scholarly journals 72. Massive Weight Gain in People with HIV (PWH) Starting Initial Antiretroviral Therapy (ART): Risk Factors and Predictive Ability of Early Weight Gain

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S47-S48
Author(s):  
Tanit Phupitakphol ◽  
Dean McEwen ◽  
Kellie Hawkins ◽  
Edward Gardner

Abstract Background Using a clinic cohort of ART naïve PWH, we sought to understand factors associated with massive weight gain as well as to assess if early weight gain could help predict massive weight gain at two years. Methods This was a retrospective cohort study of PWH from a large, urban clinic initiating first ART from January 2005 through March 2019, who had 21 – 27 months follow-up without ART changes, and were suppressed (HIV-RNA < 200 cps/ml) during that time. We defined massive weight gain as the top 20% of weight gainers at two years measured by percent (%) gain compared to baseline. Using bivariate and multivariate logistic regression (including factors in bivariate analysis with p< 0.20), we assessed the association of demographics, ART regimen, baseline CD4 count, HIV viral load, and body mass index (BMI) with weight gain at 2 years. We also assessed early weight gain (between 4 and 12 wks) and its association with massive weight gain at two years. Results Of 266 PWH included (table1), the median age was 36 years (IQR 29 - 45), 9% were women, 14% black, and 43% Latino. Overall, median % weight gain at 2 years was 4% (-1.1 – 11.6) In bivariate analyses, baseline factors significantly associated with massive weight gain included lower CD4 count, higher viral load, and lower baseline BMI. In multivariate analysis the odds of having massive weight gain were higher with lower CD4 count, adjusted odds ratio (aOR) 0.8 (95% CI 0.6 – 0.9) per 100 cells/ul increase and higher viral load, aOR 2.6 (95% CI 1.4 – 4.6) per 1 log increase. Early weights were available for 217 individuals at a median of 56 days (IQR 44 – 63) after ART initiation. Early weight gain correlated with % weight gain at 2 years (R=0.58). Individuals with ≤ 3% early weight gain represented 66% of the population and had a 10% risk (14 of 144) of having massive weight gain at 2 years. In contrast, 43 individuals had > 5% early weight gain and their risk of massive weight gain at 2 years was 56% (24 of 43). Conclusion In this real-world dataset, drug class or specific NRTI use was not associated with massive weight gain which was primarily dependent on baseline CD4 count and HIV viral load. There was a moderate correlation between early weight gain and massive weight gain at 2 years which can help with patient counseling and interventions aimed at slowing weight gain in this population. Disclosures All Authors: No reported disclosures

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1564-1564
Author(s):  
Stefan K Barta ◽  
Xiaonan Xue ◽  
Dan Wang ◽  
Jeannette Y Lee ◽  
Lawrence D. Kaplan ◽  
...  

Abstract Abstract 1564 INTRODUCTION: The International Prognostic Index (IPI) and the age-adjusted IPI (aaIPI) are commonly used to predict outcomes in immunocompetent patients with aggressive B-cell Non-Hodgkin Lymphomas (NHL). Although the IPI has also been validated for AIDS-related lymphomas (ARL), HIV-infection is an important competing risk that has not been adequately evaluated as a factor contributing to prognosis in the context of contemporary rituximab-containing chemoimmunotherapy. Here, we assessed whether HIV-specific factors in addition to the IPI provided more accurate prediction of clinical outcomes than IPI alone. METHODS: We obtained patient-level data for 487 patients from 8 prospective phase 2 or 3 clinical trials including patients with HIV-associated aggressive B-cell NHL receiving initial therapy with rituximab containing chemoimmunotherapy identified by systematic literature review, and randomly divided the population in a training (N=244) and validation set (N=243). We defined an HIV-score by combining individual HIV risk-factors: (1) baseline CD4 count (cells/ul): <50 =3, 50–199=2, 200–499=1, 500 or more =0; (2) HIV viral load (copies/ml): <400=0; 400-9, 999=1,10,000 or more =2; (3) prior history of AIDS=1, thereby yielding an HIV-score that could range from 0–6. We examined the association of HIV-score in addition to patient-, and lymphoma-specific factors with overall survival (OS) using a Cox-PH-model in the training and validation set independently by comparing 4 different multivariate models by a LR-chi2 test: model 1 (included age, sex, & histology), model 2 (model 1 + aaIPI), model 3 (model 2 + number of involved extranodal disease sites [ENS]) and model 4 (model 3 + HIV-score). Next, we defined a new score (ARL-IPI) by assigning appropriate weights to each significant predictor depending on the strength of association in the multivariate model in the training set: 2 for aaIPI score (0,1,2 or 3); 1 for ENS: no ENS=0, 1 ENS=1, 2 ENS=2, 3 or more ENS=3; and 1 for HIV-score. We examined the difference in OS for 3 risk groups: low (LR), intermediate (IR) and high risk (HR) based on the ARL-IPI in the validation set. We compared the discrimination power of the ARL-IPI with the aaIPI by comparing the difference in OS across the 3 groups defined by each score. RESULTS: 487 patients were included in the analysis with a median follow-up of 2.3 years (0.1–12.1). There were no significant differences in patient characteristics between training and validation set. Considering the entire population, 77% were male, median age was 42 years (20–74), median CD4 count 174 cells/ul (0–2,457), and median HIV viral load 23,802 copies/ml (0–6×106). The histologies included DLBCL (69%), BL or BLL (29%), and other histologies (3%). All patients received rituximab plus either CHOP (49%), EPOCH (19%), CDE (15%), or other multi-agent intensive regimens (16%). In the training set, only aaIPI, ENS and HIV-score were significantly associated with OS, but not age, sex, extranodal sites as defined in the IPI (<2 or 2 or more), or histology. When tested in the validation set, the addition of the HIV-score (model 4; ARL-IPI) showed a significant improvement in predictive power for OS over all other models (p-value=0.009). When we compared the risk groups defined by the aaIPI (LR: <1, IR: 1–2, HR: 3) versus the ARL-IPI (aaIPI + ENS + HIV-score: LR: <7, IR: 7–10, HR: >10) in the validation set, the ARL-IPI was able to more clearly define prognosis based on the 3 risk groups in regards to OS (p=0.013; Table 1), which was confirmed by KM survival analysis (Figure 1). The ARL-IPI also compared favorably to a score defined by aaIPI and ENS (LR: <4, IR: 4–6, HR: >6), demonstrating the significant impact of the HIV-score on prediction power. In our dataset, the ARL-IPI could not significantly improve prediction power for CR rate or PFS compared with the two other scores. CONCLUSION: By combining HIV-associated factors with known prognostic patient- and lymphoma factors into a composite prognostic risk score (ARL-IPI) we were able to more accurately define prognosis for patients with ARL treated with chemoimmunotherapy. Disclosures: No relevant conflicts of interest to declare.


2018 ◽  
Vol 36 (5_suppl) ◽  
pp. 63-63 ◽  
Author(s):  
Natalie Galanina ◽  
Aaron Goodman ◽  
Philip R Cohen ◽  
Razelle Kurzrock

63 Title: HIV-Positive Kaposi Sarcoma and Immune Checkpoint Blockade Background: Kaposi sarcoma (KS) is an incurable, virally mediated malignancy arising in HIV-positive patients. We report the first observations on the safety and efficacy of checkpoint blockade in these patients. Methods: We identified eight evaluable patients with HIV-related Kaposi sarcoma who received ≥1 dose of checkpoint blockade. Data on demographics, treatment efficacy, and the effects on immune function (HIV and HHV8 viral load, CD4 count) and toxicity were curated. Results: Median age was 45.5 years (range, 38-63); all men; median, one prior regimen; all were treated with nivolumab 3mg/kg IV days 1 and 14 of each 28-day cycle. PD-L1 expression was assessed retrospectively and was low in 3 out of 4 patients with available data. All patients were receiving anti-retroviral therapy. The majority (75%) had preserved CD4 count and undetectable HIV viral load (Table). The response rate (RR) was 62.5% (5 of 8 patients) with 1 complete remission and 4 partial remissions; the remaining 3 patients have stable disease. Median follow up to date is 3.5 months and no patients has discontinued therapy. No grade >2 toxicities were noted. Most common side effects included fatigue, gastrointestinal discomfort, pruritis, and onycholysis. There was an overall increase in CD4 counts. Conclusions: Preliminary observations suggest that checkpoint blockade with nivolumab has low toxicity and high anti-tumor activity in KS. Additionally, patients experienced improvement in CD4 count. [Table: see text]


2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Jordan E. Cates ◽  
Daniel Westreich ◽  
Andrew Edmonds ◽  
Rodney L. Wright ◽  
Howard Minkoff ◽  
...  

Background. To evaluate the effects of HIV viral load, measured cross-sectionally and cumulatively, on the risk of miscarriage or stillbirth (pregnancy loss) among HIV-infected women enrolled in the Women’s Interagency HIV Study between 1994 and 2013.Methods. We assessed three exposures: most recent viral load measure before the pregnancy ended, log10copy-years viremia from initiation of antiretroviral therapy (ART) to conception, and log10copy-years viremia in the two years before conception.Results. The risk of pregnancy loss for those with log10viral load >4.00 before pregnancy ended was 1.59 (95% confidence interval (CI): 0.99, 2.56) times as high as the risk for women whose log10viral load was ≤1.60. There was not a meaningful impact of log10copy-years viremia since ART or log10copy-years viremia in the two years before conception on pregnancy loss (adjusted risk ratios (aRRs): 0.80 (95% CI: 0.69, 0.92) and 1.00 (95% CI: 0.90, 1.11), resp.).Conclusions. Cumulative viral load burden does not appear to be an informative measure for pregnancy loss risk, but the extent of HIV replication during pregnancy, as represented by plasma HIV RNA viral load, predicted loss versus live birth in this ethnically diverse cohort of HIV-infected US women.


PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0255834
Author(s):  
Bogusz Jan Aksak-Wąs ◽  
Miłosz Parczewski ◽  
Anna Urbańska ◽  
Małgorzata Hackiewicz ◽  
Justyna D. Kowalska

Background The life expectancy of people living with HIV (PLWH) remains shorter than that of the general population, despite significant improvement in the recent years. Mortality in HIV-infected individuals may be associated with a higher viral load at of diagnosis, a lower CD4 count, or clinical variables such as sex or route of transmission. This article investigated the role of the HLA-B*5701 varian on mortality among PLWH. Methods Material for the analysis consist of the data of 2,393 patients for whom the HLA-B*57 variant was known. Those patients were followed under the care of the Infectious Diseases Hospital in Warsaw (n = 1555) and the Clinic of Acquired Immunodeficiency of the Pomeranian Medical University in Szczecin (n = 838). Factors such as age, gender, date of HIV diagnosis, route of transmission, date of death, baseline HIV viral load and baseline CD4 counts, were collected, and end-point cross-sectional analyses were marked at 60, 120, 180 and 240 month of observation. Results HLA-B*5701 allele was found in 133 (5.5%) analyzed cases. Median age was notably higher for HLA-B*5701 positive patients [32.7 (28.3–41.3) vs. 31.6 (26.8–38.3)years p = 0.02]. HLA-B*5701 was associated with lower baseline viral load [4.21 (3.5–4.8) vs. 4.79 (4.2–5.3)log copies/ml p<0.001] and higher CD4count [448 (294.5–662) vs. 352 (176–514) cells/μl p<0.001]. There were no association between HLA-B*5701 and survival for any given end-point. Higher mortality was associated to male gender, intravenous drug users, lower CD4 count at baseline and higher baseline viral load. Conclusions In our study, the presence of HLA-B*5701 allel was not associated with mortality rate of HIV infected patients, irrespective of being associated with both higher baseline CD4 + cell count and lower baseline HIV viral load.


2019 ◽  
Author(s):  
Dereje Bayissa Demissie ◽  
Gizachew Abdissa Bulto ◽  
Wagi Tosisa Mekuria ◽  
Fikru Negassa Dufera

Abstract Abstract Background: Antiretroviral therapy (ART) is effective for elimination of mother-to-child transmission (eMTCT) of human immunodeficiency virus (HIV) infection, reducing infant mortality and ensuring maternal virologic suppression. While pregnant women require lifelong ART immediately they test HIV positive (“test and treat”) under Option B+ programs, eMTCT programs face challenges and information on the relationship between the time to ART initiation following HIV testing and treatment outcomes is limited in Ethiopia Methods: A quantitative prospective cohort design was employed to conduct the study. Five randomly selected Hospitals providing Option B+ services with routine viral load assessment by Oromia regional Laboratory (ORL) from January 2016 to January 2017 was randomly selected. Bivariate and multivariable analyses were conducted to determine factors affecting the time to ART initiation following an HIV test and logistic regression used to determine the correlation between time and treatment outcomes. Results: The study results produced and evidence of a mean VL (copies/ml) of 197.27 copies/ml. Respondents that were on ART for a shorter period ≤37 months had the least proportion of women 31% were suppressed with VL<1000 copies/ml compared to those on ART for >38 months (58.7%) were suppressed. The median (IQR) CD4 count change or difference among women that had initial and last CD4 was 581 cells/μl and mean of current CD4 count 629.17ceels/ml3 and more than 85.3% had increase CD4 count. Therefore, in this study identified that factors associated with viral load response were poor /fair adherence missing doses in the past month, missing appointments, baseline CD4 and maternal months on ART were statistically significant among HIV positive pregnant women that initiated lifelong ART on option B+ in Ethiopia. Conclusion: The study results demonstrated that HIV positive pregnant women Study results indicate that majority of the respondents 89.7% were suppressed of which 80.3% were undetectable (VL= 0 copies /ml3 and 85.3% had increased CD4 count and 10.3% were not suppressed (VL >1000 copies/ml). Therefore, strategies aimed at improving adherence among women on option B+ are to ensure that these women achieve adequate immunological outcomes. Keywords: ART Initiation Pregnant Women Option B +, Viral Load, CD4 Count


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S514-S515
Author(s):  
Ruth Serrano Pinilla ◽  
Anthony Hartzler

Abstract Background Using effective antiretroviral therapy to consistently suppress plasma HIV RNA levels to &lt; 200 copies/mL is known to improve morbidity and mortality at all stages of HIV infection and prevent transmission to sexual partners. Logistical challenges such as transporting, processing, and storing samples may threaten the accuracy of the test results. Plasma Preparation tubes (PPT) or Ethylene Diamine Tetra Acetic Acid (EDTA) tubes can be used for this test. PPT tubes contain an inert gel that migrates during centrifugation, forming a barrier between the plasma and cellular elements. Adequate separation of cellular elements may not always occur, and this can result in falsely elevated HIV Viral load (VL) due to measurement of integrated intracellular virus. It is therefore routine practice to centrifuge samples twice when PPT tubes are used. This is not necessary with EDTA tubes. In addition, there are reports that HIV RNA levels may be higher with PPT tubes are used, compared to EDTA tubes. Methods This is a quality improvement project that reviews a series of falsely elevated HIV VL in a group of patients who reported adherence and had been previously virologically suppressed. Results A total of 20 unexpectedly elevated HIV VL were identified from January to March of 2020 after introduction of a new phlebotomist in our clinic. VL ranged from 200-2530 copies/ml. Most patients (18/20) had history of virologic suppression and reported adherence. We standardized our process by using only PPT tubes and centrifuging samples twice prior to processing. Our nurses reported visible residual cellular elements in some of the plasma specimens in the tubes even after appropriate centrifugation. We continued to see suspected erroneous results. We repeated the test in EDTA tubes. 16/19 had HIV VL &lt; 20, the remainder ranged from 27-41 copies/ml. We then implemented the use of EDTA tubes in all samples. No further cases of falsely elevated VL have been seen since the change. Table 1 Conclusion We describe potential steps that can interfere in the accuracy of HIV VL results. Detailed review of past history and patient’s adherence to treatment is essential to identify systemic problems that may lead to errors. Close communication with staff and laboratory provider will be key to overcome such challenges. Disclosures All Authors: No reported disclosures


2020 ◽  
Vol 154 (Supplement_1) ◽  
pp. S66-S67
Author(s):  
A Monsrud ◽  
V Avadhani ◽  
M Mosunjac ◽  
U Krishnamurti

Abstract Introduction/Objective Upregulation of programmed death-ligand 1 (PD-L1), an immunoregulatory protein is associated with adverse outcome in several malignancies. Very few studies have evaluated PD-L1 expression in anal squamous cell carcinoma. This study aims to correlate PD-L1 expression with clinicopathologic factors and clinical outcomes. Methods After IRB approval, formalin-fixed, paraffin embedded sections of 58 cases of anal invasive squamous cell carcinoma from 2010–2018 were immunostained for PD-L1 (Dako 22C3 monoclonal antibody). Of these, 51 cases could be evaluated for PD-L1 expression. Greater than 1% of tumor cells with partial or complete membrane staining was interpreted as PD-L1 positive (PD-L1 +). PD-L1 expression was correlated with age, sex, stage, HIV status, HIV viral load, CD4 count, disease progression, and cancer specific survival. Kaplan-Meier curves for overall survival (OS) were plotted and compared using the log rank test. Cox regression analysis was performed to identify significant prognostic factors (Two-tailed p&lt; 0.05 was considered statistically significant). Results Of the 51 cases evaluated, PD-L1 was positive in 18/51 (35%) and negative in 33/51 (65%) cases. The median cancer specific survival (MCSS) was lower in PD-L1 positive cases (22 months) compared with PD-L1 negative cases (48 months), p=0.008. The number of cancer specific deaths was higher in the PD-L1 + group (50% vs. 30%), but not statistically significant (p= 0.23). Other factors that were not significantly different between the two groups were age, sex, stage, HIV status, HIV viral load, and number of patients with cancer progression. Patients with positive PD-L1 had worse OS (5yr OS: 41% for PD-L1 positive vs 64% for PD-L1 negative; p=0.02). On multivariate analysis, PD-L1 positive status remained statistically significant for worse OS, HR = 6.5 (95% CI 1.2–33.9), p=0.027. Conclusion The median cancer specific survival and 5-yr OS is significantly lower in the PD-L1 positive group. PD-L1 positive status is associated with a worse prognosis independent of stage, HIV status, HIV viral load, and CD4 count. The study highlights the potential of PD-L1 targeted therapy in better management of anal squamous cell carcinoma.


Author(s):  
RH. Sousa ◽  
LL. Souza ◽  
PT. Guedes ◽  
AC. Prado-Ribeiro ◽  
L. Rodrigues-Oliveira ◽  
...  

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