bluuebunny/crossref_metadata_2025_split huggingface dataset:
1035. Patient-Reported Outcomes on Long-Acting Cabotegravir + Rilpivirine as Maintenance Therapy: FLAIR 96-Week Results
Authors: Chounta Vasiliki , Bernal Enrique , Lombaard Johan , Katner Harold P , Walmsley Sharon , Dorey David , Spreen William , Griffith Sandy , Margolis David 
Published: January 2021

Abstract

Background
In the phase 3 FLAIR study, switching to monthly injectable long-acting (LA) cabotegravir (CAB) + rilpivirine (RPV) was noninferior to continued daily oral dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) for the maintenance of virologic suppression over 96 weeks in adults with HIV-1. Key patient-reported outcomes (PROs) through Week 96 are presented.

Methods
In FLAIR, ART-naive adult participants received induction therapy with oral DTG/ABC/3TC for 20 weeks. Those with HIV-1 RNA &lt; 50 c/mL at 16 weeks were randomized (1:1) to continue DTG/ABC/3TC or receive monthly CAB + RPV LA injections after a 4-week lead-in with daily oral CAB + RPV through Week 96. Treatment satisfaction (HIV Treatment Satisfaction Questionnaire status version [HIVTSQs]) and acceptability of injections (Perception of Injection [PIN] Questionnaire) up to Week 96 were secondary endpoints.

Results
A total of 566 participants were randomized (median age, 34 years; 22% female); baseline characteristics were similar between treatment groups. At Week 96, significantly greater improvement from baseline in total treatment satisfaction score was observed in the CAB + RPV LA vs DTG/ABC/3TC treatment group (adjusted mean difference, 2.3 [95% CI, 1.1-3.5]; P&lt; 0.001), further increasing from Weeks 24 (2.1 [0.9-3.3]) and 44 (0.7 [−0.4, 1.9]). Key drivers for the difference in HIVTSQs between treatment groups were items assessing convenience, flexibility, and satisfaction to continue with LA therapy. In participants receiving CAB + RPV LA, mean score for the “Acceptability of ISRs” dimension of PIN (scale, 1-5) significantly decreased (improved) from Week 5 to Weeks 41, 48, and 96 (2.08 to 1.71, 1.66, and 1.71, respectively; P&lt; 0.001 for all). In addition, 82% and 85% of LA participants, respectively, rated pain and local reactions due to injections as “totally” or “very acceptable” at Week 96.

Conclusion
At Week 96, FLAIR participants receiving LA therapy reported greater improvement in treatment satisfaction compared with participants continuing on daily oral medication as well as overall good acceptability of injections with improvement over time. Overall, these results support monthly CAB + RPV LA as an alternative to daily oral regimens for adults with HIV-1.

Disclosures
Vasiliki Chounta, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sharon Walmsley, FRCPC, MD, MSC, GSK (Grant/Research Support)ViiV Healthcare (Grant/Research Support) David Dorey, MMATH, GlaxoSmithKline Inc. (Employee, Shareholder) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder) Sandy Griffith, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)
1036. Persistence of Guideline-Recommended Antiretroviral Therapy Regimens among Persons Living with HIV Newly Initiating Treatment in the US
Authors: Cohen Joshua P , Wang Xingzhi , Wade Rolin L , Cuervo Helena Diaz , Dionne Dionne M 
Published: January 2021

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
1038. Rapid Start: A Changing Algorithm for the Management of HIV Infection
Authors: Gudipati Smitha , Jaziri Miriam , Tancer Stephanie , Vahia Amit T , Brar Indira 
Published: January 2021

Abstract

Background
Initiating combination antiretroviral therapy (cART) as early as the day of HIV diagnosis is a strategy of increasing interest to control the HIV epidemic and optimize the health of people living with HIV. Pilot studies have shown that starting cART immediately after diagnosis has led to earlier linkage to care and HIV-1 RNA suppression. However, there is some evidence from observational studies that starting cART on the same day as HIV diagnosis may increase the risk of loss to follow-up. Consequently, there is a need for additional data for immediate cART initiation.

Methods
A Retrospective cohort study was conducted from 2016 to 2018 to identify clinical characteristics and risk factors in patients that were diagnosed with HIV-1 with a 4th generation assay using electronic medical records. Rapid start was defined as offering cART prior to or on the first clinic visit. Categorical variables were analyzed using chi-sq test and continuous variables were analyzed using t-test. Data analysis was done using SAS 9.4.

Results
In the study period, 188 patients were identified as HIV-1 positive and cART naïve: 152 males and 34 females. Risk factors included men who have sex with men (N = 86), heterosexual transmission (N = 88), intravenous drug use (N = 18) and multiple partners (N = 15). Of the 188 patients, 40 patients were rapidly started on cART on average within 6 days of diagnosis vs 42 days in the standard of care patients (P &gt; 0.0001), with a shorter duration to clinic follow up over time (P = 0.3103). 50% patients that were rapid started on cART maintained an undetectable viral load vs 77% of the standard of care group (P = 0.3174). 90% of the rapid start patients were retained in care at 12 months vs 78% of the standard of care patients (P = 0.4950). 126 patients were started on single tablet regimens (P = 0.0001) with a trend favoring bictegravir, emtricitabine & tenofovir alafenamide (P = 0.0001).

Conclusion
Our study adds to the growing data that rapid ART initiation within seven days of HIV diagnosis could reduce loss to follow-up, improve virological suppression rates, and reduce mortality. The percentage of patients with undetectable HIV-1 viral load and retained in care was comparable to that in standard of care, indicating that starting cART immediately after diagnosis was well accepted by patients.

Disclosures
Indira Brar, MD, Gilead (Speaker’s Bureau)janssen (Speaker’s Bureau)ViiV (Speaker’s Bureau)
1039. Real World Community-Based HIV Rapid Start Antiretroviral with BFTAF Versus Conventional HIV Antiretroviral Therapy Start – The RoCHaCHa Study, a Pilot Study
Authors: Zuppelli Ashley R , Mancenido Michael , Scutaru Jacob , Danforth Alexandra , Biernbaum Robert , Corales Roberto , Valenti William M 
Published: January 2021

Abstract

Background
Trillium Health (TH) is a FQHC in Rochester, NY providing primary and specialty care, including HIV prevention and treatment. Rapid Start ART (RSA) has been shown to decrease time to virologic suppression while increasing linkage to and retention in care. However, data on BFTAF with these benefits is limited. We aim to prove RSA with BFTAF is advantageous in time to viral load suppression, linkage to and retention in care, and patient satisfaction and acceptance.

Methods
We included data from ART-naive newly diagnosed PLWH enrolled between October 2018 and March 2020 with baseline assessment and started BFTAF. Follow up visits were done per protocol though 48 weeks. The primary study endpoints include median times from: diagnosis to clinic presentation, clinic presentation to ART, and ART to undetectable viral load (VL), &lt; 200 copies/mL and &lt; 50 copies/mL. Linkage to and retention in care were measured at 3 months. Study results were compared with non-RSA historical control data. Patient reported outcomes were evaluated at study completion.

Results
Of the 27 eligible, 25 participants enrolled. Thirteen received their diagnosis at TH: screening for PrEP (6), community-based HIV/STI/HCV testing (3), community outreach (1), or routine patient screening in primary care (3). Twelve were diagnosed externally: university health centers (2), other health clinic (9), or at-home rapid HIV test (1). All accepted the RSA treatment with BFTAF; two eligible patients declined the study, but accepted RSA. 73.9% of participants were seen within 14 days of Day 84, compared with 50% of historical control group. 12 of 25 completed the primary endpoint of which 100% were highly satisfied with RSA. There were no regimen changes or virologic failures through 48 weeks.
RoCHaCHa Study Results

Conclusion
RSA with BFTAF reduced time to virologic suppression in all participants newly diagnosed with HIV-1 compared with historical non-RSA model.

Disclosures
Ashley R. Zuppelli, PHARMD, BCACP, AAHIVP, Gilead Sciences, Inc. (Grant/Research Support)Gilead Sciences, Inc. (Advisor or Review Panel member, Research Grant or Support) Michael Mancenido, DO, AAHIVS, Gilead Sciences, Inc. (Grant/Research Support) Jacob Scutaru, MD, Gilead Sciences, Inc. (Grant/Research Support) Alexandra Danforth, PHARMD, BCACP, AAHIVP, Gilead Sciences, Inc. (Grant/Research Support) Robert Biernbaum, DO, MS, FAAEM, AAHIVS, Gilead Sciences, Inc. (Grant/Research Support, Advisor or Review Panel member, Speaker’s Bureau) Roberto Corales, DO, AAHIVS, Gilead Sciences (Employee) William M. Valenti, MD, FIDSA, Gilead Sciences, Inc. (Grant/Research Support, Speaker’s Bureau)
1040. Real-World Implementation of Dolutegravir-Lamivudine to Achieve and Maintain HIV-1 Viral Suppression at an Academic Medical Center
Authors: Hiryak Kayla , Kludjian Geena , Samuel Rafik , Bettiker Robert , Koren David E 
Published: January 2021

Abstract

Background
Two-drug antiretroviral (ARV) regimens to achieve and maintain HIV viral suppression may lead to decreases in associated drug interactions, adverse events, and pill burden. Dolutegravir-lamivudine (DTG-3TC) has been established as safe and effective in treatment naïve and experienced adults. Further research is warranted to assess insertion into real-world practice.

Methods
This descriptive retrospective cohort consisted of all patients at an academic medical center HIV practice with a confirmed order of DTG-3TC between April 2019 and March 2020. Patients who were not linked to care by the site’s practices were excluded. The primary endpoint was number of patients initiated on DTG-3TC to determine uptake. Secondary endpoints included demographics and viral outcomes. Descriptive measures of central tendencies and variability were used for analysis.

Results
DTG-3TC was initiated in 49 patients. Sixty-nine percent were male (34/49), 90% carried publicly funded insurance (44/49), median age at DTG-3TC initiation was 55 years (IQR 46-60), and mean years since HIV diagnosis was 14 (SD ±8). The largest racial/ethnic category represented was Black (45%, 22/49). Forty-seven patients with a mean CD4 of 753 cells/mm3 (±413) and viral load of 88.2 copies/mL (±525) were switched from alternative regimens, mostly containing an integrase inhibitor (41/47, 87%), and with the primary rationale of medication modernization (27/47, 58%) followed by avoidance of adverse drug reactions (15/47, 32%). From 42 assessed patients, 62% had previous ARV exposure length of over 10 years. No patients were found to have significant resistance mutations to the involved agents. After initiation, 6% (3/49) of patients reported side effects. Among switch patients with follow up lab values, median CD4 (n=20) and viral load (n=21) deltas were -10 cells/mm3 (-59-67) and 0 copies/mL (0-0) respectively. Overall median length of therapy through April 1, 2020 was 110 days (71-156).

Conclusion
Initial implementation of DTG-3TC was successful in a northeast academic HIV practice primarily among virally suppressed treatment switch patients with long exposures to ARV and time since diagnosis. No clinically relevant change in CD4 or Viral Loads were immediately seen.

Disclosures
David E. Koren, PharmD, BCPS, AAHIVP, Gilead Sciences (Advisor or Review Panel member)Janssen Pharmaceuticals (Advisor or Review Panel member)Thera Technologies (Advisor or Review Panel member)
1041. Tenofovir alafenamide associated weight change in persons living with HIV
Authors: Crowder Carlysle E , Bouchard Jeannette , Weissman Sharon , Derrick Caroline 
Published: January 2021

Abstract

Background
Persons living with human immunodeficiency virus (PLWH) have a higher incidence of developing obesity, diabetes, and cardiovascular disease. TAF, a newer formulation of tenofovir, has favorable effects on renal function and bone mineral density compared to TDF. However, recent evidence suggests TAF may have a higher propensity for weight gain over TDF. The purpose of this study is to evaluate weight change in patient switched from TDF to TAF, keeping constant the other components of their antiretroviral therapy.

Methods
This retrospective observational cohort study evaluated adult PLWH who were followed for 12 months pre and post TDF to TAF therapy switch holding all other ART constant. Patients were excluded if not on TDF or TAF therapy for a minimum of 12 months, if there were additional changes to their ART, or if there was inadequate documentation of weight defined as less than 2 weight records pre and post TAF switch. Data collected included height, weight, HIV RNA, CD4 count, and presence of any current opportunistic infections or chronic comorbid conditions. The primary endpoint was change in weight after TAF switch. All variables were evaluated using linear mixed effect models over time.

Results
466 patient charts were reviewed and 55 patients met study criteria and were included in the analysis. The median age (SD) of patients included was 45.9 (12.6) years with most patients being male (67%) and black (73%). Patients had an HIV diagnoses for a mean (SD) of 10 (6.6) years with a mean (SD) CD4 count of 544 (246.8). Full baseline characteristics are recorded in Table 1. Notably, most patients had either an INSTI or PI in their baseline ART regimen (Table 1). The estimated overall marginal mean weight gain was 1.91 kg (95% CI 0.25-3.57, p=0.024). The estimated overall gain in BMI was 0.63 kg/m2 (95% CI 0.08-1.18). Significant predictors of weight gain included female gender (3.09, 95% CI 0.54 – 5.65) and use of both integrase and protease inhibitors at baseline (6.97 kg, 95% CI 3.02 – 10.92).

Conclusion
In a predominantly black, male population, there was a statistically significant change in weight after a TAF switch.
As this is the only data highlighting weight changes following tenofovir formulation change, more data is needed to elucidate the extent of weight-gain in patients on TAF-based regimens.

Disclosures
All Authors: No reported disclosures
1043. The impact of integrase strand transfer inhibitors (InSTIs) on weight gain among adults with HIV in clinical care
Authors: Thatipelli Sneha , Achenbach Chad , Galvin Shannon 
Published: January 2021

Abstract

Background
Integrase strand transfer inhibitors (InSTIs) as ART for HIV has been associated with clinically significant weight gain, in addition to the “return to health phenomenon”.

Methods
We conducted a cohort study on adults over 18 with HIV, who had baseline weights and an additional weight at least 6 months later. Individuals with malignancies, thyroid disorders, and disseminated tuberculosis or mycobacterium avium complex were excluded. To understand the impact of InSTIs on chronic vs. recently infected persons, we divided the cohort into four groups: (1) well-controlled on non-InSTI ART [WN] (2) well-controlled on InSTI ART [WI] (3) uncontrolled on non-InSTI ART [UN], and (4) uncontrolled on InSTI ART [UI]. Well-controlled persons (viral load &lt; 2000) were proxies for chronic infection on long-term ART and uncontrolled for recently infected and initiated on ART. New diagnoses of diabetes, hyperlipidemia, and hypertension were determined by ICD10 codes. Participants with a weight change more than 10 kg in 6 months were excluded.

Results
612 of the initial 910 participants in the cohort met the inclusion criteria. Comparing those who remained on the designated regimen throughout the study led to 86 WN, 153 WI, 166 UN, and 145 UI. Mean weight change at 6 months for WN was +0.22 kg (95% CI [-0.86, 1.3]), at 1 year was -0.86 kg (95% CI [-2.94, 1.22]), and at 2 years was +0.026 kg (95% CI [-2.347, 2.399]). For WI, mean weight change at 6 months was +0.21 kg (95% CI [-0.79, 1.21]), at 1 year was -0.50 kg (95% CI [-2.02, 1.04]), and at 2 years was +0.43 kg (95% CI [-1.35, 2.21]). UN gained weight until the first year (+1.74 kg at 6 mo (95% CI [0.24, 3.24]) and +3.84 kg at 1 year (95% CI [1.57, 6.11])), but plateaued at 2 years (+2.42 kg (95% CI [-0.44, 5.28])). At 6 months mean weight gain for UI was +0.78 kg (95% CI [-0.15, 1.71]), at 1 year was +2.33 kg (95% CI [1.02, 3.64]), and at 2 years was +3.04 kg (95% CI [1.2, 4.85]). WI had a higher incidence of diabetes (37% vs. 32%, p=0.40), hyperlipidemia (32% vs. 29%, p=0.66), and hypertension (34% vs. 26%, p=0.19) compared to WN.

Conclusion
InSTIs may confer a larger and more sustained weight gain among individuals in the first two years after ART initiation. Well controlled individuals did not have statistically significant weight change, but those on Insti-based ART had more metabolic diseases.

Disclosures
All Authors: No reported disclosures
1048. Weight Gain after Initiation of Anti-Retroviral Therapy in Acute HIV-1
Authors: Kaur Harmanpreet , Utay Netanya S , Lake Jordan , Arduino Roberto , Hongyu Miao 
Published: January 2021

Abstract

Background
Background: Excess weight gain with integrase strand transfer inhibitors (INSTIs) has been reported in some people with chronic HIV. In antiretroviral therapy (ART)-naïve people, greater weight gain over 18 months was reported with dolutegravir than other agents. We hypothesized that initiating an INSTI-based regimen during acute HIV infection (AHI) would result in more weight gain than a non-INSTI-based regimen, and INSTIs other than elvitegravir (EVG) would be associated with greater weight gain than EVG.

Methods
Methods: We performed a retrospective, observational, single center chart review analysis of adults with AHI (Feibig Stages 1-5) who were initiated on ART and followed for 48 (+/- 12) weeks. Changes in weight between people on INSTI- vs non-INSTI regimens were compared, and in a subgroup analysis, EVG vs non-EVG and tenofovir alafenamide (TAF) vs non-TAF were compared. Chi-square, t-test, or Wilcoxon Rank Sum test were used, when appropriate.

Results
Results: Baseline characteristics of the 61 participants are shown in Table 1. Overall median (IQR) weight change was 4.53 (1.22-8.36; within-group P&lt; 0.0001) kg (Figure 1). Median weight change in 58 people initiated on INSTI was 4.66 (1.22-8.43; P&lt; 0.0001) kg vs 1.64 (-3.08-6.57; P=0.75) kg in 3 people not on INSTI (between-group P= 0.33). Median weight change on EVG was 4.40 (0.91-6.71; P&lt; 0.0001) kg vs 7.10 (4.97-13.15; P= 0.0001) kg for non-EVG INSTIs (between-group P= 0.008, Figure 2). Median weight change on TAF (n=33) was 2.66 (0.81-7.53; P= 0.002) kg vs 5.31 (3.72-9.34; P &lt; 0.0001) kg in non-TAF (n=25) recipients (between-group P= 0.06). Lower baseline CD4+ T cell count correlated with greater weight gain (P= 0.012). No association between weight gain and race (P= 0.930) or gender (P= 0.379) was noted.
Baseline characteristics and median weight change (kg) from baseline

Weight change in elvitegravir vs non-elvitegravir integrase inhibitor regimen.

Overall weight gain seen over 48 weeks after initiation of antiretroviral therapy calculated using the Wilcoxon Rank Sum test.

Conclusion
People initiating ART during AHI gained weight over 48 weeks, with persons taking INSTIs gaining more weight, though this finding did not reach statistical significance due to small sample size. Amongst INSTI-treated persons, those not on EVG gained more weight than those on EVG. While the benefits of starting ART during AHI on immune system preservation and reservoir should not be underscored, risk and consequences of weight gain following ART initiation should be discussed when initiating ART during AHI.

Disclosures
Jordan Lake, MD, Gilead Sciences (Grant/Research Support, Scientific Research Study Investigator)