Trends and correlates in HIV viral load monitoring and viral suppression among adolescents and young adults in Dar es Salaam, Tanzania.

BACKGROUND: Adolescents and young adults (AYA) living with HIV have been shown to have lower rates of viral load testing and viral suppression as compared to older adults. We examined trends over time and predictors of HIV viral load monitoring and viral suppression among AYA in a large HIV treatment programme in Dar es Salaam, Tanzania. METHODS: We analysed longitudinal data of AYA aged 10-24 years initiated on antiretroviral therapy between January 2017 and October 2022. Trend models were used to assess changes in HIV viral load testing and viral suppression by calendar year. Generalised estimating equations were used to examine the relationship of sociodemographic and clinical factors with HIV viral load testing and viral suppression. RESULTS: Out of 15,759 AYA, the percentage of those who received a 6-month HIV viral load testing increased from 40.6% in 2017 to 64.7% in 2022 and, a notable annual increase of 5.6% (p < 0.001). A higher HIV viral load testing uptake was observed among 20- to 24-year-olds (87.7%) compared to 10- to 19-year-olds (80.2%) (p < 0.001). The likelihood of not receiving an HIV viral load test within 12 months of antiretroviral therapy initiation was higher among 10- to 19-year-olds (adjusted odds ratio [aOR] = 1.7; 95% confidence interval [CI] = 1.4-2.0), advanced HIV disease (aOR = 1.3; 95% CI = 1.12-1.53), normal nutrition status at enrolment aOR 2.6 (95% CI = 1.59-4.26) and initiation of non-nucleoside reverse transcriptase inhibitors regimen aOR 1.2 (95% CI = 1.08-1.34). The proportion of AYA with viral suppression increased from 83.0% in 2017 to 94.6% in 2022. Notably, the overall trend in viral suppression increased significantly at 2.4% annually. The risk of not achieving viral suppression was greater among 10- to 14-year-olds (aOR = 2; 95% CI = 1.75-2.43) and 15- to 19-year-olds (aOR = 1.4; 95% CI = 1.24-1.58) as compared to 20-24 years; being male (aOR = 1.16; 95% CI = 1.02-1.32); undernourished (aOR = 1.53; 95% CI = 1.17-1.99); in WHO Stage II (aOR = 1.16; 95% CI = 1.02-1.33) and III (aOR = 1.21; 95% CI = 1.03-1.42) and being on an non-nucleoside reverse transcriptase inhibitors regimen (aOR = 1.32; 95% CI = 1.18-1.48). CONCLUSION: HIV viral load testing uptake at 6 months of antiretroviral therapy initiation and viral suppression increased from 2017 to 2022; however, overall HIV viral load testing was suboptimal. Demographic and clinical characteristics can be used to identify AYA at greater risk for not having HIV viral load test and not achieving viral suppression.

Non-Linkage to Care and Non-Viral Suppression among Hispanic/Latino Persons by Birthplace and Social Vulnerability-United States, 2021.

BACKGROUND: Assessing individual- and community-level factors may help to explain differences among Hispanic/Latino adults with diagnosed HIV not linked to care and without viral suppression in the United States. METHODS: We analyzed CDC's National HIV Surveillance System data among Hispanic/Latino persons aged ≥ 18 years with HIV diagnosed during 2021 in 47 states and the District of Columbia and linked cases via census tracts to the CDC/ATSDR's Social Vulnerability Index (SVI). Adjusted prevalence ratios and 95% confidence intervals for non-linkage to care and non-viral suppression were estimated using Poisson regression model. RESULTS: Among 5,056 Hispanic/Latino adults with HIV diagnosed in 2021, 51.5% were born in the United States, 17.3% in Mexico, 9.2% in Central America, 11.1% in South America, 1.8% in Puerto Rico, 6.8% in Cuba, and 2.4% in the Caribbean. Compared with U.S.-born Hispanic/Latino adults, those born in Mexico and South America had a lower prevalence of non-linkage to care. Hispanic/Latino adults born in Mexico, South America, and the Caribbean (excluding Puerto Rico and Cuba) had a lower prevalence of non-viral suppression, compared with those born in the United States. No significant differences were observed among SVI quartiles for either care outcome. CONCLUSION: This study aimed to challenge the narrow perspective on HIV care outcomes by examining the impact of birthplace and social vulnerability among Hispanic/Latino adults. To increase HIV care and prevention among Hispanic/Latino persons, research must evaluate health disparities within the group, and efforts are needed to better understand and tailor interventions within the diverse Hispanic/Latino population.

The rollout of paediatric dolutegravir and virological outcomes among children living with HIV in Mozambique.

Background: In 2022, Mozambique introduced Dolutegravir 10mg (pDTG), as part of paediatric antiretroviral therapy for children weighing < 20 kg. Understanding real-world challenges during national rollout can strengthen health systems in resource-limited settings. Objectives: We described the transition rate to, and new initiation of, pDTG, viral load suppression (VLS) post-pDTG, and factors associated with VLS among children living with HIV. Method: We conducted a retrospective cohort study involving children aged < 9 years and abstracted data from clinical sources. We used logistic regression to assess VLS and pDTG initiation predictors. Results: Of 1353 children, 1146 initiated pDTG; 196 (14.5%) had no recorded weight. Post-pDTG switch, 98.9% (950/961) of children maintained the same nucleoside reverse transcriptase inhibitor backbone. After initiating Abacavir/Lamivudine+pDTG, 834 (72.8%) children remained on the regimen, 156 (13.6%) switched off (majority to Dolutegravir 50mg), 22 (1.9%) had ≥ 2 anchor drug switches; 134 (11.7%) had no documented follow-up regimen. Factors associated with pDTG initiation or switch were younger age (adjusted odds ratio [AOR] = 0.71 [0.63-0.80]) and a recorded weight (AOR = 55.58 [33.88-91.18]). VLS among the 294 children with a viral load (VL) test after ≥ 5 months post-pDTG was 75.5% (n = 222/294). Pre-pDTG VLS rate among treatment-experienced children was 56.5% (n = 130/230). Factors associated with VLS were older age (AOR = 1.18 [1.03-1.34]) and previous VLS (AOR = 2.27 [1.27-4.06]). Conclusion: Most eligible children initiated pDTG per guidelines, improving post-pDTG VLS. Challenges included unexplained switches off pDTG after initiation, low VL coverage and inadequate documentation in clinic records.

Evaluation of viral suppression and medication-related burden among HIV-infected adults in a secondary care facility.

Background: People living with HIV/AIDS (PLHIV) are prone to other health issues that may result from the disease or antiretroviral medicines. These persons experience other psychosocial aspects of the illness, which may negatively affect their quality of life and overall treatment outcomes. This study assessed the medication-related burden and virological response of adult PLHIV. Method: This cross-sectional study involved 417 HIV-positive adults who had been on combined antiretroviral therapy for at least a year at the State Specialist Hospital Gombe. Nigeria. Patient medication experience was measured using the Living with Medication Questionnaire version-3 (LMQ-3). Virological suppression was assessed at viral loads <1000 copies/ml and 20 copies/ml for undetectable HIV RNA levels. The LMQ-3 scores were compared with the participants' characteristics using independent t-tests or one-way analysis of variance (ANOVA). Regression analyses was employed to identify the predictors of viral suppression and medication-related burden. P value <0.05 at 95% confidence interval was considered statistically significant. Results: Of the 417 PLHIV included in this study, 271 (65%) were classified as WHO Stage 1 ART initiation, 93.8% achieved viral suppression with 291 (69.5%) whom were females. The majority of patients 382 (91.6%) were on a dolutegravir-based regimen, had no tuberculosis diagnosis at antiretroviral therapy (ART) initiation (82.5%) and were 6-10 years on ART (46.3%). Only 67.6% of the population had a moderate medication-related burden. Female sex (p < 0.0005), unsuppressed viral load (p = 0.01), second-line ART (p = 0.03), tuberculosis at ART initiation (p = 0.02), and employment (p = 0.003) were significantly associated with medication-related burden. The predictor of viral suppression was high degree of medication-related burden (AOR, 0.12; 95% CI, 0.02-0.59) while unsuppressed viral load (p = 0.01) and female gender (p = 0.002) were independent predictors of medication related burden. Conclusion: The findings from this study revealed that majority of the patients achieved viral suppression with moderate degree of medication-related burden. Targeted interventions should be directed toward younger patients, females and patients with unsuppressed viral loads.

The association between adherence to antiretroviral therapy and viral suppression under dolutegravir-based regimens: an observational cohort study from Uganda.

INTRODUCTION: Millions of people living with HIV (PLWH) take oral antiretroviral therapy (ART), which requires a lifetime of consistent medication adherence. The relationship between adherence and poor HIV outcomes is well documented. Newer ART regimens that include dolutegravir (DTG) could be more forgiving, but empirical evidence on the relationship between adherence and viral suppression under DTG is only emerging. METHODS: In this observational cohort study (secondary analysis of data from a randomized trial), we used data from 313 ART clients from a large HIV clinic in Kampala, Uganda. Over the 4-year study period (January 2018-January 2022), 91% switched from non-DTG regimens to DTG regimens. We measured adherence using Medication Event Monitoring Systems-caps and extracted prescription information and viral load measures from electronic health records. We estimated unadjusted linear regressions and adjusted models that included individual and time fixed-effects. RESULTS: Under non-DTG regimens, 96% of participants were virally suppressed (defined as viral load < 200 copies/ml) when adherence was 90% or higher in the 3 months before viral load measurement. Viral suppression was 32 percentage points lower when adherence was between 0% and 49% (95% CI -0.44, -0.20, p < 0.01), 12 percentage points lower when adherence was between 50% and 79% (95% CI -0.23, -0.02, p < 0.01), and not significantly different when adherence was between 80% and 89% (effect of 0.00, 95% CI -0.06, 0.07, p = 0.81). In contrast, for participants taking DTG, there was no statistically significant difference in viral suppression among any of the four adherence levels; more than 95% were virally suppressed at each adherence level. On average, switching to DTG increased viral suppression by 6 percentage points in our adjusted models (95% CI 0.00, 0.13, p = 0.03). CONCLUSIONS: There was no significant association between adherence levels and viral suppression among PLWH taking DTG regimens, suggesting a high degree of forgiveness for missed doses. The use of DTG should be prioritized over older regimens, particularly for those with low adherence. CLINICAL TRIAL NUMBER: NCT03494777.

The impact of analytical treatment interruptions and trial interventions on time to viral re-suppression in people living with HIV restarting ART in cure-related clinical studies: a systematic review and meta-analysis.

INTRODUCTION: To assess the effectiveness of novel HIV curative strategies, "cure" trials require periods of closely monitored antiretroviral therapy (ART) analytical treatment interruptions (ATIs). We performed a systematic review and meta-analysis to identify the impact of ATI with or without novel therapeutics in cure-related studies on the time to viral re-suppression following ART restart. METHODS: Medline, Embase and Web of Science databases were searched for human studies involving ATIs from 1 January 2015 till 22 April 2024. The primary outcome was time to first viral re-suppression (plasma HIV viral load [VL] <50 copies/ml) stratified by receipt of interventional drug with ATI (IA) or ATI-only groups. Random-effects proportional meta-analysis and multivariable Cox proportional hazards analysis were performed using R. RESULTS: Of 1073 studies screened, 13 were included that met the inclusion criteria with VL data available after restarting ART (n = 213 participants). There was no difference between time to viral suppression in IA or ATI-only cohorts (p = 0.22). For 87% of participants, viral suppression within 12 weeks of ART restart was achieved, and all eventually had at least one VL <50 copies/ml during follow-up. After adjusting for covariables, while participants in the IA cohort were associated with less rapid suppression (adjusted hazard ratio [aHR] 0.61, 95% CI 0.40-0.94, p = 0.026), other factors include greater log VL at ART restart (aHR 0.56, 95% CI 0.46-0.68, p<0.001), duration since HIV diagnosis (aHR 0.93, 95% CI 0.89-0.96) and longer intervals between HIV VL monitoring (aHR 0.66, 95% CI 0.59-0.74, p<0.001). However, the use of integrase inhibitors was associated with more rapid viral suppression (aHR 1.74, 95% CI 1.16-2.59). DISCUSSION: When designing studies involving ATIs, information on time to viral re-suppression after restarting ART is important to share with participants, and should be regularly monitored and reported, to assess the impact and safety of specific trial interventions in ATI studies. CONCLUSIONS: The majority of participants achieved viral suppression after restarting ART in ATI studies. ART regimens containing integrase inhibitors and frequent VL monitoring should be offered for people restarting ART after ATI studies to ensure rapid re-suppression.

Advancing Patient Navigation for HIV: Evaluating Models of Care for Housing and Employment.

People with HIV face challenges securing housing and employment. Patient navigation is an effective intervention that can improve the receipt of these services, which have been linked to better health outcomes. The purpose of this study was to assess implementation of patient navigation in diverse delivery settings. We also evaluated the relationship between these services and health outcomes among participants. Twelve sites in the United States (N = 1,082) implemented navigation using single or multiple navigator interventions to improve housing, employment, viral suppression, and retention in care. Sites included health departments, health centers, and AIDS service organizations (ASO). Client-level data were used to model relationships of interest. Across the 12 sites, regardless of model, housing (odds ratio (OR) = 1.18, p < .001), employment (OR = 1.09, p < .001) and retention in care (OR 1.11, p = .007) improved significantly over time; however, viral suppression did not (OR = 1.04, p = .120). Regardless of model of care, patient navigation improved housing, employment, and retention in care. This study demonstrated that while navigation supports people with HIV in securing housing and employment, models using a more intensive format worked best in specific settings. While most studies focus on unimodal strategies, this study builds on the evidence by examining how navigation models can be delivered to reduce barriers to care.

Symptomatic and Asymptomatic Neurocognitive Impairment, ART Adherence and HIV Control: A 4-Year Observational Study.

We assessed whether symptomatic neurocognitive impairment (NCI) and asymptomatic NCI -of which the clinical relevance is debated- affect HIV control and the role of ART adherence in this relationship. Observational study on the relationship between NCI and viral control during the 2 years before and the 2 after the neurocognitive evaluation (NCE) of 322 PLWH on ART. Viral load (VL) was defined as undetectable, very low-level (VLLV), low-level (LLV), or high-level viremia (HLV), and classified overtime as persistent (p; ≥2 consecutive values in the same worst category), viral failure (VF; ≥1 HLV requiring ART changes), or optimal control. Adherence was the proportion of days covered by ART. Frascati criteria were used. Adjusted models were performed for factors associated with viral control. Mediation analyses informed causality in the path from NCI to viral control through adherence. Sensitivity analyses were focused on the year following NCE for only participants with optimal viral control before. Among the participants (53 ± 10 years, CD4 + T-cells 630/µL), 41.6% and 10.8% presented asymptomatic and symptomatic NCI. Over 3,304 VLs, 8.4% and 22.1% of participants had VF and pLLV/pVLLV. Both symptomatic and asymptomatic NCI were independently associated with VF (aRRR = 8.5; aRRR = 4.3) and pVLLV/pLLV (aRRR = 4.3; aRRR = 2.1). Specific cognitive domains showed independent associations with VL categories (models' P < 0.001). Adherence partially mediated these relationships (models' P < 0.001). Sensitivity analysis confirmed these findings. Prevalence and severity of poor viral control increased as the severity of NCI increased, with ART adherence mediating this relationship. The current "asymptomatic" attribution used by Frascati's criteria could overlook clinical risks.

Using the Index of Concentration at the Extremes to Evaluate Associations of Economic and Hispanic/Latino-White Racial Segregation with HIV Outcomes Among Adults Aged ≥ 18 Years with Diagnosed HIV - United States, 2021.

OBJECTIVE(S): To examine associations between Index of Concentration at the Extremes (ICE) measures (proxy for structural racism) for economic and Hispanic/Latino-White racial segregation and HIV outcomes among adults in the U.S. METHODS: Census tract-level HIV diagnoses, linkage to HIV medical care within 1 month of diagnosis (linkage), and viral suppression within 6 months of diagnosis (viral suppression) data for 2021 from the National HIV Surveillance System were used. Three ICE measures were obtained from the American Community Survey: ICEincome (income segregation), ICErace (Hispanic/Latino-White racial segregation), and ICEincome + race (Hispanic/Latino-White racialized economic segregation). Rate ratios (RRs) for HIV diagnosis and prevalence ratios (PRs) for linkage and viral suppression were used to examine differences in HIV outcomes across ICE quintiles with Quintile5 (Q5: most privileged) as reference group and adjusted by selected characteristics. RESULTS: Among the 32,529 adults, diagnosis rates were highest in Quintile1 (Q1: most deprived) for ICEincome (28.7) and ICEincome + race (28.4) and Q2 for ICErace (27.0). We also observed higher RRs in HIV diagnosis and lower PRs in linkage and viral suppression (except for ICErace for linkage) in Q1 compared to Q5. Higher RRs and lower PRs in ICE measures were observed among males (diagnosis), adults aged 18‒34 (diagnosis and linkage) and aged ≥ 45 (viral suppression), and among adults in the South (all 3 HIV outcomes). CONCLUSIONS: Barriers in access to care/treatment in more Hispanic/Latino-White racialized economic segregated communities perpetuate the disproportionate impact of HIV on the population. Removing barriers to HIV care/treatment created by systemic racism/segregation may improve HIV outcomes and reduce disparities.

Functional Multivariable Logistic Regression With an Application to HIV Viral Suppression Prediction.

Motivated by improving the prediction of the human immunodeficiency virus (HIV) suppression status using electronic health records (EHR) data, we propose a functional multivariable logistic regression model, which accounts for the longitudinal binary process and continuous process simultaneously. Specifically, the longitudinal measurements for either binary or continuous variables are modeled by functional principal components analysis, and their corresponding functional principal component scores are used to build a logistic regression model for prediction. The longitudinal binary data are linked to underlying Gaussian processes. The estimation is done using penalized spline for the longitudinal continuous and binary data. Group-lasso is used to select longitudinal processes, and the multivariate functional principal components analysis is proposed to revise functional principal component scores with the correlation. The method is evaluated via comprehensive simulation studies and then applied to predict viral suppression using EHR data for people living with HIV in South Carolina.

Health System Responses to Address Treatment Gaps of Unsuppressed Adolescents on HIV Treatment in Public Primary Health Care Facilities in Windhoek, Namibia.

Background: Adolescents living with HIV (ALHIV) face unique challenges that result in persistent gaps in achieving and maintaining suppressed viral load. Although effective evidence-based interventions to address treatment gaps in adolescents are readily available, health systems in resource-constrained, high HIV prevalence settings are challenged to implement them to achieve epidemic control. Here, we describe the health system responses to address the treatment gap of unsuppressed ALHIV on antiretroviral therapy in Windhoek, Namibia. Methods: We conducted a qualitative descriptive and exploratory study in Windhoek between June and October 2023. Nineteen purposively selected key informants, ranging from pediatric HIV program managers to healthcare providers, were interviewed. In-depth interviews were audio-recorded and transcribed verbatim. The transcripts were uploaded to ATLAS.ti and subjected to thematic analysis. Results: The four main themes elucidated challenges related to adherence and retention as well as health system responses in the form of interventions and support programs. The predominant adherence and retention challenges faced by ALHIV were mental health issues, behavioral and medication-related challenges, and inadequate care and social support. The health system responses to the identified challenges included providing psychosocial support, peer support, optimization of treatment and care, and the utilization of effective service delivery models. Key health system support elements identified included adequately capacitated human resources, efficient medication supply chain systems, creating and maintaining an enabling environment for optimum care, and robust monitoring systems as essential to program success. Conclusion: The health system responses to address the remaining treatment gaps of unsuppressed ALHIV in Windhoek are quite varied and, although evidence-based, appear to be siloed. We recommend harmonized, multifaceted guidance, integrating psychosocial, treatment, care, and peer-led support, and strengthening client-centred differentiated service delivery models for unsuppressed adolescents.

Changing how the third 95 is counted: suitable indicators for measuring U = U with findings from Taiwan.

INTRODUCTION: The World Health Organisation has implemented multiple HIV prevention policies and strived to achieve the 90-90-90 goal by 2020, achieving the 95-95-95 goal by 2030, which refers to 95% of patients living with HIV knowing their HIV status, 95% of patients living with HIV receiving continual care and medication, and 95% of patients living with HIV exhibiting viral suppression. However, how to measure the status of viral suppression varies, and it is hard to indicate the quality of HIV care. The study aimed to examine the long-term viral load suppression in these cases and explore potential factors affecting the control of long-term viral load. METHODS: This study analyzed viral load testing data from HIV patients who are still alive during the period from notification up to 2019-2020. Three indicators were calculated, including durable viral suppression, Viremia copy-years, and Viral load > 1,500 copies/ml, to assess the differences between them. RESULTS: Among the 27,706 cases included in the study, the proportion of persistent viral load suppression was 87%, with 4% having viral loads exceeding 1,500 copies/ml. The average duration from notification to viral load suppression was 154 days, and the geometric mean of annual viral replication was 90 copies*years/ml. Regarding the last available viral load measurement, 96% of cases had an undetectable viral load. However, we observed that 9.3% of cases, while having an undetectable viral load for their last measurement, did not show consistent long-term viral load suppression. An analysis of factors associated with non-persistent viral load suppression revealed higher risk in younger age groups, individuals with an educational level of high school or below, injection drug users, cases from the eastern region, those seeking care at regional hospitals, cases with drug resistance data, individuals with lower healthcare continuity, and those with an initial CD4 count below 350 during the study period. CONCLUSIONS: The recommendation is to combine it with the indicator of sustained viral load suppression for a more accurate assessment of the risk of HIV transmission within the infected community.

Experiences of support by unsuppressed adolescents living with HIV and their caregivers in Windhoek, Namibia: a qualitative study.

Background: Adolescents living with HIV (ALHIV) lag behind younger children and adults in the achievement of HIV care and treatment targets for HIV epidemic control. Treatment outcomes for adolescents may be influenced by their experiences with the support provided in HIV programs. We report on the experiences of virally unsuppressed adolescents and their caregivers with the current support in primary healthcare settings in Namibia. Methods: A qualitative descriptive and exploratory study was conducted in 13 public primary healthcare facilities in Windhoek, Namibia. A total of 25 in-depth interviews were conducted with unsuppressed adolescents (n = 14) and their caregivers (n = 11) between August and September 2023. The audio-recorded interviews were transcribed verbatim, and uploaded into ATLAS.ti software, and subjected to thematic content analysis. Findings: Three main support domains for the unsuppressed adolescents emerged from our analysis, namely: psychosocial, clinical and care, and socioeconomic support. The psychosocial support was delivered through peer support (teen clubs and treatment supporters) and enhanced adherence counselling mostly. The clinical and care support included implementing adolescent-friendly HIV services, differentiated service delivery approaches, and caregivers and healthcare worker care support for improved ART adherence, clinic attendance and continuous engagement in care. Socioeconomic support was provided for nutritional support, transport to access clinics, and school supplies, as well as income-generating projects. Conclusion: Psychosocial, clinical and care, and socioeconomic support are key elements in addressing the needs of adolescents challenged with achieving viral suppression. Health systems may benefit from whole-of-society and whole-of-government approaches to meet the needs of ALHIV that are beyond the scope of health service delivery such as nutritional, education and socioeconomic influences on both the health and well-being of ALHIV.

Pharmacist-Driven Rapid Initiation of Antiretroviral Therapy Decreases Time to Viral Suppression in People With HIV.

Background: Rapid initiation of antiretroviral therapy (rapid ART) improves clinical outcomes in people with HIV and is endorsed by clinical guidelines. However, logistical challenges limit widespread implementation. We describe an innovative rapid ART model led by pharmacists and its impact on clinical outcomes, including time to viral suppression (TVS). Methods: On 1 January 2019, we implemented Pharmacist-Driven Rapid ART (PHARM-D RAPID ART), including rapid ART initiation by pharmacists. Our retrospective cohort study compared TVS, using a Cox proportional hazards model, and clinical outcomes among individuals with a new HIV diagnosis before (1 January 2017 to 31 December 2017) and after (1 January 2019 to 31 December 2019) implementation. Results: A total of 108 individuals were included. TVS was significantly shorter (P < .001) for the PHARM-D RAPID ART group (n = 51) compared with the preimplementation group (n = 57) (median: 30 days and 66 days, respectively). Those in the PHARM-D RAPID ART group were significantly more likely to achieve VS at any given time during the study period (adjusted hazard ratio: 3.47 [95% confidence interval, 2.25-5.33]). A total of 94.1% (48/51) of patients in the PHARM-D RAPID ART group were retained in care at 1 year. With a median follow-up of 2.4 years in the PHARM-D RAPID ART group, 98% remained suppressed at last recorded viral load. Conclusions: A pharmacist-driven model for rapid ART delivery decreases TVS with high rates of retention in care and durable VS. This model could improve clinical outcomes and increase program feasibility and sustainability.

Impact of Maternal Viral Suppression on Growth Patterns for HIV-Exposed Uninfected Infants in Kenya.

Background and Objective: Children born to mothers living with human immunodeficiency virus (HIV) are at risk for poor health outcomes but data characterizing these associations are limited. Our objective was to determine the impact of maternal viral suppression on growth patterns and malnutrition for infants who are HIV-exposed but uninfected (HEU). Methods: We conducted a retrospective cohort analysis of clinical data for infants who were HEU and their mothers (September 2015 - March 2019) in Kenya. Infants were stratified based on maternal viral suppression status (≥ or <1000 copies/mL); t-tests were used to compare groups. Growth indicators were evaluated with Chi-square, Fisher's exact, and area under the curve. Moderate-to-severe underweight status, stunting, and wasting were defined by weight-for-age (WFA), height-for-age (HFA), and weight-for-height (WFH), z-scores ≤2, and were used to define malnutrition. Multivariate logistic regression analyses were performed to evaluate potential associations with malnutrition indicators between WFH and HFA. Results: Among 674 infants who were HEU, 48.7% were male and 85.0% had mothers who were virally suppressed. The median age at first and last clinic visits was 1.5 and 16.4 months, respectively. WFA and HFA z-scores over time differed by sex, and WFA and HFA differed based on maternal viral suppression (P < 0.05). Male infants had higher adjusted odds for stunted status, and as children aged, they had slightly increased odds of becoming underweight or stunted. Maternal viral suppression and timing of maternal antiretroviral therapy initiation in relation to the prevention of vertical transmission (PVT) enrollment did not significantly affect malnutrition indicators. Conclusion and Global Health Implications: Maternal viral suppression status was not associated with increased odds of more severe malnutrition indicators in children who were HEU. However, overall growth patterns over time, measured by z-scores of growth indicators, did differ based on maternal viral suppression status, and to a lesser degree, by gender.

Virological non-suppression and associated factors among adult patients receiving antiretroviral therapy at selected health facilities in uMgungundlovu district of KwaZulu Natal, South Africa: a cross-sectional study.

Introduction: virological non-suppression is not only associated with increased risk of transmission of the Human Immunodeficiency virus (HIV) to others; perinatally and sexually, but it also decreases the life expectancy among the individuals who are on antiretroviral therapy (ART). This study sought to determine the level of virological non-suppression among ART patients from selected health facilities of a sub-district in uMgungundlovu district. This sub-district has high HIV transmission rates in KwaZulu Natal (KZN) and had one of the highest HIV prevalence in the district in 2018; population weighted HIV prevalence of 36.3% among men and women aged 15-49 years old, which was twice the average national prevalence of 18.8%. Methods: this descriptive, cross-sectional, and quantitative study was conducted among participants who were HIV-positive, 18 years old and above, and initiated on ART between January 2017 and January 2019 at selected PHC facilities of Vulindlela sub district. Health facility treatment registers, patient medical files and face-to-face interviews were used to collect the data and these were captured onto an Excel spreadsheet, cleaned, coded before importation into Epiinfo 17 for statistical analyses. Logistic regression analyses were conducted to investigate the factors associated with virological non-suppression. Results: the study found a majority of participants were females (240/401 (60%)). The mean age of the participants was 38.1 (SD=11.2), with most participants who were between the ages of 29 and 39 years old (167 (41.7%)). Virological non-suppression was observed among 10% (40/401) of participants. The odds of virological non-suppression were higher among participants who were married (aOR 4.76, 95% CI 1.49-15.19; p=0.008). Conclusion: a virological non-suppression of 10% translates to viral suppression of 90%, which is below the target of UNAIDS 95-95-95 strategy. Hiding and skipping medication indicate how non-disclosure continues to hinder HIV treatment adherence. High odds of virological non-suppression among married participants indicate non-disclosure of the positive HIV status, or lack in spousal support.

Bulevirtide monotherapy in patients with chronic HDV: Efficacy and safety results through week 96 from a phase III randomized trial.

BACKGROUND & AIMS: Bulevirtide (BLV), a first-in-class entry inhibitor, is approved in Europe for the treatment of chronic hepatitis delta (CHD). BLV monotherapy was superior to delayed treatment at week (W) 48, the primary efficacy endpoint, in the MYR301 study (NCT03852719). Here, we assessed if continued BLV therapy until W96 would improve virologic and biochemical response rates, particularly among patients who did not achieve virologic response at W24. METHODS: In this ongoing, open-label, randomized phase III study, patients with CHD (N = 150) were randomized (1:1:1) to treatment with BLV 2 mg/day (n = 49) or 10 mg/day (n = 50), each for 144 weeks, or to delayed treatment for 48 weeks followed by BLV 10 mg/day for 96 weeks (n = 51). Combined response was defined as undetectable hepatitis delta virus (HDV) RNA or a decrease in HDV RNA by ≥2 log10 IU/ml from baseline and alanine aminotransferase (ALT) normalization. Other endpoints included virologic response, ALT normalization, and change in HDV RNA. RESULTS: Of 150 patients, 143 (95%) completed 96 weeks of the study. Efficacy responses were maintained and/or improved between W48 and W96, with similar combined, virologic, and biochemical response rates between BLV 2 and 10 mg. Of the patients with a suboptimal early virologic response at W24, 43% of non-responders and 82% of partial responders achieved virologic response at W96. Biochemical improvement often occurred independently of virologic response. Adverse events were mostly mild, with no serious adverse events related to BLV. CONCLUSIONS: Virologic and biochemical responses were maintained and/or increased with longer term BLV therapy, including in those with suboptimal early virologic response. BLV monotherapy for CHD was safe and well tolerated through W96. IMPACT AND IMPLICATIONS: In July 2023, bulevirtide was fully approved for the treatment of chronic hepatitis delta (CHD) in Europe based on clinical study results from up to 48 weeks of treatment. Understanding the efficacy and safety of bulevirtide over the longer term is important for healthcare providers. In this analysis, we demonstrate that bulevirtide monotherapy for 96 weeks in patients with CHD was associated with continued improvements in combined, virologic, and biochemical responses as well as liver stiffness from week 48 at both the 2 mg and 10 mg doses. Patients with suboptimal virologic responses to bulevirtide at week 24 also benefited from continued therapy, with the majority achieving virologic response or biochemical improvement by week 96. GOV IDENTIFIER: NCT03852719.

Associations Between Alcohol Use, Antiretroviral Therapy Use, and Viral Load Suppression Among People Living with HIV in Rural Central Uganda.

Alcohol use among people living with HIV (PWH) is common and may negatively affect engagement in HIV care. We evaluated the relationships between alcohol use, ART use, and viral suppression among PWH in Uganda. PATH/Ekkubo was a trial evaluating a linkage to HIV care intervention in four Ugandan districts, Nov 2015-Sept 2021. Our analytical sample included: (1) baseline data from individuals not enrolled in the intervention trial (previously diagnosed HIV+); and 12-month follow-up data from the control group (newly diagnosed or previously diagnosed, but not in care). Level of alcohol use was categorized using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C): none (AUDIT-C = 0), low (women = 1-2, men = 1-3), medium (women = 3-5, men = 4-5), high/very high (6-12). Multivariable logistic regression models evaluated associations between alcohol use, ART use and viral suppression (a viral load of < 20); we also stratified by gender. Among 931 PWH, medium (OR: 0.43 [95% CI 0.25-0.72]) and high/very high (OR: 0.22 [95% CI 0.11-0.42]) levels of alcohol use were associated with lower odds of being on ART. In a sub-sample of 664, medium use (OR: 0.63 [95% CI 0.41-0.97]) was associated with lower odds of viral suppression. However, this association was not statistically significant when restricting to those on ART, suggesting the relationship between alcohol use and viral suppression is explained by ART use. Among men, high/very high, and among women, medium alcohol use levels were associated with lower odds of being on ART and being virally suppressed. Interventions for PWH who use higher levels of alcohol may be needed to optimize the benefits of Uganda's Universal Test and Treat strategy.

I Can't Afford it Right Now, So it Doesn't Matter" Structural Drivers of Viral Suppression Among Men Who Have Sex With Men: A Longitudinal Qualitative Approach.

Background: Racial disparities in outcomes across the HIV care continuum, including in viral suppression, have been observed among sexual minority men (SMM) living with HIV. Structural factors are drivers of these disparities, yet data is lacking at the individual level on how day-to-day experiences of these structural factors contribute to losing viral suppression, and what happens to SMM after loss of viral suppression, including whether they achieve viral suppression again over time. Method: We conducted longitudinal semi-structured interviews with a subsample of men living with HIV drawn from a larger cohort study. Three Black and 2 White SMM participated in a series of three interviews after they lost viral suppression, and then again at 6- and 12-months follow-up. The focus of the interviews was on experiences with structural issues (e.g., housing, transportation, employment, insurance) and their impact on HIV care. Results: Content analysis showed that multiple structural issues disrupted HIV care, particularly insurance, housing stability, transportation, and employment. Black SMM described experiencing multiple compounding structural barriers, and they struggled to achieve viral suppression again. Conclusions: These data show how SMM living with HIV are impacted by structural barriers to HIV care over time. Black SMM experienced multiple, compounding barriers, and these negatively impacted HIV care outcomes over time. Efforts to address long-standing HIV care-related disparities need to address the mechanisms of structural racism.

HIV viral suppression and risk of viral rebound in patients on antiretroviral therapy: a two- year retrospective cohort study in Northern Tanzania.

BACKGROUND: The world is moving towards the third target of the Joint United Nations Programme on HIV/AIDS to ensure most people receiving antiretroviral therapy (ART) are virologically suppressed. Little is known about viral suppression at an undetectable level and the risk of viral rebound phenomenon in sub-Saharan Africa which covers 67% of the global HIV burden.This study aimed to investigate the proportion of viral suppression at an undetectable level and the risk of viral rebound among people living with HIV receiving ART in northern Tanzania. METHODOLOGY: A hospital based-retrospective study recruited people living with HIV who were on ART for at least two years at Kibong'oto Infectious Disease Hospital and Mawenzi Regional Referral Hospital in Kilimanjaro Region, Tanzania. Participants' two-year plasma HIV were captured at months 6, 12, and 24 of ART. Undetectable viral load was defined by plasma HIV of viral load (VL) less than 20copies/ml and viral rebound (VR) was considered to anyone having VL of more than 50 copies/ml after having history of undetectable level of the VL less than 20copies/ml. A multivariable log-binomial generalized linear model was used to determine factors for undetectable VL and viral VR. RESULTS: Among 416 PLHIV recruited, 226 (54.3%) were female. The mean (standard deviation) age was 43.7 (13.3) years. The overall proportion of undetectable VL was 68% (95% CI: 63.3-72.3) and 40.0% had viral rebound (95% CI: 34.7-45.6). Participants who had at least 3 clinic visits were 1.3 times more likely to have undetectable VL compared to those who had 1 to 2 clinic visits in a year (p = 0.029). Similarly, participants with many clinical visits ( > = 3 visits) per year were less likely to have VR compared to those with fewer visits ( = 2 visits) [adjusted relative risk (aRR) = 0.64; 95% CI: 0.44-0.93]. CONCLUSION: Participants who had fewer clinic visits per year(ART refills) were less likely to achieve viral suppression and more likely to experience viral rebound. Enhanced health education and close follow-up of PLHIV on antiretroviral therapy are crucial to reinforce adherence and maintain an undetectable viral load.