Higher CD4 Counts Research Articles

COVID-19 Breakthrough Infections Among People With HIV: A Statewide Cohort Analysis.

This study aims to identify COVID-19 breakthrough infections among people with HIV (PWH) across different phases of the pandemic and explore whether differential immune dysfunctions are associated with breakthrough infections. This retrospective population-based cohort study used data from an integrated electronic health record (EHR) database in South Carolina (SC). Breakthrough infection was defined as the first COVID-19 diagnosis documented in the state agency after the date an individual was fully vaccinated (ie, 2 doses of Pfizer/BNT162b2 or Moderna/mRNA-1273, or 1 dose of Janssen/Ad26.COV2.S) through June 14, 2022. We analyzed the risk and associated factors of the outcome using Cox proportional hazards models. Among 7596 fully vaccinated PWH, the overall rate of breakthrough infections was 118.95 cases per 1000 person-years. When compared with the alpha-dominant period, the breakthrough infection rate was higher during both delta-dominant (HR: 1.50; 95% CI: 1.25 to 1.81) and omicron-dominant (HR: 2.86; 95% CI: 1.73 to 4.73) periods. Individuals who received a booster dose had a lower likelihood of breakthrough infections (HR: 0.19; 95% CI: 0.15 to 0.24). There was no association of breakthrough infections with degree of HIV viral suppression, but a higher CD4 count was significantly associated with fewer breakthroughs among PWH (>500 vs <200 cells/mm3: HR: 0.68; 95% CI: 0.49 to 0.94). In our PWH population, the incidence of breakthrough infections was high (during both delta-dominant and omicron-dominant periods) and mainly associated with the absence of a booster dose in patients older than 50 years, with comorbidities and low CD4 count.

Immunological and virological response to fostemsavir in routine US clinical care: An OPERA cohort study.

Fostemsavir is a novel attachment inhibitor used with other antiretrovirals in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1. Real-world immunological and virological responses were assessed in individuals starting fostemsavir in the OPERA cohort. Among adults with HIV-1 starting fostemsavir between 2 July 2020 and 1 September 2022, 6-month and 12-month changes in CD4 T-cell count and CD4%, and maintenance/achievement of viral load (VL) <50 copies/mL were described and stratified by baseline VL (suppressed: <50 copies/mL; viraemic: ≥50 copies/mL) and CD4 count (high: ≥350 cells/μL; low: <350 cells/μL). Of 182 individuals starting fostemsavir, 64% were viraemic (34% low CD4, 30% high CD4) and 36% were suppressed (16% low CD4, 20% high CD4). The suppressed/low CD4 group had the largest median increases in CD4 count (6-month: 30 cells/μL [interquartile range {IQR} 9-66], 12-month: 66 cells/μL [IQR 17-125]), and CD4% (6-month: 1.0% [IQR -0.3-2.8], 12-month: 1.9% [IQR 1.3-3.9]). Regardless of baseline VL, those with a high baseline CD4 count experienced a greater variability in immunological response than those with low CD4 counts (12-month standard deviation range 172-231 cells/μL vs. 69-90 cells/μL). VL <50 copies/mL was maintained in most suppressed individuals; nearly half of the viraemic/high CD4 group and a third of the viraemic/low CD4 group achieved a VL <50 copies/mL at either timepoint. After 6 or 12 months of fostemsavir use, virological response was low in viraemic individuals, although most suppressed individuals did maintain suppression. While immunological response varied across individuals, virologically suppressed HTE individuals with low CD4 counts may benefit from immunological improvements with fostemsavir.

Incidence Rate and Risk Factors for Developing Active Tuberculosis Among People Living With HIV in Georgia 2019-2020 Cohort.

Tuberculosis (TB) is a leading cause of morbidity and mortality among people with HIV (PHIV) globally. Our study is the first to evaluate TB incidence and its risk factors among PHIV in the country of Georgia, where previously no data were available. A retrospective cohort study was conducted among persons newly diagnosed with HIV in Georgia during 2019-2020. Active TB incidence was calculated within a minimum of 2-year follow-up period from HIV diagnosis. Cox proportional hazard model was used for evaluating risk factors for TB development. The median age in the final cohort of 1165 PHIV was 38 (interquartile range, 30-48) and 76.3% were male. Twenty-nine percent of patients had a CD4 cell count <200 at HIV diagnosis and 89.9% initiated antiretroviral therapy (ART). TB incidence rate was 10/1000 person-years (p-y; 95% confidence interval [CI], 9.6-10.4), with rates being higher within several subgroups, mainly: PHIV aged 40-49 years (17.5/1 000 p-y [95% CI, 16.8-18.2]); those not receiving ART (22/1000 p-y [95% CI, 20.9-23.1]); those with CD4 < 200 at baseline (28/1000 p-y [95% CI, 27.4-28.6]); and those who developed AIDS (29.1/1 000 p-y [95% CI, 28.6-29.6]). Age (aHR, 1.2; 95% CI, 1.03-1.39; P = .01) and AIDS diagnosis (aHR, 3.2; 95% CI, 3.06-27.9; P = .001) were associated with TB development, whereas high CD4 count was protective against TB (aHR, 0.18; 95% CI, .06-.61; P = .005). Study results highlight an imperative role of CD4 cell count management and the need for early HIV diagnosis and timely initiation of ART to ensure an effective immune response against tuberculosis, stressing the need for further in-depth evaluation of the TB preventive treatment delivery system's efficiency and gaps.

Integrative Transcriptomic and Single-Cell Protein Characterization of Colorectal Carcinoma Delineates Distinct Tumor Immune Microenvironments Associated with Overall Survival.

Colorectal carcinoma (CRC) is a heterogeneous group of tumors with varying therapeutic response and prognosis, and evidence suggests the tumor immune microenvironment (TIME) plays a pivotal role. Using advanced molecular and spatial biology technologies, we aimed to evaluate the TIME in patients with CRC to determine whether specific alterations in the immune composition correlated with prognosis. We identified primary and metastatic tumor samples from 31 consented patients, which were profiled with whole-exome sequencing and bulk RNA-seq. Immune cell deconvolution followed by gene set enrichment analysis and unsupervised clustering was performed. A subset of tumors underwent in situ analysis of the TIME spatial composition at single-cell resolution through Imaging Mass Mass Cytometry. Gene set enrichment analysis revealed two distinct groups of advanced CRC, one with an immune activated phenotype and the other with a suppressed immune microenvironment. The activated TIME phenotype contained increased Th1 cells, activated dendritic cells, tertiary lymphoid structures, and higher counts of CD8+ T cells whereas the inactive or suppressed TIME contained increased macrophages and a higher M2/M1 ratio. Our findings were further supported by RNA-seq data analysis from the TCGA CRC database, in which unsupervised clustering also identified two separate groups. The immunosuppressed CRC TIME had a lower overall survival probability (HR 1.66, p=0.007). This study supports the pertinent role of the CRC immune microenvironment in tumor progression and patient prognosis. We characterized the immune cell composition to better understand the complexity and vital role that immune activity states of the TIME play in determining patient outcome.

A Pilot Randomized Control Trial of the Striving Towards EmPowerment and Medication Adherence (STEP-AD) Intervention for Black Women Living with HIV

Black women living with HIV (BWLWH) face adversities associated with lower HIV medication adherence, viral non-suppression, and mental health symptoms (e.g., post-traumatic stress disorder) such as trauma/violence, racism, HIV-related discrimination/stigma, and gender-related stressors. We developed the first intervention based in cognitive behavioral therapy and culturally congruent coping for BWLWH to increase medication adherence and decrease PTSD symptoms by enhancing resilience, self-care, engagement in care, and coping for trauma, racism, HIV-related discrimination/stigma, and gender-related stressors. A pilot randomized control trial was conducted with BWLWH and histories of trauma who were at risk for their HIV viral load remaining or becoming detectable (i.e., below 80% medication adherence, detectable viral load in the past year, and/or missed HIV-related appointments). 119 BWLWH were assessed at baseline and 70 met inclusion criteria, completed one session of Life-Steps adherence counseling, and were randomized to either nine sessions of STEP-AD (Striving Towards EmPowerment and Medication Adherence) or ETAU (enhanced treatment as usual consisting of biweekly check-ins). Women completed a post intervention follow up assessment (3 months post baseline) and 3-month post intervention follow-up (6 months post baseline). Via STATA the difference-in-difference methodology with mixed models compared STEP-AD to ETAU on changes in outcomes over time. BWLWH in STEP-AD compared to E-TAU had significantly higher ART adherence (estimate = 9.36 p = 0.045) and lower likelihood of being clinically diagnosed with PTSD (OR = .07, estimate = − 2.66, p = 0.03) as well as borderline significance on higher CD4 count (estimate = 161.26, p = 0.05). Our findings suggest preliminary efficacy of STEP-AD in improving ART adherence, mental health, and immune function.

The impact of HIV and CD4 count stratification on all cause mortality for adenocarcinoma and squamous cell lung cancers in the antiretroviral therapy era: Analysis of National Veterans Affairs and Kaiser Permanente Northern cohorts.

8070 Background: Since the widespread introduction of antiretroviral therapy (ART), people living with HIV (PWH) have experienced substantially decreased morbidity and mortality. However, PWH are at higher risk for lung cancer and have decreased cancer survival rates compared to people without HIV (PWoH). Few studies have evaluated histology-specific lung cancer survival by stage and HIV immune control. Methods: A retrospective cohort study was conducted with newly diagnosed non-small cell lung cancer (NSCLC), including PWH with PWoH, identified between 2008 and 2020 from the US Department of Veterans Affairs and Kaiser Permanente, California. Adjusted hazard ratios for 5-year survival by CD4 count (≥ 500 cells/mm3, &lt;500 cells/mm3, ref: PwOH) were estimated using Cox models stratified by subtype (adenocarcinoma, squamous) and TNM (I, II/III, IV) stage. Results: This cohort consisted of 562 PWH (53% adenocarcinoma, 33% squamous cell) and 91,370 PWoH (52% adenocarcinoma, 33% squamous cell, 15% not specified). The PWH cohort tended to be younger (62 vs. 69 years), male (97% vs. 83%), and non-Hispanic Black race (48% vs. 14%), compared to PWoH. Among PWH, 41% had CD4 ≥500 cells/mm3, 59% had CD4 &lt;500 cells/mm3 . The median survival in years for PWoH, PWH CD4 count ≥500 cell/mm3and &lt;500 cells/mm3 were: 2.4 ±0.10, 2.3 ± 0.17, 2.0±0.17, respectively for adenocarcinoma, and 2.1±0.01, 2.3±0.21, 1.6±0.17 respectively for squamous cell carcinoma. The table shows the adjusted HR for all-cause mortality for Adenocarcinoma and Squamous Cell Carcinoma comparing PWH ≥500 and PWH&lt;500 to PWoH (as reference) stratified by stage. Conclusions: Although it is well known that low CD counts (&lt;200) are associated with poor cancer outcomes, higher CD4 counts (CD&lt;500) at the time of lung cancer diagnosis may still play a role in the treatment outcomes of NSCLC. PWH who have CD4 counts ≥500 appear to have similar survival compared to PWoH, but CD4&lt;500, those with (vs. without) HIV have higher rates of mortality for both adenocarcinoma and squamous cell histologies. Adjusted hazard ratios (HR)* with 95% confidence intervals (CI) for 5-year all-cause-mortality associated with HIV by CD4 count (reference: PWoH), across Adenocarcinoma and Squamous Cell Cancer histology and baseline cancer stage. [Table: see text]

Exosomal microRNAs associated with tuberculosis among people living with human immunodeficiency virus

ObjectiveTo investigate the diagnostic value of selected exosomal miRNAs for Tuberculosis (TB) among people living with human immunodeficiency virus (PLHIV). MethodsA total of 43 adult HIV patients, including 20 diagnosed with TB and 23 controls, were enrolled. The levels of six exosomal miRNAs (miR-20a, miR-20b, miR-26a, miR-106a, miR-191, and miR-486) were measured using qRT-PCR. ResultsThe levels of these six exosomal miRNAs (miR-20a, miR-20b, miR-26a, miR-106a, miR-191, and miR-486) were significantly higher in the plasma of TB patients compared to controls among PLHIV. The Receiver Operating Characteristic (ROC) curve of these six miRNAs showed a fair performance in distinguishing TB patients from controls, with Area Under Curve (AUC) values of 0.78 (95 %CI 0.63–0.93), 0.81 (95 %CI 0.67–0.95), 0.77 (95 %CI 0.61–0.93), 0.84 (95 %CI 0.70–0.98), 0.82 (95 %CI 0.68–0.95) and 0.79 (95 %CI 0.65–0.93), respectively. These miRNAs showed higher AUC values for extrapulmonary tuberculosis compared to pulmonary tuberculosis. An analysis of subgroups was performed based on CD4 + T cell count (＜200 and ≥ 200 cells·µL−1). In the high CD4 count group, all these six exosomal miRNAs appeared to have higher AUC values compared to the low CD4 count group. ConclusionsThese six exosomal miRNAs could serve as potential biomarkers for diagnosing TB among PLHIV.

Trends in preterm birth in women living with HIV in Switzerland over the last three decades: A multicentric, prospective, cohort study.

HIV infection and its management during pregnancy to reduce perinatal transmission has been associated with preterm birth (PTB). This management has drastically changed. We aimed to evaluate changes in rates of PTB over 34 years in women living with HIV (WLWH) in Switzerland, and to identify factors and interventions associated with these changes. We analysed data from 1238 singleton pregnancies, prospectively collected by the Swiss Mother and Child HIV Cohort Study (MoCHiV) and the Swiss HIV Cohort Study (SHCS) between 1986 and 2020. Rates of PTB in this cohort were compared with that of the general Swiss population for three time periods according to changing treatment strategies recommended at the time. We evaluated the association of PTB with sociodemographic, HIV infection and obstetric variables in uni- and multivariate logistic regression. Rate of PTB in WLWH was highest prior to 2010 (mean 20.4%), and progressively decreased since then (mean 11.3%), but always remained higher than in the general population (5%). Older maternal age, lower CD4 count and detectable viraemia at third trimester (T3), drug consumption and mode of delivery were all significantly associated with both PTB and period of study in univariate analysis. There was no association between PTB and type of antiretroviral regimen. No difference was found in the rate of spontaneous labor between PTB and term delivery groups. Only higher CD4 count at T3 and vaginal delivery were significantly associated with a decrease in PTB over time in multivariate analysis. Preterm birth in WLWH in Switzerland has drastically decreased over the last three decades, but remains twice the rate of that in the general population. Improved viral control and changes in mode of delivery (vaginal birth recommended if viral loads are low near birth) have led to this progress.

Primary headache disorders among people living with HIV in Lusaka, Zambia

ObjectiveWe completed a cross-sectional survey study to determine headache prevalence and its association with HIV characteristics among people living with HIV (PLHIV) in Lusaka, Zambia. BackgroundHeadaches are common but their association with HIV status is unknown. MethodsThe HARDSHIP survey, a headache epidemiology questionnaire previously validated in Zambia, was distributed during a 3-month period to 3666 consecutive adult PLHIV attending routine clinic appointments at the Adult Infectious Diseases Centre at the University Teaching Hospital in Lusaka, Zambia. HIV disease characteristics were abstracted from their charts. Results1015 (27.7%) participants responded to the survey. Adjusted for age, 64% reported having a headache within the last year unrelated to another illness. Among participants, 201 met criteria for migraine (20%), 259 for tension-type headache (26%), 18 for probable medication-overuse headache (2%), and 121 for undetermined headache (12%). Prevalence for tension-type headache was significantly higher than that of migraine (P < 0.001). After adjusting for age and sex, higher CD4 counts were associated with migraine. No other associations were observed between overall headache or headache type with HIV disease characteristics including CD4 count, viral load, antiretroviral regimen, and time since HIV diagnosis. ConclusionsHeadaches are highly prevalent among this cohort of PLHIV in Zambia. Optimizing headache treatment and integrating it into routine HIV care may improve quality of life for a substantial proportion of PLHIV in Zambia.

A 'hidden problem': Nature, prevalence and factors associated with sexual dysfunction in persons living with HIV/AIDS in Uganda.

We conducted a clinic-based cross-sectional survey among 710 people living with HIV/AIDS in stable 'sexual' relationships in central and southwestern Uganda. Although sexual function is rarely discussed due to the private nature of sexual life. Yet, sexual problems may predispose to negative health and social outcomes including marital conflict. Among individuals living with HIV/AIDS, sexual function and dysfunction have hardly been studied especially in sub-Saharan Africa. In this study, we aimed to determine the nature, prevalence and factors associated with sexual dysfunction (SD) among people living with HIV/AIDS (PLWHA) in Uganda. We conducted a clinic based cross sectional survey among 710 PLWHA in stable 'sexual' relationships in central region and southwestern Uganda. We collected data on socio-demographic characteristics (age, highest educational attainment, religion, food security, employment, income level, marital status and socio-economic status); psychiatric problems (major depressive disorder, suicidality and HIV-related neurocognitive impairment); psychosocial factors (maladaptive coping styles, negative life events, social support, resilience, HIV stigma); and clinical factors (CD4 counts, body weight, height, HIV clinical stage, treatment adherence). Sexual dysfunction (SD) was more prevalent in women (38.7%) than men (17.6%) and majority (89.3% of men and 66.3% of women) did not seek help for the SD. Among men, being of a religion other than Christianity was significantly associated with SD (OR = 5.30, 95%CI 1.60-17.51, p = 0.006). Among women, older age (> 45 years) (OR = 2.96, 95%CI 1.82-4.79, p<0.01), being widowed (OR = 1.80, 95%CI 1.03-3.12, p = 0.051) or being separated from the spouse (OR = 1.69, 95% CI 1.09-2.59, p = 0.051) were significantly associated with SD. Depressive symptoms were significantly associated with SD in both men (OR = 0.27, 95%CI 0.74-0.99) and women (OR = 1.61, 95%CI 1.04-2.48, p = 0.032). In women, high CD4 count (OR = 1.42, 95% CI 1-2.01, p = 0.05) was associated with SD. Sexual dysfunction has considerable prevalence among PLWHA in Uganda. It is associated with socio-demographic, psychiatric and clinical illness factors. To further improve the quality of life of PLWHA, they should be screened for sexual dysfunction as part of routine assessment.

Framingham risk score based vascular outcomes in acute versus chronic HIV cohorts after 6 years of ART.

Immune dysregulation persists in people with HIV (PWH) on antiretroviral therapy (ART) and may lead to accelerated vascular ageing and cardiovascular disease (CVD). While delayed time to initiation of ART has been linked to worse cardiovascular outcomes, the effect of ART initiation during acute infection on these outcomes is not well understood. Participants were enrolled from the SEARCH010/RV254 acute HIV (AHI) and HIV-NAT chronic HIV (CHI) cohorts in Thailand. Participants with 6-year follow-up and viral suppression (viral load < 50 copies/μL) at follow-up were included. Both unmatched cohorts and age and gender-matched cohorts were analysed. Demographics, HIV laboratories, and cardiovascular risk factors from enrolment and 6-year follow-up were obtained from electronic records. Framingham Risk Score (FRS), vascular age (VA), vascular age deviation (VAD), and 10-year atherosclerotic cardiovascular disease (ASCVD) risk were calculated from previously published equations. Vascular outcomes in AHI and CHI cohorts were compared, and univariable and multivariable linear regression analyses were used to investigate risk factors associated with worse vascular scores. In all, 373 AHI participants and 608 CHI participants were identified. AHI participants were of younger age, had a higher prevalence of syphilis and a lower prevalence of prior hepatitis B, tuberculosis, diabetes, and hypertension. Higher CD4 T-cell and lower CD8 T-cell counts were seen in the AHI cohort at enrolment and 6-year follow-up. In all participants, the AHI cohort had a lower median FRS (p < 0.001) and VA (p < 0.001), but higher VAD (p < 0.001). However, in matched cohorts, no differences were found in FRS-based outcomes. In all participants, higher VAD after 6 years of ART was associated with higher body mass index (p < 0.001) and higher CD4 count (p < 0.001), which persisted in multivariable analysis. When FRS components were analysed individually, CD4 count was associated only with male sex and cholesterol. We did not identify differences in FRS-based vascular outcomes at 6 years in matched cohorts of participants who started ART during AHI versus CHI. We identified a correlation between higher CD4 count and worse FRS-based vascular outcomes, which may be driven by underlying metabolic risk factors. Further study is needed to confirm these findings and evaluate underlying mechanisms.

Susceptibility to mycobacterial infection in VEXAS syndrome.

VEXAS is a recently described acquired auto-inflammatory and hematologic syndrome caused by somatic mutations in UBA1. To date, VEXAS is not a recognized cause of acquired immunodeficiency. Two of our 10 VEXAS patients developed a disseminated Mycobacterium avium infection. To shed light on this observation, we retrospectively studied all patients with disseminated non-tuberculous mycobacterial infections (NTMi) seen at our institution over 13 years. Inclusion criteria were a positive blood/bone marrow culture, or 2 positive cultures from distinct sites, or one positive culture with 2 involved sites. patient 1 presented with fever, rash, orbital cellulitis and lung infiltrates. Patient 2 presented with fever and purpura. In both cases, Mycobacterium avium was identified on bone marrow culture. Twenty cases of disseminated NTMi were reviewed. Among 11 HIV-negative patients, three had chronic immune-mediated disease; three had untreated myeloid neoplasm; two had VEXAS; one had undergone kidney transplantation; one had GATA-2 deficiency; and one had no identified aetiology. None had lymphoid neoplasia or had undergone bone marrow transplantation. HIV-negative cases had higher CD4 counts than HIV-positive patients (median CD4: 515/mm3 vs 38/mm3, p< 0.001). Monocytopenia was present in seven cases. At 2 years, six patients had died, including both VEXAS patients. VEXAS patients have an intrinsic susceptibility to disseminated NTMi, which may result from monocytic dysfunction. NTMi can mimic VEXAS flare. Clinicians should maintain a high suspicion for opportunistic infections before escalating immunosuppressive therapy. Further studies are needed to confirm and better decipher the herein reported observations.

COVID-19 Severity in People With HIV Compared With Those Without HIV.

People with HIV (PWH) may be at risk for more severe COVID-19 outcomes. We compared risk for severe COVID-19 in PWH with matched individuals without HIV. We identified adults in Massachusetts with a positive SARS-CoV-2 test, March 2020-July 2022, using electronic medical record data from 3 large clinical practice groups. We then used regression models to compare outcomes among PWH versus propensity score-matched people without HIV (matched 20:1) for severe COVID-19 (pneumonia or acute respiratory distress syndrome), hospitalization, and hospital length of stay. We identified 171,058 individuals with COVID-19; among them, 768 PWH were matched to 15,360 individuals without HIV. Overall, severe COVID-19 and hospitalization were similar in PWH and those without HIV (severe COVID-19: 3.8% vs 3.0%, adjusted odds ratio [OR] 1.27, 95% confidence interval [CI]: 0.86-1.87; hospitalization: 12.1% vs 11.3%, adjusted OR: 1.08, 95% CI: 0.87 to 1.35). Compared with people without HIV, PWH with low CD4 T-cell counts (<200 cells/mm 3 ) had more severe COVID-19 (adjusted OR: 3.99, 95% CI: 2.06 to 7.74) and hospitalization (adjusted OR: 2.26, 95% CI: 1.35 to 3.80), but PWH with high CD4 counts had lower odds of hospitalization (adjusted OR: 0.73, 95% CI: 0.52 to 1.03). PWH with low CD4 T-cell counts had worse COVID-19 outcomes compared with people without HIV, but outcomes for those with high CD4 counts were similar to, or better than, those without HIV. It is unclear whether these findings are generalizable to settings where PWH have less access to and engagement with health care.

Human Immunodeficiency Virus (HIV) Viral Load Fluctuation Mirrors the Haemoglobin Levels and Predicts the Risk of Anaemia

Background: Anaemia is a common complication of HIV infection that can have a significant impact on the health and wellbeing of affected individuals. Evaluating the relationship between haemoglobin concentration, CD4 count and viral load is therefore important in order to predict and reduce the risk of anaemia in people living with HIV. Objectives: The aim of this study was to evaluate the relationship between haemoglobin concentration, CD4 count and viral load in people living with HIV. Method: This retrospective cross-sectional study was carried out at Parirenyatwa Opportunistic Infections Clinic, Zimbabwe. The study was conducted from November 2022 to April 2023. The data collected from each patient`s data base included; demographics, haemoglobin value, CD4 count and viral load count. Data collected during this study were captured on spreadsheet using Microsoft excel and the data were analyzed using the Graph Pad prism software. Results: A total of 244 participants were enrolled into the study from the Parirenyatwa Group of Hospitals Opportunistic Infections Clinic of which 102 (41.8%) were male and 142 (58.2%) were female. Participants with high CD4 count and low viral load had a mean haemoglobin of 13.3g/dL, those with low CD4 count and high viral load count had a mean haemoglobin of 8.3g/dl, those with high CD4 count and high viral load count had a mean haemoglobin of 12.5g/dl and those with low CD4 and low viral load count had a mean haemoglobin of 10.70g/dl. Conclusion: The overall finding from this study was that haemoglobin levels of people living with HIV is greatly affected by viral load and CD4 counts and that patients’ haemoglobin levels inversely tract the HIV viral loads. Low CD4 count and/ or high viral load count is associated with anaemia in people living with HIV.

Investigating the Relationship between Medication Adherence Behaviors and the Achievement of Sustained Viral Load Suppression among People Living with HIV (PLHIV) on Antiretroviral Therapy (ART) in Akwa Ibom State, from 2018 - 2022

Background: Nigeria is still endemic for Human Immuno-Deficiency Virus (HIV), and currently among the top five countries with the highest burdens of HIV infection. For a successful HIV program, there should be good access to antiretroviral therapy (ART) and record of viral load suppression (VLS). This study aimed at investigating the relationship between medication adherence behavior (MAB) and sustained VLS among people living with HIV (PLHIV) receiving ART in Akwa Ibom State. Methods: This was a retrospective cohort study of the medical records of 1,763 PLHIV receiving ART services from January 2018 to December 2022, in selected ten health facilities in Akwa Ibom State. Relevant demographic, clinical, immunological, viral load (VL) information were obtained from the patients’ medical records and databases. The proportion of VLS and associated variables were then analyzed. Results: Out of the 2,550 PLHIV whose medical records were accessed, data for 1,763 PLHIV was accepted for analysis. A total of 795 (45.1%) male and 968 (54.9%) female participated in the study, with a mean age of 38.4 ± 5 years. While 23.8% (n = 420) have unsuppressed VL of &gt;1,000 copies/mL; 76.2% (n = 1,343) of participants achieved VLS of &lt;1,000 copies/mL. 90.4% (n = 1,213) of the virally suppressed participants recorded moderate to high medication adherence levels (X2 = 94.977, df = 2, p-value = 2.2 x 10-16). CD4 counts and HAART regimen have significant impact on VLS (p &lt; 0.05), while pregnancy status, TB Infection, duration on HAART, and WHO disease stage do not have significant effects on VLS (p &gt; 0.05). Conclusion: There was a strong evidence to reject the null hypothesis, which states that there is no positive association between MAB and sustained VLS among PLHIV on ART (p &lt; 0.05). The VLS rate in this study indicates a good HIV epidemic control. Good medication adherence level, high baseline CD4 count, and being on first line HAART regimen were strongly associated with VLS.

A cross-sectional study of the factors influencing adherence to antiretroviral therapy among adults with human immunodeficiency virus infection in a tertiary care hospital in Puducherry, India.

Combating human immunodeficiency virus/acquired immunodeficiency syndrome epidemic has been possible due to advances in prevention strategies and Antiretroviral therapy (ART). Optimal adherence to ART is a major factor in achieving the desired immunological, virological, and patient well-being outcomes. Several socio-demographic, patient, treatment, and health-care system-related factors influence nonadherent behavior to ART. This study was planned to assess (1) ART adherence level, (2) factors and reasons associated with nonadherence, and (3) impact of suboptimal adherence on treatment outcomes. This was a cross-sectional analytical study of 300 patients in a tertiary care hospital in Puducherry, India. Random sampling was used to collect data from patient treatment cards and a predesigned structured questionnaire. The pill count method was used to calculate adherence level. Nonadherence was chosen as a dependent variable and factors affecting adherence were chosen as independent variables. Test for significance was carried out by Chi-square test and Fisher's exact test. Optimal adherence was seen in 68.3%. Factors significantly associated with nonadherence were lower education level, high prior CD4 count, irregular follow-up, missing doses in the past, and being late for pharmacy pill refills. Adherence was positively associated with mean increase in CD4 count over 6 months. In our study, the adherence rate is suboptimal which can lead to failure of ART. Nonadherence was associated with a decrease in CD4 count overtime. Most of the factors significantly affecting ART adherence were patient behavior related. These factors can be used for target intervention during reinforcement adherence counseling.

Assessment of treatment outcomes for HIV Positives transitioned from Tenofovir/Lamivudine/Efavirenz to Tenofovir/Lamivudine/Dolutegravir in a Nigerian Tertiary Hospital

Objective: Dolutegravir, an integrase inhibitor replaced nevirapine or efavirenz (both NRTIs) in a fixed dose combination with Tenofovir/Lamivudine, as the preferred first-line option for the prevention and treatment of HIV infection. This study aimed to assess the treatment outcomes of the new Tenofovir/Lamivudine/Dolutegravir (TLD) regimen at the Federal Medical Centre Abeokuta. Methods: This retrospective study used data drawn from the treatment register of patients who transitioned from Tenofovir/Lamivudine/Efavirenz (TLE) to TLD. Data were analyzed using SPSS v23. Descriptive statistics were used to describe categorical and continuous variables. Statistically significant independent variables in univariate analyses were included in the multivariate model. The level of significance was set at p&lt;0.05. Results: The 358 cases reviewed showed a mean age of 44.29 ± 11.5 years. The majority (267; 74.6%) were females. Viral load suppression (≤1000 copies/ml) was achieved in 313 (87.4%) while on TLE but increased to 339 (94.7%) when transitioned to TLD. Also, 36.3% had a high CD4 count while on TLE, this increased to 67.3%. The mean CD4 counts (428.59±251.85) while using TLE increased exponentially when transitioned to TLD (634.89±244.72) (t-31.601; p-value- 0.001). Before the transition, 90.5% of respondents were at WHO stage 1 compared to 92.5% after the transition to TDF/3TC/DTG. Conclusion: Treatment outcome was greatly improved in terms of virologic, immunologic and clinical parameters among patients who transitioned from TDF/3TC/EFV to TDF/3TC/DTG. The outcome of this work supports and encourages the use of TDF/3TC/DTG as the preferred first-line regimen in HIV treatment for the patient’s maximum clinical benefit.

2661. Characterization of Mpox in Southeast Michigan

Abstract Background More than 30,000 cases of mpox have been identified in the United States. Data suggest that about 40% of affected persons are co-infected with HIV. Although most cases are self-limiting, patients with low CD4 counts are at increased risk of developing severe clinical manifestations and dying. Methods Retrospective case-control study comparing mpox cases among people with HIV (PWH) and HIV-uninfected persons from July to Dec 2022, at Henry Ford Health in Southeast Michigan. Demographic data, clinical characteristics, treatment, and outcomes were evaluated. Results 54 patients were diagnosed with mpox. Overall, 42 (78%) were MSM or bisexual men, 36 (67%) Black, and 34 (63%) PWH; median age was 34.5 years (Table 1). The majority (63%) had prior sexually transmitted infections (STIs), which were more common in PWH (82% vs 30%, p&amp;lt; 0.001). About one-third had multiple sexual partners; more than half engaged in insertive or receptive anal intercourse. 32 (94%) of PWH were on ART, 26 (76%) had CD4 counts &amp;gt;200 and 19 (60%) had undetectable viral load; mean CD4 count was 602 and viral load 7942. Of the HIV-uninfected persons, 5 (25%) were on PrEP. Receipt of mpox vaccine was uncommon in either group. All patients presented with rash that was disseminated in 35%. Fever/chills, lymphadenopathy, headache, proctitis and pharyngitis were the most common manifestations and did not differ among the two groups. Concomitant STIs were present in 22 (48%) of 46 persons tested; syphilis co-infection was more prevalent among PWH (35% vs 25%, p&amp;lt; 0.006). Hospitalization and receipt of tecovirimat were similar between the two groups; no patients died. Demographics, Risk Factors, Clinical Manifestations and Outcomes of Mpox Patients Conclusion Overall, there were no significant differences in clinical manifestations or outcomes between PWH and HIV-uninfected persons with mpox except for syphilis co-infection. Most of our PWH cohort was on ART and virally suppressed with high CD4 count. Hence, efforts should focus on rapid treatment of PWH with effective ART to achieve virological suppression and immunological recovery to minimize clinical complications and severe outcomes associated with opportunistic pathogens. Vaccinating all high-risk individuals, early mpox recognition and testing, and screening for additional STIs should be prioritized. Disclosures Indira Brar, MD, Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Gilead: Honoraria|Janssen: Grant/Research Support|Janssen: Honoraria|ViiV: Advisor/Consultant|ViiV: Grant/Research Support|ViiV: Honoraria

1573. Viral Blips While on Antiretroviral Therapy are Associated with Virologic Failure

Abstract Background Blips in HIV viral load (VL) while on antiretroviral therapy (ART) are of unclear clinical significance. In this study, we examined the association between blips and virologic failure (VF). Methods We used data from the US Military HIV Natural History Study (NHS) cohort. Included participants were diagnosed with HIV after 2006, had been on ART for ≥ 6months, and had ≥3 VLs recorded and measured using an assay with a lower limit of detection of &amp;lt; 50 copies/mL. VF was defined as two consecutive VLs ≥ 200 copies/mL spanning 90 days or a single VL ≥1000 copies/mL. Blips were defined as VL of 51-999 copies/mL, that were preceded and followed by a VL ≤ 50 copies/mL and were differentiated by magnitude as low-level (VL 51-199 copies/mL) or high-level (200-999 copies/mL). Detectable VLs that did not meet criteria for VF or blips were grouped as low-level viremia (LLV; 51-199 copies/mL), and higher low-level viremia (hLLV; 200-999 copies/mL). Cox proportional hazards models adjusted for demographic characteristics, time updated CD4 counts, ART, and viral load were used. Hazard ratios and 95% confidence intervals are presented. Results A total of 988 participants (median age 34.1 years, 96.7% male, 41.7% African American) were included, of which 55 (5.6%) experienced VF (Table 1). While 191 participants (19.3%) experienced blips, it was the highest VL status in 146 (14.8%) (Table 2). Having blips and low-level viremia was associated with increasing hazard of VF, graded by type and level of viremia (low-level blip 1.86 [1.10 – 3.14]; high-level blip 3.56 [1.13 – 11.18]; LLV 4.10 [3.06-5.51]; hLLV 10.51 [6.28-17.61]. Other factors associated with VF were African American race and higher VL at ART initiation. Whereas higher CD4 counts, and use of integrase strand transfer inhibitors (relative to Non-Nucleoside Reverse Transcriptase inhibitors) were protective (Table 3). Conclusion Detectable viremia, including blips, are associated with an increased risk of VF. The magnitude of the viremia appears important with dose-response-type impact (i.e., viral loads &amp;gt;200 copies/mL having a greater hazard of VF). These findings suggest that individuals with viral blips at a minimum should undergo evaluation for medication adherence and may benefit from more frequent VL monitoring. Disclosures All Authors: No reported disclosures

Long Term Assessment of Anti-SARS-CoV-2 Immunogenicity after mRNA Vaccine in Persons Living with HIV.

(1) Background: Waning of neutralizing and cell-mediated immune response after the primary vaccine cycle (PVC) and the first booster dose (BD) is of concern, especially for PLWH with a CD4 count ≤200 cells/mm3. (2) Methods: Neutralizing antibodies (nAbs) titers by microneutralization assay against WD614G/Omicron BA.1 and IFNγ production by ELISA assay were measured in samples of PLWH at four time points [2 and 4 months post-PVC (T1 and T2), 2 weeks and 5 months after the BD (T3 and T4)]. Participants were stratified by CD4 count after PVC (LCD4, ≤200/mm3; ICD4, 201-500/mm3, and HCD4, >500/mm3). Mixed models were used to compare mean responses over T1-T4 across CD4 groups. (3) Results: 314 PLWH on ART (LCD4 = 56; ICD4 = 120; HCD4 = 138) were enrolled. At T2, levels of nAbs were significantly lower in LCD4 vs. ICD4/HCD4 (p = 0.04). The BD was crucial for increasing nAbs titers above 1:40 at T3 and up to T4 for WD614G. A positive T cell response after PVC was observed in all groups, regardless of CD4 (p = 0.31). (4) Conclusions: Waning of nAbs after PVC was more important in LCD4 group. The BD managed to re-establish higher levels of nAbs against WD614G, which were retained for 5 months, but for shorter time for Omicron BA.1. The T cellular response in the LCD4 group was lower than that seen in participants with higher CD4 count, but, importantly, it remained above detectable levels over the entire study period.