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To describe the prevalence of diagnosed depression, anxiety, bipolar disorder, and schizophrenia in people with HIV (PWH) and the differences in HIV care continuum outcomes in those with and without mental health disorders (MHDs).Observational study of participants in the North American AIDS Cohort Collaboration on Research and Design.PWH (≥18 years) contributed data on prevalent schizophrenia, anxiety, depressive, and bipolar disorders from 2008 to 2018 based on International Classification of Diseases code mapping. Mental health (MH) multimorbidity was defined as having two or more MHD. Log binomial models with generalized estimating equations estimated adjusted prevalence ratios (aPR) and 95% confidence intervals for retention in care (≥1 visit/year) and viral suppression (HIV RNA ≤200 copies/ml) by presence vs. absence of each MHD between 2016 and 2018.Among 122 896 PWH, 67 643 (55.1%) were diagnosed with one or more MHD: 39% with depressive disorders, 28% with anxiety disorders, 10% with bipolar disorder, and 5% with schizophrenia. The prevalence of depressive and anxiety disorders increased between 2008 and 2018, whereas bipolar disorder and schizophrenia remained stable. MH multimorbidity affected 24% of PWH. From 2016 to 2018 (N = 64 684), retention in care was marginally lower among PWH with depression or anxiety, however those with MH multimorbidity were more likely to be retained in care. PWH with bipolar disorder had marginally lower prevalence of viral suppression (aPR = 0.98 [0.98-0.99]) as did PWH with MH multimorbidity (aPR = 0.99 [0.99-1.00]) compared with PWH without MHD.The prevalence of MHD among PWH was high, including MH multimorbidity. Although retention and viral suppression were similar to people without MHD, viral suppression was lower in those with bipolar disorder and MH multimorbidity.

BackgroundDuring the COVID-19 pandemic, patients experienced significant care disruptions, including lab monitoring. We investigated changes in the time between viral load (VL) checks for people with HIV associated with the pandemic.MethodsThis was an observational analysis of VLs of people with HIV in routine care at a large subspecialty clinic. At pandemic onset, the clinic temporarily closed its onsite laboratory. The exposure was time period (time-varying): pre-pandemic (January 1st 2019-March 15th, 2020); pandemic lab-closed (March 16th-July 12th, 2020); and pandemic lab-open (July 13th-December 31st, 2020). We estimated time from an index VL to a subsequent VL, stratified by whether the index VL was suppressed (≤200 copies/mL). We also calculated cumulative incidence of a non-suppressed VL following a suppressed index VL, and of re-suppression following a loss of viral suppression.ResultsCompared to pre-pandemic, hazard ratios for next VL check were: 0.34 (95% CI: 0.30, 0.37, lab-closed) and 0.73 (CI: 0.68, 0.78, lab-open) for suppressed patients; 0.56 (CI: 0.42, 0.79, lab-closed) and 0.92 (95% CI: 0.76, 1.10, lab-open) for non-suppressed patients. The 12-month cumulative incidence of loss of suppression was the same in the pandemic lab-open (4%) and pre-pandemic period (4%). The hazard of re-suppression following loss of suppression was lower during the pandemic lab-open versus the pre-pandemic period (hazard ratio: 0.68, 95% CI: 0.50, 0.92).ConclusionsEarly pandemic restrictions and lab closure significantly delayed VL monitoring. Once the lab re-opened, non-suppressed patients resumed normal monitoring. Suppressed patients still had a delay, but no significant loss of suppression.SummaryDuring the early COVID-19 pandemic, people with HIV experienced disruptions in viral load monitoring due to lab closure and pandemic restrictions. Loosening restrictions resolved delays for non-suppressed, but not suppressed patients. Delays did not significantly increase proportion of non-suppressed patients.

BACKGROUND: People with HIV (PWH) have a higher hospitalization rate than the general population. The Veterans Aging Cohort Study (VACS) Index at study entry well predicts hospitalization in PWH, but it is unknown if the time-updated parameter improves hospitalization prediction. We assessed the association of parameterizations of the VACS Index 2.0 with the 5-year risk of hospitalization. SETTING: PWH ≥ 30 years old with at least 12 months of antiretroviral therapy (ART) use, and contributing hospitalization data from 2000 to 2016 in North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) were included. Three parameterizations of the VACS Index 2.0 were assessed and categorized by quartile: 1) “baseline” measurement at study entry, 2) time-updated measurements, and 3) cumulative scores calculated using the trapezoidal rule. METHODS: Discrete-time proportional hazard models estimated the crude and adjusted associations (and 95% confidence intervals [CI]) of the VACS Index parameterizations and all-cause hospitalizations. The Akaike information criterion (AIC) assessed the model fit with each of the VACS Index parameters. RESULTS: Among 7,289 patients, 1,537 were hospitalized. Time-updated VACS Index fitted hospitalization best with a more distinct dose-response relationship (score

OBJECTIVE To project the future age distribution of people with HIV using antiretroviral therapy (ART) in the US, under expected trends in HIV diagnosis and survival (baseline scenario) and achieving the Ending the HIV Epidemic (EHE) goals of a 75% reduction in HIV diagnoses from 2020-25 and sustaining levels to 2030 (EHE75% scenario). DESIGN An agent-based simulation model with mathematical functions estimated from North American AIDS Cohort Collaboration on Research and Design data and parameters from the US Centers for Disease Control and Prevention's annual HIV surveillance reports. METHODS The PEARL (ProjEcting Age, multimoRbidity, and poLypharmacy in adults with HIV) model simulated individuals in 15 subgroups of sex-and-HIV acquisition risk and race/ethnicity. Simulation outcomes from the baseline scenario are compared with outcomes from the EHE75% scenario. RESULTS Under the baseline scenario, PEARL projects a substantial increase in number of ART-users over time, reaching a population of 909,638 [95%uncertaintyrange(UR):878,449-946,513] by 2030. The overall median age increased from 50 years (y) in 2020 to 52y in 2030, with 23% of ART-users age ≥65y in 2030. Under the EHE75% scenario, the projected number of ART-users was 718,348 [703,044-737,817] (median age=56y) in 2030, with a 70% relative reduction in ART-users

OBJECTIVE To examine recent trends and differences in all-cause and cause-specific hospitalization rates by race, ethnicity, and gender among persons with HIV (PWH) in the United States and Canada. DESIGN HIV clinical cohort consortium. METHODS We followed PWH at least 18 years old in care 2005-2015 in six clinical cohorts. We used modified Clinical Classifications Software to categorize hospital discharge diagnoses. Incidence rate ratios (IRR) were estimated using Poisson regression with robust variances to compare racial and ethnic groups, stratified by gender, adjusted for cohort, calendar year, injection drug use history, and annually updated age, CD4+, and HIV viral load. RESULTS Among 27 085 patients (122 566 person-years), 80% were cisgender men, 1% transgender, 43% White, 33% Black, 17% Hispanic of any race, and 1% Indigenous. Unadjusted all-cause hospitalization rates were higher for Black [IRR 1.46, 95% confidence interval (CI) 1.32-1.61] and Indigenous (1.99, 1.44-2.74) versus White cisgender men, and for Indigenous versus White cisgender women (2.55, 1.68-3.89). Unadjusted AIDS-related hospitalization rates were also higher for Black, Hispanic, and Indigenous versus White cisgender men (all P

BACKGROUND Adolescents and young adults (AYA) with HIV experience poorer health outcomes compared with adults. To improve care for AYA with HIV, information about patterns of costly health care resource utilization is needed. METHODS Among 13-30 year olds in the US HIV Research Network, we stratified outpatient visits, emergency department (ED) visits, and inpatient days/person-year (PY) by HIV acquisition model [perinatal (PHIVY) and nonperinatal (NPHIVY)], age (13-17, 18-23, and 24-30 years), CD4 strata (

Author(s): Krebs, Emanuel; Zang, Xiao; Enns, Benjamin; Min, Jeong E; Behrends, Czarina N; Del Rio, Carlos; Dombrowski, Julia C; Feaster, Daniel J; Gebo, Kelly A; Golden, Matthew; Marshall, Brandon DL; Metsch, Lisa R; Schackman, Bruce R; Shoptaw, Steven; Strathdee, Steffanie A; Nosyk, Bohdan; Localized Economic Modeling Study Group | Abstract: ObjectiveEffective interventions to reduce the public health burden of HIV/AIDS can vary in their ability to deliver value at different levels of scale and in different epidemiological contexts. Our objective was to determine the cost-effectiveness of HIV treatment and prevention interventions implemented at previously documented scales of delivery in six US cities with diverse HIV microepidemics.DesignDynamic HIV transmission model-based cost-effectiveness analysis.MethodsWe identified and estimated previously documented scale of delivery and costs for 16 evidence-based interventions from the US CDC's Compendium of Evidence-Based Interventions and Best Practices for HIV Prevention. Using a model calibrated for Atlanta, Baltimore, Los Angeles, Miami, New York City and Seattle, we estimated averted HIV infections, quality-adjusted life years (QALY) gained and incremental cost-effectiveness ratios (healthcare perspective; 3% discount rate, 2018$US), for each intervention and city (10-year implementation) compared with the status quo over a 20-year time horizon.ResultsIncreased HIV testing was cost-saving or cost-effective across cities. Targeted preexposure prophylaxis for high-risk MSM was cost-saving in Miami and cost-effective in Atlanta ($6123/QALY), Baltimore ($18 333/QALY) and Los Angeles ($86 117/QALY). Interventions designed to improve antiretroviral therapy initiation provided greater value than other treatment engagement interventions. No single intervention was projected to reduce HIV incidence by more than 10.1% in any city.ConclusionCombination implementation strategies should be tailored to local epidemiological contexts to provide the most value. Complementary strategies addressing factors hindering access to HIV care will be necessary to meet targets for HIV elimination in the United States.

BACKGROUND: Despite the high prevalence of hepatitis C virus (HCV) among persons living with HIV (PWH), the prevalence of HCV screening, treatment, and sustained virologic response (SVR) is unknown. This study aims to characterize the continuum of HCV screening and treatment among PWH in HIV care. SETTING: Adult patients enrolled at 12 sites of the HIV Research Network located in 3 regions of the United States were included. METHODS: We examined the prevalence of HCV screening, HCV coinfection, direct-acting antiretroviral (DAA) treatment, and SVR-12 between 2014 and 2015. Multivariate logistic regression was performed to identify characteristics associated with outcomes, adjusted for site. RESULTS: Among 29,071 PWH (age 18–87, 74.8% male, 44.4% black), 77.9% were screened for HCV antibodies; 94.6% of those screened had a confirmatory HCV RNA viral load test. Among those tested, 61.1% were determined to have chronic HCV. We estimate that only 23.4% of those eligible for DAA were prescribed DAA, and only 17.8% of those eligible evidenced initiating DAA treatment. Those who initiated treatment achieved SVR-12 at a rate of 95.2%. Blacks and people who inject drugs (PWID) were more likely to be screened for HCV than whites or those with heterosexual risk. Persons older than 40 years, whites, Hispanics, and PWID [adjusted odds ratio (AOR) 8.70 (7.74 to 9.78)] were more likely to be coinfected than their counterparts. When examining treatment with DAA, persons older than 50 years, on antiretroviral therapy [AOR 2.27 (1.11 to 4.64)], with HIV-1 RNA

Background Prescription opioid use is greater among people living with HIV (PLWH), yet little is known about the prevalence of specific types of high-risk use among these individuals. Setting We analyzed clinical and demographic data from the HIV Research Network and prescribing data from Medicaid for noncancer patients seeking HIV treatment at 4 urban clinics between 2006 and 2010. Methods HIV Research Network patients were included in the analytic sample if they received at least one incident opioid prescription. We examined 4 measures of high-risk opioid use: (1) high daily dosage; (2) early refills; (3) overlapping prescriptions; and (4) multiple prescribers. Results Of 4605 eligible PLWH, 1814 (39.4%) received at least one incident opioid prescription during follow-up. The sample was 61% men and 62% African American with a median age of 44.5 years. High-risk opioid use occurred among 30% of incident opioid users (high daily dosage: 7.9%; early refills: 15.9%; overlapping prescriptions: 16.4%; and multiple prescribers: 19.7%). About half of the cumulative incidence of high-risk use occurred within 1 year of receiving an opioid prescription. After adjusting for study site, high-risk opioid use was greater among patients with injection drug use as an HIV risk factor [adjusted hazard ratio (aHR) = 1.39, 95% confidence interval: 1.11 to 1.74], non-Hispanic whites [aHR = 1.61, (1.21 to 2.14)], patients age 35-45 [aHR = 1.94, (1.33 to 2.80)] and 45-55 [aHR = 1.84, (1.27 to 2.67)], and patients with a diagnosis of chronic pain [aHR = 1.32, (1.03 to 1.70)]. Conclusions A large proportion of PLWH received opioid prescriptions, and among these opioid recipients, high-risk opioid use was common. High-risk use patterns often occurred within the first year, suggesting this is a critical time for intervention.

BACKGROUND Some individuals who appear poorly retained by clinic visit-based retention measures are using antiretroviral therapy (ART) and maintaining viral suppression. We examined whether individuals with a gap in HIV primary care (≥180 days between HIV outpatient clinic visits) obtained ART during that gap after 180 days. SETTING HIV Research Network data from 5 sites and Medicaid Analytic Extract eligibility and pharmacy data were combined. METHODS Factors associated with having both an HIV primary care gap and a new (ie, nonrefill) ART prescription during a gap were evaluated with multinomial logistic regression. RESULTS Of 6892 HIV Research Network patients, 6196 (90%) were linked to Medicaid data, and 4275 had any Medicaid ART prescription. Over half (54%) had occasional gaps in HIV primary care. Women, older people, and those with suppressed viral load were less likely to have a gap. Among those with occasional gaps (n = 2282), 51% received a new ART prescription in a gap. Viral load suppression before gap was associated with receiving a new ART prescription in a gap (odds ratio = 1.91, 95% confidence interval: 1.57 to 2.32), as was number of days in a gap (odds ratio = 1.04, 95% confidence interval: 1.02 to 1.05), and the proportion of months in the gap enrolled in Medicaid. CONCLUSIONS Medicaid-insured individuals commonly receive ART during gaps in HIV primary care, but almost half do not. Retention measures based on visit frequency data that do not incorporate receipt of ART and/or viral suppression may misclassify individuals who remain suppressed on ART as not retained.

Screening persons living with HIV for gonorrhea and chlamydia has been recommended since 2003. We compared annual gonorrhea/chlamydia testing to syphilis and lipid testing among 19,368 adults (41% men who have sex with men, 30% heterosexual men, and 29% women) engaged in HIV care. In 2004, 22%, 62%, and 70% of all patients were tested for gonorrhea/chlamydia, syphilis, and lipid levels, respectively. Despite increasing steadily [odds ratio per year (95% confidence interval): 1.14 (1.13 to 1.15)], gonorrhea/chlamydia testing in 2010 remained lower than syphilis and lipid testing (39%, 77%, 76%, respectively). Interventions to improve gonorrhea/chlamydia screening are needed. A more targeted screening approach may be warranted.

BACKGROUND Earlier HIV diagnosis and engagement in care improve outcomes and is cost effective, as a result, in 2006, the Centers for Disease Control and Prevention (CDC) revised the HIV-screening guidelines. We sought to determine whether the CD4 count (CD4) at presentation, a surrogate for time to presentation, increased during the study period. Our a priori hypothesis was that the CD4 at presentation increased during the study period, particularly after the CDC guideline revision. METHODS We performed a retrospective cohort study and analyzed data from the HIV Research Network, a consortium of 18 US clinics caring for HIV-infected patients. HIV-infected adults (≥18 years old) newly presenting for care between 2003 and 2011 were included in this study. Multivariable linear regression examined associations with CD4 at enrollment. Calendar year was modeled as a linear spline with a change in slope at 2008, allowing determination of the mean change in CD4 per year during 2003-2007 and 2008-2011. RESULTS Over 13,543 newly presenting subjects enrolled from 2003 to 2011. Median CD4 at enrollment rose from 285 to 317 cells per cubic millimeter between 2003-2007 and 2008-2011 (P < 0.001). After adjusting for age, race/ethnicity, gender, HIV risk factor, and clinic site, the mean increase in the CD4 count at presentation per year was 13.3 cells per cubic millimeter per year (95% confidence interval 6.4 to 20.1 cells per cubic millimeter per year) greater during 2008-2011 than during 2003-2007. CONCLUSIONS We demonstrate a small, but statistically significant, increase in CD4 at presentation after the CDC guideline revision. More efforts are needed to decrease time to presentation to HIV care.

We examined trends in health insurance coverage among 36,999 HIV-infected adults in care at 11 US HIV clinics between 2006 and 2012. Aggregate health insurance coverage was stable during this time. The proportions of patient-years with private, Medicaid, Medicare, and no insurance during this period were 15.9%, 35.7%, 20.1%, and 28.4%, respectively. Medicaid coverage was more prevalent among women than men, blacks, and Hispanics than whites, and individuals with injection drug use risk compared with other transmission risk factors. Hispanics and younger age groups were more likely to be uninsured than other racial/ethnic and older age groups, respectively.

Objective Clostridium difficile is the most commonly reported infectious diarrhoea in HIV-infected patients in the United States. We set out to determine the incidence, risk factors and clinical presentation of C. difficile infections (CDIs) in a cohort of HIV-infected individuals. Design We performed a nested, case-control analysis with four non-CDI controls randomly selected for each case. Methods We assessed the incidence of CDI in the Johns Hopkins HIV Clinical Cohort between 1 July 2003 and 31 December 2010. Incident cases were defined as first positive C. difficile cytotoxin assay or PCR for toxin B gene. We used conditional logistic regression models to assess risk factors for CDI. We abstracted data on the clinical presentation and outcomes from case chart review. Results We identified 154 incident CDI cases for an incidence of 8.3 cases per 1000 patient years. No unique clinical features of HIV-associated CDI were identified. In multivariate analysis, risk of CDI was independently increased for CD4 cell count of 50 cells/μl or less [adjusted odds ratio (AOR) 20.7, 95% confidence interval (CI) 2.8-151.4], hospital onset CDI (AOR 26.7, 95% CI 3.1-231.2) and use of clindamycin (AOR 27.6, 95% CI 2.2-339.4), fluoroquinolones (AOR 4.5, 95% CI 1.2-17.5), macrolides (AOR 6.3, 95% CI 1.8-22.1), gastric acid suppressants (AOR 3.1, 95% CI 1.4-6.9) or immunosuppressive agents (AOR 6.8, 95% CI 1.2-39.6). Conclusion The incidence of CDI in HIV-infected patients was twice that previously reported. Our data show that compromised cellular immunity, as defined by CD4 cell count of 50 cells/μl or less, is a risk factor for CDI. Clinicians should be aware of the increased CDI risk, particularly in those with severe CD4 cell count suppression.

Objective HIV infection and low CD4+ T-cell count are associated with an increased risk of persistent oncogenic HPV infection – the major risk factor for cervical cancer. Few reported prospective cohort studies have characterized the incidence of invasive cervical cancer (ICC) in HIV-infected women.

Retention in care is key to improving HIV outcomes. The goal of this study was to describe 'churn' in patterns of entry, exit, and retention in HIV care in the United States and Canada.Adults contributing ≥1 CD4 count or HIV-1 RNA (HIV-lab) from 2000 to 2008 in North American AIDS Cohort Collaboration on Research and Design clinical cohorts were included. Incomplete retention was defined as lack of 2 HIV-laboratories (≥90 days apart) within 12 months, summarized by calendar year. Beta-binomial regression models were used to estimate adjusted odds ratios (OR) and 95% confidence intervals (CI) of factors associated with incomplete retention.Among 61,438 participants, 15,360 (25%) with incomplete retention significantly differed in univariate analyses (P0.001) from 46,078 (75%) consistently retained by age, race/ethnicity, HIV risk, CD4, antiretroviral therapy use, and country of care (United States vs. Canada). From 2000 to 2004, females (OR = 0.82, CI: 0.70 to 0.95), older individuals (OR = 0.78, CI: 0.74 to 0.83 per 10 years), and antiretroviral therapy users (OR = 0.61, CI: 0.54 to 0.68 vs. all others) were less likely to have incomplete retention, whereas black individuals (OR = 1.31, CI: 1.16 to 1.49, vs. white), those with injection drug use HIV risk (OR = 1.68, CI: 1.49 to 1.89, vs. noninjection drug use), and those in care longer (OR = 1.09, CI: 1.07 to 1.11 per year) were more likely to have incomplete retention. Results from 2005 to 2008 were similar.From 2000 to 2008, 75% of the North American AIDS Cohort Collaboration on Research and Design population was consistently retained in care with 25% experiencing some changes in status or churn. In addition to the programmatic and policy implications, the findings of this study identify patient groups who may benefit from focused retention efforts.

With the advent of effective antiretroviral therapy (ART), the spectrum of disease experienced by those with HIV infection has changed. Viral suppression is common1 and incident AIDS defining events are rare.2 Yet, those with HIV infection continue to experience excess mortality 3;4 which is incompletely described by age, CD4 count, and HIV-1 RNA alone.5 Despite ART, chronic HIV infection appears to exacerbate generic pathophysiologic processes associated with aging which increase physiologic vulnerability relative to demographically similar uninfected individuals.6–8 Consistent with current treatment guidelines9, HIV providers routinely monitor general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV) but have no index with which to integrate these data into an overall estimate of disease burden or mortality risk. Such a comprehensive measure would be useful as a means of more effectively motivating behavior change in the clinical setting10, improved risk stratification in the analysis of observational data11 and more effective randomized trials12. For example, indices such as the Framingham Risk Index has enhanced research and care in cardiovascular disease13 and several geriatric risk indices are enhancing research and care for those aging without HIV infection.14 While the cumulative evidence supporting the accuracy and generalizability of the VACS Index exceeds that for any prior HIV risk index, the VACS Index builds upon important prior research.15–22 Most prior indices emphasized AIDS defining conditions, CD4 cell count, and HIV-1 RNA. Some recognized the importance of age and anemia16;20. However much has changed since these indices were developed and validated. Specifically, the increasing role of multi-organ system injury (reflected by FIB 4, eGFR, and hemoglobin) and of hepatitis C infection (HCV), and the decreasing role of AIDS Defining Illnesses, CD4 count, and HIV-1 RNA. By including FIB-4, HCV, eGFR, hemoglobin and age, and placing less weighting upon CD4 count and HIV-1 RNA, the VACS Index better reflects more of the major common pathways of physiologic injury among those on antiretroviral therapy. As a result, the Veterans Aging Cohort Study Index (VACS Index) discriminates risk of mortality more effectively than an index restricted to CD4 count, HIV-1 RNA and age (Restricted Index).23 24 Importantly, the discrimination of the VACS Index rivals that of indices in clinical use including the Framingham Index13 and those recommended for use among geriatric patients.14 Nevertheless, prognostic indices developed in one sample (those within the Veterans Affairs Healthcare System (VA)) may not generalize to a new sample or important subgroups.25 Further, indices effective at one particular point in clinical care (ART initiation) may not generalize beyond treatment initation.25 We use data from the North American AIDS Cohort Collaboration (NA-ACCORD) to test the generalizability of the VACS Index outside the VA and at differing intervals of exposure to ART. We then combine data from NA-ACCORD and VA to translate index scores to an estimated absolute risk of mortality and compare predicted to observed mortality by cohort and subgroups defined by sex, age, race, and HIV-1 RNA titer.

The incidence of and risk factors for community-acquired pneumonia (CAP) are described from 2000 to 2005 in a multicenter US cohort of HIV-infected children. In 736 patients, 87 episodes of CAP (33.2 events/1000 person-years) had a mean CD4% of 23% (controls: 30%) and mean CD4 cell count of 668 cells/μl (controls: 870 cells/μl). CAP incidence decreased 44% from 2000-2001 to 2002-2005. On multivariate analysis, viral load at least 100 000 copies/ml (odds ratio 3.98; confidence interval 1.05-15.13) was associated with CAP. Herd immunity through pneumococcal immunization may have diluted the effect of individual immunization in this cohort.

Background: The delivery of HIV healthcare historically has been expensive. The most recent national data regarding HIV healthcare costs were from 1996–1998. We provide updated estimates of expenditures for HIV management. Methods: We performed a cross-sectional review of medical records at 10 sites in the HIV Research Network, a consortium of high-volume HIV care providers across the United States. We assessed inpatient days, outpatient visits, and prescribed antiretroviral and opportunistic illness prophylaxis medications for 14 691 adult HIV-infected patients in primary HIV care in 2006. We estimated total care expenditures, stratified by the median CD4 cell count obtained in 2006 (� 50, 51–200, 201–350, 351–500, >500 cells/ml). Per-unit costs of care were based on Healthcare Cost and Utilization Project (HCUP) data for inpatient care, discounted average wholesale prices for medications, and Medicare physician fees for outpatient care. Results: Averaging over all CD4 strata, the mean annual total expenditures per person for HIV care in 2006 in three sites was US $19 912, with an interquartile range from US $11 045 to 22 626. Average annual per-person expenditures for care were greatest for those with CD4 cell counts 50 cell/ml or less (US $40 678) and lowest for those with CD4 cell counts more than 500 cells/ml (US $16 614). The majority of costs were attributable to medications, except for those with CD4 cell counts 50 cells/ml or less, for whom inpatient costs were highest. Conclusion: HIV healthcare in the United States continues to be expensive, with the majority of expenditures attributable to medications. With improved HIV survival, costs may increase and should be monitored in the future. 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins AIDS 2010, 24:2705–2715

OBJECTIVES The prevalence of HIV infection in older patients (> or =50 years) is increasing due to HAART, and new HIV infections in older patients. Some earlier studies suggest that older patients respond differently to HAART than younger patients. The objective of this study is to compare the effectiveness of HAART in older and younger HIV patients. DESIGN Retrospective analysis of an observational clinical cohort. METHODS Virologic and immunologic response, progression to AIDS and mortality were compared between 670 younger patients ( or =50 years) by t-test, Kaplan-Meier methods, and multivariate Cox proportional hazards analysis. RESULTS Compared with younger patients, older patients were more likely to be on nonnucleoside reverse transcriptase inhibitors based versus protease inhibitor based regimens (42 vs. 29%, P < 0.01). Time to HIV-1 RNA virologic suppression was less in older than in younger patients (3.2 vs. 4.4 months, P < 0.01). Immunologic response did not differ by age. Older patients had fewer AIDS-defining opportunistic infections (22 vs. 31%, P < 0.01), but higher mortality (36 vs. 27%, P = 0.04) and shorter survival (25th percentile survivor function 36.2 vs. 58.5 months, P = 0.02) than younger patients. Older age was associated with more rapid virologic suppression [adjusted hazard ratio = 1.33 (1.09-1.63)] and earlier mortality [adjusted hazard ratio = 1.56 (1.14-2.14)]. Nonnucleoside reverse transcriptase inhibitors based regimens were associated with more rapid virologic suppression [adjusted hazard ratio = 1.22 (1.03-1.44)]. CONCLUSION Time to virologic suppression after HAART initiation was shorter in older patients, although CD4 response did not differ by age. Older patients had fewer opportunistic infections, but survival was shorter. Our data suggest a need to better understand causes of mortality in older patients.

To describe the risk factors, clinical presentation, and long-term follow up of patients enrolled in a clinical cohort of HIV-infected patients who were diagnosed and treated for neurosyphilis.Comprehensive demographic, clinical, and therapeutic data were collected prospectively on all patients between 1990 and 2006. Patients were diagnosed with neurosyphilis if they had positive syphilis serologies and any of the following: (a) one or more cerebrospinal fluid abnormalities on lumbar puncture [white blood cells10/microl; protein50 mg/dl; reactive venereal diseases research laboratory], (b) an otherwise unexplained neurological finding.Of 231 newly diagnosed syphilis cases, 41 neurosyphilis cases met entry criteria (median age 38.6 years, 79.1% male). Risk factors for neurosyphilis included a CD4 cell count of less than 350 cells/ml at the time of syphilis diagnosis (odds ratio: 2.87; 95% confidence interval: 1.18-7.02), a rapid plasma regain titer1: 128 (2.83; 1.11-7.26), and male sex (2.46; 1.06-5.70). Use of any highly active antiretroviral therapy before syphilis infection reduced the odds of neurosyphilis by 65% (0.35; 0.14-0.91). Sixty-three percent of cases presented with early neurosyphilis and the median time to neurosyphilis diagnosis was 9 months. Symptomatic patients had more cerebrospinal fluid abnormalities on initial lumbar puncture than asymptomatic patients (P = 0.01). Follow-up lumbar puncture within 12 months revealed that only 38% had resolution of all cerebrospinal fluid abnormalities. At 1 year, 38% had persistence of their major symptom despite adequate treatment for neurosyphilis. Twelve of 41 (29%) patients were retreated for syphilis.Early neurosyphilis was common in this cohort. Highly active antiretroviral therapy to reverse immunosuppression may help mitigate neurological complications of syphilis.

To investigate the association between the introduction of HAART and invasive pneumococcal disease (IPD) in HIV-infected patients.Incidence of IPD was determined from 1990 to 2003 in a cohort of HIV-infected individuals and a nested case-control study assessed risk factors of IPD.There were 72 cases over 19,020 person-years of follow-up (overall IPD rate, 379/100,000 person-years). In the calendar periods 1990-1995, 1995-1998, and 1998-2003, the IPD incidence per 100,000 person-years was 279 [95% confidence interval (CI), 150-519], 377 (95% CI, 227-625) and 410 (95% CI, 308-545), respectively (P = 0.516). CD4 cell count200 cells/microl [odds ratio (OR), 3.0; 95% CI, 1.2-7.6), HIV RNA50,000 copies/ml (OR, 2.8; 95% CI, 1.2-6.5), hepatitis C (OR, 4.9; 95% CI, 1.7-14.9), serum albumin (OR, 0.1; 95% CI, 0.04-0.5), injection drug use in women (OR, 3.8; 95% CI, 1.6-8.8), and education beyond high school (OR, 0.2; 95% CI, 0.05-0.8) were significantly associated with IPD in multivariate analysis. No treatment factor, including HAART (OR, 0.7; 95% CI, 0.3-1.5) and pneumococcal vaccination (OR, 0.9; 95% CI, 0.5-1.6), was associated with IPD.IPD incidence did not change significantly during the widespread dissemination of HAART in this cohort. IPD risk was associated with several sociodemographic and clinical factors.

Background: National data from the mid-1990s demonstrated that many eligible patients did not receive highly active antiretroviral therapy (HAART) and that racial and gender disparities existed in HAART receipt. We examined whether demographic disparities in the use of HAART persist in 2001 and if outpatient care is associated with HAART utilization. Methods: Demographic, clinical, and pharmacy utilization data were collected from 10 US HIV primary care sites in the HIV Research Network (HIVRN). Using multivariate logistic regression, we examined demographic and clinical differences associated with receipt of HAART and the association of outpatient utilization with HAART. Results: In our cohort in 2001, 84% of patients received HAART and 66% had 4 or more outpatient visits during calendar year (CY) 2001. Of those with 2 or more CD4 counts below 350 cells/mm 3 in 2001, 91% received HAART; 82% of those with 1 CD4 test result below 350 cells/mm 3 received HAART; and 77% of those with no CD4 counts below 350 cells/mm 3 received HAART. Adjusting for care site in multivariate analyses, age >40 years (adjusted odds ratio [AOR] = 1.13), male gender (AOR = 1.23), Medicaid coverage (AOR = 1.16), Medicare coverage (AOR = 1.73), having 1 or more CD4 counts less than 350 cells/mm 3 (AOR = 1.33), and having 4 or more outpatient visits in a year (OR = 1.34) were significantly associated with an increased likelihood of HAART. African Americans (odds ratio [OR] = 0.84) and those with an injection drug use risk factor (OR = 0.86) were less likely to receive HAART. Conclusions: Although the overall prevalence of HAART has increased since the mid-1990s, demographic disparities in HAART receipt persist. Our results support attempts to increase access to care and frequency of outpatient visits for underutilizing groups as well as increased efforts to reduce persistent disparities in women, African Americans, and injection drug users (IDUs).

To examine the epidemiology, treatment patterns, and costs of cytomegalovirus (CMV) retinitis treatment in the post-HAART (highly active antiretroviral therapy) era, a retrospective cohort study was performed using data from US managed-care plans from 1997-2002. Cases with CMV retinitis were defined by requiring diagnosis codes for HIV (or AIDS), CMV, and retinitis and claims for anti-CMV treatment. Costs of oral, intravenous, and intraocular treatment periods were examined. The incidence of enrolled HIV or AIDS cases increased from 7 per million members in 1997 to 150 per million members in 2001. The incidence of CMV retinitis decreased from 23 per 10,000 HIV or AIDS cases in 1997 to 8 per 10,000 HIV or AIDS cases in 2001. The average duration of a CMV episode was 192 days and the average cost was 19,576 US dollars. In a multiple linear regression model adjusting for age, gender, insurance type, geographic region, HAART use, and co-existing AIDS-defining illnesses, intraocular and oral treatment periods saved 7135 and US dollars and 6866 US dollars, respectively, per treatment period compared with intravenous treatment (P < 0.05). The incidence of CMV retinitis decreased in this managed-care population during the post-HAART era. Use of oral or intraocular treatment saves costs compared with intravenous treatment in a managed-care environment.

Current guidelines recommend consideration of CD4 cell percentage as well as CD4 cell count in therapeutic decisions. The relative value of CD4 cell count compared with CD4 cell percentage in predicting risk of AIDS-defining illnesses (ADIs) in the post-HAART (highly active antiretroviral therapy) era is unknown. Data from an observational clinical cohort of adult HIV-infected patients were used to assess the risk of developing an ADI associated with specific absolute CD4 counts (CD4) and CD4%'s (CD4%) using all CD4-CD4% pairs obtained after January 1996. The incidence of developing an ADI was assessed over a maximum of 6 months after the CD4-CD4% pair was obtained. Using multivariable negative binomial regression, the incidence rate ratio (IRR) for developing an ADI by CD4 and CD4% categories was computed. A total of 15,736 CD4-CD4% pairs from 2185 patients who developed 608 ADIs was analyzed. The IRR for developing an ADI by absolute CD4 was 17.9 (95% CI: 13.2, 24.4) events/100 person-years for50 cells/mm, 6.2 (95% CI: 4.4, 7.9) for 50-100 cells/mm, and 2.7 (95% CI: 1.9, 4.0) for 100-200 cells/mm, compared with the referent stratum of 200-350 cells/mm. Without adjustment for absolute CD4, the IRR was 14.4 (95% CI: 9.3,22.6) for CD4%7%, 3.7 (95% CI: 2.4,5.9) for 7-14%, 1.9 (95% CI: 1.1, 3.1) for 15-21%, compared with the referent stratum of21%. However, in a multivariable analysis adjusting for absolute CD4, CD4%, and other clinical and demographic variables, the absolute CD4 but not the CD4% was associated strongly with developing an ADI. The results suggest that CD4% adds little further predictive information after accounting for the absolute CD4 count for the short-term risk of developing an ADI. The absolute CD4 count is the more important measure of immune status and is preferred over the CD4% for making treatment decisions in HIV-infected adults.

This systematic review addresses 2 questions pertinent to the need for pretreatment liver biopsy in patients with chronic hepatitis C: how well do liver biopsy results predict treatment outcomes for chronic hepatitis C? How well do biochemical blood tests and serologic measures of fibrosis predict the biopsy findings in chronic hepatitis C? Medline and other electronic databases were searched from January 1985 to March 2002. Additional articles were sought in references of pertinent articles and recent journals and by querying experts. Articles were eligible for review if they reported original human data from a study that used virological, histological, pathologic, or clinical outcome measures. Paired reviewers assessed the quality of each eligible study and abstracted data. Studies suggested that advanced fibrosis or cirrhosis on initial liver biopsy is associated with a modestly decreased likelihood of a sustained virological response (SVR) to treatment. Also, studies relatively consistently showed that serum aminotransferases have modest value in predicting fibrosis on biopsy; that extracellular matrix tests hyaluronic acid and laminin may have value in predicting fibrosis, and that panels of tests may have the greatest value in predicting fibrosis or cirrhosis. Biochemical and serologic tests were best at predicting no or minimal fibrosis, or at predicting advanced fibrosis/cirrhosis, and were poor at predicting intermediate levels of fibrosis. Thus, evidence suggests that liver biopsy may have some usefulness in predicting efficacy of treatment in patients with chronic hepatitis C, and biochemical blood tests and serologic tests currently have only modest value in predicting fibrosis on liver biopsy.

This systematic review addresses the following questions: (1) What is the efficacy of using screening tests for hepatocellular carcinoma (HCC) in improving outcomes in chronic hepatitis C, and (2) what are the sensitivity and specificity of screening tests for HCC in chronic hepatitis C? The search strategy involved searching Medline and other electronic databases between January 1985 and March 2002. Additional articles were identified by reviewing pertinent articles and journals and by querying experts. Articles were eligible for review if they reported original human data from studies of screening tests that used virological, histological, pathologic, or clinical outcome measures. Data collection involved paired reviewers who assessed the quality of each study and abstracted data. One nonrandomized prospective cohort study suggested that HCC was detected earlier and was more often resectable in patients who had twice yearly screening with serum alpha-fetoprotein (AFP) and hepatic ultrasound than in patients who had usual care. Twenty-four studies, which included patients with chronic hepatitis C or B or both, addressed the sensitivities and specificities of screening tests. They were relatively consistent in showing that the sensitivity of serum AFP for detecting HCC usually was moderately high at 45% to 100%, with a specificity of 70% to 95%, for a threshold of between 10 and 19 ng/mL. The few studies that evaluated screening with ultrasound reported high specificity, but variable sensitivity. In conclusion, screening of patients with chronic hepatitis C with AFP and ultrasound may improve detection of HCC, but studies are needed to determine whether screening improves clinical outcomes.

Objective: To assess the temporal association of changes in substance abuse with antiretroviral therapy use and adherence, HIV-1 RNA suppression, and CD4 cell count changes in patients attending an urban clinic. Design: Prospective cohort study. Methods: Six-hundred and ninety-five HIV-1-infected individuals, who completed two or more semi-annual standardized surveys and in whom antiretroviral therapy was indicated, were included in the analysis. Surveys addressed antiretroviral therapy use and adherence, and use of illicit drugs and alcohol. Substance abuse was defined as active heroin, cocaine, or heavy alcohol use in the 6 months preceding survey. The units of analysis were consecutive pairs of surveys (couplets) in individual participants. Couplets in which participants denied substance abuse in both surveys were compared to couplets in which participants switched from non-use to substance abuse, and couplets in which participants reported substance abuse in both surveys were compared to couplets where participants switched from substance abuse to non-use. Results: Switching from non-use to substance abuse was strongly associated with worsening antiretroviral therapy use and adherence, less frequent HIV-1 RNA suppression, and blunted CD4 cell increases, compared to remaining free of substance abuse. Alternatively, switching from substance abuse to non-use was strongly associated with improvements in antiretroviral therapy use and adherence, and HIV-1 treatment outcomes, compared to persisting with substance abuse. Conclusions: This longitudinal study highlights the dynamic nature of substance abuse and its temporal association with the effectiveness of HIV-1 treatment in patients attending an inner-city clinic.

In the USA, Medicaid is the principal payer of the health care costs of patients with HIV infection. We wished to determine how the costs to Medicaid of patients in Maryland infected with HIV have changed in the setting of highly active antiretroviral treatment.Observational cohort study.Analysis of combined economic and clinical data of patients from the Johns Hopkins HIV Service, the provider of primary and sub-specialty care for a majority of HIV-infected patients in the Baltimore metropolitan region. All patients were enrolled in Medicaid and received care longitudinally in Maryland from 1 January 1995 through 31 December 1997. Monthly Medicaid payments were calculated for all inpatient and outpatient services by fiscal year, CD4 cell count, and use of protease inhibitors.For inpatients with a CD4 cell countor = 50 x 10(6) cells/l, the total health care average monthly payments remained unchanged ($2629 in 1995, $2585 in 1997). Total mean monthly payments increased for those with a CD4 cell count50 x 10(6) cells/l (CD4 cell count 50-200 x 10(6) cells/l, $1172 in 1995 and $1615 in 1997, P0.05; CD4 cell count 201-500 x 10(6) cells/l, $1078 in 1995 and $1305 in 1997, P0.05). However, when data were stratified according to use of a protease inhibitor-containing regimen (used during approximately 50% of follow-up time in 1996-1997) it was found that hospital inpatient payments decreased significantly in all CD4 strata for patients on a protease inhibitor-containing regimen whereas pharmacy payments increased significantly. Inpatient payments associated with treating opportunistic illness were lower in 1996-1997 for patients receiving protease inhibitor therapy compared with those not receiving protease inhibitors. On balance, total health care payments tended to be slightly lower for patients receiving a protease inhibitor regimen.Although protease inhibitor-containing antiretroviral regimens are being used by only about half of our Medicaid-insured patients, when they are used, there are significantly lower hospital inpatient and community care costs, as well as lower costs associated with the treatment of opportunistic illness. Even with the concurrent increase in their pharmacy costs, total health care costs were stable or slightly lower for these patients. We believe this is a favorable result suggesting a good clinical value being achieved without an increase in costs.

Background Rapid changes in HIV epidemiology and antiretroviral therapy may have resulted in recent changes in patterns of healthcare utilization. Objective The objective of this study was to examine sociodemographic and clinical correlates of inpatient and outpatient HIV-related health service utilization in a multistate sample of patients with HIV. Design Demographic, clinical, and resource utilization data were collected from medical records for 2000, 2001, and 2002. Setting This study was conducted at 11 U.S. HIV primary and specialty care sites in different geographic regions. Patients In each year, HIV-positive patients with at least one CD4 count and any use of inpatient, outpatient, or emergency room services. Sample sizes were 13,392 in 2000, 15,211 in 2001, and 14,403 in 2002. Main outcome measures Main outcome measures were number of hospital admissions, total days in hospital, and number of outpatient clinic/office visits per year. Inpatient and outpatient costs were estimated by applying unit costs to numbers of inpatient days and outpatient visits. Results Mean numbers of admissions per person per year decreased from 2000 (0.40) to 2002 (0.35), but this difference was not significant in multivariate analyses. Hospitalization rates were significantly higher among patients with greater immunosuppression, women, blacks, patients who acquired HIV through drug use, those 50 years of age and over, and those with Medicaid or Medicare. Mean annual outpatient visits decreased significantly between 2000 and 2002, from 6.06 to 5.66 visits per person per year. Whites, Hispanics, those 30 years of age and over, those on highly active antiretroviral therapy (HAART), and those with Medicaid or Medicare had significantly higher outpatient utilization. Inpatient costs per patient per month (PPPM) were estimated to be 514 dollars in 2000, 472 dollars in 2001, and 424 dollars in 2002; outpatient costs PPPM were estimated at 108 dollars in 2000, 100 dollars in 2001, and 101 dollars in 2002. Conclusion Changes in utilization over this 3-year period, although statistically significant in some cases, were not substantial. Hospitalization rates remain relatively high among minority or disadvantaged groups, suggesting persistent disparities in care. Combined inpatient and outpatient costs for patients on HAART were not significantly lower than for patients not on HAART.