Vilija R. Joyce

Quality of Life of Patients With Advanced HIV/AIDS: Measuring the Impact of Both AIDS-Defining Events and Non-AIDS Serious Adverse Events

Objective:To investigate the relative magnitude and duration of impact of AIDS-defining events (ADEs) and non-AIDS serious adverse events (SAEs) on health-related quality of life (HRQoL) among patients with advanced HIV/AIDS. Methods:We use data from OPTIMA (OPTions In Management with Antiretrovirals), a multinational, randomized, open, control, clinical management trial of treatment strategies for patients with multidrug-resistant HIV and advanced immune disease. Longitudinal models were used to determine the effects of ADEs and SAEs on HRQoL across periods before, during, and after event onset. The Medical Outcomes Study HIV Health Survey (MOS-HIV) physical and mental health summary scores (MOS-PHS and MOS-MHS), EQ-5D, and the Health Utilities Index Mark 3 HRQoL measures were all assessed at regular follow-up intervals during the trial. Results:ADEs occurred much less frequently than SAEs (n = 147 vs. n = 821) in the study sample population of 368 patients, during median follow-up of 3.96 years. Although both ADEs and SAEs had significant negative impacts on HRQoL, SAEs had at least as large an impact upon HRQoL as ADEs when both were included in a multivariate linear regression model, controlling for other covariates. However, the effect of ADEs on HRQoL was more persistent, with larger magnitude of effect across all instruments in time intervals further from the onset of the event. Conclusions:Non-AIDS SAEs occurring in patients with late-stage HIV/AIDS seem to have at least as important an immediate impact on patient HRQoL as ADEs; however, the impact of ADEs seems to be more persistent. Our findings call for a greater emphasis on the detection and active prevention of non-AIDS SAEs in patients with late-stage HIV/AIDS.

Risk of Cardiovascular Events Associated With Current Exposure to HIV Antiretroviral Therapies in a US Veteran Population

BACKGROUND To characterize the association of antiretroviral drug combinations on risk of cardiovascular events. METHODS Certain antiretroviral medications for human immunodeficiency virus (HIV) have been implicated in increasing risk of cardiovascular disease. However, antiretroviral drugs are typically prescribed in combination. We characterized the association of current exposure to antiretroviral drug combinations on risk of cardiovascular events including myocardial infarction, stroke, percutaneous coronary intervention, and coronary artery bypass surgery. We used the Veterans Health Administration Clinical Case Registry to analyze data from 24 510 patients infected with HIV from January 1996 through December 2009. We assessed the association of current exposure to 15 antiretroviral drugs and 23 prespecified combinations of agents on the risk of cardiovascular event by using marginal structural models and Cox models extended to accommodate time-dependent variables. RESULTS Over 164 059 person-years of follow-up, 934 patients had a cardiovascular event. Current exposure to abacavir, efavirenz, lamivudine, and zidovudine was significantly associated with increased risk of cardiovascular event, with odds ratios ranging from 1.40 to 1.53. Five combinations were significantly associated with increased risk of cardiovascular event, all of which involved lamivudine. One of these-efavirenz, lamivudine, and zidovudine-was the second most commonly used combination and was associated with a risk of cardiovascular event that is 1.60 times that of patients not currently exposed to the combination (odds ratio = 1.60, 95% confidence interval, 1.25-2.04). CONCLUSIONS In the VA cohort, exposure to both individual drugs and drug combinations was associated with modestly increased risk of a cardiovascular event.

Determinants of the cost of health services used by veterans with HIV.

BackgroundThe effect of adherence, treatment failure, and comorbidities on the cost of HIV care is not well understood. ObjectiveTo characterize the cost of HIV care including combination antiretroviral treatment (ART). Research DesignObservational study of administrative data. SubjectsTotal 1896 randomly selected HIV-infected patients and 288 trial participants with multidrug-resistant HIV seen at the US Veterans Health Administration (VHA). MeasuresComorbidities, cost, pharmacy, and laboratory data. ResultsMany HIV-infected patients (24.5%) of the random sample did not receive ART. Outpatient pharmacy accounted for 62.8% of the costs of patients highly adherent with ART, 32.2% of the cost of those with lower adherence, and 6.2% of the cost of those not receiving ART. Compared with patients not receiving ART, high adherence was associated with lower hospital cost, but no greater total cost. Individuals with a low CD4 count (<50 cells/mm3) incurred 1.9 times the cost of patients with counts >500. Most patients had medical, psychiatric, or substance abuse comorbidities. These conditions were associated with greater cost. Trial participants were less likely to have psychiatric and substance abuse comorbidities than the random sample of VHA patients with HIV. ConclusionsPatients receiving combination ART had higher medication costs but lower acute hospital cost. Poor control of HIV was associated with higher cost. The cost of psychiatric, substance abuse, rehabilitation, and long-term care and medications other than ART, often overlooked in HIV studies, was substantial.

Effect of Treatment Interruption and Intensification of Antiretroviral Therapy on Health-Related Quality of Life in Patients with Advanced HIV: A Randomized, Controlled Trial

Background. The effect of antiretroviral therapy (ART) interruption or intensification on health-related quality of life (HRQoL) in advanced HIV patients is unknown. Objective. To assess the impact of temporary treatment interruption and intensification of ART on HRQoL. Design. A 2 x 2 factorial open label randomized controlled trial. Setting. Hospitals in the United States, Canada, and the United Kingdom. Patients. Multidrug resistant (MDR) HIV patients. Intervention. Patients were randomized to receive a 12-wk interruption or not, and ART intensification or standard ART. Measurements. The Health Utilities Index (HUI3), EQ-5D, standard gamble (SG), time tradeoff (TTO), visual analog scale (VAS), and the Medical Outcomes Study HIV Health Survey (MOS-HIV). Results. There were no significant differences in HRQoL among the four groups during follow-up; however, there was a temporary significant decline in HRQoL on some measures within the interruption group during interruption (HUI3 −0.05, P = 0.03; VAS −5.9, P = 0.002; physical health summary −2.9, P = 0.001; mental health summary −1.9, P = 0.02). Scores declined slightly overall during follow-up. Multivariate analysis showed significantly lower HRQoL associated with some clinical events. Limitations. The results may not apply to HIV patients who have not experienced multiple treatment failures or who have not developed MDR HIV. Conclusions. Temporary ART interruption and ART intensification provided neither superior nor inferior HRQoL compared with no interruption and standard ART. Among surviving patients, HRQoL scores declined only slightly over years of follow-up in this advanced HIV cohort; however, approximately one-third of patients died during the trial follow up. Lower HRQoL was associated with adverse clinical events.

Cost-Effectiveness of Supported Employment for Veterans With Spinal Cord Injuries

OBJECTIVE To estimate the cost-effectiveness of a supported employment (SE) intervention that had been previously found effective in veterans with spinal cord injuries (SCIs). DESIGN Cost-effectiveness analysis, using cost and quality-of-life data gathered in a trial of SE for veterans with SCI. SETTING SCI centers in the Veterans Health Administration. PARTICIPANTS Subjects (N=157) who completed a study of SE in 6 SCI centers. Subjects were randomly assigned to the intervention of SE (n=81) or treatment as usual (n=76). INTERVENTION A vocational rehabilitation program of SE for veterans with SCI. MAIN OUTCOME MEASURES Costs and quality-adjusted life years, which were estimated from the Veterans Rand 36-Item Health Survey, extrapolated to Veterans Rand 6 Dimension utilities. RESULTS Average cost for the SE intervention was

Cost-effectiveness of newer antiretroviral drugs in treatment-experienced patients with multidrug-resistant HIV disease.

1821. In 1 year of follow-up, estimated total costs, including health care utilization and travel expenses, and average quality-adjusted life years were not significantly different between groups, suggesting the Spinal Cord Injury Vocational Integration Program intervention was not cost-effective compared with usual care. CONCLUSIONS An intensive program of SE for veterans with SCI, which is more effective in achieving competitive employment, is not cost-effective after 1 year of follow-up. Longer follow-up and a larger study sample will be necessary to determine whether SE yields benefits and is cost-effective in the long run for a population with SCI.

Quality Of End-Of-Life Care Is Higher In The VA Compared To Care Paid For By Traditional Medicare

Objective:Newer antiretroviral drugs provide substantial benefits but are expensive. The cost-effectiveness of using antiretroviral drugs in combination for patients with multidrug-resistant HIV disease was determined. Design:A cohort state-transition model was built representing treatment-experienced patients with low CD4 counts, high viral load levels, and multidrug-resistant virus. The effectiveness of newer drugs (those approved in 2005 or later) was estimated from published randomized trials. Other parameters were estimated from a randomized trial and from the literature. The model had a lifetime time horizon and used the perspective of an ideal insurer in the United States. The interventions were combination antiretroviral therapy, consisting of 2 newer drugs and 1 conventional drug, compared with 3 conventional drugs. Outcome measures were life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness. Results:Substituting newer antiretroviral drugs increased expected survival by 3.9 years in advanced HIV disease. The incremental cost-effectiveness ratio of newer, compared with conventional, antiretroviral drugs was

Mapping MOS-HIV to HUI3 and EQ-5D-3L in Patients With HIV

75,556/QALY gained. Sensitivity analyses showed that substituting only one newer antiretroviral drug cost

Cost-Effectiveness of Treatments for Genotype 1 Hepatitis C Virus Infection in Non-VA and VA Populations

54,559 to

The Effect of Interferon-Free Regimens on Disparities in Hepatitis C Treatment of US Veterans

68,732/QALY, depending on assumptions about efficacy. Substituting 3 newer drugs cost