Differences In Viral Suppression Research Articles

1704. Regional and Racial Disparities in Response to Antiretroviral Therapy (ART) among People Living with Human Immunodeficiency Virus (PLWH)

BackgroundThis study evaluated differences in viral suppression by race and region among PLWH in care at 10 community practices.MethodsPLWH (≥18 yrs) starting a new ART between Jan’15-Sept’19 with viral load at regimen prescription (Rx) and ≥6 months (mo) of prior history were selected from Trio Health HIV EMR database. Logistic regression [LR] estimated the association of covariates with outcome “viremic” (viral load >50 cells/ml) among those with viral load recorded 12-15 mo after baseline (BSL). Sensitivity analyses were conducted using viral loads at 9-15 mo, in patients (pts) on their BSL regimens for ≥12 mo, and pts with dispensing data. Covariates: BSL suppression, gender, race, age, payer, region (South vs non-South), BSL single vs multi-tablet regimen (STR vs MTR), and switch status from BSL regimen. Multicollinearity was not present.ResultsOf 20271 PLWH, 10373 (51%) were treated in South (41% not suppressed at BSL including 30% treatment-naïve [TN]) and 9898 (49%) in non-South (32% not suppressed including 26% TN). The following groups had higher suppression rates at 12-15 mo: males (83%) vs females (80%) p=0.003; white (85%) vs black (78%) and other known race (78%) p< 0.001; insured by commercial or Medicare insurance (both 85%) vs Medicaid (76%) or uninsured (71%) p< 0.001; treated in non-South (88%) vs South (77%) p< 0.001; age ≥50 (87%) vs < 50 (80%) p< 0.001, those who did not switch from BSL regimen (84%) vs switchers (82%) p< 0.001; on STR (84%) vs MTR (81%) p< 0.001.In LR, pts less likely to be suppressed at 12-15 mo were: < 50 adjusted odds ratio (aOR)=0.76 (0.67-0.88), unspecified gender vs female aOR=0.51 (0.28-0.92), black vs white aOR=0.65 (0.56-0.74), other race (Asian, etc.) vs white aOR=0.73 (0.59-0.91), insured by Medicaid vs commercially aOR=0.64 (0.50-0.82), uninsured vs commercially insured aOR=0.63 (0.53-0.75), treated in South aOR=0.43 (0.38-0.50), switched from BSL regimen aOR=0.75 (0.66-.086), on MTR vs STR aOR=0.81 (0.72-0.92), viremic at BSL aOR=0.41 (0.36-0.47). Sensitivity analyses results were similar.ConclusionOur findings highlighted higher rates of viremia among younger, black or other non-white race, pts treated in the South, on Medicaid or uninsured, on MTR, even after accounting for other characteristics.Disclosures Keith M. Rawlings, MD, ViiV Healthcare (Employee) Joseph J. Eron, MD, Gilead Sciences (Consultant, Research Grant or Support)Janssen (Consultant, Research Grant or Support)Merck (Consultant)ViiV Healthcare (Consultant, Research Grant or Support) Julie Priest, MSPH, GlaxoSmithKline (Employee, Shareholder) Janna Radtchenko, MBA, Trio Health (Employee) Joseph Mrus, MD, MSc, ViiV Healthcare (Employee) Moti Rampogal, MD, Gilead Sciences (Consultant, Research Grant or Support, Speaker’s Bureau)Janssen (Consultant, Research Grant or Support, Speaker’s Bureau)Merck (Consultant, Research Grant or Support)ViiV Healthcare (Consultant, Research Grant or Support, Speaker’s Bureau) Alan Oglesby, MPH, ViiV Healthcare (Employee) Richard A. Elion, MD, Gilead Sciences (Advisor or Review Panel member, Research Grant or Support, Speaker’s Bureau)Jannssen (Speaker’s Bureau)Proteus (Research Grant or Support)Trio Health (Employee)ViiV Healthcare (Advisor or Review Panel member, Research Grant or Support)

Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial

SummaryBackgroundCommunity-based delivery of antiretroviral therapy (ART) for HIV, including ART initiation, clinical and laboratory monitoring, and refills, could reduce barriers to treatment and improve viral suppression, reducing the gap in access to care for individuals who have detectable HIV viral load, including men who are less likely than women to be virally suppressed. We aimed to test the effect of community-based ART delivery on viral suppression among people living with HIV not on ART.MethodsWe did a household-randomised, unblinded trial (DO ART) of delivery of ART in the community compared with the clinic in rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda. After community-based HIV testing, people living with HIV were randomly assigned (1:1:1) with mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills. The primary outcome was HIV viral suppression at 12 months. If the difference in viral suppression was not superior between study groups, an a-priori test for non-inferiority was done to test for a relative risk (RR) of more than 0·95. The cost per person virally suppressed was a co-primary outcome of the study. This study is registered with ClinicalTrials.gov, NCT02929992.FindingsBetween May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men. Retention at the month 12 visit was 95% (n=1253). At 12 months, community-based ART increased viral suppression compared with the clinic group (306 [74%] vs 269 [63%], RR 1·18, 95% CI 1·07–1·29; psuperiority=0·0005) and the hybrid approach was non-inferior (282 [68%] vs 269 [63%], RR 1·08, 0·98–1·19; pnon-inferiority=0·0049). Community-based ART increased viral suppression among men (73%, RR 1·34, 95% CI 1·16–1·55; psuperiority<0·0001) as did the hybrid approach (66%, RR 1·19, 1·02–1·40; psuperiority=0·026), compared with clinic-based ART (54%). Viral suppression was similar for men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group. With efficient scale-up, community-based ART could cost US$275–452 per person reaching viral suppression. Community-based ART was considered safe, with few adverse events.InterpretationIn high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender. Community-based ART should be implemented and evaluated in different contexts for people with detectable viral load.FundingThe Bill & Melinda Gates Foundation; the University of Washington and Fred Hutch Center for AIDS Research; the Wellcome Trust; the University of Washington Royalty Research Fund; and the University of Washington King K Holmes Endowed Professorship in STDs and AIDS.

Outcomes of Integrase Inhibitor-based Antiretroviral Therapy in a Clinical Cohort of Treatment-experienced Children, Adolescents and Young Adults With HIV Infection.

Data on integrase strand transfer inhibitor (INSTI) use in children, adolescents and young adults with HIV are limited. We evaluated virologic and safety outcomes following INSTI initiation among treatment-experienced children, adolescents and young adults. The DC Cohort is a multicenter observational study of individuals receiving HIV care in Washington, DC. This analysis included treatment-experienced participants 0-24 years of age who initiated an INSTI during 2011-2017. Viral suppression (VS) and safety outcomes were quantified. Differences in VS by age, sex and CD4 count were assessed using Kaplan-Meier curves. Of 141 participants (median age 20 years; 35% <18 years; 60% male; 89% Black; 62% perinatally-infected), 35% had VS and 65% lacked VS on INSTI initiation. Dolutegravir was the most commonly prescribed INSTI (55%). Among participants without VS at INSTI initiation, 46% achieved VS after a median of 2.7 months. Participants 13-24 (vs. 0-12) years old (P = 0.011) and participants with CD4 counts <350 (vs. >500) cells/μL were less likely to achieve VS (P < 0.001). Among participants with VS at INSTI initiation, 51% sustained VS through a median of 11.0 months of follow-up; of the 49% with transient viremia, 77% later achieved VS again. There were no safety concerns associated with the use of INSTIs. More than half of treatment-experienced children, adolescents and young adults with detectable viremia at INSTI initiation did not achieve VS, while half of those with prior VS experienced transient viremia. Further evaluation of long-term outcomes associated with INSTI use among children, adolescents and young adults is warranted.

Correction: Project YES! Youth Engaging for Success: A randomized controlled trial assessing the impact of a clinic-based peer mentoring program on viral suppression, adherence and internalized stigma among HIV-positive youth (15-24 years) in Ndola, Zambia.

[This corrects the article DOI: 10.1371/journal.pone.0230703.].

Project YES! Youth Engaging for Success: A randomized controlled trial assessing the impact of a clinic-based peer mentoring program on viral suppression, adherence and internalized stigma among HIV-positive youth (15-24 years) in Ndola, Zambia.

BackgroundYouth-led strategies remain untested in clinic-based programs to improve viral suppression (VS) and reduce stigma among HIV-positive adolescents and young adults (AYA) in sub-Saharan Africa. In response, Project YES! placed paid HIV-positive youth peer mentors (YPM) in four HIV clinics in Ndola, Zambia including a Children’s Hospital (pediatric setting), an adult Hospital and two primary care facilities (adult settings).MethodsA randomized controlled trial was conducted from December 2017 to February 2019. Consecutively recruited 15 to 24-year-olds were randomly assigned to an intervention arm with monthly YPM one-on-one and group sessions and optional caregiver support groups, or a usual care comparison arm. Survey data and blood samples were collected at baseline and at the six-month midline. Generalized estimating equation models evaluated the effect of study arm over time on VS, antiretroviral treatment (ART) adherence gap, and internalized stigma.ResultsOut of 276 randomized youth, 273 were included in the analysis (Intervention n = 137, Comparison n = 136). VS significantly improved in both arms (I:63.5% to 73.0%; C:63.7% to 71.3.0%) [OR:1.49, 95% CI:1.08, 2.07]. In a stratified analysis intervention (I:37.5% to 70.5%) versus the comparison (C:60.3% to 59.4%) participants from the pediatric clinic experienced a relative increase in the odds of VS by a factor of 4.7 [interaction term OR:4.66, 95% CI:1.84, 11.78]. There was no evidence of a study arm difference in VS among AYA in adult clinics, or in ART adherence gaps across clinics. Internalized stigma significantly reduced by a factor of 0.39 [interaction term OR:0.39, 95% CI:0.21,0.73] in the intervention (50.4% to 25.4%) relative to the comparison arm (45.2% to 39.7%)ConclusionsProject YES! engaged AYA, improving VS in the pediatric clinic and internalized stigma in the pediatric and adult clinics. Further research is needed to understand the intersection of VS and internalized stigma among AYA attending adult HIV clinics.Trial registrationClinicalTrials.gov NCT04115813.

The Effect of an Integrated Health System Specialty Pharmacy on HIV Antiretroviral Therapy Adherence, Viral Suppression, and CD4 Count in an Outpatient Infectious Disease Clinic.

Adherence to antiretroviral (ARV) therapy is critical in order to achieve and maintain viral suppression and improve immune function. Clinical pharmacists and pharmacies focused on human immunodeficiency virus (HIV) have demonstrated the ability to increase ARV medication adherence and subsequently have a positive effect on these lab markers. To evaluate the effect of an integrated health system specialty pharmacy service with a clinic-embedded, HIV-trained pharmacist and pharmacy technician on ARV medication adherence rate, viral load, and CD4 count. This was a single-center, retrospective cohort study conducted from August 7, 2017, to June 30, 2018, at an indigent outpatient infectious disease clinic within Atrium Health (AH), a not-for-profit health system based in Charlotte, NC. The intervention group (opt-in group) received HIV patient care that involved the health system specialty pharmacy service. Once a patient was enrolled in the specialty pharmacy service, medication reconciliation was completed by the pharmacist, financial assistance and prior authorizations were completed if needed; prescriptions were delivered to the patient; and monthly refills calls were conducted to assess adherence, tolerability, and medication changes. The control group (opt-out group) received HIV patient care that did not incorporate the health system specialty pharmacy. The primary endpoints were medication adherence, viral suppression, and CD4 counts. Within-group comparisons from baseline to follow-up were made along with group-to-group comparisons. Adherence was calculated using medication possession ratio. For those patients using Atrium Health Specialty Pharmacy Service (AH SPS; n = 46), the overall median adherence rate was higher at 100% versus only 94% for those patients (n = 50) that opted out of the service (P < 0.01). All but 3 patients (21.7% at baseline vs. 6.5% at follow-up, P = 0.03) using AH SPS reached viral suppression, and all but 1 had improved immune function with a CD4 count of 200 or greater by the end of the observation period (P = 0.03). The change in viral suppression and CD4 count of 200 or greater was not statistically improved between baseline and follow-up in those opting out of using AH SPS. When comparing the 2 groups at reaching these endpoints, there was no statistically significant difference in viral suppression and CD4 count. AH SPS was able to demonstrate improved ARV adherence in those patients using an integrated specialty pharmacy with an embedded pharmacy team, coordinated monthly medication delivery, and refill reminder and adherence calls. This in turn led to improved viral suppression and immune markers by the end of the observation window for patients using AH SPS. No outside funding supported this study. The authors have nothing to disclose.

Pregnancy and neonatal outcomes in women with HIV-1 exposed to integrase inhibitors, protease inhibitors and non-nucleoside reverse transcriptase inhibitors: an observational study.

Recommended regimens for pregnant women with HIV-1 are composed of two nucleoside reverse transcriptase inhibitors (NRTI) plus either a ritonavir-boosted protease inhibitor (PI) or an integrase strand transfer inhibitor (ISTI), with non-nucleoside reverse transcriptase inhibitors (NNRTI) representing an alternative drug class. The study's purpose was to compare these three options in terms of pregnancy outcomes. Data from a national observational study of pregnant women with HIV-1 were used. The analysis included all pregnancies reported between 2008 and 2018, ending in live births and exposed within 32weeks of gestation to three-drug regimens composed of a NRTI backbone plus a PI, a NNRTI or a ISTI, without class switching during pregnancy. Clinical and laboratory outcomes were evaluated in univariate and multivariable analyses. Overall, 794 exposed pregnancies were analyzed (PI 78.4%, NNRTI 15.4%, ISTI 6.2%). Almost all outcomes had similar rates in the three groups. Women who received PI in pregnancy were less likely to be virologically suppressed at third trimester. PI use was associated with higher bilirubin and triglyceride levels, and ISTI use with a lower rate of low birthweight. The differences in viral suppression at third trimester and in low birthweight were not maintained in multivariable analyses that were adjusted for confounders. We found no major differences in a wide range of outcomes relevant for pregnant women with HIV. Such results are reassuring, and this information may be helpful in a context of preconception counseling when therapeutic choices for pregnancy are discussed between women and care providers.

1904. Impact of Mail Order Pharmacy Use on Viral Suppression Among HIV-Infected Patients

BackgroundThere are many barriers to adherence to antiretroviral medications, including pharmacy accessibility. Few studies have evaluated the impact of pharmacy distance or use of mail order pharmacy services on HIV viral load suppression relative to use of an “in-person” pharmacy. The purpose of our study was to determine whether there is a difference in viral suppression rates among patients who utilize mail order pharmacy services vs. an in-person pharmacy for filling antiretroviral prescriptions. Our study also looked at the effect of distance and travel time to viral suppression for patients who use in-person pharmacy services.MethodsThis was a single-center, retrospective cohort study of adult HIV-positive patients who received care between 2006 and 2015 at an urban HIV care clinic. We collected patient demographic information, ART regimen, home address, pharmacy address, and laboratory values. For patients who utilized retail pharmacies, patients’ home addresses and the location of the pharmacy were geocoded using ESRI’s StreetMap Premium geocoding service. We calculated patients’ travel distance to pharmacy and travel time to pharmacy along a street network in a private vehicle. Chi-squared tests and logistic regression were used to determine the association between in-person or mail order pharmacy services and distance to pharmacy and viral suppression (viral load ≤200 copies/mL).ResultsThere were 214 patients in the mail order group and 214 patients included the in-person pharmacy group. Baseline characteristics were similar between the groups, with the exception of more people who inject drugs in the mail order group (6.1% vs. 1.8%, P = 0.05). No difference in viral load suppression was observed between groups (21.7% vs. 20.2%, P = 0.679). There was no difference in viral suppression depending on the distance (1.46 miles away in viral suppressed patients vs. 1.36 miles, P = 0.75) or travel time to pharmacy (7 minutes vs. 6.6 minutes, P = 0.75) for the in-person pharmacy group. Factors found to be significantly associated with suppressed viral loads were older age, white race, and higher CD4 counts.ConclusionViral suppression was not associated with pharmacy type, distance to pharmacy, or travel time to pharmacy.Disclosures All authors: No reported disclosures.

Impact of Alternative Encounter Types on HIV Viral Suppression Rates in an Integrated Health System.

Kaiser Permanente Mid-Atlantic States (KPMAS) members are increasingly utilizing electronic encounter types, such as telephone appointments and secure messaging for healthcare purposes, although their impact on health outcomes is unknown. We evaluated whether use of alternative encounters by adult human immunodeficiency virus (HIV)-infected patients affected the likelihood of achieving viral suppression (VS). Our study population of 3114 patients contributed 6520 patient-years between 2014 and 2016. We compared VS (HIV RNA <200 copies/mL) by number of in-person visits (1 or ≥2), with further stratification for additional phone and/or e-mail encounters (none, phone only, e-mail only, and both phone and e-mail). Rate ratios (RRs) for VS by number of in-person visits and encounter types were obtained from Poisson modeling, adjusting for age, sex, race/ethnicity, and HIV risk. Compared to those with ≥2 visits, patients with one in-person visit alone were significantly less likely to achieve VS (RR = 0.93; 95% confidence interval, CI: [0.87-1.00]), as were those with one in-person visit plus a telephone encounter (0.93; [0.90-0.97]). We did not find significant differences in VS comparing patients with one in-person visit plus e-mail only (RR = 1.00; 95% CI: [0.97-1.02]) or plus e-mail and telephone (0.99; [0.97-1.01]) to those with ≥2 in-person visits. If supplemented by e-mail communications (with or without telephone contact), patients with one in-person visit per year had similar estimated rates of VS compared with ≥2 in-person visits. More research is needed to know if these findings apply to other care systems.

HIV Treatment Cascade by Housing Status at Enrollment: Results from a Retention in Care Cohort.

Though housing instability is linked to poor HIV health outcomes, studies that assess the HIV treatment cascade by housing status are limited. Using data from a multi-site Retention in Care initiative we constructed HIV treatment cascades for participants (n = 463) of five grantee sites. We found no significant differences in viral suppression at follow-up among participants who were unstably housed at enrollment (49%) as compared to those who were stably housed at enrollment (54%). Among participants with available data at 6- or 12-month follow-up, 94% were engaged in care, 90% were retained in, 94% were on ART, and 71% had suppressed viral load. Some site-level differences were noted; at two of the sites participants who were stably housed were more likely to be retained in care and on ART. Overall, findings demonstrated that participants moved successfully through the HIV treatment cascade regardless of housing status at enrollment, suggesting that evidence-based support and services to help people living with HIV/AIDS can help mitigate barriers to engagement in care associated with lack of stable housing.

Racial and Ethnic Differences in Viral Suppression Among HIV-Positive Women in Care.

Women with HIV diagnoses are less likely to be virally suppressed than men. Women of different racial/ethnic groups may be differentially affected by sociodemographic factors. We examined differences in viral suppression among women by race/ethnicity and associated variables to inform prevention interventions. We used data from the 2010-2014 cycles of the Medical Monitoring Project, a cross-sectional survey of HIV-positive adults in care. We limited analyses to black, Hispanic, and white women. We calculated weighted prevalences of recent viral suppression (undetectable or <200 copies/mL) and sustained viral suppression (consistent viral suppression during the past 12 months) among women by race/ethnicity. We computed adjusted prevalence differences (aPDs) and 95% confidence intervals (CIs) for viral suppression by racial/ethnic group, controlling for selected variables, including available social determinants of health variables. Among women, 62.9% were black, 19.8% Hispanic, and 17.3% white. Overall, 74.3% had recent viral suppression, and 62.3% had sustained viral suppression. Compared with white women (79.7%, CI: 77.2 to 82.2), black (72.5%, CI: 70.3 to 74.7; PD: 7.2) and Hispanic (75.4%, CI: 72.6 to 78.3; PD: 4.3) women were less likely to have recent viral suppression. In multivariable analyses, after adjusting for antiretroviral therapy adherence, HIV disease stage, age, homelessness, and education, black-white aPDs remained significant for recent (aPD: 4.8, CI: 1.6 to 8.1) and sustained (aPD: 5.0, CI: 1.1 to 9.0) viral suppression. Viral suppression was suboptimal for all women, but more for black and Hispanic women. Differences between black, Hispanic, and white women may be partially due to antiretroviral therapy adherence, HIV disease stage, and social determinants of health factors.

Mortality and treatment response amongst HIV-infected patients 50\xa0years and older accessing antiretroviral services in South Africa

BackgroundLittle is known about the clinical presentation and outcomes amongst older HIV infected populations accessing ART in sub-Saharan Africa. We compared mortality amongst HIV infected patients accessing ART that were < 50 years to those ≥50 years in Kwa-Zulu Natal, South Africa.MethodsWe undertook a retrospective review of medical records of patients that accessed HIV services at the CAPRISA AIDS Treatment program (CAT) between June 2004 to December 2012 (N = 4003). HIV infected patients, 14 years or older were enrolled. All-cause mortality and treatment response to ART in those < 50 years to those ≥50 years were compared. A Kaplan-Meier curve and log-rank test were used to compare the cumulative probability of death between the two age groups with the primary endpoint being mortality. Statistical analysis was done using SAS (version 9.4.; SAS Institute Inc., Cary, NC, USA).ResultsOf 4003 individuals, 262 (6.5%) were ≥ 50 years (older group). The median age in those ≥50 years and < 50 year was 54.5 and 32.0 years, respectively. The younger group was mainly female (64.7%). There was no difference in mortality rate, between the older (6.9/100 person-years (py), 95% confidence interval (CI): 4.7–9.6) and younger group (5.3/100 py, 95% CI: 4.7–5.8) at 60 months (p = 0.137). In the multivariable model older patients had a significantly higher risk of death compared to younger patients. (hazard ratio (HR) 1.60, 95% CI: 1.08–2.39, p = 0.019).The rate of CD4+ cell count increase was higher in those < 50 years (β = 0.34, 95% CI: 0.19–0.50, p < 0.001) with no difference in viral suppression. The older group showed significantly higher prevalence of diabetes (6.3%) and hypertension (21.5%), p < 0.001.ConclusionART initiation in older HIV infected patients was associated with a higher mortality compared to those younger than 50 years. ART immunological response was less robust in older individuals. The increase in hypertension and diabetes among older patients suggests the need to restructure and integrate primary and specialized health care services into ART services.

Comparison of Time to Viral Suppression Among Treatment-Naïve HIV-Infected Adults Initiating Combination Antiretroviral Therapy by Antiretroviral Regimen Class

BackgroundAntiretroviral therapy (ART) regimens for the treatment of HIV that incorporate the integrase strand inhibitor (INSTI) class of antiretroviral medications have high efficacy and tolerability, and may result in faster time to virologic suppression compared with regimens that contain protease inhibitors (PIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs). However, differences in viral suppression are not well-defined in routine clinical settings.MethodsWe performed a retrospective single-center chart review of treatment-naïve HIV patients initiating ART between 2013 and 2016. Among patients on different ART regimen types, we compared rates of achievement of viral suppression (defined as viral load less than limit of detection or <20 copies/uL) over time and median time to viral suppression using chi-square and independent samples median testing. Patients who were prescribed nonstandard regimens, were nonadherent, or discontinued or changed ART within 6 months were excluded.ResultsOne hundred and fifty-five patients—45 (29.0%) female and 110 (71%) male—met study inclusion criteria. Mean age at ART initiation was 41.3 years (SD 12.5), and mean baseline viral load was 293,974 copies/uL. Twelve (7.7%) patients had an opportunistic infection diagnosed at time of ART initiation. Seventy-one (45.8%) initiated an INSTI-based ART regimen, 58 (37.4%) initiated a NNRTI-based regimen, and 26 (16.8%) initiated a PI-based regimen. Eighty-one (52.3%) patients had documented viral suppression, with median time to viral suppression 105 days (IQR 49–159). Patients on INSTI regimens were more likely to achieve viral suppression by 6 months (93.2% compared with 69.7% on NNRTIs and 30.8% on PIs), and had lower median time to suppression (62.6 days vs. 140.5 days on NNRTI regimens and 154.5 days on PI regimens, P = 0.002).ConclusionIn this cohort, patients on INSTI-based ART regimens experienced higher rates of viral suppression at 6 months and shorter time from ART initiation to viral suppression. In HIV patients on INSTI-based ART regimens, virologic failure should be suspected prior to the current recommendation of 6 months.Disclosures All authors: No reported disclosures.

High Levels of Viral Suppression Among East African HIV-Infected Women and Men in Serodiscordant Partnerships Initiating Antiretroviral Therapy with High CD4 Counts and During Pregnancy

People who are asymptomatic and feel healthy, including pregnant women, may be less motivated to initiate ART or achieve high adherence. We assessed whether ART initiation, and viral suppression 6, 12 and 24-months after ART initiation, were lower in HIV-infected members of serodiscordant couples who initiated during pregnancy or with higher CD4 counts. We used data from the Partners Demonstration Project, an open-label study of the delivery of integrated PrEP and ART (at any CD4 count) for HIV prevention among high-risk HIV serodiscordant couples in Kenya and Uganda. Differences in viral suppression (HIV RNA <400 copies/ml) among people initiating ART at different CD4 count levels (≤350, 351-500, and >500 cells/mm3) and during pregnancy were estimated using Poisson regression. Of 865 HIV-infected participants retained after becoming eligible for ART during study follow-up, 95% initiated ART. Viral suppression 24-months after ART initiation was high overall (97%), and comparable among those initiating ART at CD4 counts >500, 351-500 and ≤350 cells/mm3 (96% vs 97% vs 97%; relative risk [RR] 0.98; 95% CI: 0.93-1.03 for CD4 >500 vs <350 and RR 0.99; 95% CI: (0.93-1.06) for CD4 351-500 vs ≤350). Viral suppression was as likely among women initiating ART primarily to prevent perinatal transmission as ART initiation for other reasons (p=0.9 at 6 months and p=0.5 at 12 months). Nearly all HIV-infected partners initiating ART were virally suppressed by 24 months, irrespective of CD4 count or pregnancy status. These findings suggest that people initiating ART at high CD4 counts or due to pregnancy can adhere to ART as well as those starting treatment with symptomatic HIV disease or low CD4 counts.

HIV viral kinetics and T cell dynamics in antiretroviral naïve persons starting an integrase strand transfer inhibitor and protease inhibitor regimen

Background: Nucleos(t)ide reverse transcriptase inhibitor (NRTI)-sparing regimens may potentially minimize antiretroviral (ART) toxicities, but demonstrate mixed efficacy and toxicity results. The impact of an integrase strand transfer inhibitor (INSTI) and protease inhibitor (PI) regimen on HIV viral dynamics and T cell kinetics remains underdescribed.Objective: To compare the effect of raltegravir + ritonavir boosted lopinavir (RAL + LPV/r) to efavirenz/tenofovir disoproxil fumarate/emtricitabine (EFV/TDF/FTC) on HIV kinetics and T cell dynamics.Methods: Fifty participants naïve to ART underwent HIV viral kinetic sampling evaluated using biexponential mixed effects modeling. A subset of 28 subjects (with complete viral suppression) underwent flow cytometry and evaluation of soluble markers of inflammation at weeks 0, 4, and 48 of ART.Results: RAL + LPV/r compared to EFV/TDF/FTC resulted in a prolonged first phase viral decay rate (18 vs. 13 days p < 0.01). From weeks 0 to 4, RAL + LPV/r was associated with a trend toward greater decreases in activated CD4+ T cells (−3.81 vs. −1.18 p = 0.09) and less decreases in activated effector memory CD4+ T cells (−0.63 vs. −2.69 p-0.07). These trends did not persist to week 48. No differences were noted at any time point for soluble markers of immune activation.Conclusions: The prolonged first phase viral decay observed with RAL + LPV/r in persons starting ART did not result in differences in viral suppression at week 48. We also observed trends in declines in certain cellular markers of immune activation but it remains unclear if this could translate to long-term immunologic benefits in persons on an INSTI + PI.

Continuum of Care Among People Living with Perinatally Acquired HIV Infection in New York City, 2014.

The HIV care continuum outlines the steps from HIV infection to diagnosis, linkage to care, and viral suppression among people living with HIV. We examined data for steps along the HIV care continuum among people living with perinatally acquired infection in New York City using surveillance data. This study included data for people who acquired HIV infection perinatally and lived in New York City as of December 31, 2014. We defined "in care" as having ≥1 CD4 or viral load test in 2014, "in continuous care" as having ≥2 CD4 or viral load tests ≥3 months apart in 2014, and "virally suppressed" as having a viral load of #200 copies per milliliter in the most recent test in 2014. We estimated factors associated with viral suppression from a weighted log-binomial regression model that included sex, race/ethnicity, age, and country of birth as independent variables. As of December 31, 2014, an estimated 1,596 people were living with perinatally acquired HIV infection in New York City. All were diagnosed, 96% were in care, 80% were in continuous care, and 61% were virally suppressed. The multivariable analysis showed significant differences in viral suppression by race/ethnicity and age. Black patients (59%, 534/907) were the least likely of all racial/ethnic groups examined to have a suppressed viral load. By age, compared with 73% (80/109) of children aged 0-12 years who were virally suppressed, 58% (568/987) of adults aged 20-29 years and 56% (54/96) of adults aged 30-39 years were virally suppressed; the adjusted prevalence ratio was 0.80 (95% confidence interval [CI] 0.69, 0.92) for those aged 20-29 years and 0.79 (95% CI 0.63, 0.99) for those aged 30-39 years. The low level of viral suppression among people living with perinatally acquired infection found in this study warrants further exploration to identify the best management strategies to improve viral suppression in this population, especially those transitioning from pediatric to adult health care.

Impact of Pill Burden on Adherence, Risk of Hospitalization, and Viral Suppression in Patients with HIV Infection and AIDS Receiving Antiretroviral Therapy.

To evaluate the impact of pill burden on outcomes in patients with human immunodeficiency virus (HIV) infection and acquired immune deficiency syndrome (AIDS) receiving antiretroviral therapy (ART) as a single-tablet regimen (STR) or multiple-tablet regimen (MTR). Retrospective cohort study. South Carolina Medicaid medical and pharmacy paid claims data were obtained from the South Carolina Revenue and Fiscal Affairs Office; laboratory data were obtained from the South Carolina Department of Health and Environmental Control. A total of 2174 patients covered by South Carolina Medicaid who were dispensed a complete ART STR (580 patients) or MTR (1594 patients) lasting at least 60 days between January 1, 2006, and December 31, 2013. Outcomes were ART adherence; risk of, time to, and total number of hospitalizations; and viral load suppression. Patients were followed from the index date (start date of their complete ART regimen) until the earliest date of one of the following: treatment discontinuation; treatment switch from MTR to STR, or vice versa; end of study period; last date of Medicaid eligibility; or death. Differences in outcomes were evaluated by using bivariate χ(2) and Wilcoxon rank sum tests, as well as multivariate regression models controlling for covariates measured during a 6-month baseline period. The STR and MTR cohorts were, on average, similar in terms of age at index date, Charlson Comorbidity Index score, sex, drug abuse, and mental health diagnoses, but they differed significantly in racial composition, index year of regimen, previous treatment, baseline viral load, and CD4 measures. The bivariate analysis revealed that the STR cohort was more adherent (p<0.0001), had a lower risk of hospitalization (p=0.0076), and had a higher proportion of patients with viral suppression (64.5% vs 49.5%, p<0.0001). In addition, multivariate regression models revealed that the STR cohort was more adherent and was associated with a lower risk of hospitalization (hazard ratio 0.71, 95% confidence interval 0.59-0.86), but no significant difference in viral load suppression was noted between the STR and MTR cohorts. The STR was associated with higher adherence rates and a lower risk of hospitalization (both in the adjusted and unadjusted analyses) in South Carolina Medicaid patients with HIV infection and AIDS. A higher proportion of patients in the STR cohort had viral suppression during the follow-up period in the unadjusted analysis compared with the MTR cohort; however, no significant difference in viral suppression was observed when controlling for adherence.

Understanding Cross-Sectional Racial, Ethnic, and Gender Disparities in Antiretroviral Use and Viral Suppression Among HIV Patients in the United States.

To examine racial/ethnic and gender disparities in antiretroviral (ART) use and viral suppression among HIV-infected persons in care and identify factors that might account for observed disparities.The Medical Monitoring Project (MMP) is a complex sample survey of HIV-infected adults receiving medical care in the United States.We used weighted interview and medical record data collected 06/2009 to 05/2012 to estimate the prevalence of ART use and viral suppression among gender-stratified racial/ethnic groups. We used χ2 tests to identify significant differences in outcomes between white men versus other groups, and logistic regression models to identify the most parsimonious set of factors that could account for each observed difference.We found no significant disparity in ART use between white and Hispanic men, and no disparities between white men and white and Hispanic women after adjustment for disease stage, age, and poverty. Disparities in ART use between white men and black persons persisted after adjusting for other factors, but the observed differences were relatively small. Differences in ART use and adherence, demographic characteristics, and social determinants of health such as poverty, education, and insurance accounted for the observed disparities in viral suppression between white men and all groups except black men. In our model, accounting for these factors reduced the prevalence difference in viral suppression between white and black men by almost half.We found that factors associated with disparities differed among men and women of the same race/ethnicity, lending support to the assertion that gender affects access to care and health status among HIV-infected patients. In addition to supporting efforts to increase ART use and adherence among persons living with HIV, our analysis provides evidence for the importance of social determinants of health in understanding racial/ethnic and gender differences in ART use and viral suppression.

Voucher Incentives Improve Linkage to and Retention in Care Among HIV-Infected Drug Users in Chennai, India

Drug users (DUs), a population that accounts for some of the fastest-growing human immunodeficiency virus (HIV) epidemics globally, lag behind other populations with regard to HIV-related outcomes. We evaluated the role of voucher incentives on linkage and retention in care among DUs in India. In this randomized clinical trial, 120 DUs who were aged ≥18 years, HIV-infected, antiretroviral therapy (ART) naive, and ART eligible and who reported drug use in the prior month were randomized to incentive (INC) or control (CTL) conditions for 12 months. Participants randomized to the INC arm received incentives (redeemable for food/household goods) ranging in value from USD4 to USD8 for achieving prespecified targets (eg, ART initiation, visits to ART center). Subjects in the CTL group could win vouchers in prize-bowl drawings, but HIV care behaviors were not incentivized. The primary endpoint was time to ART initiation. Sixty participants each were randomized to the INC and CTL arms between December 2009 and September 2010. Participants in the INC arm were more likely to visit the government ART center (49 vs 33; P = .002); 27 participants in the INC and 16 participants in the CTL arm initiated ART (P = .04; hazard ratio for ART = 2.33 [95% confidence interval, 1.15-4.73]). Participants in the INC arm also had significantly more visits to the ART center (median number of visits, 8 vs 3.5; P = .005). However, no difference in viral suppression was observed. Modest voucher incentives improved linkage to and retention in HIV care, but did not significantly impact viral suppression among DUs in India, a disenfranchised and difficult-to-treat population. NCT01031745.

Disparities in HIV transmission risk among HIV-infected black and white men who have sex with men, United States, 2009.

To better understand why HIV incidence is substantially higher among black than white men who have sex with men (MSM), we present the first nationally representative estimates of factors that contribute to transmission - sexual behavior, antiretroviral therapy (ART) use, and viral suppression - among HIV-infected black and white MSM in the United States. The Medical Monitoring Project (MMP) is a complex sample survey of HIV-infected adults receiving medical care in the United States. We used weighted interview and medical record data collected during June 2009 to May 2010 to estimate the prevalence of sexual behaviors, ART use, and viral suppression among sexually active HIV-infected black and white MSM. We used χ tests to assess significant differences between races and logistic regression models to identify factors that mediated the racial differences. Sexual risk behaviors among black and white MSM were similar. Black MSM were significantly less likely than white MSM to take ART (80 vs. 91%) and be durably virally suppressed (48 vs. 69%). Accounting for mediators (e.g. age, insurance, poverty, education, time since diagnosis, and disease stage) reduced, but did not eliminate, disparities in ART use and rendered differences in viral suppression among those on ART insignificant. Lower levels of ART use and viral suppression among HIV-infected black MSM may increase the likelihood of HIV transmission. Addressing the patient-level factors and structural inequalities that contribute to lower levels of ART use and viral suppression among this group will improve clinical outcomes and might reduce racial disparities in HIV incidence.