Mean CD4 Research Articles

Safety, efficacy, and affordability of ABVD for Hodgkin lymphoma in Malawi: a prospective cohort study

ABVD (doxorubicin, bleomycin, vinblastine, and dexamethasone) is a proven, curative regimen for Hodgkin lymphoma (HL). Prospective data describing HL treatment in sub-Saharan Africa are limited. We aimed to fill this knowledge gap, using data from Malawi. We report a prospective observational cohort of HL (aged 15) from a single, tertiary referral centre in Malawi. We enrolled patients with pathologicially confirmed Hodgkin lymphoma between June 1, 2013, and Dec 31, 2021 with follow-up censored on May 31, 2022. Patients were treated with ABVD and concurrent antiretroviral therapy if HIV-positive and were followed up for 5 years. The primary outcome was overall survival; secondary outcomes included progression-free survival, response assessment, and adverse events. Microcosting of HL diagnosis, treatment, and follow-up was embedded. We enrolled 38 patients with a median age of 27 years (interquartile range 19-46); eleven (28%) were HIV-positive. Of 35 patients treated with ABVD, 24 (71%) had stage III/IV, nine (26%) unfavourable limited stage, and two (6%) favourable limited stage. Among HIV-infected individuals, mean CD4 count at HL diagnosis was 179cells/uL and ten (91%) had HIV RNA < 400 copies/mL. Grade 3/4 neutropenia occurred in 24 (68%) patients and caused treatment delay in 16 (46%). Of ten deaths, seven were due to HL, two possible treatment-related toxicity, and one uncertain. 2-year overall survival was 82% (95% CI 70-96%) and 2-year progression-free survival was 64% (95% CI 50-83%). PFS appeared better for HIV-positive patients (HR 0.23 (95% CI 0.05-1.02)) after controlling for stage and performance status (p=0.05). We estimated $2708 (2022 USD) for HL diagnosis, treatment, and follow-up in our cohort. Our findings suggest that treatment with ABVD is safe, efficacious, and affordable for HL in Malawi. Outcomes are worse than in high-income countries due to HL progression. Future studies are needed to understand outcome inequities and to assess efficacy of therapies for patients with relapsed or refractory HL in Malawi. National Institutes of Health, Lineberger Comprehensive Cancer Center.

DOLAMA 200: Effectiveness and Safety of a Dual Therapy with Dolutegravir Plus Lamivudine in Treatment-Experienced HIV-1 Infected Real World Participants in Spain.

The continuous pharmacological advances in antiretroviral treatment (ART) and the increasing understanding of HIV drug resistance has led to a change in the paradigm of ART optimization in the setting of the viral suppression of treatment-experienced patients with the emerging evidence of the effectiveness and safety of dual therapies. The aim of this study is to determine the antiviral efficacy and safety of switching to Dolutegravir + Lamivudine in people living with HIV, and to analyze the rate of patients with virologic failure (VF). A total of 200 patients were included with a median age of 51 years, 189 cells/µL of nadir CD4+, 13 years on ART and four previous ART regimens. Among the 168 patients who completed a follow-up at 48 weeks, a total of five VFs occurred, resulting in a 2.98% (5/168) VF rate. The results of the intention-to-treat analysis were a VF rate of 2.54% (5/197), and the rate of patients/year with viral suppression was 98.3% (298/303) in the observed data analysis. We observed a significant improvement in mean CD4 lymphocytes, the CD4/CD8 ratio and lipid profiles. The optimization of ART to DTG plus 3TC is a cost-effective switch option for treatment-experienced HIV patients, and also improves their lipid profiles.

Prevalence of prolonged QTc interval among HIV infected patients on highly active antiretroviral therapy (HAART) and its relationship with CD4 cells count and viral load at a tertiary hospital in North Eastern Nigeria.

Patients living with HIV infection remain at increased risk of cardiovascular diseases and sudden cardiac death. Various prevalence of electrocardiographic (ECG) abnormalities among HIV-infected patients were reported: Attamah et al reported the prevalence of electrocardiographic abnormalities among HIV-infected patients as 34.5%, while Orunta et al reported a prevalence of 42.9%, and Njoku et al reported a prevalence of 93.0%. Human immunodeficiency virus-infected patients are at increased risk of developing prolonged QT interval. Sani et al reported the prevalence of prolonged corrected QT interval among HIV-infected patients as 45.0%. Innocent et al reported a prevalence of48.0%, while Ajala et al reported a prevalence of 18%. Prolonged QTc interval increases the risk of premature ventricular contraction which can degenerate into ventricular tachycardia and or ventricular that can result in sudden cardiac death. The study was a cross-sectional conducted among HIV-infected patients receiving HAART at the Federal Medical Centre Nguru, Yobe State, North Eastern Nigeria. One hundred and seven (107) subjects were recruited into the study comprising thirty-three (37.0%) males and 70(65.4%) females. The mean CD4 cell count, and viral load of the studied patients were 612.64±34.75 cells/μL and4646.30±58.68 copies/mL respectively. Twenty (18.7%) patients had prolonged QTc interval, this gave us the prevalence of prolonged QTc in this study as 18.7%. The commonest cardiac rhythm was sinus rhythm (69.2%), followed by sinus tachycardia (26.2%) and atrial fibrillation 5(4.7%). Other electrocardiographic findings include First-degree atrioventricular block was seen in seven (6.5%) patients, Premature ventricular contractions were found in16.8%, RBBB was observed in 2.8%, 3.7% of patients had LBBB and 4.7% had left posterior hemiblock. The distribution of QTc interval according to CD4 cells count and viral revealed a statistically significant difference across the groups. All the patients with prolonged QTc interval had lower CD4 cells count and higher viral load suggesting that HIV disease severity is associated with prolonged QTc interval. In conclusion, the study revealed that the prevalence of prolonged QTc interval among HIV infected patients on highly active antiretroviral therapy was found to be 18.7%, and that HIV disease severity increases the risk of developing prolonged QTc interval.

Comparative immunogenicity and neutralizing antibody responses post heterologous vaccination with CoronaVac (Sinovac) and Vaxzevria (AstraZeneca) in HIV-infected patients with varying CD4+ T lymphocyte counts

ABSTRACT The immune response to heterologous coronavirus disease (COVID-19) vaccination in people living with HIV (PLWH) is still unclear. Herein, our prospective cohort study aimed to compare the immune response of heterologous vaccination with CoronaVac (Sinovac) and Vaxzevria (AstraZeneca) between PLWH having CD4 counts ≤ 200 cells/µL (low CD4+) and > 200 cells/µL (high CD4+). Anti-receptor-binding domain (RBD) immunoglobulin G (IgG) levels and the percentage inhibition of neutralizing antibodies (nAbs) were analyzed at 2 and 12 weeks after immunization. Participants in the low and high CD4+ groups had mean CD4+ counts of 139 and 575 cell/µL, respectively. Two and 12 weeks after immunization, in the low CD4 group, the median anti-RBD-IgG levels were 159 IU/mL and 143 IU/mL, respectively, whereas the nAb level was 71% and decreased to 47.2%, respectively. Contrarily, the median anti-RBD-IgG levels in the high CD4+ group were 273 IU/mL and 294 IU/mL, respectively, whereas the nAb levels were 89.3% and relatively stable at 81.6%. However, although immune responses between the two study groups were not significantly different, a decline in nAb levels was observed at 12 weeks in the low CD4+ group. Therefore, a COVID-19 booster vaccine dose is suggested for immunoprotection.

Characterization of natural killer and cytotoxic T-cell immune infiltrates in pancreatic ductal adenocarcinoma.

Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer with poor response to systemic therapies, including immunotherapy. Given the immunotherapeutic potential of natural killer (NK) cells, we evaluated intratumoral NK cell infiltrates along with cytotoxic T cells in PDAC to determine their association with patient outcomes. We analyzed tumors from 93 PDAC patients treated from 2012 to 2020. Predictor variables included tumor-infiltrating lymphocytes (TILs), T-cell markers (CD3, CD8, CD45RO), NK marker (NKp46), and NK inhibitory marker (major histocompatibility complexclass I[MHC-I]) by immunohistochemistry. Primary outcome variables were recurrence-free survival (RFS) and overall survival (OS). Mean TILs, CD3, and NKp46 scores were 1.3 ± 0.63, 20.6 ± 17.5, and 3.1 ± 3.9, respectively. Higher expression of CD3 and CD8 was associated with higher OS, whereas NK cell infiltration was not associated with either RFS or OS. There was a tight positive correlation between MHC-I expression and all T-cell markers, but not with NKp46. Overall NK cell infiltrates were low in PDAC and did not predict clinical outcomes, whereas T-cell infiltrates did. Further characterization of the immune infiltrate in PDAC, including inhibitory signals and suppressive cell types, may yield better biomarkers of prognosis and immune targeting in this refractory disease.

SCALA: a randomized phase I trial comparing subcutaneous and intravenous alemtuzumab in patients with progressive multiple sclerosis.

Alemtuzumab is administered intravenously (IV) for relapsing-remitting multiple sclerosis (RRMS), with limited studies of subcutaneous (SC) treatment. We sought to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), and safety profile of SC-administered alemtuzumab in people with progressive multiple sclerosis (PMS). SCALA was a phase I, open-label, randomized, parallel-group study with two 12-month periods and a safety monitoring phase to 60 months. Of 29 screened participants, 24 were enrolled and randomized 2:1 to two 12 mg/day alemtuzumab treatments (60 and 36 mg total; SC:IV). Key inclusion criteria: ⩾18 years with a PMS diagnosis. Key exclusion criteria included RRMS diagnosis and prior treatment with anti-CD52 antibodies. Primary endpoint: CD3+ lymphocyte count. Secondary endpoints: PD and PK parameters. Demographics were broadly similar for participants in the SC (16) and IV (8) arms; more participants with primary PMS received SC (44%) versus IV (25%) treatment. After the first course, the mean CD3+ cell count/µL was reduced at month 1 in both arms (SC: baseline (BL) 1326 to 48 vs IV: BL 1155 to 84). Lymphocyte counts partially repopulated by month 12, with mean CD3+ cell counts/µL of SC 599 versus IV 528. The mean lymphocyte counts/µL decreased again after the second course at month 13 in both arms (SC: 90 vs IV: 129), with partial repopulation by month 24. Alemtuzumab serum concentrations were lower following SC administration relative to IV, with 32% bioavailability. There were no adverse events leading to permanent treatment discontinuation or death. In SCALA, there were similar patterns of lymphocyte depletion and repopulation for participants receiving SC or IV alemtuzumab. In both arms, alemtuzumab had a manageable safety profile, with no emerging safety concerns. The general stabilization of neurological outcomes observed over 60 months underscores the potential long-term benefits of alemtuzumab treatment. Clinicaltrials.gov identifier: NCT02583594.

Shorter total sleep time is associated with lower CD4+/CD8+ T cell ratios in virally suppressed men with HIV.

Although poor sleep quality is associated with lower CD4+ T cell counts among people living with HIV (PLWH), the association between objective sleep metrics and T lymphocyte subset counts is unknown. We evaluated the association between polysomnography (PSG) derived sleep metrics and T lymphocyte subpopulations in a cohort of men living with HIV. Virally suppressed men living with HIV participating in the Multicenter AIDS Cohort Study underwent home overnight PSG. We assessed the association of PSG parameters with CD4+ and CD8+ T cell counts and the CD4+/CD8+ T cell ratio. Overall, 289 men with mean (±SD) age 55.3 ± 11.3 years and mean CD4+ T cell count 730 ± 308 cells/mm3 were evaluated. Total sleep time (TST) was significantly associated with CD8+ but not CD4+ T cell counts. After adjusting for age, race, depressive symptoms, antidepressant use, and non-nucleoside reverse transcriptase inhibitors use, every hour of shorter TST was associated with an additional 33 circulating CD8+ T cells/mm3 (p = 0.05) and a 5.6% (p = 0.0007) decline in CD4+/CD8+ T cell ratio. In adjusted models, every hour of shorter rapid eye movement (REM) sleep was associated with an additional 113 CD8+ T cells/mm3 (p = 0.02) and a 15.1% lower CD4+/CD8+ T cell ratio (p = 0.006). In contrast, measures of sleep efficiency and sleep-disordered breathing were not associated with differences in T lymphocyte subpopulations. Our findings suggest that shorter TST and REM sleep durations are associated with differences in T lymphocyte subpopulations among men living with HIV. Addressing sleep may reflect a novel opportunity to improve immune function in PLWH.

Immunovirological response and adverse effects of dolutegravir-based regimen in people living with HIV/AIDS

Background: After the WHO and NACO recommendation and implementation of dolutegravir (DTG)-based regimen as the preferred first-line regimen for adults living with HIV and as a preferred second-line regimen for adult people living with HIV (PLHIV) for whom non-DTG-based regimens are failing, only a few studies are present on its efficacy and adverse effects as first line and as a switch option in this part of the world. Objectives: The primary and secondary objectives were to evaluate the immunovirological response and to assess the adverse effects of DTG-based regimens in PLHIV/AIDS respectively. Materials and Methods: This prospective longitudinal study was conducted in the Regional Institute of Medical Sciences, Imphal for a period of 22 months, to study the immunovirological response and adverse effects of DTG-based regimen in PLHIV/AIDS. Results: Mean CD4 cells count ± standard deviation (cells/µL) was 495.42 ± 215.13 at enrollment, 529.53 ± 202.86 at 6 months, and 578.84 ± 204.84 at 1 year on DTG-based regimen. Increase in mean CD4 cells count was 34.11 cells/µL after 6 months (95% confidence interval [CI]: 22.76–45.46, P&lt;0.000) and 83.42 cells/µL (95% CI: 68.57–98.26, P &lt;0.000) after 1 year of starting DTG regimen. At enrollment, 92% (n = 92) were virologically suppressed, whereas 8% (n = 8) were not. After DTG, 98/100 (98%) of patients were virologically suppressed at 6 months and 12 months. An increase in mean weight by 1.24 kg after 6 months (95% CI: 0.93–1.54, P &lt;0.000) and 2.2 kg (95% CI: 1.67–2.72, P &lt;0.000) after 1 year from baseline was noted. The increase in mean random blood sugar (RBS) was 6.22 mg% (95% CI: 2.51–9.92, P &lt;0.000) at 6 months and 12.15 mg% (95% CI: 6.19–8.10, P&lt;0.000) at 1 year of initiation of DTG. There were two cases where RBS &gt;300 mg% after 1 year of DTG. Conclusions: Treatment with a DTG-based regimen in treatment-naïve PLHIV and/or switching from the previous antiretroviral therapy regimen to DTG based has good immunological response and high rates of viral suppression without major clinical adverse effects. Weight gain and hyperglycemia should be monitored in patients on DTG.

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.

Prolonged infusion time of cyclophosphamide plus granulocyte colony-stimulating factor (G-CSF) as a mobilization regimen may improve mobilization efficiency in newly diagnosed multiple myeloma patients: a single center experience

Objectives This study aimed to clarify the effectiveness and safety of two different infusion durations of cyclophosphamide (CTX) plus granulocyte colony-stimulating factor (G-CSF) for peripheral blood stem cell mobilization in patients with newly diagnosed multiple myeloma (NDMM). Methods One hundred and fifty-six consecutive NDMM patients receiving CTX plus G-CSF mobilization and autologous stem cell transplantation during the period of September 2008 to May 2020 were selected for retrospective analysis. According to differences in prolonged infusion time of CTX, they were divided into a 24-h group (24-h continuous infusion) and a control group (4-6 h of infusion). Mobilization and safety of infusion were analyzed. Flow cytometry was used to detect the peripheral blood CD34+ cell count. Multivariate analysis was performed to determine the factors influencing the number of CD34+ cells. Results The mean CD34+ cell counts collected in 24-h and control groups were 6.78 (interquartile range [IQR] 3.59-11.69) and 4.48 (IQR 2.39-6.30) ×106/kg, respectively (p < 0.001). Meanwhile, the target number of CD34+ cells/kg (defined as ≥4 × 106/kg) was collected from 51 (75%) of cases in 24-h group vs. 45 (51%) in the control group (p = 0.002). Multivariate analysis identified the independence of CTX infusion time as a factor influencing the target number of CD34+ cells/kg [odds ratio OR, 4.045; 95% CI: 1.630-10.038, p = 0.003]. The post-transplantation time to neutrophil engraftment was 10 (IQR 9-11) in 24-h group and 11 (IQR 10-12) in control group (p < 0.001). Finally, no statistical differences were identified between groups in terms of hematologic and non-hematologic toxicities. Conclusions For patients with NDMM, 24-h continuous infusion of CTX plus G-CSF contributes to improved mobilization efficiency and equivalent toxicity as a stem cell mobilization regimen.

Rapid ART initiation with bictegravir/emtricitabine/tenofovir alafenamide in individuals presenting with advanced HIV disease (Rainbow study)

BackgroundA rapid ART initiation approach can be beneficial in people with advanced HIV disease, in consideration of their high morbidity and mortality. The aim of our study was to evaluate the feasibility, efficacy and safety of rapid ART start with BIC/FTC/TAF in this setting. MethodsPilot, single-centre, single-arm, prospective, phase IV clinical trial conducted in a tertiary Italian hospital. Thirty ART-naïve people presenting with advanced HIV-1 diagnosis (defined as the presence of an AIDS-defining event and/or CD4 cell count <200 µL), were enrolled. Main exclusion criteria were active tuberculosis, cryptococcosis and pregnant/breastfeeding women. BIC/FTC/TAF was started within 7 days from HIV diagnosis. The primary endpoint was clinical or virologic failure (VF). Immunological parameters, safety, feasibility, neurocognitive performances and patient-reported outcomes were assessed as well. ResultsOver the study period, 40 (34%) of 116 patients diagnosed with HIV infection at INMI Spallanzani had advanced disease, of whom 30 (26%) were enrolled. The proportion of participants with HIV-RNA <50 cp/mL was 9/30 (30%) at week (w) 4, 19/30 (63%) at w12, 24/30 (80%) at w24, 23/30 (77%) at w36 and 27/30 (90%) at w48. Two unconfirmed VF occurred. No ART discontinuation due to toxicity or VF was observed. No ART modification was performed based on the review of genotype and no mutations for the study drugs were detected. Mean CD4 cells count changed by 133 cells/μL at BL to 309 cells/μL at w 48 and 83% of participants had a CD4 > 200 cells/µL at w 48. Two participants developed IRIS and one was diagnosed with disseminated TB and needed an ART switch. InterpretationsOur results support the feasibility, efficacy and safety of BIC/FTC/TAF as a rapid ART strategy in patients with advanced HIV disease.

Demographic Distribution Pattern and Antiretroviral Therapy Status Among HIV Patients in Selected Tertiary Hospitals in Abeokuta, Ogun State

The occurrence of human immunodeficiency virus (HIV) in Nigeria is relatively high and compromised with low antiretroviral therapy (ART) coverage. The study aimed at investigating the effect of ART on the CD4 cell count among seropositive individuals. Blood samples of HIV patients visiting three referral hospitals in Abeokuta were collected and CD4 cell count determined via flow cytometry method. Socio-demographic data of patients were also collected and analyzed using STATA/IC. A total of 615 seropositive blood samples were collected from three hospitals. The female to male ratio was found to be 2:1 of which age bracket 20-40 years had the highest infective number (63.3%) among other age categories. There was higher HIV occurrence among the married (52%) than the single (26.8%), while those with primary or secondary education had the highest (42.4%) compared to tertiary education (36.7%) and no formal education (9.1%). The CD4 count of infected cases showed that 51.2% had CD4 count between 100-200 cells/µL with 5.2% above 200 cells/µL. Also only 47.3% of the total infected cases placed on ART had a mean CD4 cell count (132.1±4.23) higher than those not on ART (CD4 count = 98.67±3.56). As a way of effectively managing HIV in Ogun State and meeting the 2030 set goal of USAIDS there is need for more HIV screening for early commencement of ART towards suppressing viral load.

Status of HIV and comorbidities in refugees with HIV from Ukraine.

To describe the clinical characteristics of refugees with HIV from Ukraine that seek continuation of medical care in Germany. Fourty-six refugees with HIV that had left Ukraine between 24 February and 30 December 2022 were examined. Information on patients' history was obtained using a standardized questionnaire for clinical care. Interviews were conducted in Russian during their first clinical presentation. Fourty-six persons (41 females and 5 males) were included and their mean age was 39.6 (±8.4) years. The mean time since HIV diagnosis was 8.0 (median, IQR 7.15) years and 70.3% of participants currently received tenfofovir-DF, lamividine and dolutegravir. Most refugees had an undetectable HIV viral load and their current mean CD4 T cell count was 702 (SD ± 289) per μL. Serology revealed previous hepatitis B infection in 50.4% without evidence for replication, with undetectable anti-hepatitis B surface antigen in the remaining refugees. Antibodies against hepatitis C were present in 23 refugees (50%), but only 10 patients had been diagnosed with hepatitis C previously. Five refugees had undergone successful antiviral treatment for hepatitis C. Detectable HCV-RNA was evident in nine patients (19.6%). Sixteen (38.6%) refugees had a positive tuberculosis (TB) interferon gamma release assay, and four were on TB treatment for previously diagnosed infection. One had been diagnosed with multidrug-resistant (MDR) TB, two with pre-extensively drug-resistant (pre-XDR) TB and two with XDR TB and were treated with combinations of second-line and novel agents according to WHO guidelines. Based on this preliminary analysis of a not fully representative cohort, refugees with HIV from Ukraine were young, mostly healthy females highly adherent to antiretroviral therapy. The rate of transmittable co-infections urges early diagnostic evaluation and treatment.

Could Active TB be a Major Contributor to the Disparity in Presentation and Mortality for cHL in HIV + and HIV - Individuals in South Africa?

CONCLUSIONS Classical Hodgkin lymphoma (cHL) outcomes in people living with HIV (PLWH) in South Africa are substantially worse than those in HIV-negative patients. Prior and current tuberculosis (TB) infection are common amongst PLWH and cHL in South Africa. We set out to evaluate the effect of active TB disease on presenting characteristics and outcomes in newly diagnosed cHL patients receiving care in Johannesburg, South Africa. With approvals from the Human Research Ethics Committee of the University of the Witwatersrand and the Johns Hopkins Institutional Review Boards, we conducted a prospective, observational study of newly diagnosed patients with cHL ≥18 years at Chris Hani Baragwanath Academic and Netcare Olivedale Hospitals in Johannesburg, South Africa between March 2021 and April 2023. Participants' data include history, abstracted HIV status, CD4 count, HIV viral load at the time of cHL diagnosis, baseline laboratory data, staging work-up, and review of diagnostic pathology. TB diagnosis was based on routine clinical procedures. Pre-treatment whole blood was collected in cell stabilizing tubes and processed locally using a plasma cell-free DNA (cfDNA) protocol. cfDNA was then isolated in the USA with subsequent analysis of fragment length, cfDNA and gDNA concentrations, and EBV copy number. Among 43 patients, 28 (65%) were PLWH. Fifty-one percent were female, mean age was 41 years and 98% of patients were diagnosed with advanced stage disease and B-symptoms. Forty-seven percent had marrow involvement including 18/28 (64%) PLWH. Among PLWH, mean CD4 count was 180 and 61% of patients had viral load &amp;lt;50 copies at time of diagnosis. There was no difference in age, sex, stage, performance status or International Prognostic Index (IPI) by HIV serostatus. PLWH had higher plasma EBV copy number at presentation (3.6 vs. -0.2 median Log 10copies/mL, p=0.0123) and higher cfDNA (41.8 vs. 19.8 ng/mL), and lower overall survival at 1-year (57.1% vs. 86.7%, p=0.0489) compared to HIV-seronegative. Overall, 10 cHL patients were receiving treatment for active TB (23%); Most 9/10, were PLWH. Patients with TB and cHL were more likely to have bone marrow involvement (90% vs 33%; p=0.002) and significantly lower mean CD4 count (70.6 vs 232.2;p=0.009), hemoglobin (6.9 vs 9.6;p=0.01), platelet count (77.7 vs 363.5;p=0.0002) and albumin (22.7 vs 33.1; p=0.0004) at time of diagnosis compared to those without active TB. In univariate analysis, HIV serostatus, active TB infection, bone marrow involvement, lower mean platelet count, absolute lymphocyte count and albumin, IPI, baseline EBV and plasma cfDNA were all associated with increased mortality. Active TB infection was common amongst PLWH with newly diagnosed cHL in South Africa. Bone marrow involvement and traditional laboratory markers of poor prognosis including anemia and hypoalbuminemia were more common among patients with TB. The role that active TB and its treatment plays in the increased mortality for HIV(+) cHL patients warrants further investigation.

Allogeneic Stem Cell Transplant for High-Risk Transfusion Dependent Thalassemia [Tdt] - a Comparative Analysis of Flu/Bu/Cy/ATG Versus Flu/Thio/Treo Regimen

Background &amp; Significance: Allogeneic stem cell transplantation (allo-SCT) is the curative treatment for transfusion dependent thalassemia (TDT), until the gene therapy is readily accessible, which could revolutionize the treatment approach. 1 Later, Mathews et al. identified additional factors affecting outcomes, leading to the recognition of a specific very high-risk subgroup within Class III, referred to as Vellore high risk (HR) or Class IIIB. 2, 3 Following the identification of Class IIIB, treosulfan (Treo) was introduced as a treatment option due to its favorable low hepatic toxicity profile. 4, 5 Several studies have reported the use of Treo-based conditioning in the high-risk subset, showing treatment-related mortality (TRM) rates ranging from 7 to 21%. 6 - 8 Here, we present our (allo-SCT) experience for transfusion-dependent thalassemia (TDT) using the Flu/Bu/Cy/rabbit ATG or Flu/Thio/Treo as a conditioning regimen in a high risk cohort. Study design &amp; Methods: We did a retrospective analysis of all transfusion dependent thalassemia [TDT] patients who underwent allogeneic stem cell transplant [allo-SCT] with Flu/Bu/Cy/ATG or Flu/Thio/Treo as a conditioning regimen. TDT patients who have received conditioning other than this were excluded from the study. The objective of the study is the assess the rate of thalassemia free survival [TFS], thalassemia GVHD free survival [TGFS], overall survival [OS], graft rejection and non-relapse mortality [NRM]. Results: We included a total of 64 patients in our study. Forty-one patients in Flu/Bu/Cy/ATG group and 23 patients were in Flu/Thio/Treo group. The median age of the patients was 9 years (range: 8 -14) and 10 years (8 - 15) in Flu/Bu/Cy/ATG and Flu/Thio/Treo group respectively. Upon presentation, the distribution of patients among Class I, II, and III were 2(4.9%) v/s 1(4.4%), 27(65.8%) v/s 11(47.8%), and 12(29.3%) v/s 11(47.8%) respectively. The graft source was bone marrow in 38 (92.7%) patients all in Flu/Bu/Cy group, whereas 3 (7.3%) v/s 23(100%) in peripheral blood stem cells. The mean CD34 stem cell dose administered was 3.4 × 10^6/kg (range: 0.7 - 9.8) v/s 5 × 10^6/kg (1.65 - 6.1). Neutrophil and platelet engraftment occurred at a median of 17 days (range: 11 - 26) v/s 15.5 days (range: 12 - 20) and 18 days (11 - 47) v/s 15 (9 - 41) respectively. Table:1 Primary rejection was in 3 (7.3%) whereas 2 (4.8%) were secondary rejection in Flu/Bu/Cy group only. Mixed chimerism was observed in a higher percentage of patients in the Flu/Bu/Cy/ATG group 17 (41.5%) compared to the Flu/Thio/Treo group 4 (17.4%). Veno-occlusive disease was reported in 14 (34.1%) v/s 4 (17.4%) patients, with [6 (14.6%) v/s 0] cases being mild, [6 (14.6%) v/s 3 (13%)] cases moderate, and [2 (4.8%) v/s 1 (4.3%)] case severe. Acute and Chronic graft-versus-host disease occurred in patients [7 (17.1%) v/s 10 (43.5%)] and [1 (2.4%) v/s 7 (30.4)] patients respectively. Fortunately, there were no cases of treatment-related mortality in Flu/Bu/Cy/ATG whereas 3 (13.3%) TRM was observed in Flu/Thio/Treo group. The overall survival at a median follow-up of 25 months were 100% v/s 87% [CI: 64.8 - 95.6] was statistically significant (p=0.02). Thalassemia GVHD free survival at a median follow-up was highly significant with a p value of 0.024 {83.7% [CI: 66.9 - 92.5] v/s 55% [CI: 31.3 - 73.5] (p = 0.024)} in Flu/Bu/Cy and Flu/Thio/Treo group respectively. Fig:1 Conclusion: In conclusion, the study suggests that the Flu/Bu/Cy/ATG conditioning regimen resulted in better overall survival [OS] and thalassemia GVHD free survival [TGFS] compared to Flu/Thio/Treo regimen in a high-risk transfusion dependent thalassemia [TDT] patients undergoing allo-SCT. However, it is essential to consider the limitations of the study, such as its retrospective nature and the relatively small sample size, before making any definitive conclusion. Further research with large sample sizes and prospective study designs may be needed to confirm these finding.

1379. Evaluation of Cardiovascular Disease Risk among People Living with HIV in Lebanon

Abstract Background Since the introduction of antiretroviral therapy (ART), People Living with HIV (PLHIV) have become more prone to developing chronic illnesses, such as cardiovascular diseases (CVD), than to suffer from AIDS related conditions. The global burden of CVD associated with HIV has tripled over the last two decades, especially in low/middle income countries. Scarce data exist on the prevalence of CVD and CVD risk factors among PLHIV in the Middle East and North Africa (MENA) region. Therefore, we aim to examine the prevalence of CVD risk factors and calculate the CV risk in a cohort of PLHIV in Lebanon. Methods This is a retrospective chart review conducted between 2018 and 2023 at an HIV clinic in a tertiary care center in Lebanon. The study population includes adult subjects receiving ART and with at least 6 months of undetectable viral loads. Data included demographics, laboratory values, HIV-specific data, and review of traditional CVD risk factors. Atherosclerotic Cardiovascular Disease (ASCVD) risk score was calculated using the American College of Cardiology Risk Estimator Plus, to estimate patients’ 10-year risk for developing ASCVD. Descriptive statistics were implemented to summarize the cohort’s characteristics and the prevalence of CVD risk factors. Results A total of 85 HIV-infected subjects were included in the analysis. Subjects’ characteristics are summarized in table 1. The majority were males (89.4%), and the mean age was 43.31±12.28 years. The prevalence of smoking, alcohol consumption, and illicit drug use was 70.6%, 54.1%, and 20%, respectively. The mean BMI was 26.1±5 kg/m². Additionally, 20.2 % of subjects had dyslipidemia, 6% had diabetes, and 15.5% had hypertension. The mean current CD4 cell count was 687.83 ±356 cells/ml. The cohort had a mean ASCVD risk score of 8.8%, higher than that of age-matched population (mean ASCVD risk score of US firefighters aged 40-44 years is 1.8%). Conclusion This study shows the prevalence of traditional CVD risk factors among PLHIV receiving effective ART in Lebanon. The cohort mean ASCVD risk score indicates an intermediate risk for developing CVD over the next decade. in the MENA region, we need larger studies to inform on the prevalence of CVD among PLHIV, and to develop guidelines to mitigate the risk. Disclosures All Authors: No reported disclosures

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

Tolerability and effectiveness of albuvirtide combined with dolutegravir for hospitalized people living with HIV/AIDS.

Treatment options for hospitalized people living with HIV/AIDS (PLWHA) with opportunistic infections and comorbidities are limited in China. Albuvirtide (ABT), a new peptide drug, is a long-acting HIV fusion inhibitor with limited drug-drug interactions and fast onset time. This single-center, retrospective cohort study investigated the effectiveness and safety of ABT plus dolutegravir (DTG) therapy in a real-world setting. We performed a chart review on the electronic patient records for hospitalized PLWHA using ABT plus DTG between April and December 2020. The clinical outcomes were retrospectively analyzed. Among 151 PLWHA (mean age 47.6 ± 15.9 years), 140 (93%) had at least 1 episode of bacterial and/or fungal infections and 64 (42%) had other comorbidities including syphilis, hepatitis B, and/or hypertension. ABT plus DTG was given to 87 treatment-naïve (TN) and 64 treatment-experienced (TE) PLWHA. Regardless of treatment history, mean HIV-1 RNA levels significantly decreased from 4.32 log10copies/mL to 2.24 log10copies/mL, 2.10 log10copies/mL and 1.89 log10copies/mL after 2, 4 and 8 weeks of treatment, respectively (P < .0001). Compared with baseline mean CD4 + T-cell counts of 122.72 cells/μL, it increased to 207.87 cells/μL (P = .0067) and 218.69 cells/μL (P = .0812) after 4 and 8 weeks of treatment. Except for limited laboratory abnormalities such as hyperuricemia, increased creatinine level, and hyperglycemia observed after treatment, no other clinical adverse events were considered related to ABT plus DTG. Data suggests that ABT plus DTG is safe and effective for critically-ill hospitalized PLWHA. In view of the rapid viral load suppression and restoration of CD4 + count within 8 weeks of treatment, its clinical application warrants further investigation.

Hematological Profile Of Hiv/Aids Individuals With Opportunistic Respiratory Mycoses And Immune Status: A Cross Sectional Study In Uyo Nigeria

Hematological abnormalities are strong predictors of morbidity and mortality among HIV infection. This study was aimed to determine hematological indices, abnormalities and the immune status of HIV/AIDS subjects having opportunistic pulmonary mycoses in Uyo, Nigeria. A cross sectional study was adopted using 230 subjects with pulmonary symptoms attending the Anti-retroviral clinics in University of Uyo Teaching Hospital and Saint Luke’s Hosipital, Anua, Akwa Ibom State, Nigeria. The hematological parameters and CD4 counts was determined using blood and sputum was used for mycological examinations. Data was analysed using statistical package for the Social Sciences (SPSS) and was significant at p = 0.05. HIV subjects were more prevalent in female 98(68.89%) than male 56(31.11%). The most commonest fungi was Aspergillus niger (44.76%) and the least was Cryptococcus species (9.00%). The common hematological abnormality was anaemia with 86(86.9%), lymphopenia 33(33.3%) and thrombocytopenia 3(3.0%) among HIV/AIDS subjects with mycoses. The mean CD4 counts was 396.5±31.61 cells/µl (HIV) and 981.7±17.51 cells/µl (control individual). The CD4 counts below 200 cells/μl was observed in 19.4%(35) of AIDS patients. HIV/AIDS subjects with mycoses may develop hematological abnormalities such as anaemia, neutropenia and leucopenia due to low immune status.&#x0D; &#x0D;

Abstract 15795: Outcomes After Cardiac Implantable Electronic Devices Among People With and Without HIV

Introduction: The long-term outcomes of cardiovascular implantable electronic devices (CIED) in people with HIV (PWH) is unknown despite higher rates of sudden cardiac death and heart failure in HIV. Objective To compare outcomes between PWH and the general population who have CIEDs. Methods: Retrospective cohort study of patients receiving care at two academic hospitals in San Francisco who got CIEDs (pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy ± defibrillator) from 2000-2018. Since CIEDs were rarer in PWH than in those without HIV, we also did a nested case-control study. Case and controls were matched by age, sex, and CIED type. Death data was obtained from the National Death Index. Results: We identified 3,268 patients who got CIEDs; 1% was PWH. In PWH at CIED implantation, mean HIV duration was 19 years, mean CD4 count was 449 cells/uL, 78% had undetectable viral loads, and all were on antiretroviral therapy. PWH were younger than the control (mean age 62 vs. 69 years, p &lt; 0.01). Both groups had similar rates of hypertension, diabetes, CAD, smoking, and drug use, but more PWH had hepatitis C than the control (25% vs. 3.0%, p &lt; 0.01). Both groups had a similar number of pacemakers (56% vs. 58%, p = 0.86) and defibrillators (44% vs. 39%, p = 0.56). Post-procedure, five (16%) PWH had lead failure or infection while nine (14%) controls had lead failure. One PWH with site infection reported IV drug use. Post CIED placement, median survival in years was 5.3 in PWH vs. 6.4 in controls. No strong association between HIV status and survival (HR 1.9 [95% CI 0.7 to 5.0]) was seen ( F igure ). Conclusions: To our knowledge, this is the first study looking at survival post CIED between PWH and the general population. Our findings suggest that the number of PWH getting CIEDs remains low despite no definitive evidence of procedural complications; and that PWH have similar survival to those without HIV. More studies exploring barriers to CIED placement in PWH are needed.