High Levels of Antiretroviral Use and Viral Suppression Among Persons in HIV Care in the United States, 2010

Contemporary data on patterns of antiretroviral therapy (ART) use in the U.S. are needed to inform efforts to improve the HIV care cascade

Using observational data to emulate a randomized trial of dynamic treatment switching strategies

BACKGROUND: When a clinical treatment fails or shows suboptimal results, the question of when to switch to another treatment arises. Treatment switching strategies are often dynamic because the time of switching depends on the evolution of an individual's time-varying covariates. Dynamic strategies can be directly compared in randomized trials. For example, HIV-infected individuals receiving antiretroviral therapy could be randomized to switching therapy within 90 days of HIV-1 RNA crossing above a threshold of either 400 copies/ml (tight-control strategy) or 1000 copies/ml (loose-control strategy).METHODS: We review an approach to emulate a randomized trial of dynamic switching strategies using observational data from the Antiretroviral Therapy Cohort Collaboration, the Centers for AIDS Research Network of Integrated Clinical Systems and the HIV-CAUSAL Collaboration. We estimated the comparative effect of tight-control vs. loose-control strategies on death and AIDS or death via inverse-probability weighting.RESULTS: Of 43 803 individuals who initiated an eligible antiretroviral therapy regimen in 2002 or later, 2001 met the baseline inclusion criteria for the mortality analysis and 1641 for the AIDS or death analysis. There were 21 deaths and 33 AIDS or death events in the tight-control group, and 28 deaths and 41 AIDS or death events in the loose-control group. Compared with tight control, the adjusted hazard ratios (95% confidence interval) for loose control were 1.10 (0.73, 1.66) for death, and 1.04 (0.86, 1.27) for AIDS or death.CONCLUSIONS: Although our effective sample sizes were small and our estimates imprecise, the described methodological approach can serve as an example for future analyses

Late Presentation for HIV Care in the United States and Canada

Initiatives to improve early detection and access to HIV services have increased over time. We assessed the immune status of patients at initial presentation for HIV care from 1997-2007 in 13 US and Canadian clinical cohorts

Effect of Early versus Deferred Antiretroviral Therapy for HIV on Survival

BACKGROUND The optimal time for the initiation of antiretroviral therapy for asymptomatic patients with human immunodeficiency virus (HIV) infection is uncertain. METHODS We conducted two parallel analyses involving a total of 17,517 asymptomatic patients with HIV infection in the United States and Canada who received medical care during the period from 1996 through 2005. None of the patients had undergone previous antiretroviral therapy. In each group, we stratified the patients according to the CD4+ count (351 to 500 cells per cubic millimeter or >500 cells per cubic millimeter) at the initiation of antiretroviral therapy. In each group, we compared the relative risk of death for patients who initiated therapy when the CD4+ count was above each of the two thresholds of interest (early-therapy group) with that of patients who deferred therapy until the CD4+ count fell below these thresholds (deferred-therapy group). RESULTS In the first analysis, which involved 8362 patients, 2084 (25%) initiated therapy at a CD4+ count of 351 to 500 cells per cubic millimeter, and 6278 (75%) deferred therapy. After adjustment for calendar year, cohort of patients, and demographic and clinical characteristics, among patients in the deferred-therapy group there was an increase in the risk of death of 69%, as compared with that in the early-therapy group (relative risk in the deferred-therapy group, 1.69; 95% confidence interval [CI], 1.26 to 2.26; P<0.001). In the second analysis involving 9155 patients, 2220 (24%) initiated therapy at a CD4+ count of more than 500 cells per cubic millimeter and 6935 (76%) deferred therapy. Among patients in the deferred-therapy group, there was an increase in the risk of death of 94% (relative risk, 1.94; 95% CI, 1.37 to 2.79; P<0.001). CONCLUSIONS The early initiation of antiretroviral therapy before the CD4+ count fell below two prespecified thresholds significantly improved survival, as compared with deferred therapy

End-Stage Renal Disease Among HIV-Infected Adults in North America

Background. Human immunodeficiency virus (HIV)-infected adults, particularly those of black race, are at high-risk for end-stage renal disease (ESRD), but contributing factors are evolving. We hypothesized that improvements in HIV treatment have led to declines in risk of ESRD, particularly among HIV-infected blacks

A Single-Item Measure of Health-Related Quality-of-Life for HIV-Infected Patients in Routine Clinical Care

Measurement of health-related quality-of-life (HRQL) captures dimensions of health not otherwise assessed. However, HRQL measurement is time-consuming and difficult to incorporate into a routine clinical care setting. The purpose of this study was to assess the construct validity, discriminative ability, and feasibility of administering a single-item health status measure (EVGGFP) of HRQL rating health as excellent, very good, good, fair, or poor among HIV-infected patients in routine clinical care. Patients attending an urban HIV specialty clinic completed a survey assessing their current symptom burden, HRQL as measured by EVGGFP and by a 7-domain, 21-item HRQL instrument (HRQL-21), and sociodemographic factors ('n' = 269). Patients were predominantly men (91%), 27% reported a history of intravenous drug use, and over half had some college education. We used multiple regression analysis to examine the association between HRQL assessed by EVGGFP and the HRQL-21. We compared the discriminative ability of EVGGFP and the HRQL-21 to detect differences in CD4 cell count, plasma HIV-1 RNA level, and symptom burden. We found that HRQL scores determined by EVGGFP were significantly associated with domain scores from the HRQL-21 (adjusted R² 0.42-0.69). The discriminative ability of EVGGFP was equivalent to that of the HRQL-21. EVGGFP had high sensitivity and low to moderate specificity in identifying patients with poor overall HRQL who might benefit from more comprehensive evaluation of multiple HRQL domains. EVGGFP can be used to assess health status among HIV-infected patients in routine clinical care and may be useful in settings in which comprehensive HRQL assessment is not practical

Primary Care Delivery Is Associated With Greater Physician Experience and Improved Survival Among Persons with AIDS

OBJECTIVE: It has been shown that greater physician experience in the care of persons with AIDS prolongs survival, but how more experienced primary care physicians achieve better outcomes is not known. DESIGN/SETTING/PATIENTS: Retrospective cohort study of HIV-infected patients enrolled in a large staff-model health maintenance organization from 1990 through 1999. MEASUREMENTS: Adjusted odds of medical service delivery and adjusted hazard ratio of death by physician experience level (least, moderate, most) and service utilization. MAIN RESULTS: Primary care delivery by physicians with greater AIDS experience was associated with improved survival. After controlling for disease severity, patients cared for by the most experienced physicians were twice as likely to receive a primary care visit in a given month compared with patients of the least and moderately experienced physicians (

Pharmacy-based assessment of adherence to HAART predict virologic and immunologic treatment response and clinical progression to AIDS and death

Although adherence to HAART at a level above 95% has been associated with optimal viral suppression, the impact of different levels of adherence on long-term clinical outcomes has not been determined. We used an objective pharmacy-based measure to examine the association between three levels of adherence to HAART and disease progression among a population-based cohort of HIV-infected patients attending an urban HIV specialty clinic. Higher levels of adherence to HAART were significantly associated with longer time to virologic failure (P0.2). Patients who progressed to AIDS or death had significantly higher viral loads (P¼0.01) and lower CD4 cell counts (P=0.03) than patients who experienced virologic failure, but did not progress

Ascertainment and Verification of End-Stage Renal Disease and End-Stage Liver Disease in the North American AIDS Cohort Collaboration on Research and Design

The burden of HIV disease has shifted from traditional AIDS-defining illnesses to serious non-AIDS-defining comorbid conditions. Research aimed at improving HIV-related comorbid disease outcomes requires well-defined, verified clinical endpoints. We developed methods to ascertain and verify end-stage renal disease (ESRD) and end-stage liver disease (ESLD) and validated screening algorithms within the largest HIV cohort collaboration in North America (NA-ACCORD). Individuals who screened positive among all participants in twelve cohorts enrolled between January 1996 and December 2009 underwent medical record review to verify incident ESRD or ESLD using standardized protocols. We randomly sampled 6% of contributing cohorts to determine the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ESLD and ESRD screening algorithms in a validation subcohort. Among 43,433 patients screened for ESRD, 822 screened positive of which 620 met clinical criteria for ESRD. The algorithm had 100% sensitivity, 99% specificity, 82% PPV, and 100% NPV for ESRD. Among 41,463 patients screened for ESLD, 2,024 screened positive of which 645 met diagnostic criteria for ESLD. The algorithm had 100% sensitivity, 95% specificity, 27% PPV, and 100% NPV for ESLD. Our methods proved robust for ascertainment of ESRD and ESLD in persons infected with HIV

Factors Associated With Severity of COVID-19 Disease in a Multicenter Cohort of People With HIV in the United States, March-December 2020.

BackgroundUnderstanding the spectrum of COVID-19 in people with HIV (PWH) is critical to provide clinical guidance and risk reduction strategies.SettingCenters for AIDS Research Network of Integrated Clinic System, a US multisite clinical cohort of PWH in care.MethodsWe identified COVID-19 cases and severity (hospitalization, intensive care, and death) in a large, diverse HIV cohort during March 1, 2020-December 31, 2020. We determined predictors and relative risks of hospitalization among PWH with COVID-19, adjusted for disease risk scores.ResultsOf 16,056 PWH in care, 649 were diagnosed with COVID-19 between March and December 2020. Case fatality was 2%; 106 (16.3%) were hospitalized, and 12 died. PWH with current CD4 count &lt;350 cells/mm 3 [aRR 2.68; 95% confidence interval (CI): 1.93 to 3.71; P &lt; 0.001] or lowest recorded CD4 count &lt;200 cells/mm 3 (aRR 1.67; 95% CI: 1.18 to 2.36; P &lt; 0.005) had greater risks of hospitalization. HIV viral load and antiretroviral therapy status were not associated with hospitalization, although most of the PWH were suppressed (86%). Black PWH were 51% more likely to be hospitalized with COVID-19 compared with other racial/ethnic groups (aRR 1.51; 95% CI: 1.04 to 2.19; P = 0.03). Chronic kidney disease, chronic obstructive pulmonary disease, diabetes, hypertension, obesity, and increased cardiovascular and hepatic fibrosis risk scores were associated with higher hospitalization risk. PWH who were older, not on antiretroviral therapy, and with current CD4 count &lt;350 cells/mm 3 , diabetes, and chronic kidney disease were overrepresented among PWH who required intubation or died.ConclusionsPWH with CD4 count &lt;350 cells/mm 3 , and a history of CD4 count &lt;200 cells/mm 3 , have a clear excess risk of severe COVID-19, accounting for comorbidities associated with severe outcomes. PWH with these risk factors should be prioritized for COVID-19 vaccination and early treatment and monitored closely for worsening illness