Retention in Medical Care Among Insured Adolescents and Young Adults With Diagnosed HIV Infection, United States, 2010-2014.

OBJECTIVES: Retention in care is a critical component of effective HIV treatment, and adolescents and young adults are at higher risk of inadequate retention than older adults. The objective of our study was to examine the patterns of retention in care among adolescents and young adults with HIV infection by analyzing Medicaid and commercial health insurance claims data. METHODS: We evaluated retention in care for HIV-diagnosed adolescents and young adults aged 13-24 using the 2010-2014 MarketScan Medicaid and MarketScan Commercial Claims health insurance databases. The study period extended 36 months from the date of the first claim with a code for HIV or AIDS. We determined the unweighted proportion retained in care for the Medicaid and Commercial Claims cohorts for months 0-24 and 25-36. We assessed associations between demographic characteristics and retention in care using logistic regression. RESULTS: A total of 378 adolescents and young adults were in the Medicaid cohort and 1028 in the Commercial Claims cohort. In the Medicaid and Commercial Claims cohorts, respectively, 186 (49%) and 591 (57%) adolescents and young adults were retained in care during months 0-24. In the Medicaid cohort, 113 (73%) people retained in care and 69 (45%) people not retained in care during months 0-24 were retained in care during months 25-36. In the Commercial Claims cohort, 313 (77%) and 94 (31%) retained and not retained people, respectively, were found to be in care during months 25-36. CONCLUSIONS: Notable proportions of HIV-diagnosed adolescents and young adults are not adequately retained in care; public health interventions tailored to this population are needed.

Prevalence, Incidence, and Clearance of Human Papillomavirus Types Covered by Current Vaccines in Men With Human Immunodeficiency Virus in the SUN Study.

BACKGROUND: High-risk anal human papillomavirus (HPV) infection is prevalent among men living with human immunodeficiency virus (HIV); the association between 9-valent (9v) high-risk HPV (HR-HPV) vaccine types and abnormal cytology has not been well characterized. METHODS: We followed a prospective cohort study of persons with HIV at 7 HIV clinics in 4 US cities from March 2004 through June 2012. Annually, providers collected separate anal swabs for HPV detection and cytopathologic examination. Among men, we examined prevalence, incidence, and clearance of 9v HR-HPV vaccine types, compared with other HR types, and associations with abnormal cytology to assess potential vaccine impact. RESULTS: Baseline prevalence of any anal 9v HR-HPV type among men who have sex with men (MSM) and men who have sex with women (MSW) was 74% and 25% (P < .001), respectively. Among 299 MSM, abnormal cytology was detected in 161 (54%) MSM and was associated with the presence of any 9v HR-HPV (relative risk [RR], 1.8 [95% confidence interval {CI}, 1.3-2.6]; P < .001). Among 61 MSW, abnormal anal cytology was detected in 12 (20%) and was associated with the presence of any 9v HR-HPV (RR, 4.3 [95% CI, 1.6-11.5]; P < .001). CONCLUSIONS: Among men with HIV, the prevalence of the 7 HR-HPV types in the 9v vaccine was high and was associated with abnormal cytology. These findings indicate that men with HIV could benefit from prophylactic administration of the 9v HPV vaccine.

Adherence and Viral Suppression Among Participants of the Patient-centered Human Immunodeficiency Virus (HIV) Care Model Project: A Collaboration Between Community-based Pharmacists and HIV Clinical Providers.

BACKGROUND: Human immunodeficiency virus (HIV) viral suppression (VS) decreases morbidity, mortality, and transmission risk. METHODS: The Patient-centered HIV Care Model integrated community-based pharmacists with HIV medical providers and required them to share patient clinical information, identify therapy-related problems, and develop therapy-related action plans.Proportions adherent to antiretroviral therapy (proportion of days covered [PDC] ≥90%) and virally suppressed (HIV RNA <200 copies/mL), before and after model implementation, were compared. Factors associated with postimplementation VS were determined using multivariable logistic regression; participant demographics, baseline viral load, and PDC were explanatory variables. PDC was modified to account for time to last viral load in the year postimplementation, and stratified as <50%, 50% to <80%, 80% to <90%, and ≥90%. RESULTS: The 765 enrolled participants were 43% non-Hispanic black, 73% male, with a median age of 48 years; 421 and 649 were included in the adherence and VS analyses, respectively. Overall, proportions adherent to therapy remained unchanged. However, VS improved a relative 15% (75% to 86%, P < .001). Higher PDC (adjusted odds ratio [AOR], 1.74 per 1-level increase in PDC category [95% confidence interval {CI}, 1.30-2.34]) and baseline VS (AOR, 7.69 [95% CI, 3.96-15.7]) were associated with postimplementation VS. Although non-Hispanic black persons (AOR, 0.29 [95% CI, .12-.62]) had lower odds of suppression, VS improved a relative 23% (63% to 78%, P < .001). CONCLUSIONS: Integrated care models between community-based pharmacists and primary medical providers may identify and address HIV therapy-related problems and improve VS among persons with HIV.

Antiretroviral Adherence Level Necessary for HIV Viral Suppression Using Real-World Data.

BACKGROUND: A benchmark of near-perfect adherence (≥95%) to antiretroviral therapy (ART) is often cited as necessary for HIV viral suppression. However, given newer, more effective ART medications, the threshold for viral suppression may be lower. We estimated the minimum ART adherence level necessary to achieve viral suppression. SETTINGS: The Patient-centered HIV Care Model demonstration project. METHODS: Adherence to ART was calculated using the proportion of days covered measure for the 365-day period before each viral load test result, and grouped into 5 categories (<50%, 50% to <80%, 80% to <85%, 85% to <90%, and ≥90%). Binomial regression analyses were conducted to determine factors associated with viral suppression (HIV RNA <200 copies/mL); demographics, proportion of days covered category, and ART regimen type were explanatory variables. Generalized estimating equations with an exchangeable working correlation matrix accounted for correlation within subjects. In addition, probit regression models were used to estimate adherence levels required to achieve viral suppression in 90% of HIV viral load tests. RESULTS: The adjusted odds of viral suppression did not differ between persons with an adherence level of 80% to <85% or 85% to <90% and those with an adherence level of ≥90%. In addition, the overall estimated adherence level necessary to achieve viral suppression in 90% of viral load tests was 82% and varied by regimen type; integrase inhibitor- and nonnucleoside reverse transcriptase inhibitor-based regimens achieved 90% viral suppression with adherence levels of 75% and 78%, respectively. CONCLUSIONS: The ART adherence level necessary to reach HIV viral suppression may be lower than previously thought and may be regimen-dependent.

Brief Report: Aging Attenuates the Association Between Coronary Artery Calcification and Bone Loss Among HIV-Infected Persons.

INTRODUCTION: Studies among HIV-uninfected persons (mostly in their sixth decade of life) show that detectable coronary artery calcium (CAC) is independently associated with low bone mineral density (BMD), suggesting a possible common pathogenic mechanism. AIM: We assessed the relationship between CAC and BMD, which has not been well described among younger to middle-aged HIV-infected persons. METHODS: We studied participants with baseline CAC and BMD measures from a prospective cohort of HIV-infected persons enrolled in the Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN) during 2004-2006. We used logistic regression to assess the association between detectable CAC (>0 Agatston score) and BMD (g/cm, T-score), and adjusted for known traditional and HIV-related risk factors. RESULTS: Among 472 participants (76% male, 30% non-Hispanic black, median age 41 years, and 71% with HIV RNA < 400 copies/mL), the majority had no detectable CAC (82%), but had baseline osteopenia (53%) or osteoporosis (10%). In univariate analysis, participants with detectable CAC had lower femoral neck/total hip T-scores, lower femoral neck/total hip/lumbar spine BMD, and higher rates of osteopenia/osteoporosis. After adjustment for age, all associations were no longer significant; adjustment for traditional risk factors excluding age and HIV-related variables failed to attenuate these associations. CONCLUSIONS: We found aging attenuates the association between detectable CAC and BMD in this cohort. Aging remains an important contributor to non-AIDS-defining illnesses. These data reinforce the importance of developing screening and prevention strategies for aging HIV-infected persons given their excess risk across a wide spectrum of end-organ complications.

Prevalence and Incidence of Anal and Cervical High-Risk Human Papillomavirus (HPV) Types Covered by Current HPV Vaccines Among HIV-Infected Women in the SUN Study.

Background: Nonavalent (9v) human papilloma virus vaccine targets high-risk human papillomavirus (HR-HPV) types 16, 18, 31, 33, 45, 52, 58, and low-risk 6, 11. We examined prevalence, incidence, and clearance of anal and cervical HR-HPV in HIV-infected women. Methods: The SUN Study enrolled 167 US women in 2004-2006. Anal and cervical specimens were collected annually for cytology and identification of 37 HPV types: 14 HR included: 9v 16, 18, 31, 33, 45, 52, 58; non-9v 35, 39, 51, 56, 59, 66, 68. Results: Baseline characteristics of 126 women included: median age 38 years; 57% non-Hispanic black; 67% HIV RNA < 400 copies/mL; 90% CD4 counts ≥200 cells/mm3. HPV prevalence at anus and cervix was 90% and 83%; for 9v HR-HPV types, 67% and 51%; non-9v HR-HPV, 54% and 29%, respectively. The 9v and non-9v HR-HPV incidence rates/100 person-years were similar (10.4 vs 9.5; 8.5 vs 8.3, respectively); 9v clearance rates were 42% and 61%; non-9v 46% and 59%, in anus and cervix, respectively. Conclusions: Anal HR-HPV prevalence was higher than cervical, with lower clearance; incidence was similar. Although prevalence of non-9v HR-HPV was substantial, 9v HR-HPV types were generally more prevalent. These findings support use of nonavalent vaccine in HIV-infected women.

Prevalence, Incidence, and Clearance of Anal High-Risk Human Papillomavirus Infection Among HIV-Infected Men in the SUN Study.

Background: The natural history of anal human papilloma virus (HPV) infection among human immunodeficiency virus (HIV)-infected men is unknown. Methods: Annually, from 2004 to 2012, we examined baseline prevalence, incidence, and clearance of anal HPV infection at 48 months, and associated factors among HIV-infected men. Results: We examined 403 men who have sex with men (MSM) and 96 men who have sex with women (MSW) (median age 42 years for both, 78% versus 81% prescribed cART, median CD4+ T-lymphocyte cell count 454 versus 379 cells/mm3, and 74% versus 75% had undetectable viral load, respectively). Type 16 prevalence among MSM and MSW was 38% versus 14% (P < .001), and incidence 24% versus 7% (P = .001). Type 18 prevalence was 24% versus 8% (P < .001), and incidence 13% versus 4% (P = .027). Among MSM and MSW, clearance of prevalent HPV 16 and HPV 18 was 31% and 60% (P = .392), and 47% and 25% (P = .297), respectively. Among MSM, receptive anal sex (with or without a condom) was associated with persistent HPV 16 (OR 2.24, P < .001). Conclusions: MSM had higher prevalence and incidence of HPV than MSW, but similar clearance. Receptive anal sex may predict cancer risk among HIV-infected MSM.

Retention in Medical Care Among Insured Children with Diagnosed HIV Infection - United States, 2010-2014.

In 2014, an estimated 2,477 children aged <13 years were living with diagnosed human immunodeficiency virus (HIV) infection in the United States (1). Nationally, little is known about how well children with a diagnosis of HIV infection are retained in medical care. CDC analyzed insurance claims data to evaluate retention in medical care for children in the United States with a diagnosis of HIV infection. Data sources were the 2010-2014 MarketScan Multi-State Medicaid and MarketScan Commercial Claims and Encounters databases. Children aged <13 years with a diagnosis of HIV infection in 2010 were identified using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnostic billing codes for HIV or acquired immunodeficiency syndrome (AIDS), resulting in Medicaid and commercial claims cohorts of 163 and 129 children, respectively. Data for each child were evaluated during a 36-month study period, counted from the date of the first claim containing an ICD-9-CM code for HIV or AIDS. Each child's consistency of medical care was assessed by evaluating the frequency of medical visits during the first 24 months of the study period to see if the frequency of visits met the definition of retention in care. Frequency of medical visits was then assessed during an additional 12-month follow-up period to evaluate differences in medical care consistency between children who were retained or not retained in care during the initial 24-month period. During months 0-24, 60% of the Medicaid cohort and 69% of the commercial claims cohort were retained in care, among whom 93% (Medicaid) and 85% (commercial claims) were in care during months 25-36. To identify areas for additional public health action, further evaluation of the objectives for national medical care for children with diagnosed HIV infection is indicated.

Do Persons Living with HIV Continue to Fill Prescriptions for Antiretroviral Drugs during a Gap in Care? Analysis of a Large Commercial Claims Database.

The significance of a gap in HIV care depends, at least partially, on whether patients continue to fill prescriptions for antiretroviral (ARV) drugs during the gap in care. We used a billing claims database to determine the proportion of persons who filled ≥1 prescription for ARV drugs during a gap in care (no clinic visit in >6 months). Persons were stratified into 3 groups: "never" (prescriptions never filled), "sometimes" (prescriptions filled >0%-<100% of months), and "always" (prescriptions filled monthly). Logistic regression analyses were conducted to determine factors associated with "never" filling ARV drugs. Of 14 308 persons, 69% (n = 9817), 13% (n = 1928), and 18% (n = 2563) "never," "sometimes," and "always" filled ARV drugs during the gap in care. Persons aged 18 to 29 years (odds ratio [OR] = 1.56, 95% confidence interval [CI] 1.39-1.74), women (OR = 1.67, CI 1.52-1.83), and persons from the Northeast region of the United States (OR = 1.86, CI 1.69-2.03) were more likely to never fill ARV drugs than persons aged ≥30 years, men, and persons outside the Northeast, respectively. Efforts should be made to minimize gaps in care, emphasize importance of therapy, and provide adherence support.

False-positive pregnancy test after transfusion of solvent/detergent-treated plasma.

BACKGROUND: The transmission of pathogens, antibodies, and proteins is a possible consequence of blood product transfusion. A female patient had an unexpected positive serum ß-human chorionic gonadotropin result, indicative of pregnancy, after she had received a transfusion with 1 unit of platelet concentrate, 4 units of red blood cells, and 4 units of pooled solvent/detergent-treated plasma (Octaplas). STUDY DESIGN AND METHODS: To investigate the possibility of passive transfusion of ß-human chorionic gonadotropin from the plasma transfusion, one additional unit from the same batch was thawed and analyzed. To validate the ß-human chorionic gonadotropin assay for use in solvent/detergent-treated plasma and to investigate any interference in the assay, dilution experiments were performed using the implicated plasma batch diluted with male and non-pregnant female sera. Also, plasma from a known pregnant woman was diluted with Octaplas (tested negative for ß-human chorionic gonadotropin) and with a male serum to validate the assay for use in solvent/detergent-treated plasma. RESULTS: The implicated solvent/detergent-treated plasma had a mean ß-human chorionic gonadotropin level of 91.5 mIU/mL. Results from the dilution experiments revealed an excellent correlation (r > 0.99) between ß-human chorionic gonadotropin measurement in solvent/detergent-treated plasma and male serum and no over or under recovery of the expected results. Further measurements of ß-human chorionic gonadotropin levels in the female recipient revealed an estimated half-life of 6 hours. CONCLUSION: This case demonstrates the importance of considering the possibility of passive transmission of analytes to a patient from the transfusion of blood products. Furthermore, the measurement of ß-human chorionic gonadotropin is valid in solvent/detergent-treated plasma using a Roche Cobas analyzer.

Reengagement in Care After a Gap in HIV Care Among a Population of Privately Insured Persons with HIV in the United States.

The HIV care continuum illustrates steps needed to reach HIV viral suppression, including retention in care. The continuum's retention measure does not account for gaps or reengagement in care and thus provides an incomplete picture of long-term engagement. We used a claims database to determine the proportion of privately insured persons with HIV who experienced a gap in care and subsequently reengaged between 2008 and 2012. A gap was defined as no office visit claim in >6 months and reengagement as ≥1 office visit claim after a gap. Cox proportional hazards models were conducted to determine factors associated with time to first gap and time to reengagement. Of 5142 persons in the study, 79% were males and median age was 46 years (range, 19-64 years). No race/ethnicity data were available. Thirty percent (n = 1555) experienced a gap. Median time to first gap was 15 months (IQR: 6-30). Median gap length was 3.2 months. Seventy percent with a gap reengaged; 22% reengaged more than once. Of 1086 patients who reengaged, 224 (21%) eventually had a terminal gap. Residence in the North Central region (HR 0.73, 95% CI 0.62-0.87) and having ≥1 Charlson comorbidities (HR 0.85, 95% CI 0.73-0.99) were associated with shorter time to reengagement. The majority who experienced a gap reengaged within a relatively short period and remained in the cohort at 60 months. However, 21% of those reengaging had a terminal gap by 60 months, which should alert providers to the eventual potential for loss to follow-up. The analysis was limited by inability to distinguish between HIV-specific and non-HIV-specific care visits.

High Prevalence of Low Bone Mineral Density and Substantial Bone Loss over 4 Years Among HIV-Infected Persons in the Era of Modern Antiretroviral Therapy.

HIV-infected persons are living longer on combination antiretroviral therapy (cART) but experiencing more comorbidities including low bone mineral density (BMD). Using data from the Study to Understand the Natural History of HIV and AIDS in the Era of Effective Therapy (SUN Study), we determined the prevalence of low BMD (T-score below one standard deviation of the reference mean) and compared it with matched controls from the National Health and Nutrition Examination Survey (NHANES). We also assessed 4-year longitudinal BMD changes among participants virologically suppressed on cART. Of 653 participants included in this analysis (77% male, 29% black, median age 41 years, median CD4(+) cell count 464 cells/mm(3), 89% with HIV RNA <400 copies/ml), 51% and 10% had baseline osteopenia and osteoporosis, respectively. Low BMD at the femoral neck was significantly more prevalent than for the NHANES controls (47% versus 29%, p<0.001). Lower body mass index, nonwhite race, longer tenofovir exposure, older age, being unemployed or retired, and lower apolipoprotein E were independently associated with baseline osteoporosis. Among 170 participants virologically suppressed on cART and with longitudinal BMD data, 31% experienced substantial bone loss (≥5% BMD decline from baseline) over 4 years. Female sex, current smoking, and longer stavudine use were more common among participants who had substantial bone loss, although these variables failed to reach statistical significance. Low BMD was highly prevalent among HIV-infected persons. One-third of participants experienced substantial bone loss despite cART, suggesting the need for monitoring and potential clinical interventions.

Evaluating patterns in retention, continuation, gaps, and re-engagement in HIV care in a Medicaid-insured population, 2006-2012, United States.

We used the US-based MarketScan(®) Medicaid Multi-state Databases to determine the un-weighted proportion of publically insured persons with HIV that were retained, continued, and re-engaged in care. Persons were followed for up to 84 months. Cox proportional hazards models were conducted to determine factors associated with gaps in care. Of the 6463 HIV cases identified in 2006, 61% were retained during the first 24 months, and 53% continued in care through 78 months. Between 8% and 30% experienced a gap in care, and 59% of persons who experienced a gap in care later re-engaged in care. Persons with one or more Charlson co-morbidities (HR 0.72, 95% CI 0.64-0.81), ages 40-59 (0.79, 0.71-0.88), mental illness diagnosis (0.79, 0.72-0.87), hepatitis C co-infection (0.83, 0.75-0.93), and female sex (0.86, 0.78-0.94) were less likely to experience a gap in care. Between 27% and 38% of those not retained in care continued to receive HIV-related laboratory services. This Medicaid claims database combines features of both clinic visits-based and surveillance lab-based surrogate measures to give a more complete picture of engagement in care than single-facility-based studies.

Short communication: The Veterans Aging Cohort Study Index is an effective tool to assess baseline frailty status in a contemporary cohort of HIV-infected persons.

The Veterans Aging Cohort Study (VACS) Index has previously been used to identify frail HIV-infected persons. However, data demonstrating the independent association between the VACS Index and baseline frailty status is lacking. Furthermore, the ability of the VACS Index to also reflect transitions in frailty status over time is unknown. We used data from the Study to Understand the Natural History of HIV and AIDS in the Era of Effective Therapy (SUN Study) to determine independent association of baseline frailty status with the VACS Index. We also evaluated VACS Index changes with frailty status transitions over time. We included 303 participants (median age 48 years, 76% men, 57% non-Hispanic white, 91% with plasma HIV RNA <400 copies/ml, and median CD4(+) cell count 595 cells/ml) with baseline and follow-up frailty assessments and used the Fried's criteria to define frailty status. There were 184 (61%) nonfrail, 112 (37%) prefrail, and seven (2%) frail participants at baseline. Prefrail/frail participants had significantly higher median VACS Index scores compared with nonfrail participants (18 versus 10, p<0.001). In multivariable analysis, prefrailty/frailty was independently associated with a higher VACS Index score (odds ratio 1.025, p=0.019). After a median follow-up of 12 months, participants who remained prefrail/frail compared to those who remained nonfrail continued to have higher median VACS Index scores. The VACS Index score did not significantly change with transitions in frailty status over time. Our study highlights the potential utility of the VACS Index in frailty assessment within the clinical setting.

Accurate quantitation of D+ fetomaternal hemorrhage by flow cytometry using a novel reagent to eliminate granulocytes from analysis.

BACKGROUND: Quantitation of fetomaternal hemorrhage (FMH) is performed to determine the dose of prophylactic anti-D (RhIG) required to prevent D immunization of D- women. Flow cytometry (FC) is the most accurate method. However, maternal white blood cells (WBCs) can give high background by binding anti-D nonspecifically, compromising accuracy. STUDY DESIGN AND METHODS: Maternal blood samples (69) were sent for FC quantitation of FMH after positive Kleihauer-Betke test (KBT) analysis and RhIG administration. Reagents used were BRAD-3-fluorescein isothiocyanate (FITC; anti-D), AEVZ5.3-FITC (anti-varicella zoster [anti-VZ], negative control), anti-fetal hemoglobin (HbF)-FITC, blended two-color reagents, BRAD-3-FITC/anti-CD45-phycoerythrin (PE; anti-D/L), and BRAD-3-FITC/anti-CD66b-PE (anti-D/G). PE-positive WBCs were eliminated from analysis by gating. Full blood counts were performed on maternal samples and female donors. RESULTS: Elevated numbers of neutrophils were present in 80% of patients. Red blood cell (RBC) indices varied widely in maternal blood. D+ FMH values obtained with anti-D/L, anti-D/G, and anti-HbF-FITC were very similar (r = 0.99, p < 0.001). Correlation between KBT and anti-HbF-FITC FMH results was low (r = 0.716). Inaccurate FMH quantitation using the current method (anti-D minus anti-VZ) occurred with 71% samples having less than 15 mL of D+ FMH (RBCs) and insufficient RhIG calculated for 9%. Using two-color reagents and anti-HbF-FITC, approximately 30% patients had elevated F cells, 26% had no fetal cells, 6% had D- FMH, 26% had 4 to 15 mL of D+ FMH, and 12% patients had more than 15 mL of D+ FMH (RBCs) requiring more than 300 µg of RhIG. CONCLUSION: Without accurate quantitation of D+ FMH by FC, some women would receive inappropriate or inadequate anti-D prophylaxis. The latter may be at risk of immunization leading to hemolytic disease of the newborn.

Routine brief risk-reduction counseling with biannual STD testing reduces STD incidence among HIV-infected men who have sex with men in care.

BACKGROUND: We evaluated whether routine biannual sexually transmitted disease (STD) testing coupled with brief risk-reduction counseling reduces STD incidence and high-risk behaviors. METHODS: The SUN study is a prospective observational HIV cohort study conducted in 4 US cities. At enrollment and every 6 months thereafter, participants completed a behavioral survey and were screened for STDs, and if diagnosed, were treated. Medical providers conducted brief risk-reduction counseling with all patients. Among men who have sex with men (MSM), we examined trends in STD incidence and rates of self-reported risk behaviors before and after exposure to the risk-reduction intervention. The "preintervention" visit was the study visit that was at least 6 months after enrollment STD screening and treatment and at which the participant was first exposed to the intervention. The "postintervention" visit was 12 months later. RESULTS: Among 216 MSM with complete STD and behavioral data, median age was 44.5 years; 77% were non-Hispanic white; 83% were on highly active antiretroviral treatment; 84% had an HIV RNA level <400 copies/mL and the median CD4 (cluster of differentiation 4) count was 511 cells/mm. Twelve months after first exposure to the risk-reduction intervention, STD incidence declined from 8.8% to 4.2% (P = 0.041). Rates of unprotected receptive or insertive anal intercourse with HIV-positive partners increased (19% to 25%, P = 0.024), but did not change with HIV-negative partners or partners of unknown HIV status (24% to 22%, P = 0.590). CONCLUSIONS: STD incidence declined significantly among HIV-infected MSM after implementing frequent, routine STD testing coupled with risk-reduction counseling. These findings support adoption of routine STD screening and risk-reduction counseling for HIV-infected MSM.

Effect of abacavir on acute changes in biomarkers associated with cardiovascular dysfunction.

BACKGROUND: This study examined the effect of abacavir on acute changes in biomarkers associated with cardiovascular dysfunction. METHODS: Among the Study to Understand the Natural History of HIV/AIDS in the Era of Effective therapy (SUN) participants, we identified 25 individuals (cases) who were HLA-B5701-negative and who had ≥ 2 weeks without abacavir exposure at one visit and ≥ 2 weeks with abacavir exposure at the consecutive visit while maintaining viral suppression. We identified 43 individuals (controls) similarly unexposed and exposed to tenofovir. We assessed concentrations of prothrombin fragment F(1+2), D-dimer, high-sensitivity C-reactive protein, interleukin-8, intercellular adhesion molecule-1, vascular adhesion molecule-1, E-selectin, P-selectin, serum amyloid A and serum amyloid P. We examined the median percentage change of these biomarkers from the unexposed to exposed state among cases and controls compared with the expected assay variability using a sign test, and compared changes among cases with controls using the Wilcoxon rank-sum test. RESULTS: Baseline characteristics were similar between cases and controls: median age 45 versus 46 years, 80% versus 81% male, 64% versus 63% non-Hispanic White and median CD4(+) T-cell count 538 versus 601 cells/mm(3), respectively. Mean exposure times were 65 and 15 weeks for abacavir and tenofovir, respectively. We observed no significant changes in biomarkers from the unexposed to exposed state among cases or controls compared with the expected assay variability. We found that no biomarkers were significantly increased among cases compared with controls; however, prothrombin fragment F(1+2) was significantly lower among controls (P=0.035). CONCLUSIONS: In virologically suppressed contemporary HIV-infected patients, abacavir exposure was not associated with increases in biomarkers associated with increased cardiovascular risk.

Prevalence and risk factors associated with herpes simplex virus-2 infection in a contemporary cohort of HIV-infected persons in the United States.

BACKGROUND: We compared the herpes simplex virus type 2 (HSV-2) seroprevalence in a contemporary HIV cohort with the general US population and determined risk factors for HSV-2 infection among HIV-infected persons. METHODS: The Study to Understand the Natural History of HIV and AIDS in the Era of Effective Therapy (SUN) Study is a prospective observational cohort of 700 HIV-infected adults enrolled in 4 U.S. cities between 2004 and 2006. At baseline, participants completed a behavioral risk questionnaire and provided specimens for HSV-2 serology. We calculated HSV-2 seroprevalence, standardized by age, gender, and race among HIV-infected persons compared with the general US adult population, using data from the National Health and Nutrition Examination Survey from 2003 to 2006. We examined risk factors associated with HSV-2 infection among HIV-infected persons using multivariate logistic regression. RESULTS: Among 660 (94%) SUN participants with adequate specimens for HSV-2 serologic testing, 548 (83%) were 20 to 49 years old (median age, 39 years; 77% male; 59% non-Hispanic white; median CD4 count, 470 cells/mm; 74% with HIV RNA viral loads <400 copies/mL). HSV-2 seroprevalence was significantly higher among HIV-infected adults (59.7%, 95% confidence interval: 55.8-63.6) compared with the general US population (19.2%, 95% confidence interval: 17.5-21.1). In multivariate analysis, we found that older age, female gender, black non-Hispanic race/ethnicity, being currently unemployed, high-risk anal HPV infection, and longer duration since HIV diagnosis were associated with significantly higher odds of HSV-2 infection. CONCLUSION: HSV-2 seroprevalence is 3 times as high among HIV-infected adults as in the general U.S. population. Clinicians should be aware that increased risk for HSV-2 infection was distributed broadly among HIV-infected persons and not limited to those with high-risk sexual behaviors.

Cystatin C and baseline renal function among HIV-infected persons in the SUN Study.

In the combination antiretroviral therapy (cART) era, renal dysfunction remains common. The Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN) (ClinicalTrials.gov number, NCT00146419) is a prospective observational cohort study of HIV-infected adults. At baseline, comprehensive data were collected, including cystatin C and measures of renal function. Univariate and multivariate regression analyses were performed to identify factors associated with baseline renal dysfunction [estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73 m(2) calculated using the simplified Modification of Diet in Renal Disease equation] and elevated cystatin C (>1.0 mg/liter) in a cross-sectional analysis. Among 670 subjects with complete data (mean age 41 years, mean CD4 cell count 530 cells/mm(3), 79% prescribed cART), the mean eGFR was 96.8 ml/min/1.73 m(2). Forty percent of subjects had renal dysfunction; 3.3% had chronic kidney disease (eGFR < 60 ml/min/1.73 m(2)). Elevated cystatin C was present in 18% of subjects. In multivariate analysis, renal dysfunction was associated with older age, non-Hispanic white race/ethnicity, higher body mass index (BMI), hypertension, higher cystatin C levels, and current prescription of ritonavir. Factors associated with elevated cystatin C included hepatitis C coinfection, hypertension, current smoking, older age, current tenofovir use, detectable plasma HIV RNA, and elevated microalbuminuria. The prevalence of chronic kidney disease (CKD) was low in this contemporary HIV cohort. However, mild to moderate renal dysfunction was common despite the widespread use of cART.

High Prevalence of Echocardiographic Abnormalities among HIV-infected Persons in the Era of Highly Active Antiretroviral Therapy.

BACKGROUND: in the era of highly active antiretroviral therapy (HAART), human immunodeficiency virus (HIV)-infected persons have higher cardiovascular disease risk. Little is known about asymptomatic abnormalities in cardiac structure and function in this population. METHODS: the Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN Study) is a prospective, observational, multi-site cohort of 656 HIV-infected participants who underwent baseline echocardiography during 2004-2006. We examined prevalence of and factors associated with left ventricular systolic dysfunction (LVSD), diastolic dysfunction (DD), pulmonary hypertension (PHTN), left ventricular hypertrophy (LVH), and left atrial enlargement (LAE). RESULTS: participant characteristics were as follows: median age, 41 years; 24% women; 29% non-Hispanic black; 73% receiving HAART; and median CD4+ cell count, 462 cells/µL. Among evaluable participants, 18% had LVSD, 26% had DD, 57% had PHTN (right ventricular pressure >30 mm Hg), 6.5% had LVH, and 40% had LAE. In multivariate analyses, significant factors (P < .05) associated with LVSD were history of MI, elevated highly sensitive C-reactive protein (hsCRP) level, and current tobacco smoking; for DD, elevated hsCRP level and hypertension; for PHTN, current use of ritonavir; for LVH, hypertension, diabetes, non-white race, female sex with elevated body mass index, calculated as the weight in kilograms divided by the square of height in meters, of ≥ 25, elevated hsCRP level, and current use of abacavir; for LAE, hypertension and recent marijuana use. CONCLUSIONS: in this large contemporary HIV cohort, the prevalence of subclinical functional and structural cardiac abnormalities was greater than expected for age. Abnormalities were mostly associated with expected and often modifiable risks. Lifestyle modification should become a greater priority in the management of chronic HIV disease.