scholarly journals Persistent Low-level Viremia While on Antiretroviral Therapy Is an Independent Risk Factor for Virologic Failure

2019 ◽  
Vol 69 (12) ◽  
pp. 2145-2152 ◽  
Author(s):  
Christie Joya ◽  
Seung Hyun Won ◽  
Christina Schofield ◽  
Tahaniyat Lalani ◽  
Ryan C Maves ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Proportional Hazards ◽  
Limit Of Detection ◽  
Virologic Failure ◽  
Transcriptase Inhibitor ◽  
Cox Proportional Hazards ◽  
The Body ◽  
Strand Transfer ◽  
Low Level ◽  
Art Initiation

Abstract Background Whether persistent low-level viremia (pLLV) predicts virologic failure (VF) is unclear. We used data from the US Military HIV Natural History Study (NHS), to examine the association of pLLV and VF. Methods NHS subjects who initiated combination antiretroviral therapy (ART) after 1996 were included if they had 2 or more VLs measured with a lower limit of detection of ≤50 copies/mL. VF was defined as a confirmed VL ≥200 copies/mL or any VL >1000 copies/mL. Participants were categorized into mutually exclusive virologic categories: intermittent LLV (iLLV) (VL of 50–199 copies/mL on <25% of measurements), pLLV (VL of 50–199 copies/mL on ≥25% of measurements), high-level viremia (hLV) (VL of 200–1000 copies/mL), and continuous suppression (all VL <50 copies/mL). Cox proportional hazards models were used to evaluate the association between VF and LLV; hazard ratios and 95% confidence interval (CI) are presented. Results Two thousand six subjects (median age 29.2 years, 93% male, 41% black) were included; 383 subjects (19%) experienced VF. After adjusting for demographics, VL, CD4 counts, ART regimen, prior use of mono or dual antiretrovirals, and time to ART start, pLLV (3.46 [2.42–4.93]), and hLV (2.29 [1.78–2.96]) were associated with VF. Other factors associated with VF include black ethnicity (1.33 [1.06–1.68]) and antiretroviral use prior to ART (1.79 [1.34–2.38]). Older age at ART initiation (0.71 [0.61–0.82]) and non-nucleoside reverse transcriptase inhibitor (0.68 [0.51–0.90]) or integrase strand transfer inhibitor use (0.26 [0.13–0.53]) were protective. Conclusion Our data add to the body of evidence that suggests persistent LLV is associated with deleterious virologic consequences.

scholarly journals Trends and factors associated with modification or discontinuation of the initial antiretroviral regimen during the first year of treatment in the Turkish HIV-TR Cohort, 2011–2017

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Volkan Korten ◽  
◽  
Deniz Gökengin ◽  
Gülhan Eren ◽  
Taner Yıldırmak ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Virologic Failure ◽  
Risk Function ◽  
Transcriptase Inhibitor ◽  
Cox Proportional Hazards ◽  
Antiretroviral Drugs ◽  
Competing Risk ◽  
First Year ◽  
Strand Transfer ◽  
Factors Associated

Abstract Background There is limited evidence on the modification or stopping of antiretroviral therapy (ART) regimens, including novel antiretroviral drugs. The aim of this study was to evaluate the discontinuation of first ART before and after the availability of better tolerated and less complex regimens by comparing the frequency, reasons and associations with patient characteristics. Methods A total of 3019 ART-naive patients registered in the HIV-TR cohort who started ART between Jan 2011 and Feb 2017 were studied. Only the first modification within the first year of treatment for each patient was included in the analyses. Reasons were classified as listed in the coded form in the web-based database. Cumulative incidences were analysed using competing risk function and factors associated with discontinuation of the ART regimen were examined using Cox proportional hazards models and Fine-Gray competing risk regression models. Results The initial ART regimen was discontinued in 351 out of 3019 eligible patients (11.6%) within the first year. The main reason for discontinuation was intolerance/toxicity (45.0%), followed by treatment simplification (9.7%), patient willingness (7.4%), poor compliance (7.1%), prevention of future toxicities (6.0%), virologic failure (5.4%), and provider preference (5.4%). Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based (aHR = 4.4, [95% CI 3.0–6.4]; p < 0.0001) or protease inhibitor (PI)-based regimens (aHR = 4.3, [95% CI 3.1–6.0]; p < 0.0001) relative to integrase strand transfer inhibitor (InSTI)-based regimens were significantly associated with ART discontinuation. ART initiated at a later period (2015-Feb 2017) (aHR = 0.6, [95% CI 0.4–0.9]; p < 0.0001) was less likely to be discontinued. A lower rate of treatment discontinuation for intolerance/toxicity was observed with InSTI-based regimens (2.0%) than with NNRTI- (6.6%) and PI-based regimens (7.5%) (p < 0.001). The percentage of patients who achieved HIV RNA < 200 copies/mL within 12 months of ART initiation was 91% in the ART discontinued group vs. 94% in the continued group (p > 0.05). Conclusion ART discontinuation due to intolerance/toxicity and virologic failure decreased over time. InSTI-based regimens were less likely to be discontinued than PI- and NNRTI-based ART.

scholarly journals Antiretroviral drug class and anaemia risk in the current treatment era among people living with HIV in the USA: a clinical cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e031487
Author(s):  
Barbara N Harding ◽  
Bridget M Whitney ◽  
Robin M Nance ◽  
Heidi M Crane ◽  
Greer Burkholder ◽  
...  
Keyword(s):  
Cohort Study ◽  
Proportional Hazards ◽  
Transcriptase Inhibitor ◽  
Severe Anaemia ◽  
Cox Proportional Hazards ◽  
People Living With Hiv ◽  
Strand Transfer ◽  
Clinical Cohort ◽  
Increased Risk ◽  
Living With Hiv

ObjectiveAnaemia is common among people living with HIV (PLWH) and has been associated with certain, often older, antiretroviral medications. Information on current antiretroviral therapy (ART) and anaemia is limited. The objective was to compare the associations between anaemia incidence or haemoglobin change with core ART classes in the current ART era.DesignRetrospective cohort study.SettingUSA-based prospective clinical cohort of PLWH aged 18 and above receiving care at eight sites between January 2010 and March 2018.Participants16 505 PLWH were included in this study.Main outcome measuresAnaemia risk and haemoglobin change were estimated among PLWH for person-time on a protease inhibitor (PI) or an integrase strand transfer inhibitor (INSTI)-based regimen, relative to a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based reference. We also examined PLWH on regimens containing multiple core classes. Cox proportional hazards regression analyses were conducted to measure the associations between time-updated ART classes and incident anaemia or severe anaemia. Linear mixed effects models were used to examine the relationships between ART classes and haemoglobin change.ResultsDuring a median of 4.9 years of follow-up, 1040 developed anaemia and 488 developed severe anaemia. Compared with NNRTI use, INSTI-based regimens were associated with an increased risk of anaemia (adjusted HR (aHR) 1.26, 95% CI 1.00 to 1.58) and severe anaemia (aHR 1.51, 95% CI 1.07 to 2.11) and a decrease in haemoglobin level. Time on multiple core classes was also associated with increased anaemia risk (aHR 1.39, 95% CI 1.13 to 1.70), while no associations were found for PI use.ConclusionThese findings suggest INSTI use may increase the risk of anaemia. If confirmed, screening for anaemia development in users of INSTIs may be beneficial. Further research into the underlying mechanisms is warranted.

scholarly journals Greater Weight Gain in Treatment-naive Persons Starting Dolutegravir-based Antiretroviral Therapy

2019 ◽  
Vol 70 (7) ◽  
pp. 1267-1274 ◽  
Author(s):  
Kassem Bourgi ◽  
Peter F Rebeiro ◽  
Megan Turner ◽  
Jessica L Castilho ◽  
Todd Hulgan ◽  
...  
Keyword(s):  
Weight Gain ◽  
Antiretroviral Therapy ◽  
Transcriptase Inhibitor ◽  
Virologic Suppression ◽  
Strand Transfer ◽  
Care Clinic ◽  
Art Initiation ◽  
Treatment Naïve ◽  
Transfer Inhibitor ◽  
Restricted Cubic Splines

Abstract Background Recent studies have reported weight gain in virologically suppressed persons living with human immunodeficiency virus (PLWH) switched from older antiretroviral therapy (ART) to newer integrase strand transfer inhibitor (INSTI)–based regimens. In this study, we investigated whether weight gain differs among treatment-naive PLWH starting INSTI-based regimens compared to other ART regimens. Methods Adult, treatment-naive PLWH in the Vanderbilt Comprehensive Care Clinic cohort initiating INSTI-, protease inhibitor (PI)–, and nonnucleoside reverse transcriptase inhibitor (NNRTI)–based ART between January 2007 and June 2016 were included. We used multivariable linear mixed-effects models to generate marginal predictions of weights over time, adjusting for baseline clinical and demographic characteristics. We used restricted cubic splines to relax linearity assumptions and bootstrapping to generate 95% confidence intervals. Results Among 1152 ART-naive PLWH, 351 initiated INSTI-based regimens (135 dolutegravir, 153 elvitegravir, and 63 raltegravir), 86% were male, and 49% were white. At ART initiation, median age was 35 years, body mass index was 25.1 kg/m2, and CD4+ T-cell count was 318 cells/μL. Virologic suppression at 18 months was similar between different ART classes. At all examined study time points, weight gain was highest among PLWH starting dolutegravir. At 18 months, PLWH on dolutegravir gained 6.0 kg, compared to 2.6 kg for NNRTIs (P &lt; .05), and 0.5 kg for elvitegravir (P &lt; .05). PLWH starting dolutegravir also gained more weight at 18 months compared to raltegravir (3.4 kg) and PIs (4.1 kg), though these differences were not statistically significant. Conclusions Treatment-naive PLWH starting dolutegravir-based regimens gained significantly more weight at 18 months than those starting NNRTI-based and elvitegravir-based regimens.

scholarly journals Low-Level Viremia Predicts Virological Failure in HIV-Infected Omani Patients Receiving Antiretroviral Therapy

2020 ◽  
Vol 19 ◽  
pp. 232595822097981
Author(s):  
Zied Gaifer ◽  
Mohamed-Rachid Boulassel
Keyword(s):  
Antiretroviral Therapy ◽  
Virological Failure ◽  
Proportional Hazards ◽  
Undetectable Viral Load ◽  
Incidence Rates ◽  
Cox Proportional Hazards ◽  
Hiv Patients ◽  
Low Level ◽  
Hiv Rna ◽  
Increased Risk

Background: The implication and clinical significance of low-level viremia (LLV) in HIV patients are still not clear. This study aimed to characterize the clinical outcomes and to evaluate whether LLV could predict future virological failure in a well-defined cohort of HIV-infected Omani patients attending a large HIV clinic. Methods: Patients on regular antiretroviral therapy (ART) for at least 12 months, and had at least 2 HIV RNA measurements 1 year after starting ART, were prospectively enrolled in a cohort study. LLV was defined as plasma HIV RNA between 50-200 copies/mL that persists after at least 2 consecutive measurements after 12 months of ART. Multivariate Cox proportional hazards regression model was used to measure the association among virological failure, LLV and potential predictors. Results: After 12 months of starting ART, 60 patients (40%) had undetectable viral load (UVL) < 50 copies/mL, while 37 patients (24%) had LLV and 53 patients (35%) had primary virological failure > 200 copies/mL. The incidence rates of subsequent secondary virological failure for UVL and LLV groups, were 3 and 7 cases per 1000 patient-months, respectively. Compared to UVL group, LLV group had increased risk of subsequent secondary virological failure with hazard ratio of (4.437 [95% CI, 1.26-15.55]; p = 0.02). Age, duration of HIV infection, pretreatment HIV RNA level, pretreatment CD4+ cell count, and ART adherent were associated with subsequent secondary virological failure. Conclusion: Collectively, Omani HIV patients with LLV were at a higher risk for HIV virological failure, and should be monitored closely. Further studies are need to assess whether ART modification in LLV patients would lower the risk of virological failure.

scholarly journals Incidence and Risk Factors for Overweight and Obesity after Initiation of Antiretroviral Therapy in Dar es Salaam, Tanzania

2018 ◽  
Vol 17 ◽  
pp. 232595821875975 ◽  
Author(s):  
Alexander Kintu ◽  
Enju Liu ◽  
Ellen Hertzmark ◽  
Donna Spiegelman ◽  
Rachel Margaret Zack ◽  
...  
Keyword(s):  
Risk Factors ◽  
Antiretroviral Therapy ◽  
Proportional Hazards ◽  
Dar Es Salaam ◽  
Normal Weight ◽  
Cox Proportional Hazards ◽  
Overweight And Obesity ◽  
P Value ◽  
Art Initiation ◽  
Cox Proportional Hazards Models

Objective: To describe the incidence of and risk factors for overweight and obesity following antiretroviral therapy (ART) initiation. Methods: We used Cox proportional hazards models to investigate risk factors for incident overweight and obesity in 79 074 individuals aged 15 years or older who initiated ART in Dar es Salaam, Tanzania. Results: Twenty-five percent of the patients became overweight and 10% became obese. The incidence rate of obesity was 3.2 per 100 person-years (95% confidence interval [CI]: 3.1-3.3) in patients who were of normal weight before starting ART and 22.6 per 100 person-years (95% CI: 21.9-23.3) in those who were overweight. Lower CD4 count was associated with a higher risk of overweight and obesity ( P value for trend < .0001). Conclusion: There is a high burden of overweight and obesity after starting ART, leading to proportions of these 2 conditions that are similar to those in the general population.

scholarly journals Impact of long-term antiretroviral therapy on gut and oral microbiotas in HIV-1-infected patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mayumi Imahashi ◽  
Hirotaka Ode ◽  
Ayumi Kobayashi ◽  
Michiko Nemoto ◽  
Masakazu Matsuda ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Reverse Transcriptase ◽  
Transcriptase Inhibitor ◽  
Strand Transfer ◽  
Intestinal Dysbiosis ◽  
Α Diversity ◽  
Reverse Transcriptase Inhibitor ◽  
Hiv 1 ◽  
Over Time

AbstractIn HIV-1-infected patients, antiretroviral therapy (ART) is a key factor that may impact commensal microbiota and cause the emergence of side effects. However, it is not fully understood how long-term ART regimens have diverse impacts on the microbial compositions over time. Here, we performed 16S ribosomal RNA gene sequencing of the fecal and salivary microbiomes in patients under different long-term ART. We found that ART, especially conventional nucleotide/nucleoside reverse transcriptase inhibitor (NRTI)-based ART, has remarkable impacts on fecal microbial diversity: decreased α-diversity and increased ß-diversity over time. In contrast, dynamic diversity changes in the salivary microbiome were not observed. Comparative analysis of bacterial genus compositions showed a propensity for Prevotella-enriched and Bacteroides-poor gut microbiotas in patients with ART over time. In addition, we observed a gradual reduction in Bacteroides but drastic increases in Succinivibrio and/or Megasphaera under conventional ART. These results suggest that ART, especially NRTI-based ART, has more suppressive impacts on microbiota composition and diversity in the gut than in the mouth, which potentially causes intestinal dysbiosis in patients. Therefore, NRTI-sparing ART, especially integrase strand transfer inhibitor (INSTI)- and/or non-nucleotide reverse transcriptase inhibitor (NNRTI)-containing regimens, might alleviate the burden of intestinal dysbiosis in HIV-1-infected patients under long-term ART.

scholarly journals 1036. Persistence of Guideline-Recommended Antiretroviral Therapy Regimens among Persons Living with HIV Newly Initiating Treatment in the US

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S548-S549
Author(s):  
Joshua P Cohen ◽  
Xingzhi Wang ◽  
Rolin L Wade ◽  
Helena Diaz Cuervo ◽  
Dionne M Dionne
Keyword(s):  
Antiretroviral Therapy ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Treatment Discontinuation ◽  
Forest Plot ◽  
Current Guideline ◽  
First Line ◽  
Persons Living With Hiv ◽  
Living With Hiv

Abstract Background Discontinuation of first-line antiretroviral therapy (ART) may lead to poor outcomes for persons living with HIV (PLWH). While single-tablet regimens (STRs) have been associated with greater persistence compared to multi-tablet regimens (MTRs), few real-world studies have assessed persistence with current guideline-recommended ART regimens. The study aims to assess persistence among treatment-naïve PLWH initiating guideline-recommended ART regimens Methods Longitudinal pharmacy claims were extracted from IQVIA’s US LRx database for PLWH initiating ART between Jan 1, 2016 - Jul 31, 2019 (index period), with the observational period up to Jan 31, 2020. Index date was defined as the date of the first ART claim for STRs, or the date of the last filled drug of 1st set of claims for MTRs. Persistence was measured as the number of days until treatment discontinuation (≥ 90-day gap in therapy) and presented via Kaplan-Meier curves. Risk of discontinuation was assessed via Cox proportional hazards models, with BIC/FTC/TAF used as the reference ART regimen. Results Overall, 90,949 PLWH initiated STRs and 20,737 initiated MTRs. Average (SD) age was 43 (14) years, 75% were male, and 75% had commercial insurance. At 6 months of follow-up, 71% of PLWH initiating STRs and 56% initiating MTRs remained on their ART regimen. The proportion remaining on their index regimen at 6 months of follow-up was 79% for BIC/FTC/TAF, 73% for EVG/COBI/FTC/TAF, 71% for DTG/ABC/3TC, 69% for DTG + FTC/TAF, 67% for EFV/FTC/TDF, 62% for EVG/COBI/FTC/TDF, and 38% for DTG + FTC/TDF. Risk of discontinuation was higher for MTRs compared to STRs (hazard ratio [HR]: 1.63, 95% CI: 1.61 - 1.66). Compared to the referent BIC/FTC/TAF, risk of discontinuation was higher for EVG/COBI/FTC/TAF (HR: 1.54, 95% CI: 1.48 - 1.60), DTG/ABC/3TC (HR: 1.58, 95% CI: 1.52, 1.65), DTG + FTC/TAF (HR: 1.83, 95% CI: 1.74 - 1.93), EFV/FTC/TDF (HR: 2.31, 95% CI: 2.21 - 2.41), EVG/COBI/FTC/TDF (HR: 2.58, 95% CI: 2.47 - 2.70), and DTG + FTC/TDF (HR: 6.20, 95% CI: 5.83 - 6.59). Table 1. Persistence with ART by regimen for STR and MTR Figure 1. Forest Plot of Hazard Ratios for Treatment Discontinuation Conclusion Among US adult PLWH, STRs were associated with longer persistence on first-line therapy compared to MTRs. Among STRs, persistence was highest for BIC/FTC/TAF. Disclosures All Authors: No reported disclosures

scholarly journals Sociodemographic, lifestyle and therapeutic predictors of 2-year survival in HIV-infected persons receiving antiretroviral therapy in Benin

2017 ◽  
Vol 8 (1) ◽  
Author(s):  
Charles Sossa Jerome ◽  
Maurice Agonnoudé ◽  
Ghislain Emmanuel Sopoh ◽  
Ali Imorou Bah-Chabi ◽  
Amédée De Souza ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Proportional Hazards Regression ◽  
Persons Living With Hiv ◽  
Immunodeficiency Virus ◽  
Living With Hiv ◽  
Transversal Study ◽  
Death Data ◽  
Hiv Aids

The benefits of antiretroviral therapy (ART) for treating human immunodeficiency virus (HIV) infection have been well described. The objective of this study was to identify the predictors of two-year survival in persons living with HIV/AIDS (PLWHA) in Benin. This retrospective transversal study included all patients from 46 HIV/AIDS therapy sites across Benin who started ART between July 1st, 2011 and June 30th, 2012. The independent variables were patients’ sociodemographic, clinical, biological and therapeutic characteristics and their ART regimen. The main dependent variable was the time of death. Data were collected from medical records, using documentary review. Cox proportional hazards regression models were used to investigate factors associated with survival. Among the 771 PLWHA participants of the study, 18 (2.3%) died within the two-year period. The estimated mortality of the 771 PLWHA was 3% at 24 months. Among the sociodemographic, lifestyle and therapeutic characteristics studied, the main predictor of two-year mortality was poor adherence [odds ratio = 4.15, 95% confidence interval (1.55- 11.28)]. This study confirms that improving the survival of PLWHA receiving ART requires enhanced adherence.

scholarly journals Factors associated with high-risk low-level viremia leading to virologic failure: 16-year retrospective study of a Chinese antiretroviral therapy cohort

2019 ◽  
Author(s):  
Tong Zhang ◽  
Haibo Ding ◽  
Minghui An ◽  
Xiaonan Wang ◽  
Wen Tian ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
High Risk ◽  
Virologic Failure ◽  
Baseline Viral Load ◽  
Factors Associated ◽  
Low Level ◽  
Subtype B ◽  
High Level ◽  
Hiv 1

Abstract Background: Low level viremia (LLV) often occurs during antiretroviral therapy (ART) against HIV-1. However, its impact on virologic failure (VF) is controversial because of non-uniform definitions of LLV and VF. Methods: A long-term first line regimen ART cohort from 2002–2018 from Shenyang, northeast China, was retrospectively studied. All participants were followed up every 3 to 6 months to evaluate the treatment effect. The high-risk LLV subgroups leading to VF (with strict standards) were explored with Cox proportional hazards model and linear mixed-effect model. The association factors of high-risk LLV were further explored using multivariate logistic regression analyses. Results: A total of 2155 HIV-1 infected participants were included; of these, 38.8% showed LLV. Both high level LLV (HLLV) and any other level LLV coupled with high level blip (HBL) showed higher risk of VF (hazards ratios, HRHLLV=5.93, and HRHBL=2.84, p<0.01 respectively). Moreover, HR increased with prolonged duration of LLV. Independent factors associated with high-risk LLV included the zenith baseline viral load (VL) above 6 log copies/ml (aOR=3.49, p=0.002), nadir baseline CD4+T cell counts below 200 cells/ml (aOR=1.78, p=0.011), Manchu (aOR=2.03, p=0.003), ART over 60 months (aOR=1.81, p=0.004), AZT+3TC+NVP (aOR=2.26, p<0.001) or DDI-based regimen (aOR=9.96, p<0.001), and subtype B’ infection (aOR=8.22, p=0.001). Conclusions: In case of VF with strict standards, high-risk LLV leading to VF includes VL above 400 copies/ml, occurring at least once. Serious laboratory indicators or advanced stage of infection, long term ART and subtype B’ infection might also predict the occurrence of high-risk LLV.

scholarly journals Class of antiretroviral drugs and anemia risk in the current treatment era

2019 ◽  
Author(s):  
B.N. Harding ◽  
B.M. Whitney ◽  
R.M. Nance ◽  
H.M. Crane ◽  
G. Burkholder ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Antiretroviral Drugs ◽  
Hemoglobin Level ◽  
People Living With Hiv ◽  
List Type ◽  
Severe Anemia ◽  
Strand Transfer ◽  
Laboratory Test Results ◽  
Increased Risk

AbstractOBJECTIVESAnemia is common among people living with HIV (PLWH) and has been associated with certain, often older, antiretroviral medications. Information on current antiretroviral therapy (ART) and anemia is limited. The objectives were to compare associations between anemia incidence or hemoglobin change with core ART classes in the current ART era.DESIGNRetrospective cohort study.SETTINGU.S.-based prospective clinical cohort of PLWH aged 18 and above receiving care at 8 sites between 1/2010-3/2018.PARTICIPANTS16,505 PLWH were included in this study.MAIN OUTCOME MEASURESAnemia risk and hemoglobin change were measured for person-time on a protease inhibitor (PI) or an integrase strand transfer inhibitor (INSTI), relative to a non-nucleoside reverse transcriptase inhibitor (NNRTI) reference. We also examined PLWH on multiple core classes. Cox proportional hazards regression analyses were conducted to measure associations between time-updated ART classes and incident anemia or severe anemia. Linear mixed effects models were used to examine relationships between ART classes and hemoglobin change.RESULTSDuring a median of 4.9 years of follow-up, 1,040 developed anemia and 488 developed severe anemia during. Compared to NNRTI use, INSTI-based regimens were associated with an increased risk of anemia (adjusted hazard ratio [aHR] 1.17, 95% confidence interval [CI] 0.94-1.47) and severe anemia (aHR1.55 95%CI 1.11-2.17), and a decrease in hemoglobin level. Time on multiple core classes was also associated with increased anemia risk (aHR 1.30, 95%CI 1.06-1.60) and severe anemia risk (aHR 1.35, 95%CI 0.99-1.85), while no associations were found for PI use.CONCLUSIONThese findings suggest INSTI use may increase the risk of anemia. If confirmed, screening for anemia development in users of INSTIs may be beneficial. Further research into underlying mechanisms is warranted.Strengths and limitations of this studyThis study utilized a large and geographically diverse population of PLWH in care across the U.S.This study leveraged comprehensive clinical data, including information on diagnoses, medication use, laboratory test results, demographic information, and medical history.This study investigated associations between specific types of ART core regimens and anemia risk.This observational study is subject to residual confounding.This study focused on anemia assessed from hemoglobin lab values taken at regular medical care visits without excluding participants with conditions strongly associated with hemoglobin level through non-traditional HIV mechanisms.

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