulation model with the transition of all patients treated with not recommended regimens to recommended or alternative regimens, a total of €18.036,41 and €10.078,35 may have been achieved, respectively. A high prescription variability of cART has emerged. This finding is unlikely to be determined by clinical needs, especially because of the high frequency of not recommended regimens. Our findings highlight the need of standardized prescription strategies and that the introduction of PTR may allow a saving of up 10.4% of total cART expenses.

The use of Combination AntiRetroviral Therapy (cART) has decreased the morbidity and mortality of patients infected with HIV. However, adherence to cART remains crucial to prevent virological failure and disease progression. The aim of this study was to assess adherence to treatment among patients treated with Single Tablet Regimen (STR) or with multi‐pill regimens based on Protease Inhibitors (PI), Non‐Nucleoside Reverse‐Transcriptase Inhibitors (NNRTI), or raltegravir (RAL). An observational retrospective cohort analysis based on administrative and clinical databases was conducted at the National Institute for Infectious Diseases (Rome, Italy). HIV‐positive patients treated with a cART between Jan 1st, 2008–Dec 31st, 2010 were included. Patients were followed‐up for one year since the first prescription during the inclusion period or up to death or switch of at least one drug of the regimen. Adherence and selective non‐adherence (days without backbone or 3rd drug) were calculated using pharmacy refill compliance [1]. cART regimens were classified based on number of daily pills (STR vs multi‐pill regimen) and on type of third drug. Viral Load (VL) and CD4 cell counts at the end of the follow‐up were evaluated. A total of 1,604 patients were analyzed, 70.0% male, age 45.0±8.7, 14.3% newly treated. Patients on STR were 159 (9.9%), PI 878 (54.7%), NNRTI 523 (32.6%), RAL 44 (2.7%). Presence of at least one AIDS‐defining conditions (according to Centers for Disease Control classification) was 30% in the STR group, 34% PI, 26% NNRTI, 34% RAL (p=n.s.). Adherence was 80.4±14.7% for STR, 71.8±21.8% PI, 77.1±20.3% NNRTI, 74.0±22.4% RAL. Selective non‐adherence was 5.5% (18 days) PI, 2.8% (8 days) NNRTI, 12.5% (43 days) RAL (Figure 1). At the end of the follow‐up, VL/CD4 values were available among 709 patients (44%); CD4 count >500 cell/mm3 was observed among 61% of patients on STR, 44% PI, 48% NNRTI, 42% RAL and VL < 50 copies/ml was observed among 96% of patients on STR, 78% PI, 88% NNRTI, 87% RAL. Interruptions in cART refill remain a relevant problem across all cART regimens. Patients on STR displayed a higher adherence rate compared to multi‐pill regimes (PI, NNRTI, and RAL), primarily due to lack of selective non‐adherence. Patients on STR experienced also higher rates of VL < 50 and CD4 > 500. The use of an STR regimen appears an effective therapeutic option to avoid selective non‐adherence and, consequently, to prevent virological failure and disease progression.Non‐adherence to cART regimens.image

Criteria of cART initiation after a first ADE have been modified over time based on evidence suggesting that treatment should be initiated earlier. The impact of these changes on clinical practice is unknown. Objective of this analysis was to evaluate temporal changes of time of starting cART after a first diagnosis of ADE in ART‐naïve patients (pts).MethodsAll HIV+ enrolled in ICONA Foundation Study who presented with a diagnosis of ADE while cART‐naïve regardless of CD4 cell count were included. Pts were grouped according to have ADE for which additional medications that may have interactions with cART are required (Tb, atypical mycobacteriosis, non‐Hodgkin lymphoma) [group A], ADE treatable only by cART (PML, isosporidiasis/cryptosporidiasis, KS, wasting syndrome) [group B] and ADE treatable with specific drugs (PCP, toxoplasmic encephalitis, CMV disease, esoph candidiasis, bacterial pneumonia, cervical cancer, cryptococcosis) [group C]. Standard survival analysis by KM was used to estimate the cumulative percentage of pts starting cART, overall and after stratification for calendar period of diagnosis (1996–2000, 2001–2008, 2009–2011) and type of ADE (groups A, B, C). Multivariable Cox regression was used to investigate association between calendar year of ADE and time to cART initiation after controlling for demographics.Summary of resultsA total of 715 pts with a first ADE were observed over 1996‐2011 (group A, n=187; B, n=123; C, n=405). 519 (73%) male, median age 38 (IQR:33–45), median CD4+64 (23–187)/mm3 and HIV/RNA 5.25 (4.57–5.70) log10 cps/mL, with no differences by calendar period. By 30 days from ADE, 23% (95% CI: 19–27) of those diagnosed in 1996–2000 have started cART vs. 32% (95% CI: 25–39) in 2001–2008 and 36% (28–44) after 2009 (log‐rank p=0.001). After stratifying by CD4 at ADE, 45% of pts with CD4<50/mm3, 30% of those with 51–200/mm3 and 16% of those>201/mm3 had started cART by 30 days (p<0.0001). Restricting the analysis to pts diagnosed after 2009, the percentages of cART initiation were 9% for group A, 52% for group B and 39% for group C (p=0.05). The table shows the relative hazards of starting cART from fitting a multivariable Cox regression model.ConclusionsIn our 'real‐life' setting, time from AIDS diagnosis to cART was significantly shorter in pts diagnosed in more recent years, although for most ADE cART initiation was less prompt than expected, even in pts with severe immunodeficiency.










Calendar Period
Crude RH (95% CI)
p‐value
Adjusted RH (95% CI)
p‐value




1996–1999
1.00

1.00



2000–2008
1.19 (0.95, 1.50)
0.132
1.18 (0.88, 1.57)
0.272


2009+
1.51 (1.16, 1.96)
0.002
1.36 (0.89, 2.08)
0.151


Type of ADE
Crude RH (95%)
p‐value
Adjusted RH (95% CI)
p‐value


A
1.00

1.00



B
2.59 (1.90, 3.53)
<.001
2.24 (1.44, 3.48)
<.001


C
2.09 (1.65, 2.67)
<.001
1.14 (0.99, 2.00)
0.058

BACKGROUND: UNAIDS has set a 90-90-90 target to curb the HIV epidemic by 2020, but methods used to assess whether countries have reached this target are not standardised, hindering comparisons. METHODS: Through a collaboration formed by the European Centre for Disease Prevention and Control (ECDC) with European HIV cohorts and surveillance agencies, we constructed a standardised, four-stage continuum of HIV care for 11 European Union (EU) countries for 2013. Stages were defined as: 1) number of people living with HIV (PLHIV) in the country by end of 2013; 2) proportion of stage 1 ever diagnosed; 3) proportion of stage 2 ever initiated ART; and 4) proportion of stage 3 who became virally-suppressed (≤200 copies/mL). Case surveillance data were used primarily to derive stages 1 (using back-calculation models) and 2, and cohort data for stages 3 and 4. RESULTS: In 2013, 674,500 people in the 11 countries were estimated to be living with HIV, ranging from 5,500 to 153,400 in each country. Overall HIV prevalence was 0.22% (range 0.09%-0.36%). Overall proportions, of each previous stage, were 84% diagnosed, 84% on ART, and 85% virally-suppressed (60% of PLHIV). Two countries achieved ≥90% for all stages, and over half had reached ≥90% for at least one stage. CONCLUSIONS: EU countries are nearing the 90-90-90 target. Reducing the proportion undiagnosed remains the greatest barrier to achieving this target, suggesting further efforts are needed to improve HIV testing rates. Standardising methods to derive comparable continuums of care remains a challenge.