Emerging from the Shadows: Trends in HIV Ambulatory Care, Viral Load Testing, and Viral Suppression in a U.S. HIV Cohort, 2019-2022: Impact of COVID-19 Pandemic.

OBJECTIVES: Analyze the acute impact and the longer-term recovery of COVID-19 pandemic effects on clinical encounter types, HIV viral load (VL) testing and suppression (HIV VL<200 copies/mL). DESIGN: Longitudinal cohort study of participants seen during 2019-2022 at eight HIV Outpatient Study (HOPS) sites. METHODS: Generalized linear mixed models (GLMM) estimated monthly rates of all encounters, office and telemedicine visits, and HIV VL tests using 2010-2022 data. We examined factors associated with non-suppressed VL (VL ≥ 200 copies/mL) and not having ambulatory care visits during the pandemic using GLMM for logistic regression with 2017-2022 and 2019-2022 data, respectively. RESULTS: Of 2351 active participants, 76.0% were male, 57.6% aged ≥ 50 years, 40.7% non-Hispanic White, 38.2% non-Hispanic Black, 17.3% Hispanic/Latino, and 51.0% publicly insured. The monthly rates of in-person and telemedicine visits varied during 2020 through mid-year 2022. Multivariable logistic regression showed persons with no encounters were more likely to be male or have VL ≥ 200 copies/mL. For participants with ≥1 VL test, the prevalence rate of HIV VL ≥ 200 copies/mL during 2020 was close to the rates from 2014 to 2019. The change in probability of viral suppression was not associated with participant's age, sex, race/ethnicity or insurance type. CONCLUSION: In thent encounters declined over 2 years during the pandemic with variations in telemedicine and in-person events, with relative maintenance of viral suppression. Ongoing recovery from the impact of COVID-19 on ambulatory care will require continued efforts to improve retention and patient access to medical services.

Incidence of Hyperlipidemia among Adults Initiating Antiretroviral Therapy in the HIV Outpatient Study (HOPS), USA, 2007-2021.

Current U.S. guidelines recommend integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) as initial treatment for people with HIV (PWH). We assessed long-term effects of INSTI use on lipid profiles in routine HIV care. We analyzed medical record data from the HIV Outpatient Study's participants in care from 2007 to 2021. Hyperlipidemia was defined based on clinical diagnoses, treatments, and laboratory results. We calculated hyperlipidemia incidence rates and rate ratios (RRs) during initial ART and assessed predictors of incident hyperlipidemia by using Poisson regression. Among 349 eligible ART-naïve PWH, 168 were prescribed INSTI-based ART (36 raltegravir (RAL), 51 dolutegravir (DTG), and 81 INSTI-others (elvitegravir and bictegravir)) and 181 non-INSTI-based ART, including 68 protease inhibitor (PI)-based ART. During a median follow-up of 1.4 years, hyperlipidemia rates were 12.8, 22.3, 22.7, 17.4, and 12.6 per 100 person years for RAL-, DTG-, INSTI-others-, non-INSTI-PI-, and non-INSTI-non-PI-based ART, respectively. In multivariable analysis, compared with the RAL group, hyperlipidemia rates were higher in INSTI-others (RR = 2.25; 95% confidence interval (CI): 1.29-3.93) and non-INSTI-PI groups (RR = 1.89; CI: 1.12-3.19) but not statistically higher for the DTG (RR = 1.73; CI: 0.95-3.17) and non-INSTI-non-PI groups (RR = 1.55; CI: 0.92-2.62). Other factors independently associated with hyperlipidemia included older age, non-Hispanic White race/ethnicity, and ART without tenofovir disoproxil fumarate. PWH using RAL-based regimens had lower rates of incident hyperlipidemia than PWH receiving non-INSTI-PI-based ART but had similar rates as those receiving DTG-based ART, supporting federal recommendations for using DTG-based regimens as the initial therapy for ART-naïve PWH.

Weight Gain and Metabolic Effects in Persons With HIV Who Switch to ART Regimens Containing Integrase Inhibitors or Tenofovir Alafenamide.

BACKGROUND: The timing and magnitude of antiretroviral therapy-associated weight change attributions are unclear. SETTING: HIV Outpatient Study participants. METHODS: We analyzed 2007-2018 records of virally suppressed (VS) persons without integrase inhibitor (INSTI) experience who switched to either INSTI-based or another non-INSTI-based ART, and remained VS. We analyzed BMI changes using linear mixed models, INSTI- and tenofovir alafenamide (TAF) contributions to BMI change by linear mixed models-estimated slopes, and BMI inflection points. RESULTS: Among 736 participants (5316 person-years), 441 (60%) switched to INSTI-based ART; the remainder to non-INSTI-based ART. The mean follow-up was 7.15 years for INSTI recipients and 7.35 years for non-INSTI. Preswitch, INSTI and non-INSTI groups had similar median BMI (26.3 versus 25.9 kg/m 2 , P = 0.41). INSTI regimens included raltegravir (178), elvitegravir (112), and dolutegravir (143). Monthly BMI increases postswitch were greater with INSTI than non-INSTI (0.0525 versus 0.006, P < 0.001). A BMI inflection point occurred 8 months after switch among INSTI users; slopes were similar regardless of TAF use immediately postswitch. Among INSTI + TAF users, during 8 months postswitch, 87% of BMI slope change was associated with INSTI use, 13% with TAF use; after 8 months, estimated contributions were 27% and 73%, respectively. For non-INSTI+TAF, 84% of BMI gain was TAF-associated consistently postswitch. Persons switching from TDF to TAF had greater BMI increases than others ( P < 0.001). CONCLUSION: Among VS persons who switched ART, INSTI and TAF use were independently associated with BMI increases. During 8 months postswitch, BMI changes were greatest and most associated with INSTI use; afterward, gradual BMI gain was largely TAF-associated.

A Heavy Burden: Preexisting Physical and Psychiatric Comorbidities and Differential Increases Among Male and Female Participants After Initiating Antiretroviral Therapy in the HIV Outpatient Study, 2008-2018.

Attention to non-AIDS comorbidities is increasingly important in the HIV care and management in the United States. We sought to assess comorbidities before and after antiretroviral therapy (ART) initiation among persons with HIV (PWH). Using the 2008-2018 HIV Outpatient Study (HOPS) data, we assessed changes in prevalence of physical and psychiatric comorbidities, by sex, among participants initiating ART. Cox proportional hazards models were fit to investigate factors associated with the first documented occurrence of key comorbidities, adjusting for demographics and other covariates, including insurance type, CD4+ cell count, ART regimen, and smoking status. Among 1,236 participants who initiated ART (median age 36 years, CD4 cell count 375 cells/mm3), 79% were male, 66% non-white, 44% publicly insured, 53% ever smoked, 33% had substance use history, and 22% had body mass index ≥30 kg/m2. Among females, the percentages with at least one condition were: at ART start, 72% had a physical and 42% a psychiatric comorbidity, and after a median of 6.1 years of follow-up, these were 87% and 63%, respectively. Among males, the percentages with at least one condition were: at ART start, 61% had a physical and 32% a psychiatric comorbidity, and after a median of 4.6 years of follow-up, these were 82% and 53%, respectively. In multivariable Cox proportional hazards analyses, increasing age and higher viral loads (VL) were associated with most physical comorbidities, and being a current/former smoker and higher VL were associated with all psychiatric comorbidities analyzed. HOPS participants already had a substantial burden of physical and psychiatric comorbidities at the time of ART initiation. With advancing age, PWH who initiate ART experience a clinically significant increase in the burden of chronic non-HIV comorbidities that warrants continued surveillance, prevention, and treatment.

Disparities in Treatment with Direct-Acting Hepatitis C Virus Antivirals Persist Among Adults Coinfected with HIV and Hepatitis C Virus in US Clinics, 2010-2018.

Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfection carries substantial risk for all-cause mortality and liver-related morbidity and mortality, yet many persons coinfected with HIV/HCV remain untreated for HCV. We explored demographic, clinical, and sociodemographic factors among participants in routine HIV care associated with prescription of direct-acting antivirals (DAAs). The HIV Outpatient Study (HOPS) is an ongoing longitudinal cohort study of persons with HIV in care at participating clinics since 1993. There are currently eight study sites in six US cities. We analyzed medical records data of HOPS participants diagnosed with HCV since June 2010. Sustained virological response (SVR) was documented with first undetectable HCV viral load (VL). We assessed factors associated with being prescribed DAAs by multi-variable logistic regression and described the cumulative rate of SVR. Among 306 eligible participants, 131 (43%) were prescribed DAA therapy. Factors associated with greater odds of being prescribed DAA were older age, private health insurance, higher CD4 cell count, being a person who injects drugs, and receiving care at publicly funded sites (p < 0.05). Of 127 (97%) participants with at least 1 follow-up HCV VL, 110 (87%) achieved SVR at 12 weeks. Of the total 131 participants, 123 (94%) eventually achieved SVR. Less than half of HIV/HCV coinfected patients in HOPS have been prescribed DAAs. Interventions are needed to address deficits in DAA prescription, including among patients with public or no health insurance, younger age, and lower CD4 cell count.

HIV viral exposure and mortality in a multicenter ambulatory HIV adult cohort, United States, 1995-2016.

ABSTRACT: The aim of this study was to identify viral exposure (VE) measures and their relationship to mortality risk among persons with HIV.Prospective multicenter observational study to compare VE formulae.Eligible participants initiated first combination antiretroviral therapy (cART) between March 1, 1995 and June 30, 2015. We included 1645 participants followed for ≥6 months after starting first cART, with cART prescribed ≥75% of time, who underwent ≥2 plasma viral load (VL) and ≥1 CD4+ T-lymphocyte cell (CD4) measurement during observation. We evaluated all-cause mortality from 6 months after cART initiation until June 30, 2016. VE was quantified using 2 time-updated variables: viremia copy-years and percent of person-years (%PY) spent >200 or 50 copies/mL. Cox models were fit to estimate associations between VE and mortality.Participants contributed 10,453 person years [py], with median 14 VLs per patient. Median %PY >200 or >50 were 10% (interquartile range: 1%-47%) and 26% (interquartile range: 6%-72%), respectively. There were 115 deaths, for an overall mortality rate of 1.19 per 100 person years. In univariate models, each measure of VE was significantly associated with mortality risk, as were older age, public insurance, injection drug use HIV risk history, and lower pre-cART CD4. Based on model fit, most recent viral load and %PY >200 copies/mL provided the best combination of VE factors to predict mortality, although all VE combinations evaluated performed well.The combination of most recent VL and %PY >200 copies/mL best predicted mortality, although all evaluated VE measures performed well.

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

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/mm3 (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; P < .001). Multivariable factors positively associated (P < .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.

Perceptions of Long-Acting Injectable Antiretroviral Treatment Regimens in a United States Urban Academic Medical Center.

Patient acceptance of long-acting injectable antiretroviral (LAI-ARV) HIV-1 regimens will determine uptake. Although previous literature reports high satisfaction, these data stem from clinical trials subject to selection bias. This cross-sectional survey from the HIV practices of an urban academic medical center assessed perceptions and preferences using Likert scales toward overall acceptability, proposed frequencies, injection-site reaction durations, and distribution venue. 59% of surveys were completed resulting 202 respondents. 60% were male, 72% black, and the median age was 49 (IQR 36-58). 93% reported a once daily tablet frequency, 69% reported single tablet regimens, and 59% reported missing zero doses in the prior 30 days. Patients self-categorized as likely (57%) or unlikely (43%) to accept LAI-ARV. Both decreasing frequencies between injections and durations of injection-site reactions resulted higher acceptability scores. 57% of respondents preferred receiving an injectable from their clinician's office over other potential options. These data demonstrate positive LAI-ARV acceptance potential.

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

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/mm3 to 640 cells/mm3 from 1993 to 2017. Mortality fell from 121 to 16 per 1000 person-years from 1994 to 2017 (P < .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.

Rates of suicidal ideation among HIV-infected patients in care in the HIV Outpatient Study 2000-2017, USA.

BACKGROUND: Suicidal ideation (SI) refers to an individual thinking about, considering or planning suicide. Identifying and characterizing persons with HIV (PWH) at greater risk for SI may lead to better suicide prevention strategies and quality of life improvement. METHODS: Using clinical data gathered from medical chart abstraction for HIV Outpatient Study (HOPS) participants from 2000 to 2017, we assessed SI frequency among PWH in care and explored factors associated with the presence of SI diagnoses using linear mixed models analyses. RESULTS: Among 6706 participants, 224 (3.3%) had a charted diagnosis of SI. Among those with SI, median age (interquartile range [IQR]) was 43.4 years [IQR: 38.7-50.3], median (IQR) CD4+ cell count was 439 cells/mm3 (IQR: 237-686), 71.4% were male, 54% were men who have sex with men (MSM), 25.4% heterosexual, and 13.4% persons who inject drugs. In multivariable analysis, persons at increased risk for SI were more likely to be: <50 years old (adjusted rate ratio [aRR] 1.86, 95% confidence interval [95%CI] 1.36-2.53), non-Hispanic/Latino black (aRR 1.75; 95%CI 1.29-2.38), have CD4+ cell count <350 cells/mm3 (aRR 1.32; 95%CI 1.05-1.65), have a viral load ≥50 copies/mL (aRR 1.49; 95%CI 1.12-1.98), have stopped antiretroviral therapy (aRR 1.46; 95%CI 1.10-1.95), have a history of: alcohol dependence (aRR 2.75; 95%CI 1.67-4.52), and drug overdose (aRR 4.09; 95%CI 2.16-7.71). CONCLUSION: Routine mental health assessment and monitoring are needed in HIV clinical practice to better understand factors associated with SI and to inform the development of preventive interventions.

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

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.

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

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/m2), 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.

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

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.

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

[This corrects the article DOI: 10.1371/journal.pone.0189973.].

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

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.

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

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%), p < .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.

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

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 (log10 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.

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

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 (P = .024), with decreases observed (P < .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.

Pulmonary effects of immediate versus deferred antiretroviral therapy in HIV-positive individuals: a nested substudy within the multicentre, international, randomised, controlled Strategic Timing of Antiretroviral Treatment (START) trial.

BACKGROUND: Observational data have been conflicted regarding the potential role of HIV antiretroviral therapy (ART) as a causative factor for, or protective factor against, COPD. We therefore aimed to investigate the effect of immediate versus deferred ART on decline in lung function in HIV-positive individuals. METHODS: We did a nested substudy within the randomised, controlled Strategic Timing of Antiretroviral Treatment (START) trial at 80 sites in multiple settings in 20 high-income and low-to-middle-income countries. Participants were HIV-1 infected individuals aged at least 25 years, naive to ART, with CD4 T-cell counts of more than 500 per µL, not receiving treatment for asthma, and without recent respiratory infections (baseline COPD was not an exclusion criterion). Participants were randomly assigned to receive ART (an approved drug combination derived from US Department of Health and Human Services guidelines) either immediately, or deferred until CD4 T-cell counts decreased to 350 per µL or AIDS developed. The randomisation was determined by participation in the parent START study, and was not specific to the substudy. Because of the nature of our study, site investigators and participants were not masked to the treatment group assignment; however, the assessors who reviewed the outcomes were masked to the treatment group. The primary outcome was the annual rate of decline in lung function, expressed as the FEV1 slope in mL/year; spirometry was done annually during follow-up for up to 5 years. We analysed data on an intention-to-treat basis, and planned separate analyses in smokers and non-smokers because of the known effects of smoking on FEV1 decline. The substudy was registered at ClinicalTrials.gov number NCT01797367. FINDINGS: Between March 11, 2010, and Aug 23, 2013, we enrolled 1026 participants to our substudy, who were then randomly assigned to either immediate (n=518) or deferred (n=508) ART. Median baseline characteristics included age 36 years (IQR 30-44), CD4 T-cell count 648 per µL (583-767), and HIV plasma viral load 4·2 log10 copies per mL (3·5-4·7). 29% were female and 28% were current smokers. Median follow-up time was 2·0 years (IQR 1·9-3·0). We noted no differences in FEV1 slopes between the immediate and deferred ART groups either in smokers (difference of -3·3 mL/year, 95% CI -38·8 to 32·2; p=0·86) or in non-smokers (difference of -5·6 mL/year, -29·4 to 18·3; p=0·65) or in pooled analyses adjusted for smoking status at each study visit (difference of -5·2 mL/year, -25·1 to 14·6; p=0·61). INTERPRETATION: The timing of ART initiation has no major short-term effect on rate of lung function decline in HIV-positive individuals who are naive to ART, with CD4 T-cell counts of more than 500 per µL. In light of updated WHO recommendations that all HIV-positive individuals should be treated with ART, regardless of their CD4 T-cell count, our results suggest an absence of significant pulmonary harm with such an approach. FUNDING: US National Heart Lung and Blood Institute, US National Institute of Allergy and Infectious Diseases, Division of AIDS, Agence Nationale de Recherches sur le SIDA et les Hipatites Virales (France), Australian National Health and Medical Research Council, Danish National Research Foundation, European AIDS Treatment Network, German Ministry of Education and Research, UK Medical Research Council and National Institute for Health Research, and US Veterans Health Administration Office of Research and Development.