bluuebunny/crossref_metadata_2025_split huggingface dataset:
1258. B/F/TAF in HIV-Infected Adults with Substance Use Disorders: BASE Week 48 Results
Authors: Havens Josh , Bares Sara H , Lyden Elizabeth , Lyden Elizabeth , Lyden Elizabeth , Podany Anthony , Scarsi Kimberly , Fadul Nada , Swindells Susan 
Published: December 2022

Abstract

Background
People with HIV (PWH) and substance use disorders (SUD) are at higher risk of non-adherence. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) exhibits high rates of efficacy with a favorable adverse event profile. The BASE study (NCT03998176) is a Phase 4, single-arm study evaluating the effectiveness and safety of B/F/TAF among PWH and SUD.

Methods
Viremic (HIV RNA &gt;1000 copies [c]/mL) treatment-naïve or -experienced PWH and ongoing SUD initiated B/F/TAF once daily for 48 weeks (W). The primary endpoint was HIV RNA &lt; 50 c/mL (FDA Snapshot Algorithm) at W48. Secondary endpoints were safety, adherence (dried blood spot [DBS] levels of emtricitabine-triphosphate [FTC-TP] and tenofovir-diphosphate [TVF-DP]), substance use (NIDA ASSIST) and quality of life (SF-12).

Results
Forty-three participants enrolled; 95% reported methamphetamine use. Median age was 38 years (range: 21-62); 19% female, 81% White, 14% Black, 16% Latinx. At W48, 21 participants (49%) had HIV RNA &lt; 50 c/mL (ITT, Figure 1). Four participants (9%) experienced confirmed virologic failure; none developed treatment-emergent resistance. Seventeen participants (40%) experienced grade ≥3 adverse events; none attributed to B/F/TAF. Five participants reported suicidal ideation; none resulted in discontinuation. Observed mean FTC-TP and TVF-DP concentrations in DBS corresponded to 5-6 doses/week (FTC-TP: &gt;3.6 pmol/7mm punches; TVF-DP: &gt;1733 fmol/7 mm punches; Figure 2). NIDA ASSIST scores declined from baseline, with methamphetamine use decreasing most (-7.9 points; -29%). SF-12 physical/mental scores increased 1.2 and 7.6 points, respectively, but remained below mean US scores.
Longitudinal virologic outcomes, intent-to-treat analysis
Mean observed intracellular emtricitabine triphosphate (FTC-TP) and tenofovir diphosphate (TFV-DP) in dried blood spots at weeks 6, 24, and 48
Thresholds for 2-3 doses/week (Solid Line) and 4-5 doses/week (Dashed Line) are noted for both FTC-TP and TFV-DP based on TAF-DBS data [Yager J, et al. JAIDS, 2020].
Notes: Y-axis represents femtomoles/punches

Conclusion
B/F/TAF among a high-risk population of PWH and ongoing SUD resulted in a 49% viral suppression rate at W48. No emergent resistance was noted supporting the high barrier to resistance provided by B/F/TAF.

Disclosures
Sara H. Bares, MD, Gilead Sciences: Expert Testimony|GSK ViiV Healthcare: Grant/Research Support|Janssen: Grant/Research Support Kimberly Scarsi, PharmD, Organon: Grant/Research Support.
1260. Comparing the impact of six-month antiretroviral therapy dispensing to three- to five-month dispensing on viral load suppression in Kenya and Nigeria.
Authors: Cavanaugh Joseph S , Dear Nicole , Shah Neha , Iroezindu Michael , Bahemana Emmanuel , Kibuuka Hannah , Owuoth John , Maswaii Jonah , Sing’oei Valentine , Hern Jaclyn , Esber Allahna , Crowell Trevor A , Polyak Christina , Ake Julie A 
Published: December 2022

Abstract

Background
Multi-month dispensing (MMD) of antiretroviral therapy (ART) decreases logistical burdens on HIV clinics and patients, which is especially important during the COVID-19 pandemic. HIV programs are scaling-up 6-month dispensing (6MD), but the impact on viral suppression (VS) has not been well-documented in programmatic settings.

Methods
The African Cohort Study (AFRICOS) is an international observational study of people living with HIV (PLWH) receiving HIV care. In Nigeria and Kenya, this includes 6MD. Participants undergo semiannual viral load quantification and were included in analysis if they had complete data, documentation of MMD (self-reported) and at least two follow-up visits after initiating MMD. In stratified analyses for each country, we used multivariable logistic regression with generalized estimating equations to estimate adjusted odds ratios (aOR) and 95% confidence intervals (95%CI) comparing VS &lt; 50 copies/mL among those who received 6MD to those given 3-5 months dispensing (3-5MD) of ART. Analyses were adjusted for age, education, employment, distance to clinic, duration on ART, ART regimen (TLD vs other) and self-reported ART adherence (≥ 1 missed dose in past 30 days).

Results
Between January 30, 2020, when MMD data was first collected, and September 1, 2021, 1176 PLWH in Kenya and 272 in Nigeria had at least one visit; 285 participants from Kenya, totaling 442 visits, and 177 participants from Nigeria, totaling 382 visits, met criteria and were included in analysis. At most recent visit, VS &lt; 50 copies/mL was documented in 266 (93.3%) participants from Kenya and 125 (70.6%) participants from Nigeria. Among the 35 participants given 6MD in Kenya, compared to 250 participants given 3-5MD, the aOR for VS was 0.42 (95%CI: 0.13-1.37); among the 91 participants given 6MD in Nigeria, compared to the 86 participants given 3-5MD, the aOR was 3.01 (95%CI: 1.70-5.31).

Conclusion
The positive association between 6MD and VLS in Nigeria, as compared to 3-5MD, should prompt more aggressive scale-up of 6MD. The lack of an association in Kenya merits further investigation, but likely relates to high overall VS and few participants on 6MD. Updated data from specific geographic and demographic sub-populations is needed to inform programming as 6MD is scaled.

Disclosures
All Authors: No reported disclosures.
1261. Do All Patients Prefer Telehealth Care?
Authors: Gudipati Smitha , Lee Monica , Huitsing Joanne , Markowitz Norman , Brar Indira 
Published: December 2022

Abstract

Background
COVID-19 has threatened health care for many individuals. Restriction of resources, redeployment of staff, and patient reluctance to make clinic appointments disrupts continuity of care of existing patients and limits access to care of new ones. To overcome this, our HIV clinic aggressively promoted a telehealth, MyChart (MC) application, and provided smart phone technology to those in need. Despite these efforts, we found that utilization of telehealth accounted for 4.7% of HIV clinic visits, compared to 25% in internal medicine clinics. In this report, we sought to obtain reasons why our patients were reluctant to use telehealth even in the midst of a pandemic.

Methods
All Ryan White (RW) people living with HIV (PLWH) at Henry Ford Hospital that were initiated in our telehealth pilot program were surveyed on the underutilization of MC. Utilization was determined by if PLWH responded to a MC notification sent by the telehealth navigator. Activity level was established on MC (Figure 1), and if PLWH did not respond, they were called as a follow up for survey answers.

Results
From 10/2020 – 01/2022, 206 PLWH were enrolled into our pilot program and given telehealth education. Of those successfully enrolled: 83.7% were black, 73% male, 57% were older than 45 years, 88% lived in Wayne County, and 27 needed and received pre-loaded smart phones. When contacted, 90 (44%) interacted on MC, 61 (29%) were unable to be reached and 55 (27%) successfully completed the survey (Figure 2). When asked why telehealth was not utilized, 27 (49%) stated they preferred in-person visits (Figure 3).

Conclusion
Telehealth programs can help overcome barriers to HIV care and maintain patient engagement when crises interrupt traditional care models. However, our study suggests that our PLWH preferred and felt safe engaging with in-person visits despite telehealth education and smartphone supplementation even in a pandemic. As the future of medicine moves towards telehealth management, we must not forget our vulnerable populations and find opportunities to safely engage with in-person visits.

Disclosures
Indira Brar, MD, Gilead: Grant/Research Support|Gilead: speakers bureau|Janssen: Grant/Research Support|Janssen: speakers bureau.
1263. Dolutegravir/Rilpivirine Switch Study in Persons with HIV and Chronic Kidney Disease: 24-week Assessment of Viral Suppression, Adherence, Treatment Satisfaction and Quality of Life
Authors: Kwakwa Helena , Gaye Oumar , Ruff Julia 
Published: December 2022

Abstract

Background
Single tablet regimens (STRs) improve convenience of administering antiretroviral therapy. However, for people with HIV and chronic kidney disease (CKD), STR options have been limited due to pharmacokinetic considerations. We evaluate the impact on viral suppression, adherence, treatment satisfaction and quality of life (QOL) of switching to dolutegravir/rilpivirine (DTG/RPV) for a cohort with HIV-1 and CKD.

Methods
In this 48-week single arm open label switch study, adults with HIV and a GFR&lt; 60 mL/min/1.73m2, an HIV RNA &lt; 50 copies/mL, and no known prior resistance to DTG or RPV were switched to DTG/RPV STR. HIV RNA and CD4 cell count were monitored quarterly. Standardized adherence, treatment satisfaction and QOL tools were administered at baseline, 24 weeks and 48 weeks. We present 24 week data.

Results
Between August 2019 and December 2021, 35 participants were enrolled. One participant terminated at 19 weeks when his transplant team stopped DTG/RPV due to concerns about potential drug-drug interactions following a kidney transplant. 94% of participants were Black, 57% were female, 94% were &gt; 50 years and 43% were 65 years or older. At baseline, 23% had GFR &lt; 30mL/min/1.73m2 and 55% had a GFR between 30 and 50mL/min/1.73m2. Of the 30 participants who have completed 24 weeks, 97% had an HIV RNA &lt; 50 copies/mL, 67% reported an improvement in medication adherence, 70% noted an improvement in QOL and 77% in treatment satisfaction. There were no serious adverse events.

Conclusion
For this diverse aging cohort with HIV and CKD, DTG/RPV was efficacious, well-tolerated, and associated with improvements in adherence, treatment satisfaction and QOL.

Disclosures
Helena Kwakwa, MD, MPH, ViiV Healthcare: Grant/Research Support.
1587. Clinical Utility of a Cytomegalovirus (CMV)-specific T Cell Assay in Assessing the Risk of Post-Prophylaxis CMV Infection and Post-Treatment Relapse
Authors: Bhaimia Eric , Yetmar Zachary A , Dioverti Veronica , Melendez Dante P , Theel Elitza , Razonable Raymund R 
Published: December 2022

Abstract

Background
Cytomegalovirus (CMV) causes significant morbidity in solid organ transplant recipients (SOTR). As a lack of immunity predisposes to infection, a laboratory test that measures CMV-specific cell-mediated immunity (CMV CMI) may help guide antiviral prophylaxis, predict relapses and correlate with outcomes. We assessed CMV CMI in CMV D+/R- patients during valganciclovir primary prophylaxis and in CMV viremic SOTRs during antiviral treatment, and correlated the results with post-prophylaxis CMV infection and post-treatment relapse, respectively.

Methods
CMV CMI was assessed in two groups of SOTRs using the QuantiFERON© CMV interferon-gamma release assay (IGRA), with level &gt;0.2 IU/mL suggestive of immunity. The first group included CMV D+/R- SOTRs who underwent monthly CMV CMI testing during 6 months of valganciclovir prophylaxis. These patients were prospectively followed for CMV episodes for 1 year post transplant.
The second group included SOTRs with CMV viremia or disease, who underwent CMV CMI testing at time of CMV diagnosis and at various time points during antiviral treatment. These patients were prospectively followed for CMV relapse for 1 year post-primary CMV episode. Standard definitions were used to define CMV infection and disease.

Results
In the primary prophylaxis cohort, 24 CMV mismatched (D+/R-) SOTRs were enrolled. Only 1 patient (4.2%) demonstrated a CMV CMI &gt;0.2 IU/mL by the end of prophylaxis; this patient did not develop CMV disease. Four (16.6%) patients developed post-prophylaxis CMV infection, none of which had CMV CMI &gt;0.2 IU/ml. In the post-treatment cohort, 20 CMV viremic SOTRs were enrolled, including 12 D+/R- (60%). Eighteen (90%) had CMV CMI levels &gt;0.2 IU/mL by end of treatment and none developed CMV relapse. In contrast, the single patient who relapsed after treatment had a CMV CMI response &lt; 0.2 IU/ml (p=0.05).

Conclusion
CMV D+/R- SOTRs are unlikely to develop CMV CMI during valganciclovir prophylaxis. Thus, the utility of CMV CMI for risk stratification of post-prophylaxis CMV infection in CMV D+/R- SOTRs is questionable. Conversely, CMV CMI testing may potentially be a useful marker of CMV relapse risk after treatment and guide the role of secondary antiviral prophylaxis.

Disclosures
Elitza Theel, PhD, D(ABMM), Euroimmun US: Advisor/Consultant|Oxford Immunotech: Advisor/Consultant|Roche Diagnostics: Advisor/Consultant|Serimmune Inc: Advisor/Consultant Raymund R. Razonable, MD, American Society of Transplantation: Board Member|gilead: Grant/Research Support|novartis: DSMB|regeneron: Grant/Research Support|Roche: Grant/Research Support.
1277. Provider Perspectives on Long-Acting Injectable Antiretroviral Therapy: A “Golden Ticket”?
Authors: Uhrig Castonguay Breana J , Carda-Auten Jessica , Rodriguez Humberto Gonzalez , Mayer Kenneth H , Wohl David A , Kerrigan Deanna , Barrington Clare , Fernandez Ricardo F 
Published: December 2022

Abstract

Background
Long-acting injectable antiretroviral therapy (LAI-ART) has been approved as an alternative to daily oral ART for people living with HIV (PLWH). Amidst the promise and potential challenges of LAI-ART, acceptability of this new therapeutic option remains largely unexplored beyond clinical trials. The aim of this study is to characterize perceptions and preferences related to LAI-ART among HIV care providers (HCPs).

Methods
We conducted qualitative in-depth interviews with 32 HCPs from three distinct geographic areas (Boston, MA; Chapel Hill, NC; Washington, DC) between November 2019 to March 2021. HCPs included: physicians, nurse practitioners, physician assistants, registered nurses, clinical pharmacists, social workers, medical assistants, and HIV navigators. We developed narrative summaries to understand individual perspectives and then systematically coded transcripts using Dedoose to identify recurring themes across participants.

Results
HCPs felt LAI-ART could be the “golden ticket” for patients who struggle with adherence or worry about HIV status disclosure. However, they perceived patient interest in LAI-ART would vary based on several factors. HCPs expected older patients who have lived with HIV longer and are reluctant to changing regimens, those who live far from clinic, or have a fear of needles to be less interested in LAI-ART. A recurring concern among HCPs was that LAI-ART will require frequent clinic visits, making it more burdensome to both patients and clinics. HCPs overwhelmingly preferred an 8-week over a 4-week dose schedule. To support introduction of LAI-ART, HCPs wanted: 1) clinic-wide trainings; 2) recommendations for optimal viral suppression status at LAI-ART initiation; 3) protocols for managing missed/late doses; and 4) implementation guidance to manage staff time tracking patients on LAI-ART.

Conclusion
Findings highlight the importance of understanding HCP perceptions, expectations, and concerns as these are likely to influence treatment discussions with PLWH and integration of LAI-ART. HCPs’ concerns and uncertainty regarding implementation, highlight the need for provider resources to support decision-making around LAI-ART. Additionally, clinic level guidance for the logistics of roll-out are urgently needed.

Disclosures
Kenneth H. Mayer, MD, Gilead: Advisor/Consultant|Merck: Advisor/Consultant|ViiV: Advisor/Consultant David A. Wohl, M.D., Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Janssen: Advisor/Consultant|Lilly: Grant/Research Support|Merck: Grant/Research Support|ViiV: Advisor/Consultant|ViiV: Grant/Research Support.
1280. Real-World Comparison of HIV-ASSIST with Expert Opinion in Selecting Antiretroviral Therapy for Complex Patients
Authors: Tang Michael E , Hill Lucas , Yin Jeffrey , Abulhosn Kari , Wooten Darcy 
Published: December 2022

Abstract

Background
HIV-ASSIST is an online, clinical decision support tool that helps HIV clinicians select antiretroviral (ARV) regimens for patients with HIV by accounting for individual patient characteristics. Concordance between HIV-ASSIST recommendations and expert opinion has been reported to be as high as 89% in treatment-experienced patients. We evaluated the utility of the HIV-ASSIST tool for a heavily treatment-experienced, complex patient population at the University of California, San Diego (UCSD) by comparing regimens recommended by HIV-ASSIST with regimens recommended by HIV experts.

Methods
We identified 14 patients through a routine HIV drug resistance teaching conference at our clinic. Each case was reviewed by 5 HIV clinical experts who independently recommended an ARV regimen. A consensus “best” regimen was agreed upon among the 5 experts for each patient. Consensus regimens were compared for concordance to the top 5 regimens recommended by the HIV-ASSIST tool. HIV-ASSIST regimens were also reviewed to determine if any were high or moderate risk for virologic failure due to patient or resistance characteristics, or drug-drug interactions (DDIs).

Results
The patients analyzed were medically and psychosocially complex, with a high rate of multi-class resistance (Table 1). Expert-recommended regimens were concordant with one of the top five regimens recommended by the HIV-ASSIST tool for 4/14 (28%) patients (Table 2). We further classified 20/70 (29%) regimens as high risk for virologic failure and 12/70 (17%) regimens as moderate risk for virologic failure (Figure 1). Table 2.Expert-recommended consensus regimens compared to the top 5 HIV-ASSIST regimens for 14 patients with HIV and a history of drug resistance, multimorbidity, and polypharmacy.Figure 1Classification of HIV-ASSIST regimens by HIV clinical experts as either acceptable, moderate risk or high risk for virologic failure.

Conclusion
Compared to prior reports, we found lower concordance between ART regimens recommended by HIV experts vs those recommended by the HIV-ASSIST tool in patients with HIV drug-resistance and/or complex comorbidities and potential DDIs. Moreover, several HIV-ASSIST regimens were considered at risk for virologic failure. We recommend caution in using the HIV-ASSIST tool for complex patients with significant drug resistance.

Disclosures
Lucas Hill, PharmD, AAHIVP, Gilead Sciences: Speakers Bureau.
1286. Telehealth Utilization and 2-year Outcomes among People with HIV at a Midwestern Clinic
Authors: Labisi Titilola , Regan Nichole N , Arroyo Monica , Fadul Nada 
Published: December 2022

Abstract

Background
Telehealth platforms such as video and telephone visits serve as mechanisms for HIV care delivery during the COVID-19 pandemic. While telehealth may be instrumental in HIV care, its utilization, sustainability, and impact on patients’ outcomes remain an area for further research. Hence, we compared people with HIV (PWH) utilizing telehealth services to those receiving in-person clinic services at Nebraska's largest HIV clinic in Omaha.

Methods
HIV Care visits were classified into telehealth and in-person visits. We defined telehealth users as PWH who have utilized telephone or video visits at least once between April 2020 to March 2022. Clinical and demographic comparisons between both groups were made. We conducted bivariate analyses and descriptive statistics for associations and proportions of visit type, viral loads (VL), and completed visits.

Results
A total of 4,473 visits were completed among 1,308 unique patients (172 telehealth users versus 1136 in-person). Telehealth utilization was significantly higher among patients from cities other than Omaha (&lt; 0.001) and those with income levels above the Federal Poverty Line (FPL) (0.001). Telehealth users made up 73.3% of missed appointments and 50% of canceled visits. Telehealth users were significantly more likely to have undetectable VL than in-person visit users (0.018). In addition, patients who were ≥ 45 years were significantly more likely to have undetectable VL than younger patients (&lt; 0.001).
There was no association between gender, race, or year of HIV diagnosis and visit type. Notably, transgender patients (n = 18) did not use telehealth.
Overall telehealth utilization dropped from 64% of our total visits in April 2020 to 5% in March 2022.

Conclusion
In our patient population, telehealth users were more likely to have undetectable VL, live far from the clinic, and have income levels above the FPL than in-person visit users. However, telehealth users were more likely to cancel or miss their medical appointments. Our data also suggest a low preference for telehealth among transgender people. Future studies should develop strategies to improve rates of completed visits among telehealth users, promote telehealth use among transgender men, and sustain the utilization of telehealth beyond the pandemic.

Disclosures
All Authors: No reported disclosures.
1293. Calling Attention to Pre-Exposure Prophylaxis (PrEP) for Women: A Novel Social Media Educational Campaign for Potential PrEP Users and Clinicians
Authors: Avraamides Christie , Blackstock Oni , Symowicz Jaime 
Published: December 2022

Abstract

Background
We designed and implemented an educational campaign using social media to provide information about HIV risk and prevention to Black heterosexual women (BHW) to promote PrEP awareness and enhance their relationships with clinicians.

Methods
In July and August 2021, 3 physician social media influencers who are Black women with large Black audiences shared content focusing on sexual health and PrEP on Instagram and TikTok with links to 2 surveys. An accredited webcast for clinicians followed in October 2021. It incorporated key points from the surveys and covered integrating HIV prevention into the routine care of BHW and addressing misconceptions about PrEP.

Results
The social media campaign reached over 171,000 followers and garnered 3,700 engagements, 62,441 total views, and 1.4 million impressions. Among the 171 comments, common themes included women not realizing that they could use PrEP and appreciation that the posts advocated for their health.
In total, 41 Black women responded to the surveys. 64% said they would be extremely/moderately comfortable talking with a provider about HIV prevention and PrEP (N=14). 89% would be extremely comfortable asking their provider for PrEP if they thought they needed it, but their provider did not offer it (N=9). However, some respondents still felt uncomfortable because they didn’t know what questions to ask, were embarrassed to ask questions, or were afraid of being seen as promiscuous.
To date, the webcast had 767 participants (75% in primary care and OB/GYN), and matched pre/post-test data were available for 49 learners. Learners’ confidence in their ability to integrate HIV prevention into the routine care of their BHW patients increased (53% moderately/very confident at baseline vs. 74% at post-test). Learners were more likely to ask their BHW patients about the risk behaviors of their partner(s) when taking a sexual history (51% very/extremely likely at baseline vs. 78% at post-test).

Conclusion
These results highlight the educational needs of BHW and illuminate needed improvements in clinician-patient dialogues about sexual health. Although Instagram and TikTok are known for brevity of content, they were effective in informing BHW about PrEP use for women and taking charge of their sexual health.

Disclosures
Jaime Symowicz, PhD, Gilead Sciences, Inc: Unrestricted educational grant for the educational initiative described in the abstract.