Highly Active Antiretroviral Therapy Prescription Research Articles

Off-label use of combined antiretroviral therapy, analysis of data collected by the Italian Register for HIV-1 infection in paediatrics in a large cohort of children

BackgroundEarly start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to EMA, only 35% of antiretroviral drugs are licenced in children < 2 years of age and 60% in those aged 2–12 years, due to the lack of adequate paediatric clinical studies on pharmacokinetics, pharmacodynamics and drug safety in children.MethodsAn observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018.Results22.2% (50/225) of included children were receiving an off-label HAART regimen at last check. Only 26% (13/50) of off-label children had an undetectable viral load (VL) before the commencing of the regimen and the 52.0% (26/50) had a CD4 + T lymphocyte percentage > 25%. At last check, during the off label regimen, the 80% (40/50) of patients had an undetectable VL, and 90% (45/50) of them displayed CD4 + T lymphocyte percentage > 25%. The most widely used off-label drugs were: dolutegravir/abacavir/lamivudine (16%; 8/50), emtricitbine/tenofovir disoproxil (22%; 11/50), lopinavir/ritonavir (20%; 10/50) and elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (10%; 10/50). At logistic regression analysis, detectable VL before starting the current HAART regimen was a risk factor for receiving an off-label therapy (OR: 2.41; 95% CI 1.13–5.19; p = 0.024). Moreover, children < 2 years of age were at increased risk for receiving off-label HAART with respect to older children (OR: 3.24; 95% CI 1063–7.3; p = 0.001). Even if our safety data regarding off-label regimens where poor, no adverse event was reported.ConclusionThe prescription of an off-label HAART regimen in perinatally HIV-1 infected children was common, in particular in children with detectable VL despite previous HAART and in younger children, especially those receiving their first regimen. Our data suggest similar proportions of virological and immunological successes at last check among children receiving off-label or on-label HAART. Larger studies are needed to better clarify efficacy and safety of off-label HAART regimens in children, in order to allow the enlargement of on-label prescription in children.

Antiretroviral changes during the first year of therapy.

The Brazilian HIV/AIDS management and treatment guideline (PCDT), published in 2013, recommends and standardizes the use of highly active antiretroviral therapy (HAART) in all adult patients, in spite of LTCD4 count. This study aimed to analyze the first year of HAART use in patients from a reference center on HIV/AIDS management in Fortaleza, Ceará. This descriptive study reviewed all prescription forms of antiretroviral regimens initiation and changes from January to July 2014. All antiretroviral regimen changes that occurred during the first year of therapy were evaluated. Data were analyzed with SPSS version 20. Mean, standard deviation and frequency, Student's t and Mann-Whitney tests calculations were used, with significance at p<0.05. From 527 patients initiating HAART, 16.5% (n=87) had a regimen change in the first year. These patients were mostly male (59.8%; n=52), aged 20 to 39 years, with only one HAART change (72.4%; n=63). Efavirenz was the most often changed drug, followed by tenofovir, zidovudine and lopinavir/ritonavir. Mean time of HAART changes was 120 days, with adverse reactions as the most prevalent cause. HAART was effective in decreasing viral load since second month of treatment (p=0.003) and increasing LTCD4 lymphocytes since fifth month (p<0.001). The main cause of initial HAART changes was adverse reaction and most patients had only one change in the HAART regimen. HAART prescription was in accordance to the PCDT from 2013.

An Analysis of Prescription Patterns and Incidence of Dyslipidemia in a Korean Tertiary Hospital HIV Patients Receiving High Active Antiretroviral Therapy

Highly active antiretroviral therapy (HAART) has reduced AIDS-related morbidity and mortality; however, it has been associated with metabolic abnormalities including dyslipidemia and dysglycemia depending on the regimens used. The aims of this study were to analyze the prescription patterns of antiretroviral agents and to examine the prevalence of lipid abnormalities among the prescriptions of HAART. The electronic medical records (EMR) of HIV patients were ret- rospectively reviewed from January 2007 to September 2012 based on our inclusion criteria. The patients who had taken HAART for at least 3 months were included in this study. The lipid profiles of patients on antiretrovirals (ARTs) were col- lected from his or her laboratory data, and dyslipidemia was defined as total cholesterol (TC) ≥240 mg/dL and triglycerides (TG) >200 mg/dL. Eighty-four prescriptions were discovered during the study period. Twenty-three prescriptions were the combination of two nucleoside reverse transcriptase inhibitors (NRTIs) and one non-nucleoside reverse transcriptase inhib- itor (NNRTI). Fifty-three prescriptions were the combination of two NRTIs and one protease inhibitor (PI) and thirty-nine prescriptions of them included a PI booster. Eight prescriptions were the combination of two NRTIs and one integrase inhib- itor. The Incidence of hypertriglyceridemia among the patients receiving HAART was totally about 41.7% (2NRTIs+PI reg- imen vs. 2NRTIs+NNRTI regimen vs. 2 NRTIs+integrase inhibitor regimen, 52% vs. 12.5% vs. 25%), but there was no incidence of hypercholesterolemia. This study investigated that the prescription medication patterns and dyslipidemia asso- ciated with lipid abnormalities among HIV patients receiving HAART. The types of HAART prescription regimens had an effect on the occurrence of hypertriglycemia. Further studies related to metabolic abnormalities and adverse effects of HIV patients on ARTs are needed in the near future.

Is Forced Migration a Barrier to Treatment Success? Similar HIV Treatment Outcomes Among Refugees and a Surrounding Host Community in Kuala Lumpur, Malaysia

In response to an absence of studies among refugees and host communities accessing highly active antiretroviral therapy (HAART) in urban settings, our objective was to compare adherence and virological outcomes among clients attending a public clinic in Kuala Lumpur, Malaysia. A cross-sectional survey was conducted among adult clients (≥18 years). Data sources included a structured questionnaire that measured self-reported adherence, a pharmacy-based measure of HAART prescription refills over the previous 24 months, and HIV viral loads. The primary outcome was unsuppressed viral load (≥40 copies/mL). Among a sample of 153 refugees and 148 host community clients, refugees were younger (median age 35 [interquartile range, IQR 31, 39] vs 40 years [IQR 35, 48], p < 0.001), more likely to be female (36 vs 21 %, p = 0.004), and to have been on HAART for less time (61 [IQR 35, 108] vs 153 weeks [IQR 63, 298]; p < 0.001). Among all clients, similar proportions of refugee and host clients were <95 % adherent to pharmacy refills (26 vs 34 %, p = 0.15). When restricting to clients on treatment for ≥25 weeks, similar proportions from each group were not virologically suppressed (19 % of refugees vs 16 % of host clients, p = 0.54). Refugee status was not independently associated with the outcome (adjusted odds ratio, aOR = 1.28, 95 % CI 0.52, 3.14). Overall, the proportions of refugee and host community clients with unsuppressed viral loads and sub-optimal adherence were similar, supporting the idea that refugees in protracted asylum situations are able to sustain good treatment outcomes and should explicitly be included in the HIV strategic plans of host countries with a view to expanding access in accordance with national guidelines for HAART.Electronic supplementary materialThe online version of this article (doi:10.1007/s10461-013-0494-0) contains supplementary material, which is available to authorized users.

Should highly active antiretroviral therapy be prescribed in critically ill HIV-infected patients during the ICU stay? A retrospective cohort study

BackgroundThe impact of highly active antiretroviral therapy (HAART) in HIV-infected patients admitted to the intensive care unit (ICU) remains controversial. We evaluate impact of HAART prescription in HIV-infected patients admitted to the ICU of Tourcoing Hospital from January 2000 to December 2009.ResultsThere were 91 admissions concerning 85 HIV-infected patients. Reasons for ICU admission were an AIDS-related diagnosis in 46 cases (51%). Fifty two patients (57%) were on HAART at the time of ICU admission, leading to 21 immunovirologic successes (23%). During the ICU stay, HAART was continued in 29 patients (32%), and started in 3 patients (3%). Only one patient experienced an adverse event related to HAART. Mortality rate in ICU and 6 months after ICU admission were respectively 19% and 27%. Kaplan-Meier estimates of the cumulative unajusted survival probability over 6 months were higher in patients treated with HAART during the ICU stay (Log rank: p = 0.04). No benefit of HAART in ICU was seen in the adjusted survival proportion at 6 months or during ICU stay. Prescription of HAART during ICU was associated with a trend to lower incidence of new AIDS-related events at 6 months (respectively 17% and 34% with and without HAART, p = 0.07), and with higher incidence of antiretroviral resistance after ICU stay (respectively 25% and 7% with and without HAART, p = 0.02).ConclusionsOur results suggest a lower death rate over 6 months in critically ill HIV-infected patients taking HAART during ICU stay. The optimal time to prescribe HAART in critically ill patients needs to be better defined.

Routine screening for depression: identifying a challenge for successful HIV care.

Individuals with HIV experience fluctuating levels of distress throughout the course of HIV infection. This study was conducted to examine the associations of depressive symptomatology with HIV disease in a cohort of individuals who are engaged in routine medical care. This cross-sectional study examined the prevalence of depressive symptoms that were measured as part of a standard of care behavioral assessment among individuals at an urban HIV clinic in the Midwest. Demographic characteristics, depressive symptoms, and behavioral risk factors were collected. A total of 514 individuals participated in the study, the majority of whom was male and African American. One quarter of the sample endorsed symptoms of other depressive disorder, while 18% (n = 91) endorsed symptoms of major depressive disorder as measured by the Patient Health Questionnaire-9 (PHQ-9). Among those on highly active antiretroviral therapy (HAART), individuals who were unemployed (adjusted odds ratio [AOR] = 2.47, 95% confidence interval [CI] = 1.54, 3.97), had a minor dependent (AOR = 2.17, 95% CI = 1.25, 3.77), or between the ages of 18 and 34 years (AOR = 1.37, CI = 1.03, 1.94) and detectable HIV viral load (AOR = 2.52, 95% CI = 1.22, 5.23) were more likely to report depressive disorder symptoms when controlling for age, gender, race, and education. Nearly 15% of the sample endorsed having suicidal thoughts at least once in the past two weeks. Regardless of HAART prescription, individuals who were unemployed had a higher likelihood of expressing suicidal ideation (AOR = 3.43, 95% CI = 1.66, 7.06). Given the association between depressive symptomatology and poor rates of HIV viral suppression, screening and appropriate interventions for depressive symptoms are warranted in the HIV outpatient setting to improve outcomes.

Neurological disease: the effects of HIV and antiretroviral therapy and the implications for early antiretroviral therapy initiation

The purpose of this review is to examine the literature regarding HIV-associated neurocognitive disorders, early HIV infection of the central nervous system (CNS), the role of the peripheral immune system in controlling HIV infection and disease within the brain and the potential role that early antiretroviral treatment may play in the preservation of neurocognitive health in patients with more than 500 CD4+ cells/microl. In the post highly active antiretroviral therapy (HAART) era, HIV-associated neurocognitive disorders remain prevalent and even mild-moderate immunosuppression carries a risk for the development of HIV-associated dementia. HIV infection of the CNS occurs early in the illness, and data suggest that a robust peripheral immune system is key to the long-term control of CNS HIV infection. HAART results in clinical, neuropsychological and neuroradiological improvement in patients with HIV-associated neurocognitive disorders, and the prescription of HAART regimens with good cerebrospinal fluid penetration appears to be preferable in this setting. There is little evidence that HAART causes CNS toxicity. The benefits and risks of HAART in the preservation or enhancement of neurocognitive function in well, HIV-infected patients with more than 500 CD4+ cells/microl are unknown. The prescription of HAART in well, HIV-infected patients with high CD4+ cell counts may afford enhanced control of CNS HIV infection as a result of the benefits of HAART upon peripheral immune function. In turn, this may result in superior or preserved neurocognitive performance in comparison to the current practice of commencing HAART when CD4+ cells reach 350 cells/microl or lower. This hypothesis will be tested in an upcoming randomized clinical trial.

Does Early Antiretroviral Treatment Prevent Liver Fibrosis in HIV/HCV-Coinfected Patients?

Does Early Antiretroviral Treatment Prevent Liver Fibrosis in HIV/HCV-Coinfected Patients?

The impact of methadone or buprenorphine treatment and ongoing injection on highly active antiretroviral therapy (HAART) adherence: evidence from the MANIF2000 cohort study

To date, no data exist assessing the impact of either methadone or buprenorphine on adherence to highly active antiretroviral therapy (HAART) in the long term. This study was conducted in order to evaluate whether receiving take-home methadone and buprenorphine may ensure better adherence to HAART in individuals infected with human immunodeficiency virus (HIV) through injection drug use (IDU). Longitudinal data on adherence, opioid substitution treatment (OST) and patient behaviours starting from their first HAART prescription were collected for 276 individuals HIV-infected through drug use (n=1558 visits). Out-patient hospital services delivering HIV care in Marseilles, Avignon, Nice and Ile de France. At any given visit, patients were classified both according to the type of OST received and ongoing injection. Patients who reported no injection and no OST over the whole study period were considered as 'abstinent' and used as a reference category. A logit model based on generalized estimation equations (GEE) was used to identify predictors of non-adherence. After adjustment for alcohol consumption, depression and self-reported side effects, patients ceasing injection during OST and abstinent patients exhibited comparable adherence. Patients reporting injection, on OST or not, had a twofold and threefold risk, respectively, of non-adherence compared with abstinent patients (P<0.01 linear trend). Duration on OST without injecting was associated significantly with virological success. Both access to and effectiveness of OST contribute to sustaining adherence to HAART in HIV-infected IDUs. These results advocate strongly the need of wider use of OST in countries scaling-up HAART where HIV is driven by IDUs.

Active Tuberculosis Does Not Always Imply the Initiation of Highly Active Antiretroviral Therapy in HIV-Infected Patients

Infection with HIV is an important risk factor for tuberculosis (TB). One-half million cases of TB attributable to HIV infection occur worldwide each year. Since the advent of highly active antiretroviral therapy (HAART) the morbidity and mortality of HIV-infected patients have declined. However concomitant TB treatment and HAART are hampered by a high pill burden complex drug interactions treatment-related adverse events and paradoxic reactions. Studies that have assessed the effect of HAART in the course of TB and HIV coinfection are few. All these retrospective studies suggest that coinfected patients with a CD4 count less than 100 cells/mm/3 would probably benefit from early initiation of HAART. Unlike other HIV-associated opportunistic infections TB may occur at high CD4 cell counts. The indication for HAART in these particular cases has not been assessed and current antiretroviral (ARV) treatment guidelines are based on expert opinion. We evaluated retrospectively 93 episodes of TB diagnosed in 87 HIV-infected patients from January 2000 to February 2004 at Bichat Hospital in an attempt to assess the clinical aspects and outcome of TB according to the level of immunosuppression at TB diagnosis and to the prescription of HAART in the course of TB treatment. (excerpt)

Early Onset of Tenofovir-Induced Renal Failure: Case Report and Review of the Literature

Tenofovir is an acyclic nucleotide analogue reverse transcriptase inhibitor that is commonly prescribed as part of a highly active antiretroviral therapy (HAART) regimen in HIV-infected patients. Although it is generally well tolerated, renal insufficiency has been associated with its use. We report a biopsy-proven case of acute renal failure that developed within weeks of initiating a HAART regimen containing tenofovir, and review the literature with specific attention to cases of renal failure occurring within 8 weeks of tenofovir initiation. Our patient developed renal insufficiency within 3 weeks of initiating tenofovir-containing HAART and overt renal failure was noted within 5 weeks. Renal biopsy demonstrated histopathologic changes suggestive of HIV nephropathy, despite normal baseline serum creatinine values. Thirty additional cases of tenofovir-associated renal failure have been reported. In the majority (n = 22, 73%), renal failure occurred months after initiating therapy (range: 5–26 months). However, in a significant subset (n = 8, 27%), renal failure occurred within 8 weeks of treatment initiation. Our data suggest that some patients are at risk for developing renal failure within weeks of tenofovir initiation. Thorough evaluation of renal function should be undertaken before prescription of tenofovir-containing HAART. For those in whom subclinical renal disease is discerned, added vigilance when monitoring renal function may be warranted.

The cost of antiretroviral drugs and influence on prescribing policies

With the advent of highly active antiretroviral therapy (HAART), the prognosis for HIV-infected individuals with access has been transformed. HAART provides one of the most cost-effective treatments for any chronic disease. Immediate cost remains a legitimate factor when choosing HAART regimens, however, the cost of long-term side-effects and adherence issues must also be considered. The review examines the cost issues associated with HAART prescription and its influence on prescribing policies.

Determinants of clinical progression in antiretroviral‐naïve HIV‐infected patients starting highly active antiretroviral therapy. Aquitaine Cohort, France, 1996–2002

To determine the factors associated with clinical progression (AIDS events and death) in antiretroviral-naive patients who have begun highly active antiretroviral therapy (HAART). HIV-infected patients naive to antiretroviral therapy were included in a prospective hospital-based cohort who began HAART between June 1996 and December 2001. Progression was explained by baseline characteristics using Cox proportional hazards models. Overall, data for 709 patients were analysed. In multivariate analysis, factors associated with an increased risk of progression were CD4 count < 50 cells/microL [hazard ratio (HR) = 13.0 (95% confidence interval 3.8-44.3)] and between 50 and 199 cells/microL [HR = 5.1 (1.6-16.3)], when compared with patients with CD4 count>350 cells/microL; AIDS events before HAART prescription [HR = 2.1 (1.2-3.7)]; CD8 count < 400 cells/microL [HR = 1.8 (1.1-3.0)]; and older age (HR = 1.2 by 10 years (1.0-1.5)]. In a second model including CD4 percentage, factors associated with progression were CD4 < 10% [HR = 6.3 (2.2-17.9)] and 10%<CD4 < 15% [HR = 4.2 (1.4-12.5)], when compared with patients with CD4 > 20%; CD8 count; AIDS events before HAART prescription; and older age. In a third model including the CD4:CD8 ratio, factors associated with progression were CD4:CD8 < 15% [HR = 8.2 (2.3-28.8)] and 15% < CD4:CD8 < 30% [HR = 4.6 (1.3-16.0)], when compared with patients with CD4:CD8 > 45%; AIDS events before HAART prescription; and older age. The Akaike information criteria for model analysis were 803, 805 and 815, respectively. Consideration of CD4 level in terms of CD4:CD8 ratio or CD4 percentage can be a good alternative to absolute CD4 count. Other prognostic factors such as older age, CD8 count < 400 cells/microL and AIDS events also have to be considered in the decision to initiate HAART.

Changes in the Pattern of Respiratory Diseases Necessitating Hospitalization of HIV-infectedPatients Since the Advent of Highly Active Antiretroviral Therapy

The incidence rates of opportunistic diseases, hospital admission and death have fallen markedly since the advent of highly active antiretroviral therapy (HAART). We examined the impact of HAART on the pattern of HIV-related respiratory diseases necessitating hospitalization. We retrospectively compared the numbers and etiologies of respiratory diseases diagnosed in HIV-infected patients hospitalized in the chest department of a Paris university hospital during the three years preceding widespread prescription of HAART in France (era 1, starting in July 1993) and the first three years of widespread HAART prescription (era 2, starting in July 1996). Respectively, 207 and 119 HIV-infected patients were admitted for respiratory disease in era 1 and era 2. Only 31.1% of patients admitted during era 2 were receiving HAART. Pulmonary opportunistic infections other than Pneumocystis carinii pneumonia (PCP) (p = 0.0008) and exacerbations of chronic bronchial disease due to gram-negative bacilli (p = 0.04) virtually disappeared in era 2. In contrast, PCP, bacterial pneumonia, tuberculosis, pulmonary Kaposi's sarcoma and pulmonary non-Hodgkin lymphoma showed only a twofold decrease in era 2, while lung cancer was more frequent (p = 0.004). The frequency of severe respiratory diseases necessitating hospitalization of HIV-infected patients has fallen since the advent of HAART, and their etiologic distribution has changed.

Outpatient pharmacy care and HIV viral load response among patients on HAART

Adherence to highly active antiretroviral therapy (HAART) is necessary to achieve long-term effectiveness. The impact of HIV/AIDS-specific pharmacy services on patient adherence and HIV viral suppression is currently not well described. This study aimed to compare the impact of differing levels of HIV-pharmacy care on adherence and time to HIV viral suppression among participants on HAART enrolled in a population-based HIV/AIDS drug treatment programme in British Columbia. We performed a retrospective observational study of 788 treatment-naïve patients who started HAART between August 1997 and July 2000 and were followed until 31 March 2002. The degree of outpatient pharmacy care was defined according to pharmacy dispensing site for the participants′ first prescription of HAART: highest at the AIDS-tertiary care hospital outpatient pharmacies, intermediate at HIV/AIDS drug treatment programme funded off-site pharmacies and lowest at family physician's offices. Cox-proportional hazard models examined the independent effect of pharmacy dispensing site on time to two consecutive HIV viral suppressions controlling for other prognostic factors including physicians′ experience, age, gender, injection drug use, use of therapy containing NNRTI versus PI, adherence >90%, AIDS diagnosis at baseline, baseline CD4 cell count and HIV viral load. The median time on antiretrovirals was 28 months (IQR=14–38). There were 489 (62.1%) participants who obtained their medications from the AIDS-tertiary care outpatient pharmacies; 98 (12.4%) from off-site pharmacies and 201 (25.5%) from their physicians' offices. The proportion of patients exhibiting >90% adherence to treatment was observed to be higher among patients receiving their HAART at the AIDS-tertiary care pharmacies compared to off-site pharmacies and to physicians' offices (70.4, 59.2 and 55.7%, respectively; p=0.0001). After adjusting for other prognostic factors, subjects who were first dispensed medications from the AIDS-tertiary care pharmacy were 1.42 times (CI: 1.10–1.84) more likely to achieve HIV viral suppression than those getting their medications from off-site pharmacies and physicians' offices. Providing regular outpatient pharmacy care is independently associated with improved HIV viral load response through enhanced adherence to HAART. Standardization of pharmacy practices for dispensing HAART may improve outcomes for patients who receive their HIV medications from other non-tertiary care pharmacy sites.

Differences in Prescription of Antiretroviral Therapy in a Large Cohort of HIV-Infected Patients

The objective of this study was to determine factors associated with prescription of highly active antiretroviral therapy (HAART). The authors observed 9530 patients eligible for antiretroviral therapy (ART) in more than 100 hospitals and clinics in 10 US cities. Multiple logistic regression analysis was used to assess factors associated with HAART prescription, stratifying patients by no history versus history of ART to assess the association between prescription and CD4, viral load, and outpatient visits. Overall, female gender (odds ratio [OR], 0.68; 95% confidence interval [CI], 0.60-0.76) and alcoholism (OR, 0.85; 95% CI, 0.74-0.99) were associated with decreased likelihood of HAART prescription. Enrollment at a private facility (OR, 1.33; 95% CI, 1.14-1.56), heterosexual exposure (OR, 1.34; 95% CI, 1.13-1.58), and Hispanic ethnicity (OR, 1.19; 95% CI, 1.04-1.37) were associated with prescription. For patients with no history of prescribed ART, CD4 <500 cells/microL (OR, 3.94; 95% CI, 2.02-7.66), and high viral load were associated with increased likelihood of prescription; for patients with history of ART prescription, those whose outpatient visits averaged > or =2 per 6-month interval (OR, 1.30; 95% CI, 1.10-1.54) were more likely and those with high viral load were less likely to be prescribed HAART (OR, 0.50; 95% CI, 0.44-0.56). The authors found differences in HAART prescription by gender, race, exposure mode, alcoholism, and provider type for all patients, by CD4 and viral load for patients with no history of ART prescription, and by average number of outpatient visits and viral load for patients with history of ART prescription.

Modifications of health resource-use in Italy after the introduction of highly active antiretroviral therapy (HAART) for human immunodeficiency virus (HIV) infection. Pharmaco-economic implications in a population-based setting

Objective: To assess the impact of highly active antiretroviral therapy (HAART) on health resource utilisation (HRU) and to estimate associated direct costs in a population based setting. Design: Retrospective study of all patients in the Institute of Infectious and Tropical Diseases (Brescia, Northern Italy) during a 4 years period related to the prescription of HAART has been performed: from 1997 (before HAART) to 2000 (after substantial period of HAART prescription). Main outcome measures and results: HIV inpatient admissions (IA's) decreased from 506.8/1000 patients (pts) in 1997 to 246.3/1000 pts in the year 2000. Day care admissions (DCA's) also decreased from 1658.3/1000 pts to 942/1000 pts, while outpatient consultations (OC's) increased from 2046.9/1000 pts to 2590.6/1000 pts in the same years, respectively. By contrast, a relative increase of IA's and DCA's of patients whose serostatus was HIV-negative or unknown has been found. Cost of antiretroviral therapy increased by 2582 Euro (2272 US $), while cost of HIV care (IA+DCA+OC) decreased by 1546 Euro (1360.4 US $) per patient, resulting in a saving in direct cost equal to 60% of the increase in the expenditure for antiretroviral drugs. Conclusions: Our results demonstrate the shift of HIV care from inpatient to outpatient services that occurred after HAART had been introduced into clinical practice. Despite persisting clinical benefits, an increase in total direct cost for HIV pts has been seen for the first time during the HAART era in the year 2000, probably due to an over-prescription of HAART, according to actual Guideline for antiretroviral therapy use, to pts who were not at risk of clinical progression in the short term. Pharmacoeconomical surveillance of HAART is necessary while a favourable impact on the saving in cost is expected from the new treatment guidelines that suggest a relative delay in starting HAART.

The association of perceived health, clinical status, and initiation of HAART (highly active antiretroviral therapy) in adolescents.

To examine factors associated with the initiation of highly active antiretroviral therapy (HAART) in adolescents to understand better how current National Institutes of Health (NIH) Guidelines are being used in practice. HIV infected and HAART-naive adolescents seen at 15 REACH clinical sites were selected. Repeated measures methodology using generalized estimating equations was applied to identify associations between subject demographic characteristics, risk behaviors, perceived health, and clinical status with the outcome measure of HAART initiation during the first 24 study months. A total of 219 subjects were eligible for analysis; HAART was prescribed in 115 (53%). Significant univariate associations with HAART prescription included lower CD4(+) T cell counts (OR = 1.7, 95% CI: 1.1-2.6), higher viral loads (OR = 2.7, 95% CI: 1.5-5.0), and calendar year of HAART prescription (OR as high as 2.4, 95% CI: 1.1-5.2). Multivariate results showed that after controlling for CD4(+) T cell counts below 500 cells/mm(3), higher plasma HIV-1 RNA (<or=10,000 copies per ml), and temporal factors, having a high school diploma/GED but no further education (OR = 2.7, 95% CI: 1.3-5.5) and subject's perception of poor health status (OR = .987; 95% CI: .975- .999) were independently associated with prescription of HAART. HAART was most likely to be prescribed during the first half of 1998 in this cohort (OR = 10.8; 95% CI: 4.0-29.0). In this first ever study of HAART prescription in adolescents infected with HIV, perception of poor health status and having a high school diploma/GED were independently associated with prescription of HAART suggesting that the personal decision to accept therapy is related to the belief that one's health is deteriorating and that the decision to prescribe therapy may be linked in some fashion to the prescriber's assessment of the patient's ability to master the regimen as well as clinical status.