Publications by authors named "Carl Armon"

48 Publications

Hepatitis C Virus Testing Among Men With Human Immunodeficiency Virus Who Have Sex With Men: Temporal Trends and Racial/Ethnic Disparities.

Open Forum Infect Dis 2021 Apr 17;8(4):ofaa645. Epub 2021 Apr 17.

Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.

Background: National guidelines recommend that sexually active people with human immunodeficiency virus (PWH) who are men who have sex with men (MSM) be tested for hepatitis C virus (HCV) infection at least annually. Hepatitis C virus testing rates vary by race/ethnicity in the general population, but limited data are available for PWH.

Methods: We analyzed medical records data from MSM in the HIV Outpatient Study at 9 human immunodeficiency virus (HIV) clinics from January 1, 2011 through December 31, 2019. We excluded observation time after documented past or current HCV infection. We evaluated HCV antibody testing in each calendar year among HCV-seronegative MSM, and we assessed testing correlates by generalized estimating equation analyses.

Results: Of 1829 eligible MSM who were PWH, 1174 (64.2%) were non-Hispanic/Latino white (NHW), 402 (22.0%) non-Hispanic black (NHB), 187 (10.2%) Hispanic/Latino, and 66 (3.6%) of other race/ethnicity. Most were ≥40 years old (68.9%), privately insured (64.5%), with CD4 cell count/mm (CD4) ≥350 (77.0%), and with HIV viral load <200 copies/mL (76.9%). During 2011-2019, 1205 (65.9%) had ≥1 HCV antibody test and average annual HCV percentage tested was 30.3% (from 33.8% for NHB to 28.5% for NHW; < .001). Multivariable factors positively associated ( < .05) with HCV testing included more recent HIV diagnosis, public insurance, lower CD4, prior chlamydia, gonorrhea, syphilis, or hepatitis B virus diagnoses, and elevated liver enzyme levels, but not race/ethnicity.

Conclusions: Although we found no disparities by race/ethnicity in HCV testing, low overall HCV testing rates indicate suboptimal uptake of recommended HCV testing among MSM in HIV care.
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http://dx.doi.org/10.1093/ofid/ofaa645DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8052496PMC
April 2021

The HIV Outpatient Study-25 Years of HIV Patient Care and Epidemiologic Research.

Open Forum Infect Dis 2020 May 11;7(5):ofaa123. Epub 2020 Apr 11.

Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.

Background: The clinical epidemiology of treated HIV infection in the United States has dramatically changed in the past 25 years. Few sources of longitudinal data exist for people with HIV (PWH) spanning that period. Cohort data enable investigating new exposure and disease associations and monitoring progress along the HIV care continuum.

Methods: We synthesized key published findings and conducted primary data analyses in the HIV Outpatient Study (HOPS), an open cohort of PWH seen at public and private HIV clinics since 1993. We assessed temporal trends in health outcomes (1993-2017) and mortality (1994-2017) for 10 566 HOPS participants.

Results: The HOPS contributed to characterizing new conditions (eg, lipodystrophy), demonstrated reduced mortality with earlier HIV treatment, uncovered associations between select antiretroviral agents and cardiovascular disease, and documented remarkable shifts in morbidity from AIDS opportunistic infections to chronic noncommunicable diseases. The median CD4 cell count of participants increased from 244 cells/mm to 640 cells/mm from 1993 to 2017. Mortality fell from 121 to 16 per 1000 person-years from 1994 to 2017 ( < .001). In 2010, 83.7% of HOPS participants had a most recent HIV viral load <200 copies/mL, compared with 92.2% in 2017.

Conclusions: Since 1993, the HOPS has been detecting emerging issues and challenges in HIV disease management. HOPS data can also be used for monitoring trends in infectious and chronic diseases, immunologic and viral suppression status, retention in care, and survival, thereby informing progress toward the Ending the HIV Epidemic initiative.
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http://dx.doi.org/10.1093/ofid/ofaa123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7235508PMC
May 2020

The HIV Outpatient Study-25 Years of HIV Patient Care and Epidemiologic Research.

Open Forum Infect Dis 2020 May 11;7(5):ofaa123. Epub 2020 Apr 11.

Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.

Background: The clinical epidemiology of treated HIV infection in the United States has dramatically changed in the past 25 years. Few sources of longitudinal data exist for people with HIV (PWH) spanning that period. Cohort data enable investigating new exposure and disease associations and monitoring progress along the HIV care continuum.

Methods: We synthesized key published findings and conducted primary data analyses in the HIV Outpatient Study (HOPS), an open cohort of PWH seen at public and private HIV clinics since 1993. We assessed temporal trends in health outcomes (1993-2017) and mortality (1994-2017) for 10 566 HOPS participants.

Results: The HOPS contributed to characterizing new conditions (eg, lipodystrophy), demonstrated reduced mortality with earlier HIV treatment, uncovered associations between select antiretroviral agents and cardiovascular disease, and documented remarkable shifts in morbidity from AIDS opportunistic infections to chronic noncommunicable diseases. The median CD4 cell count of participants increased from 244 cells/mm to 640 cells/mm from 1993 to 2017. Mortality fell from 121 to 16 per 1000 person-years from 1994 to 2017 ( < .001). In 2010, 83.7% of HOPS participants had a most recent HIV viral load <200 copies/mL, compared with 92.2% in 2017.

Conclusions: Since 1993, the HOPS has been detecting emerging issues and challenges in HIV disease management. HOPS data can also be used for monitoring trends in infectious and chronic diseases, immunologic and viral suppression status, retention in care, and survival, thereby informing progress toward the Ending the HIV Epidemic initiative.
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http://dx.doi.org/10.1093/ofid/ofaa123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7235508PMC
May 2020

Non-AIDS comorbidity burden differs by sex, race, and insurance type in aging adults in HIV care.

AIDS 2019 12;33(15):2327-2335

aNorthwestern University Feinberg School of Medicine, Chicago, Illinois bCerner Corporation, Kansas City, Missouri cTemple University School of Medicine, Philadelphia, Pennsylvania dInfectious Disease Research Institute, Inc., Tampa, Florida eUniversity of Illinois at Chicago, Chicago, Illinois fColorado School of Mines, Golden, Colorado gDupont Circle Physicians Group, Washington, District of Columbia hU.S. Centers for Disease Control and Prevention, Atlanta, Georgia, USA.

Objective: To understand the epidemiology of non-AIDS-related chronic comorbidities (NACMs) among aging persons with HIV (PWH).

Design: Prospective multicenter observational study to assess, in an age-stratified fashion, number and types of NACMs by demographic and HIV factors.

Methods: Eligible participants were seen during 1 January 1997 to 30 June 2015, followed for more than 5 years, received antiretroviral therapy (ART), and virally suppressed (HIV viral load <200 copies/ml ≥75% of observation time). Age was stratified (18-40, 41-50, 51-60, ≥61 years). NACMs included cardiovascular disease, cancer, hypertension, diabetes, dyslipidemia, arthritis, viral hepatitis, anemia, and psychiatric illness.

Results: Of 1540 patients, 1247 (81%) were men, 406 (26%) non-Hispanic blacks (NHB), 183 (12%) Hispanics/Latinos, 575 (37%) with public insurance, 939 (61%) MSM, and 125 (8%) with injection drug use history. By age strata 18-40, 41-50, 51-60, and at least 61 years, there were 180, 502, 560, and 298 patients, respectively. Median HIV Outpatient Study observation was 10.8 years (range: min-max = 5.0-18.5). Mean number of NACMs increased with older age category (1.4, 2.1, 3.0, and 3.9, respectively; P < 0.001), as did prevalence of most NACMs (P < 0.001). Age-related differences in NACM numbers were primarily due to anemia, hepatitis C virus infection, and diabetes. Differences (all P < 0.05) in NACM number existed by sex (women >men, 3.9 vs. 3.4), race/ethnicity (NHB >non-NHB, 3.8 vs. 3.4), and insurance status (public >private, 4.3 vs. 3.1).

Conclusions: Age-related increases existed in prevalence and number of NACMs, with disproportionate burden among women, NHBs, and the publicly insured. These groups should be targeted for screening and prevention strategies aimed at NACM reduction.
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http://dx.doi.org/10.1097/QAD.0000000000002349DOI Listing
December 2019

Chlamydia and Gonorrhea Incidence and Testing Among Patients in the Human Immunodeficiency Virus Outpatient Study (HOPS), 2007-2017.

Clin Infect Dis 2020 11;71(8):1824-1835

Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.

Background: Although chlamydia (CT) and gonorrhea (GC) infections are increasing in the United States, there are limited data on their incidence, testing rates, and associated risk factors among persons living with HIV (PLWH), including by anatomic site among men who have sex with men (MSM).

Methods: We analyzed 2007-2017 medical records data from Human Immunodeficiency Virus (HIV) Outpatient Study (HOPS) participants in care at 9 HIV clinics. We calculated CT (and GC) incidence and testing rates and assessed associations with sociodemographic and clinical factors using log-linear regression.

Results: Among 4727 PLWH, 397 had 881 CT infections and 331 had 861 GC infections, with an incidence of 2.95 and 2.88 per 100 person-years, respectively. From 2007 to 2017, incidence and testing rates increased by approximately 3.0- and 1.9-fold for CT and GC, respectively. Multivariable factors associated with incident CT (GC) included younger age, MSM, and prior diagnoses of sexually transmitted diseases (STDs). Among 1159 MSM, 583 (50.3%) had 844 CT and 843 GC tests during 2016-2017, and 26.6% of tests were 3-site (urethra, rectum, and pharynx), yielding the highest rates of CT (GC) detection. Multivariable factors associated with CT (GC) testing included younger age, non-Hispanic/Latino black race, and having prior STDs.

Conclusions: Recent CT and GC incidence and testing increased among PLWH; however, only half of MSM were tested for CT or GC during 2016-2017 and less than a third of tests were 3-site. To promote sexual health and STD prevention among PLWH who are MSM, research regarding the added value of CT and GC testing across 3 anatomic sites is needed.
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http://dx.doi.org/10.1093/cid/ciz1085DOI Listing
November 2020

Sleep disturbances in HIV-infected patients associated with depression and high risk of obstructive sleep apnea.

SAGE Open Med 2019 8;7:2050312119842268. Epub 2019 Apr 8.

Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.

Objective: To evaluate sleep disturbances in a diverse, contemporary HIV-positive patient cohort and to identify demographic, clinical, and immune correlates.

Methods: A convenience sample of 176 patients from a racially and ethnically diverse HIV-positive patient cohort in an urban population. This was a cross-sectional, epidemiologic study. We surveyed participants using multiple standardized instruments to assess depression, sleep quality, and risk for sleep apnea. We analyzed demographic, behavioral, and clinical correlates.

Results: A total of 56% of participants were female, 75% Black and 64% had heterosexual HIV risk. The median age was 49 years. Poor sleep quality (Pittsburgh Sleep Quality Index > 5) was reported by 73% of patients and 52% met insomnia diagnosis criteria. A single question about self-reported sleep problems predicted a Pittsburgh Sleep Quality Index > 5 with a sensitivity and specificity of 82% and 81%, respectively. Female sex was significantly associated with higher risk of poor sleep quality, depression, and insomnia, whereas higher risk of obstructive sleep apnea was significantly associated with older age, male sex, obesity (body mass index ⩾ 30 kg/m), and metabolic comorbidities. High risk for obstructive sleep apnea, high rate of depression, and poor sleep hygiene represent treatment targets for sleep problems in HIV patients.

Conclusion: Sleep disturbances were common in this patient cohort, although largely undiagnosed and untreated. Sleep problems are linked to worse disease progression and increased cardiovascular mortality. Screening for sleep problems with a single question had high sensitivity and specificity. In those patients with self-reported sleep problems, screening for obstructive sleep apnea, depression, and sleep hygiene habits should be part of routine HIV care.
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http://dx.doi.org/10.1177/2050312119842268DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6454647PMC
April 2019

Disparities in Viral Suppression and Medication Adherence among Women in the USA, 2011-2016.

AIDS Behav 2019 Nov;23(11):3015-3023

Division of HIV/AIDS Prevention, DHAP/NCHHSTP/CDC, Centers for Disease Control and Prevention, 1600 Clifton Rd NE MS E-45, Atlanta, GA, 30333, USA.

We assessed disparities in viral suppression (VS) and antiretroviral therapy (ART) adherence among women of the HIV Outpatient Study to inform HIV treatment strategies. We used adjusted prevalence ratios (aPR) with 95% confidence intervals (CI) to assess VS by race/ethnicity and generalized estimating equations to investigate factors associated with not achieving VS and ART non-adherence. Among 426 women (median age = 46 years), at baseline, VS was less prevalent among black women (63%) compared with Hispanic women/Latinas (73%) and white women (78%). In the multivariable analysis, factors significantly associated with not achieving VS included the following social and behavioral determinants of care: using public insurance (aPR = 1.69, CI 1.01-2.82, p = 0.044) compared to using private insurance, seeking care in a public clinic (aPR = 1.60, CI 1.03-2.50, p = 0.037) compared to seeking care in a private clinic, and ART non-adherence (aPR = 2.79, CI 1.81-4.29), p < 0.001). Although race was not a significant factor in not achieving VS, race was associated with ART non-adherence; black women were more likely to miss a dose of ART medication (aPR = 2.07, CI 1.19-3.60, p = 0.010) when compared to white women and Hispanic women/Latinas. Interventions and resources disseminated to address social barriers to care and improve VS and ART adherence among HIV-positive women, particularly black women, are warranted.
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http://dx.doi.org/10.1007/s10461-019-02494-9DOI Listing
November 2019

Time spent with HIV viral load above 1500 copies/ml among patients in HIV care, 2000-2014.

AIDS 2018 09;32(14):2033-2042

Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention, Atlanta, Georgia.

Objective: Sexual HIV transmission is more likely to occur when plasma HIV RNA level (viral load) exceeds 1500 copies/ml. We assessed the percentage of person-time spent with viral load above 1500 copies/ml (pPT >1500) among adults with HIV in care.

Design: Observational cohort in eight United States HIV clinics.

Methods: Participants had at least one HIV Outpatient Study (HOPS) clinic visit and at least two viral loads during 2000-2014. We assessed pPT above 1500 in time intervals between consecutive viral load pairs, overall and by ART status. Trends in pPT above 1500 and associations between pPT above 1500 and chosen baseline demographics and clinical characteristics were analyzed using generalized estimating equations.

Results: There were 5873 patients contributing 37 794 person-years; 86.0% person-years had prescribed ART, with increasing coverage over time. Over 2000-2014 pPT above 1500 was 24.2%, decreasing from 38.3% in 2000-2002 to 11.3% in 2012-2014. During observation time with ART prescribed, pPT above 1500 was 16.4% overall, decreasing from 29.9% in 2000-2002 to 8.0% in 2012-2014. pPT above 1500 was higher in patients less than 35 vs. at least 50 years old (31.5 vs. 15.6%), women vs. men (30.8 vs. 22.3%), and black vs. white and Latino/Hispanic patients (32.7 vs. 19.9 and 23.7%, respectively). Multivariable correlates of higher pPT above 1500 included no prescribed ART, being younger, non-Hispanic black vs. white, baseline viral load above 1500 copies/ml or lower CD4 count, and baseline public vs. private insurance.

Conclusion: pPT above 1500 declined during 2000-2014. Results support decreasing HIV transmission risk from persons in HIV care over the last decade, and the need to focus interventions on patient groups more consistently viremic.
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http://dx.doi.org/10.1097/QAD.0000000000001921DOI Listing
September 2018

Risk Factors and Incidence of Syphilis in Human Immunodeficiency Virus (HIV)-Infected Persons: The HIV Outpatient Study, 1999-2015.

Clin Infect Dis 2018 11;67(11):1750-1759

Centers for Disease Control and Prevention, Atlanta, Georgia.

Background: Since 2000, the incidence of syphilis has been increasing, especially among gay, bisexual, and other men who have sex with men (MSM) in the United States. We assessed temporal trends and associated risk factors for newly diagnosed syphilis infections among human immunodeficiency virus (HIV)-infected patients during a 16-year period.

Methods: We analyzed data from the HIV Outpatient Study (HOPS) cohort participants at 10 US HIV clinics during 1999-2015. New syphilis cases were defined based on laboratory parameters and clinical diagnoses. We performed Cox proportional hazards regression analyses of sociodemographic, clinical, and behavioral risk factors for new syphilis infections.

Results: We studied 6888 HIV-infected participants; 641 had 1 or more new syphilis diagnoses during a median follow-up of 5.2 years. Most participants were male (78%), aged 31-50 years, and 57% were MSM. The overall incidence was 1.8 (95% confidence interval [CI], 1.6-1.9) per 100 person-years (PY) and it increased from 0.4 (95% CI, .2-.8) to 2.2 (95% CI, 1.4-3.5) per 100 PY during 1999-2015. In multivariable analyses adjusting for calendar year, risk factors for syphilis included age 18-30 years (hazard ratio [HR], 1.3 [95% CI, 1.1-1.6]) vs 31-40 years, being MSM (HR, 3.1 [95% CI, 2.4-4.1]) vs heterosexual male, and being non-Hispanic black (HR, 1.6 [95% CI, 1.4-1.9]) vs non-Hispanic white.

Conclusions: The increases in the syphilis incidence rate through 2015 reflect ongoing sexual risk and highlight the need for enhanced prevention interventions among HIV-infected patients in care.
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http://dx.doi.org/10.1093/cid/ciy348DOI Listing
November 2018

HIV RNA Suppression during and after Pregnancy among Women in the HIV Outpatient Study, 1996 to 2015.

J Int Assoc Provid AIDS Care 2018 Jan-Dec;17:2325957417752259

1 Centers for Disease Control and Prevention, Atlanta, GA, USA.

Objective: To examine HIV viral suppression during/after pregnancy.

Design: Prospective observational cohort.

Methods: We identified pregnancies from 1996 to 2015. We examined HIV RNA viral load (VL), VL suppression (≤500 copies/mL), and antiretroviral therapy (ART) status at pregnancy start, end, and 6 months postpartum. We estimated risk ratios (RRs) and 95% confidence intervals (CIs) for VL nonsuppression.

Results: Among 253 pregnancies analyzed, 34.8% of women exhibited VL suppression at pregnancy start, 60.1% at pregnancy end, and 42.7% at 6 months postpartum. Median VL (log copies/mL) was 2.80 (interquartile range [IQR]: 1.40-3.85) at pregnancy start, 1.70 (IQR: 1.40-2.82) at pregnancy end, and 2.30 (IQR: 1.40-3.86) at postpartum. Risk of postpartum VL nonsuppression was also lower among women on ART and with VL suppression at pregnancy end (versus those not; adjusted RR = 0.30, 95% CI: 0.17-0.53).

Conclusions: Maintaining VL suppression among US women remains a challenge, particularly during postpartum. Achieving VL suppression earlier during pregnancy benefits women subsequently.
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http://dx.doi.org/10.1177/2325957417752259DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6748471PMC
September 2019

Disparities in HIV Viral Load Suppression by Race/Ethnicity Among Men Who Have Sex with Men in the HIV Outpatient Study.

AIDS Res Hum Retroviruses 2018 Apr 13;34(4):357-364. Epub 2018 Feb 13.

Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.

Maximizing the rates of virologic suppression (VS) among gay, bisexual, and other men who have sex with men (MSM) is essential to limiting HIV morbidity and sexual transmission of HIV in the United States. We analyzed data for MSM of non-Hispanic white (white), non-Hispanic black (black), or Hispanic/Latino race/ethnicity in the HIV Outpatient Study (HOPS) at nine U.S. HIV clinics. VS (HIV RNA <50 copies/ml) was measured closest to January 1, 2015. We modeled factors associated with VS among persons prescribed antiretroviral therapy (ART) for ≥6 months and assessed VS for a subset of participants with behavioral interview data. Among 1,303 MSM studied, 24% were black and 11% were Hispanic/Latino. Fewer black than white or Hispanic/Latino MSM had any documented ART use history (92% vs. 99% and 94%, respectively), and fewer had VS (72% vs. 91% and 81%),  < .001. In analyses of MSM prescribed ART, which adjusted for insurance type, duration of ART use, and CD4 cell count, blacks had lower prevalence of VS than whites [adjusted prevalence ratio (PR) 0.87, confidence interval (95% CI) 0.81-0.93] and Hispanics/Latinos did not (PR 0.95, 95% CI 0.88-1.02). Among 331 MSM with interview data, 6% had no VS, but reported anal sex without a condom with an HIV-uninfected or unknown HIV serostatus male partner in the past 6 months. In this study of HIV-infected MSM, blacks had a significantly lower prevalence of VS than white men. Optimizing HIV care and prevention among all MSM will require addressing underlying risk factors and social determinants of health that contribute to racial/ethnic disparities in HIV outcomes.
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http://dx.doi.org/10.1089/AID.2017.0162DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7528768PMC
April 2018

Trends of racial and ethnic disparities in virologic suppression among women in the HIV Outpatient Study, USA, 2010-2015.

PLoS One 2018 2;13(1):e0189973. Epub 2018 Jan 2.

Epidemiology Branch, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States of America.

In the United States, women accounted for 19% of new HIV diagnoses in 2015 and were less likely to reach virologic suppression when compared to men. We assessed trends and disparities in virologic suppression among HIV-positive women to inform HIV treatment strategies. Data were from a prospective cohort of the HIV Outpatient Study and collected at nine United States HIV clinics. We included women aged ≥18 years, with ≥1 visit, who were prescribed antiretroviral therapy, and had ≥1 viral load test performed between 2010 and 2015. We defined virologic suppression as viral load <50 copies/mL and calculated adjusted prevalence ratios (aPR) with 95% confidence intervals (CI) for virologic suppression by race/ethnicity and year of measure. Generalized estimating equations were used for multivariable analyses to assess factors associated with virologic suppression. Among 809 women (median age = 44 years), 482 (60%) were black, 177 (22%) white, 150 (19%) Hispanic/Latina. Virologic suppression was less prevalent among black women (73%) compared with Hispanic/Latina women (83%) and white women (91%). In multivariable analyses, not achieving virologic suppression was more likely among black women (aPR = 2.13; CI = 1.50-3.02) or Hispanic/Latina women (aPR = 1.66; CI = 1.08-2.56) compared with white women, and among women who attended public clinics (aPR = 1.42; CI = 1.07-1.87) compared with those who attended a private clinic. Between 2010 and 2015, virologic suppression among HIV-positive women increased from 68% to 83%, but racial/ethnic disparities persisted. Black and Hispanic/Latina women had significantly lower rates of virologic suppression than white women. Interventions targeting virologic suppression improvement among HIV-positive women of color, especially those who attend public clinics, are warranted.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0189973PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5749722PMC
January 2018

Incidence of Hepatitis C Virus Infection in the Human Immunodeficiency Virus Outpatient Study Cohort, 2000-2013.

Open Forum Infect Dis 2017 10;4(2):ofx076. Epub 2017 Jun 10.

Background: There are few recent studies of incident hepatitis C virus (HCV) infection among human immunodeficiency virus (HIV)-infected patients in the United States.

Methods: We studied HIV Outpatient Study (HOPS) participants seen in 9 HIV-specialty clinics who had ≥1 clinical encounter during 2000-2013 and ≥2 HCV-related tests, the first of which was a negative HCV antibody test (Ab). Hepatitis C virus incident cases were identified by first positive HCV Ab, viral load, or genotype. We assessed rates of incident HCV overall, by calendar intervals, and by demographic and HIV risk strata, and we explored risk factors for incident HCV using Cox proportional hazards models.

Results: The 1941 eligible patients (median age 40 years, 23% female, 61% men who had sex with men [MSM], and 3% persons who injected drugs [PWID]) experienced 102 (5.3%) incident HCV infections for an overall incidence of 1.07 (95% confidence interval [CI], 0.87-1.30) per 100 person-years (py). Hepatitis C virus incidence decreased from 1.83 in 2000-2003 to 0.88 in 2011-2013 ( = .024), with decreases observed ( < .05) among PWID and heterosexuals, but not among MSM. Overall, MSM comprised 59% of incident cases, and PWID were at most risk for incident HCV infection (adjusted hazard ratio [aHR] for PWID = 4.62 and 95% CI = 2.11-10.13; for MSM, aHR = 1.48 and 95% CI = 0.86-2.55 compared with heterosexuals).

Conclusions: Among HIV-infected patients in care during 2000-2013, incidence of HCV infection exceeded 1 case per 100 py. Our findings support recommendations for annual HCV screenings for HIV-infected persons, including persons with only MSM risk, to enable HCV diagnosis and treatment for coinfected individuals.
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http://dx.doi.org/10.1093/ofid/ofx076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5466816PMC
June 2017

Cardiovascular Disease Risk Prediction in the HIV Outpatient Study.

Clin Infect Dis 2016 Dec 9;63(11):1508-1516. Epub 2016 Sep 9.

Division of HIV/AIDS Prevention.

Background:  Cardiovascular disease (CVD) risk prediction tools are often applied to populations beyond those in which they were designed when validated tools for specific subpopulations are unavailable.

Methods:  Using data from 2283 human immunodeficiency virus (HIV)-infected adults aged ≥18 years, who were active in the HIV Outpatient Study (HOPS), we assessed performance of 3 commonly used CVD prediction models developed for general populations: Framingham general cardiovascular Risk Score (FRS), American College of Cardiology/American Heart Association Pooled Cohort equations (PCEs), and Systematic COronary Risk Evaluation (SCORE) high-risk equation, and 1 model developed in HIV-infected persons: the Data Collection on Adverse Effects of Anti-HIV Drugs (D:A:D) study equation. C-statistics assessed model discrimination and the ratio of expected to observed events (E/O) and Hosmer-Lemeshow χ P value assessed calibration.

Results:  From January 2002 through September 2013, 195 (8.5%) HOPS participants experienced an incident CVD event in 15 056 person-years. The FRS demonstrated moderate discrimination and was well calibrated (C-statistic: 0.66, E/O: 1.01, P = .89). The PCE and D:A:D risk equations demonstrated good discrimination but were less well calibrated (C-statistics: 0.71 and 0.72 and E/O: 0.88 and 0.80, respectively; P < .001 for both), whereas SCORE performed poorly (C-statistic: 0.59, E/O: 1.72; P = .48).

Conclusions:  Only the FRS accurately estimated risk of CVD events, while PCE and D:A:D underestimated risk. Although these models could potentially be used to rank US HIV-infected individuals at higher or lower risk for CVD, the models may fail to identify substantial numbers of HIV-infected persons with elevated CVD risk who could potentially benefit from additional medical treatment.
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http://dx.doi.org/10.1093/cid/ciw615DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5624518PMC
December 2016

Immune Responses to Circulating and Vaccine Viral Strains in HIV-Infected and Uninfected Children and Youth Who Received the 2013/2014 Quadrivalent Live-Attenuated Influenza Vaccine.

Front Immunol 2016 15;7:142. Epub 2016 Apr 15.

Children's Hospital of Colorado , Aurora, CO , USA.

The live-attenuated influenza vaccine (LAIV) has generally been more efficacious than the inactivated vaccine in children. However, LAIV is not recommended for HIV-infected children because of insufficient data. We compared cellular, humoral, and mucosal immune responses to the 2013-2014 LAIV quadrivalent (LAIV4) in HIV-infected and uninfected children 2-25 years of age (yoa). We analyzed the responses to the vaccine H1N1 (H1N1-09), to the circulating H1N1 (H1N1-14), which had significant mutations compared to H1N1-09 and to B Yamagata (BY), which had the highest effectiveness in 2013-2014. Forty-six HIV-infected and 56 uninfected participants with prior influenza immunization had blood and nasal swabs collected before and after LAIV4 for IFNγ T and IgG/IgA memory B-cell responses (ELISPOT), plasma antibodies [hemagglutination inhibition (HAI) and microneutralization (MN)], and mucosal IgA (ELISA). The HIV-infected participants had median CD4+ T cells = 645 cells/μL and plasma HIV RNA = 20 copies/mL. Eighty-four percent were on combination anti-retroviral therapy. Regardless of HIV status, significant increases in T-cell responses were observed against BY, but not against H1N1-09. H1N1-09 T-cell immunity was higher than H1N1-14 both before and after vaccination. LAIV4 significantly increased memory IgG B-cell immunity against H1N1-14 and BY in uninfected, but not in HIV-infected participants. Regardless of HIV status, H1N1-09 memory IgG B-cell immunity was higher than H1N1-14 and lower than BY. There were significant HAI titer increases after vaccination in all groups and against all viruses. However, H1N1-14 MN titers were significantly lower than H1N1-09 before and after vaccination overall and in HIV-uninfected vaccinees. Regardless of HIV status, LAIV4 increased nasal IgA concentrations against all viruses. The fold-increase in H1N1-09 IgA was lower than BY. Overall, participants <9 yoa had decreased BY-specific HAI and nasal IgA responses to LAIV4. In conclusion, HIV-infected and uninfected children and youth had comparable responses to LAIV4. H1N1-09 immune responses were lower than BY and higher than H1N1-14, suggesting that both antigenic mismatches between circulating and vaccine H1N1 and lower immunogenicity of the H1N1 vaccine strain may have contributed to the decreased H1N1 effectiveness of 2013-2014 LAIV4.
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http://dx.doi.org/10.3389/fimmu.2016.00142DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4831981PMC
May 2016

A Matter of Perspective: Comparison of the Characteristics of Persons with HIV Infection in the United States from the HIV Outpatient Study, Medical Monitoring Project, and National HIV Surveillance System.

Open AIDS J 2015 7;9:123-33. Epub 2015 Dec 7.

Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.

Comparative analyses of the characteristics of persons living with HIV infection (PLWH) in the United States (US) captured in surveillance and other observational databases are few. To explore potential joint data use to guide HIV treatment and prevention in the US, we examined three CDC-funded data sources in 2012: the HIV Outpatient Study (HOPS), a multisite longitudinal cohort; the Medical Monitoring Project (MMP), a probability sample of PLWH receiving medical care; and the National HIV Surveillance System (NHSS), a surveillance system of all PLWH. Overall, data from 1,697 HOPS, 4,901 MMP, and 865,102 NHSS PLWH were analyzed. Compared with the MMP population, HOPS participants were more likely to be older, non-Hispanic/Latino white, not using injection drugs, insured, diagnosed with HIV before 2009, prescribed antiretroviral therapy, and to have most recent CD4+ T-lymphocyte cell count ≥500 cells/mm3 and most recent viral load test<2 00 copies/mL. The MMP population was demographically similar to all PLWH in NHSS, except it tended to be slightly older, HIV diagnosed more recently, and to have AIDS. Our comparative results provide an essential first step for combined epidemiologic data analyses to inform HIV care and prevention for PLWH in the US.
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http://dx.doi.org/10.2174/1874613601509010123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4714382PMC
January 2016

Antiretroviral Regimen Durability and Success in Treatment-Naive and Treatment-Experienced Patients by Year of Treatment Initiation, United States, 1996-2011.

J Acquir Immune Defic Syndr 2016 Jan;71(1):47-56

*Department of Medicine, Emory University School of Medicine, Division of Infectious Diseases and Grady Health System, Atlanta, GA;†Cerner Corporation, Vienna, VA; and‡Feinberg School of Medicine, Northwestern University, Chicago, IL.

Background: Although modern combination antiretroviral therapy (cART) regimens are better tolerated and less complex than earlier treatments, regimen modification or discontinuation remains a concern.

Methods: We studied HIV Outpatient Study (HOPS) participants who initiated the first or second cART regimens during: 1996-1999, 2000-2003, 2004-2007, and 2008-2011. We analyzed regimen durability (time to regimen modification) and success (achieving undetectable plasma HIV RNA) for the first and second cART regimens using Kaplan-Meier curves and log-rank tests, and examined factors associated with durability and success of the first cART regimen using proportional hazards models.

Results: Durability of cART was progressively longer for cART regimens initiated in more recent periods: median first cART regimen durations were 1.0, 1.1, 2.1, and 4.6 years in 1996-1999, 2000-2003, 2004-2007, and 2008-2011, and the median second cART durations were 0.9, 1.2, 2.8, and 3.9 years, respectively (both P < 0.001). Comparing 1996-1999 and 2008-2011, the percentage of patients who achieved an undetectable HIV RNA within 6 months of first cART initiation increased from 65% to 81% and from 63% to 80% on second cART (both P < 0.001). Among patients initiating first cART during 2008-2011, black non-Hispanic/Latino race/ethnicity and ≥ twice-daily dosing were significantly associated with higher rates of regimen modification (P < 0.05), and higher baseline HIV RNA levels were associated with failure to achieve an undetectable HIV RNA (P < 0.001).

Conclusions: Among HIV-infected U.S. adults in routine HIV care, durability of the first and second cART regimens and the likelihood of prompt virological suppression increased during 1996-2011, coincident with the availability of more tolerable, less complex cART options.
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http://dx.doi.org/10.1097/QAI.0000000000000813DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4713274PMC
January 2016

Safety, immunogenicity and shedding of LAIV4 in HIV-infected and uninfected children.

Vaccine 2015 Sep 1;33(38):4790-7. Epub 2015 Aug 1.

University of Colorado Denver, 12700 E 19th Avenue, Room 11126, Aurora, CO 80045, USA. Electronic address:

Objectives: HIV-infected children have poor responses to inactivated influenza vaccines. Live vaccines (LAIVs) are highly efficacious in children, but they are not used in HIV-infected children du e to limited information. We investigated the safety, immunogenicity and viral shedding of LAIV4 in HIV-infected compared with uninfected children.

Design: Forty-six HIV-infected and 56 uninfected children 2 to 25 years old, who had been previously vaccinated against influenza, consented to receive a single dose of LAIV4. All grade adverse events (AEs) were recorded in the first month post-vaccination and serious AEs (SAEs) throughout the influenza season. Nasopharyngeal swabs for influenza PCR and IgA ELISA and blood for hemagglutination inhibition antibody (HAI) measurements were collected at entry, 2-5, 7-10 and 21-28 days post-vaccination.

Results: The HIV-infected subjects had median CD4+ cells of 649 cells/μL and plasma HIV RNA of 20 copies/mL. AEs were similar in the two groups. There were no vaccine-related SAEs. Shedding of ≥1 vaccine virus was detected in 67% HIV-infected and 50% uninfected participants (p=0.14). HAI titers did not appreciably change, but mucosal IgA antibodies significantly increased post-vaccination in both groups. High baseline HAI and IgA antibody concentrations were associated with decreased viral shedding in controls, but not in HIV-infected subjects. Similar proportions of HIV-infected vaccinees and controls reported influenza-like illnesses (12% and 6%) throughout the season.

Conclusions: LAIV4 was equally safe and immunogenic and caused similar viral shedding in HIV-infected and uninfected children. A correlate of protection against vaccine viral shedding was not identified in HIV-infected participants, although both circulating and mucosal antibodies correlated with protection in controls.
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http://dx.doi.org/10.1016/j.vaccine.2015.07.082DOI Listing
September 2015

Low bone mineral density and risk of incident fracture in HIV-infected adults.

Antivir Ther 2016 21;21(1):45-54. Epub 2015 Jul 21.

Colorado School of Mines, Golden, CO, USA.

Background: Prevalence rates of low bone mineral density (BMD) and bone fractures are higher among HIV-infected adults compared with the general United States (US) population, but the relationship between BMD and incident fractures in HIV-infected persons has not been well described.

Methods: Dual energy X-ray absorptiometry (DXA) results of the femoral neck of the hip and clinical data were obtained prospectively during 2004-2012 from participants in two HIV cohort studies. Low BMD was defined by a T-score in the interval >-2.5 to <-1.0 (osteopenia) or ≤-2.5 (osteoporosis). We analysed the association of low BMD with risk of subsequent incident fractures, adjusted for sociodemographics, other risk factors and covariables, using multivariable proportional hazards regression.

Results: Among 1,006 participants analysed (median age 43 years [IQR 36-49], 83% male, 67% non-Hispanic white, median CD4(+) T-cell count 461 cells/mm(3) [IQR 311-658]), 36% (n=358) had osteopenia and 4% (n=37) osteoporosis; 67 had a prior fracture documented. During 4,068 person-years of observation after DXA scanning, 85 incident fractures occurred, predominantly rib/sternum (n=18), hand (n=14), foot (n=13) and wrist (n=11). In multivariable analyses, osteoporosis (adjusted hazard ratio [aHR] 4.02, 95% CI 2.02, 8.01) and current/prior tobacco use (aHR 1.59, 95% CI 1.02, 2.50) were associated with incident fracture.

Conclusions: In this large sample of HIV-infected adults in the US, low baseline BMD was significantly associated with elevated risk of incident fracture. There is potential value of DXA screening in this population.
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http://dx.doi.org/10.3851/IMP2979DOI Listing
December 2016

Long-term immunologic and virologic responses on raltegravir-containing regimens among ART-experienced participants in the HIV Outpatient Study.

HIV Clin Trials 2015 08 1;16(4):139-46. Epub 2015 Jul 1.

Objectives: Raltegravir (RAL)-containing antiretroviral therapy (ART) produced better immunologic and virologic responses than optimized background ART in clinical trials of heavily ART-experienced patients, but few data exist on long-term outcomes in routine HIV care.

Methods: We studied ART-experienced HIV outpatient study (HOPS) participants seen at 10 US HIV-specialty clinics during 2007-2011.We identified patients who started (baseline date) either continuous ≥ 30 days of RAL-containing or RAL-sparing ART, and used propensity score (PS) matching methods to account for baseline clinical and demographic differences. We used Kaplan-Meier methods and log-rank tests for the matched subsets to evaluate probability of death, achieving HIV RNA < 50 copies/ml, and CD4 cell count (CD4) increase of ≥ 50 cells mm(- 3) during follow-up.

Results: Among 784 RAL-exposed and 1062 RAL-unexposed patients, 472 from each group were matched by PS. At baseline, the 472 RAL-exposed patients (mean nadir CD4, 205 cells mm(- 3); mean baseline CD4, 460 cells mm(- 3); HIV RNA < 50 copies ml(- 1) in 61%; mean years on prescribed ART, 7.5) were similar to RAL unexposed. During a mean follow-up of over 3 years, mortality rates and immunologic and virologic trajectories did not differ between the two groups. Among patients with detectable baseline HIV RNA levels, 76% of RAL-exposed and 63% of RAL-unexposed achieved HIV RNA < 50 copies ml(- 1) (P = 0.51); 69 and 58%, respectively, achieved a CD4 increase ≥ 50 cells mm(- 3) (P = 0.70).

Discussion: In our large cohort of US ART-experienced patients with a wide spectrum of clinical history, similar outcomes were observed when prescribed RAL containing versus other contemporary ART.
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http://dx.doi.org/10.1179/1528433614Z.0000000019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4657741PMC
August 2015

Trends in use of genotypic resistance testing and frequency of major drug resistance among antiretroviral-naive persons in the HIV Outpatient Study, 1999-2011.

J Antimicrob Chemother 2015 Aug 15;70(8):2337-46. Epub 2015 May 15.

Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.

Background: Monitoring antiretroviral drug resistance can inform treatment recommendations; however, there are few such data from US patients before they initiate ART.

Methods: We analysed data from HIV Outpatient Study (HOPS) participants from nine US HIV clinics who were diagnosed with HIV infection during 1999-2011. Using the IAS-USA December 2010 guidelines, we assessed the frequency of major drug resistance mutations (mDRMs) related to antiretroviral agents in viral isolates from patients who underwent commercial genotypic testing (GT) for resistance before initiating ART. We employed general linear regression models to assess factors associated with having undergone GT, and then factors associated with having mDRM.

Results: Among 1531 eligible patients, 758 (49.5%) underwent GT before first ART, increasing from 15.5% in 1999-2002 to 75.9% in 2009-11 (P < 0.001). GT was carried out a median of 1.2 months after the diagnosis of HIV. In adjusted regression analyses, patients with pre-ART CD4+ T lymphocyte counts ≥200 cells/mm(3) or with HIV RNA levels >5.0 log10 copies/mL and those with a first HOPS visit in 2006 or later were significantly (P < 0.05) more likely to have undergone GT. Of the 758 patients, 114 (15.0%) had mDRMs; mutations relating to NRTIs, NNRTIs and PIs were present in 8.0%, 7.1% and 2.6%, respectively. There was no temporal change in the frequency of mDRM, and mDRMs were associated with an HIV RNA level <4.0 log10 copies/mL.

Conclusions: During 1999-2011, GT use among antiretroviral-naive patients became more common, but a quarter of patients in recent years remained untested. The frequency of mDRMs remained stable over time at about 15%.
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http://dx.doi.org/10.1093/jac/dkv120DOI Listing
August 2015

Factors associated with cancer incidence and with all-cause mortality after cancer diagnosis among human immunodeficiency virus-infected persons during the combination antiretroviral therapy era.

Open Forum Infect Dis 2014 Mar 27;1(1):ofu012. Epub 2014 May 27.

University of Illinois at Chicago , Chicago, Illinois.

Background: Little is known about survival and factors associated with mortality after cancer diagnosis among persons infected with human immunodeficiency virus (HIV).

Methods: Using Poisson regression, we analyzed incidence rates of acquired immune deficiency syndrome (AIDS)-defining cancers (ADC), non-AIDS-defining infection-related cancers (NADCI), and non-AIDS-defining noninfection-related cancers (NADCNI) among HIV Outpatient Study participants seen at least twice from 1996-2010. All-cause mortality within each cancer category and by calendar period (1996-2000, 2001-2005, 2006-2010) were examined using Kaplan-Meier survival methods and log-rank tests. We identified risk factors for all-cause mortality using multivariable Cox proportional hazard models.

Results: Among 8350 patients, 627 were diagnosed with 664 cancers. Over the 3 time periods, the age- and sex-adjusted incidence rates for ADC and NADCNI declined (both P < .001) and for NADCI did not change (P = .13). Five-year survival differed by cancer category (ADC, 54.5%; NADCI, 65.8%; NADCNI, 65.9%; P = .018), as did median CD4 cell count (107, 241, and 420 cells/mm(3); P < .001) and median log10 viral load (4.1, 2.3, and 2.0 copies/mL; P < .001) at cancer diagnosis, respectively. Factors independently associated with increased mortality for ADC were lower nadir CD4 cell count (hazard ratio [HR] = 3.02; 95% confidence interval [CI], 1.39-6.59) and detectable viral load (≥400 copies/mL; HR = 1.72 [95% CI, 1.01-2.94]) and for NADCNI, age (HR = 1.50 [95% CI, 1.16-1.94]), non-Hispanic black race (HR = 1.92 [95% CI, 1.15-3.24]), lower nadir CD4 cell count (HR = 1.77 [95% CI, 1.07-2.94]), detectable viral load (HR = 1.96 [95% CI, 1.18-3.24]), and current or prior tobacco use (HR = 3.18 [95% CI, 1.77-5.74]).

Conclusions: Since 1996, ADC and NADCNI incidence rates have declined. Survival after cancer diagnosis has increased with concomitant increases in CD4 cell count in recent years. Advances in HIV therapy, including early initiation of combination antiretroviral therapy, may help reduce mortality risk among HIV-infected persons with cancer.
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http://dx.doi.org/10.1093/ofid/ofu012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4324175PMC
March 2014

Seasonal influenza vaccination rates in the HIV outpatient study-United States, 1999-2013.

Clin Infect Dis 2015 Mar 11;60(6):976-7. Epub 2014 Dec 11.

Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia Cerner Corporation, Vienna, Virginia.

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http://dx.doi.org/10.1093/cid/ciu979DOI Listing
March 2015

Factors associated with mortality among persistently viraemic triple-antiretroviral-class-experienced patients receiving antiretroviral therapy in the HIV Outpatient Study (HOPS).

J Antimicrob Chemother 2014 Oct 16;69(10):2826-34. Epub 2014 Jun 16.

Centers for Disease Control and Prevention, Atlanta, GA, USA.

Background: Identifying factors associated with mortality for HIV-infected patients with persistent viraemia despite antiretroviral (ARV) therapy may inform diagnostic and treatment strategies.

Methods: We analysed data from viraemic triple-ARV-class-experienced HIV Outpatient Study patients seen during 1 January 1999 to 31 December 2012 who, despite treatment that included ARVs from three major drug classes [nucleoside analogue reverse transcriptase inhibitors, non-nucleoside analogue reverse transcriptase inhibitors and protease inhibitors (PIs)], had plasma HIV RNA levels [viral load (VL)] >1000 copies/mL ['triple ARV class failure' (TCF)]. The baseline was defined as the date of meeting the TCF criteria during 1999-2008. We identified factors associated with mortality using Cox regression.

Results: Of 597 patients who met the TCF criteria (median follow-up after baseline 4.9 years), 115 (19.3%) died. Baseline factors associated with mortality were age per 10 years [hazard ratio (HR) 1.61, 95% CI 1.28-2.02], risk of HIV from use of injection drugs (HR 1.81, 95% CI 1.10-2.98), CD4+ T cell count <200 cells/mm(3) (HR 3.68, 95% CI 2.41-5.62), VL ≥5.0 log10 copies/mL (HR 2.91, 95% CI 1.88-4.49) and receiving a first combination ARV therapy regimen that was PI-based (HR 2.44, 95% CI 1.47-4.06); receiving a novel ARV agent during follow-up (HR 0.45, 95% CI 0.22-0.93) was protective. Genotypic resistance testing results were available for 274 (45.9%) of the TCF patients, of whom 47 (17.2%) died. In this group, factors associated with death were increasing age (HR 1.94, 95% CI 1.36-2.78, per 10 year increment), risk of HIV from use of injection drugs (HR 2.71, 95% CI 1.37-5.39), baseline VL ≥5.0 log10 copies/mL (HR 5.35, 95% CI 2.82-10.1) and receiving PI-based first combination ARV therapy regimen (HR 3.20, 95% CI 1.25-8.17). No HIV mutations or combinations of mutations were significantly associated with survival.

Conclusions: Factors significantly associated with mortality risk among TCF patients who received ongoing ARV therapy included traditional clinical predictors but not the presence, type or number of HIV genetic mutations. The use of novel ARV drugs by these ARV therapy-experienced patients was associated with an improved survival.
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http://dx.doi.org/10.1093/jac/dku190DOI Listing
October 2014

Is primary mycobacterium avium complex prophylaxis necessary in patients with CD4 <50 cells/μL who are virologically suppressed on cART?

AIDS Patient Care STDS 2014 Jun 15;28(6):280-3. Epub 2014 May 15.

1 Infectious Disease Research Institute, Inc. , Tampa, Florida.

We analyzed 369 patients with no prior Mycobacterium avium complex (MAC) infection and CD4 <50 cells/μL (baseline), while on combination antiretroviral therapy(cART), for incidence rates of primary MAC infection during the 6 months after baseline, by prophylaxis status. Of participants (median age, 40 years old), most were male (81%) and about half were non-white; at baseline, 81% of participants were on cART >60 days and 19% had HIV RNA <1000 copies/mL, whereas 65% had HIV RNA >10,000 copies/mL. Eleven patients had MAC infection within 6 months baseline (rate=0.6/100 person months): 4/175 on MAC prophylaxis vs. 7/194, no MAC prophylaxis (p=0.64). Of the 11 patients, seven had HIV RNA >10,000, and three >1000-9999 copies/mL at baseline (one missing). Median time to MAC infection was 62 days (IQR 43-126, maximum 139 days). No MAC infection occurred among 71 (19%) patients virologically suppressed (HIV RNA <1000 copies/mL) at baseline, including 41 patients with no MAC prophylaxis during follow-up. A small number of eligible virologically suppressed participants and the lack of data on cART/MAC prophylaxis adherence limited our observational nonrandomized study. Primary MAC prophylaxis may not be required for cART-virologically suppressed patients with CD4 <50 cells/mL.
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http://dx.doi.org/10.1089/apc.2013.0270DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4657747PMC
June 2014

Polypharmacy and risk of antiretroviral drug interactions among the aging HIV-infected population.

J Gen Intern Med 2013 Oct 20;28(10):1302-10. Epub 2013 Apr 20.

Temple University School of Pharmacy, 3307 N. Broad St., Philadelphia, PA, 19140, USA,

Background: Among aging HIV-infected adults, polypharmacy and its consequences have not been well-described.

Objective: To characterize the extent of polypharmacy and the risk of antiretroviral (ARV) drug interactions among persons of different ages.

Design And Participants: Cross-sectional analysis among patients within the HIV Outpatient Study (HOPS) cohort who were prescribed ARVs during 2006-2010.

Main Measures: We used the University of Liverpool HIV drug interactions database to identify ARV/non-ARV interactions with potential for clinical significance.

Key Results: Of 3,810 patients analyzed (median age 46 years, 34 % ≥ 50 years old) at midpoint of observation, 1,494 (39 %) patients were prescribed ≥ 5 non-ARV medications: 706 (54 %) of 1,312 patients ≥ 50 years old compared with 788 (32 %) of 2,498 patients < 50 years. During the five-year period, the number of patients who were prescribed at least one ARV/non-ARV combination that was contraindicated or had moderate or high evidence of interaction was 267 (7 %) and 1,267 (33 %), respectively. Variables independently associated with having been prescribed a contraindicated ARV/non-ARV combination included older age (adjusted odds ratio [aOR] per 10 years of age 1.17, 95 % CI 1.01-1.35), anxiety (aOR 1.78, 95 % CI 1.32-2.40), dyslipidemia (aOR 1.96, 95 % CI 1.28-2.99), higher daily non-ARV medication burden (aOR 1.13, 95 % CI 1.10-1.17), and having been prescribed a protease inhibitor (aOR 2.10, 95 % CI 1.59-2.76). Compared with patients < 50 years, older patients were more likely to have been prescribed an ARV/non-ARV combination that was contraindicated (unadjusted OR 1.44, 95 % CI 1.14-1.82), or had moderate or high evidence of interaction (unadjusted OR 1.29, 95 % CI 1.15-1.44).

Conclusions: A substantial percentage of patients were prescribed at least one ARV/non-ARV combination that was contraindicated or had potential for a clinically significant interaction. As HIV-infected patients age and experience multiple comorbidities, systematic reviews of current medications by providers may reduce risk of such exposures.
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http://dx.doi.org/10.1007/s11606-013-2449-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3785656PMC
October 2013

Association between opioid use and health care utilization as measured by emergency room visits and hospitalizations among persons living with HIV.

Clin J Pain 2013 Nov;29(11):957-61

Divisions of *General Internal Medicine †Infectious Diseases, Department of Medicine, School of Medicine, University of Colorado, CO ‡Department of Epidemiology, Children's Hospital Colorado, Aurora.

Background: Epidemiologic studies in the non-human immunodeficiency virus (HIV) positive population have shown greater health care utilization among persons with chronic non-cancer pain on opioid therapy. However, we are not aware of any similar data in the HIV positive population.

Methods: We evaluated health care utilization, as measured by emergency room (ER) visits and hospitalizations, among persons with HIV and chronic pain seen at an academic medical center, during the calendar year 2005. We compared these outcomes between patients on chronic opioid therapy with those not on opioids.

Results: In univariate models chronic opioid therapy was associated with both ER visits and hospitalization: ER visits odds ratio (OR)=2.18 (95% confidence interval [CI], 1.30-3.66), hospitalization OR=1.90 (95% CI, 1.03-3.51). After multivariate analyses only nonsignificant trends remain: ER visits OR=1.71 (95% CI, 0.95-3.08); hospitalization OR=1.28 (95% CI, 0.66-2.49).

Conclusions: In our study HIV positive individuals with chronic pain were more likely to be seen in the ER and be hospitalized if they were on opioids. However, after controlling for other variables, the association with opioids no longer remained significant.
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http://dx.doi.org/10.1097/AJP.0b013e31827c7b05DOI Listing
November 2013

Provider compliance with guidelines for management of cardiovascular risk in HIV-infected patients.

Prev Chronic Dis 2013 ;10:E10

National Jewish Health, Denver, CO, USA.

Introduction: Compliance with National Cholesterol Education Program Adult Treatment Panel III (NCEP) guidelines has been shown to significantly reduce incident cardiovascular events. We investigated physicians' compliance with NCEP guidelines to reduce cardiovascular disease (CVD) risk in a population infected with HIV.

Methods: We analyzed HIV Outpatient Study (HOPS) data, following eligible patients from January 1, 2002, or first HOPS visit thereafter to calculate 10-year cardiovascular risk (10yCVR), until September 30, 2009, death, or last office visit. We categorized participants into four 10yCVR strata, according to guidelines determined by NCEP, the Infectious Disease Society of America, and the Adult AIDS Clinical Trials Group. We calculated percentages of patients treated for dyslipidemia and hypertension, calculated percentages of patients who achieved recommended goals, and categorized them by 10yCVR stratum.

Results: Of 2,005 patients analyzed, 33.7% had fewer than 2 CVD risk factors. For patients who had 2 or more risk factors, 10yCVR was less than 10% for 28.2%, 10% to 20% for 18.2%, and higher than 20% for 20.0% of patients. Of patients eligible for treatment, 81% to 87% were treated for elevated low-density lipoprotein cholesterol/non-high-density lipoprotein cholesterol (LDL-C/non-HDL-C), 2% to 11% were treated for low HDL-C, 56% to 91% were treated for high triglycerides, and 46% to 69% were treated for hypertension. Patients in higher 10yCVR categories were less likely to meet treatment goals than patients in lower 10yCVR categories.

Conclusion: At least one-fifth of contemporary HOPS patients have a 10yCVR higher than 20%, yet a large percentage of at-risk patients who were eligible for pharmacologic treatment did not receive recommended interventions and did not reach recommended treatment goals. Opportunities exist for CVD prevention in the HIV-infected population.
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http://dx.doi.org/10.5888/pcd10.120083DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3557014PMC
May 2013

A pilot study to assess inflammatory biomarker changes when raltegravir is added to a virologically suppressive HAART regimen in HIV-1-infected patients with limited immunological responses.

Antivir Ther 2012 5;17(7):1301-9. Epub 2012 Sep 5.

Division of Infectious Diseases, Department of Medicine, National Jewish Health, Denver, CO, USA.

Background: Despite successful suppression of HIV-1 with HAART, some patients do not have robust immunological recovery. Chronic inflammation from persistent immune activation could contribute to this poor response, resulting in HIV-1 disease progression and the development of some non-HIV-1 comorbidities.

Methods: We conducted a pilot study of 30 HIV-1-infected patients with undetectable viral loads and poor CD4(+) T-cell responses on long-term stable HAART to assess whether the addition of raltegravir would have an effect on biomarkers of chronic inflammation. A total of 26 patients were followed for 1 year on the intensified regimen. In addition to T-cell responses, we evaluated changes in activated CD4(+) and CD8(+) T-cells, several pro-inflammatory cytokines and chemokines and memory cell responses to HIV-1-associated peptides.

Results: Although there was no improvement in CD4(+) T-cell counts, the percentage change in CD4(+)%, CD4(+)/CD8(+) ratios and RANTES (regulated on activation normal T-cells expressed and secreted) increased significantly while the percentage change in CD8(+) T-cell counts and CD8(+)%, activated CD4(+) T-cells and several pro-inflammatory chemokines and cytokines decreased significantly. The percentage change in HIV-1-specific nef, pol set 1, gag and env memory T-cells also declined.

Conclusions: The addition of raltegravir to a virologically suppressive HAART regimen in patients with poor immunological responses resulted in the reduction of several pro-inflammatory biomarkers; increases were seen in RANTES levels and CD4(+)/CD8(+) T-cell ratios. The clinical relevance of these observations is beyond the scope of this study.
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http://dx.doi.org/10.3851/IMP2350DOI Listing
April 2013