bluuebunny/crossref_metadata_2025_split huggingface dataset:
884. Title: Factors Associated with Lack of Viral Suppression Among Women Living with HIV in the United States: An Integrative Review
Authors: Labisi Titilola , Fadul Nada , Coleman Jason , Podany Anthony , King Keyonna 
Published: December 2021

Abstract

Background
Women account for 19% of new HIV cases in the United States (US). Transgender women are 49 times more likely than other groups to be diagnosed with HIV. HIV is one of the top ten causes of death among women between 25 to 44 years. Adherence to antiretroviral therapy (ART) and consequent viral suppression (VS) are keys to preventing sexual transmission, risk of drug resistance, and improving health outcomes. Hence, it is essential to identify factors behind VS in women living with HIV (WLWH).

Methods
This review identified and synthesized peer-reviewed studies describing reasons for lack of VS among WLWH in the US. : Using the PRISMA model, we searched CINAHL, PubMed, Embase, Scopus, and PsycINFO, then selected US studies published from 2010 to April 2021. Studies that included men, non-adults, ongoing studies, and foreign studies were excluded. 1,359 studies were assessed and screened for duplicate and eligibility.
PRISMA Model

Results
15 studies were eligible for review; 8 included all WLWH, 5 focused on pregnant WLWH, 1 included only African American WLWH and 1 included only transgender WLWH. Based on study participants and findings, results were divided into pregnancy and non-pregnancy-related factors. Pregnancy-related factors: Early ART initiation and group prenatal care improved care retention and VS. WLWH in cities were more likely to be virally suppressed at delivery than those in rural regions. Intimate partner violence (IPV) was associated with poor ART adherence and time to achieve stable VS. Also, being postpartum was associated with high viral load regardless of ART. Non-pregnancy-related factors: The most reported common factors were substance use and IPV. Other factors included social determinants of health, age, race, health insurance, income, number of pills, and regimen. Transgender-specific factors were stress, race, age, relationship, transphobic experiences, gender satisfaction, and adherence to hormone therapy.

Conclusion
Substance use, income, mental health, health insurance, race, and ART regimen were the most common factors associated with VS in WLWH. There was paucity of data on transgender-specific VS factors. More research is needed to explore VS and treatment adherence amongWLWH, especially transgender women.

Disclosures
All Authors: No reported disclosures
108. Efficacy of Dalbavancin Compared to Standard of Care for the Treatment of Osteomyelitis: A Retrospective Study
Authors: Cain Alexander , Bremmer Derek N , Carr Dustin R , Buchanan Carley , Jacobs Max , Walsh Thomas L , Moffa Matthew , Shively Nathan , Trienski Tamara 
Published: December 2021

Abstract

Background
Preliminary data suggest that the efficacy of dalbavancin, a long-acting lipoglycopeptide, may be similar to current standard of care (SoC) treatment options for osteomyelitis, and may be associated with fewer treatment related adverse events. This study assessed the incidence of treatment failure in patients receiving either dalbavancin or SoC for the treatment of osteomyelitis.

Methods
This was a multi-center, retrospective, observational cohort study of adult patients diagnosed with osteomyelitis. Patients were matched 1:2 to either dalbavancin (1500 mg infused intravenously on days 1 and 8) or SoC for osteomyelitis (oral or intravenous antibiotics) by Charlson Comorbidity Index, site of infection, and causative pathogen. The primary objective was to determine the incidence of treatment failure after a one-year follow-up period. Secondary objectives included hospital length of stay (LOS), infection related one-year readmission rates, and treatment related adverse events.

Results
A total of 132 patients were matched to receive dalbavancin (n = 42) or SoC (n = 90). Baseline characteristics were similar between the two treatment groups. The majority of patients had lower extremity osteomyelitis (76.2% vs 73.3%) with an etiology of diabetic foot infection (45.2% vs 46.7%) in the dalbavancin and SoC groups, respectively. Treatment failure was similar between those who received dalbavancin and SoC (21.4% vs 23.3%, p = 0.808). Patients who received dalbavancin had a significantly shorter hospital LOS compared to patients who received SoC regimens (5.2 days vs 7.2 days, p = 0.013). There was no difference in the rates of infection related readmissions between the dalbavancin and the SoC group (31% vs 31.1%, p = 0.985). Peripherally inserted central catheter line related complications were reported in 17.8% of patients in the SoC group, however the lower incidence of overall adverse events in the dalbavancin group was not significantly different than the SoC group (21.4% vs 36.7%, p = 0.08).

Conclusion
Dalbavancin administered as a two-dose regimen is a safe and effective option for the treatment of osteomyelitis

Disclosures
Dustin R. Carr, PharmD, BCPS, BCIDP, AAHIVP, Merck (Speaker's Bureau) Thomas L. Walsh, MD, Accelerate Diagnostics (Other Financial or Material Support, speaking fees)
887. Implementation of Long-acting Injectable Cabotegravir/Rilpivirine for HIV-1 Treatment at a Ryan White-funded Clinic in the U.S. South
Authors: Collins Lauren F , Collins Lauren F , Corbin-Johnson Della , Asrat Meron , Rankins Tonya , Harrison Latoya , Condra Alton , Sumitani Jeri , Smith Bradley L , Armstrong Wendy , Armstrong Wendy , Colasanti Jonathan 
Published: December 2021

Abstract

Background
In January 2021, the first ever long-acting injectable (LAI) antiretroviral therapy (ART), cabotegravir/rilpivirine (CAB/RPV), was approved for maintenance HIV-1 treatment in select patients with virologic suppression. LAI-ART has the potential to improve ART adherence, reduce HIV stigma, and promote equity in care outcomes, however, implementation in real-world settings has yet to be evaluated.

Methods
We launched a pilot LAI-ART program at the largest Ryan White-funded HIV clinic in the Southeast. From 4/14/21 to 5/14/21, providers referred patients interested and willing to switch to LAI-CAB/RPV who met screening criteria. Our interdisciplinary LAI team (Clinician-Pharmacy-Nursing) verified clinical eligibility (HIV-1 &lt; 200 c/ml ≥6 months and no history of virologic failure, resistance to either drug, or chronic HBV infection) and pursued medication access for 28-day oral lead-in and monthly injectable CAB/RPV. We describe demographic and clinical variables of referred PWH and early outcomes in accessing LAI-ART.

Results
Among 42 referrals, median age was 40.5 (Q1-Q3, 32-52) years, 83% were men, and 76% Black. Payor source distribution was 26% Private, 19% Medicare, 10% Medicaid, and 45% ADAP. At the time of referral, median CD4 count was 583 (Q1-Q3, 422-742) cells/mm3 and median sustained HIV-1 RNA &lt; 200 c/ml was 1427 (Q1-Q3, 961-2534) days. A total of 35 patients (74%) met clinical eligibility for LAI-CAB/RPV, including 4 patients who required a transition off proton pump inhibitor therapy to accommodate oral RPV. Ineligible PWH were excluded due to evidence of RPV resistance (n=5), possible RPV hypersensitivity (n=1), and HIV non-suppression (n=1). The table summarizes the process of pursuing LAI-ART access for the initial 10 enrollees by insurance status.

Conclusion
Our experience implementing LAI-ART at a Ryan White-funded HIV clinic in the Southern U.S. has been challenged by substantial human resource capital to attain drug, delayed therapy initiation due to insurance denials, and patient ineligibility primarily due to concern for potential RPV resistance. These barriers may perpetuate disparities in ART access and virologic suppression among PWH and need to be urgently addressed so that LAI-ART can be offered equitably.

Disclosures
Lauren F. Collins, MD, MSc, Nothing to disclose Bradley L. Smith, Pharm.D., AAHIVP, Gilead Sciences, Inc (Advisor or Review Panel member) Wendy Armstrong, MD, Nothing to disclose Jonathan Colasanti, MD, Integritas CME (Consultant, develop and deliver CME content around Rapid Entry/Rapid ART)
890. Evaluation of Association Among Integrase Inhibitors for HIV Treatment, Weight Gain, and Body Image
Authors: Zawadzka Sabina , Ganugapati Divya , Wakefield Dorothy , Dieckhaus Kevin , Chirch Lisa 
Published: December 2021

Abstract

Background
Integrase inhibitors (INSTIs) are preferred antiretroviral agents for people living with HIV (PLWH). Recent studies suggest that INSTIs may contribute to weight gain and the development of metabolic syndrome. A lack of knowledge remains about how INSTIs affect metabolic parameters that contribute to weight gain as well as the impact of weight gain on medication adherence and body image in PLWH.

Methods
We conducted a retrospective chart review along with a real time survey of PLWH who are receiving HIV care at UConn Health. Participants who were switched to or added an INSTI to their ART regimen between 2012 - 2020 were included (n=204). Patient weight was recorded in 3-month intervals for two years prior to and two years after INSTI initiation. Lipid profile parameters and hemoglobin A1c were noted pre and post INSTI switch. A survey was administered to rate perception of weight gain, body appearance, and medication adherence on a five-point Likert scale. Statistical methods included Chi-square test and Fisher’s Exact test for categorical data, and T-test or Kruskal-Wallis test for continuous data.

Results
Patients started on or switched to any INSTI regimen experienced a mean weight gain of 5 and 7 pounds at 12 and 24 months, respectively (p &lt; 0.001). Weight gain was greatest with raltegravir and elvitegravir (Figure 1,2). Bictegravir regimens resulted in a 4 pound weight loss at 24 months. An INSTI switch increased cholesterol by a mean of of 7.9mg/dL (p=0.05), with no effect on other parameters. A switch to Bictegravir increased HDL by 4mg/dL (p=0.04) and decreased triglycerides by 35mg/dL (p=0.04). Survey results showed that 100% of patients denied missing ART doses despite 69% mentioning weight gain due to ART. 97% of patients were satisfied with their ART regimen, with the majority disagreeing that their body image was negatively affected.

Conclusion
We demonstrate a link between INSTI use and weight gain up to two years following INSTI initiation, with the most weight gained within the first 12 months. Elvitegravir and raltegravir are associated with greater weight gain whereas bictegravir demonstrates weight loss and beneficial effects on lipid profile. Despite weight gain, most patients remained adherent and satisfied with their medication and denied negative perceptions of body image.

Disclosures
All Authors: No reported disclosures
891. Minimum Manufacturing Costs and National Prices for Weight Loss Treatments, as Potential Mitigation for Anti-Retroviral Related Weight Gain in HIV
Authors: Levi Jacob , Wang Junzheng , Venter Francois , Hill Andrew 
Published: December 2021

Abstract

Background
Weight gain is being observed for a wide range of antiretroviral treatments. Weight gains are higher for people taking first-line integrase inhibitor based treatments, especially those including TAF/FTC. Weight gains are higher for women and people of colour. Clinical obesity increases the risks of cardiovascular disease, diabetes, adverse birth outcomes and could lower survival rates. Anti-obesity treatments are needed to supplement lifestyle interventions and counteract progressive weight gains, but are not routinely provided as part of HIV care.

Methods
Costs of production for FDA-recommended weight loss treatments and anti-diabetic medications (orlistat, naltrexone-bupropion, topiramate, phentermine, semaglutide, liraglutide and metformin) were estimated using an established and published methodology based on costs of active pharmaceutical ingredients (API), extracted from the global shipping records database Panjiva. This was compared with national drug list price data from a range of low, medium, and high-income countries.

Figure 1. Example of methodology for calculating the estimated minimum cost of production for orlistat

Results
Weight loss and anti-diabetic treatments can be generically manufactured at low per-course costs, e.g. &85 per person per year for oral treatments such as orlistat and &1 per person per month for metformin. However, prices for a year of treatment with orlistat are as high as &1,205 in the USA and as low as &11 in Vietnam. In comparison, a month of ARV treatment costs about &15 via global health institutions like CHAI. Price for injectable (subcutaneous) treatments were higher, ranging from &1,985 for liraglutide in USA to &330 in Morocco, whilst they could potentially be profitably sold for &155 for a 12-week course. No export price data was available for semaglutide. When compared against international list prices, we found wide variations between countries.
Table 1. Summary of drug prices and minimum cost estimates

Figure 2. Orlistat course costs in a range of countries, compared with estimated minimum cost

Figure 3. Liraglutide course costs in a range of countries, compared with estimated minimum cost

Conclusion
We show that weight loss treatments can be manufactured and sold profitably for low prices, but have a wide price range between countries. Government and non-governmental healthcare systems should be evaluating weight loss agents for inclusion within ART programmes.

Disclosures
All Authors: No reported disclosures
892. Determination of the Unavailability of Alternative Antiretroviral Formulations
Authors: Murray Milena M , Flynn Devon , Sowah Leonard A , Austin Aaron , Farmer Eric 
Published: December 2021

Abstract

Background
Many pediatric and some adult people living with HIV (PLWH) are unable to swallow tablets and require alternative antiretroviral formulations (ARVF) such as liquids, chewable tablets, or powders for suspension. A growing number of issues with the timely procurement of alternative ARVF have been reported; the full scope of this problem is unknown. Without access to appropriate treatment, PLWH are at increased risk of poor disease outcomes. This study’s objective was to determine the scope of availability issues of ARVF and its potential impact on patient care.

Methods
An online survey invitation was sent to members of AAHIVM and the ACCP HIV PRN. Data collection included provider demographics, number of issues related to ARVF availability, time spent procuring ARVFs, and identification of unavailable formulations. To determine potential impact on clinical care and cost of care the time required to resolve shortages was summarized.

Results
The analyzable sample was 154, a majority of whom were pharmacists or physicians (n=132, 85.7%; Figure 1), in a clinical role (n=134, 87.0%), and serve pregnant patients (n=121, 79.2%). 85 (55.2%) practice at sites that provide care to &gt; 300 PLWH, 81 (52.6%) practice at sites that did not serve pediatric patients. 525 instances of gaps in care due to ARVF unavailability were reported. In 283 instances, a more complex regimen was prescribed due to first-choice ARVF unavailability. Providers also reported 186 situations in which a less optimal regimen was used and 140 cases of treatment delays. The average time spent to resolve such issues was 2.7 hrs (CI: 1.3 – 4.2). The longest time reported was 72 hrs; most providers spent 1 hr or less. The most common unavailable ARVF were branded ritonavir 80 mg/mL solution (n=12), zidovudine 50 mg/5 mL syrup (n=11), raltegravir 100 mg chewable tablets (n=11), and raltegravir 100 mg granules for suspension (n=10). Branded nevirapine 50 mg/5 mL suspension (n=7) and generic nevirapine 50mg/5ml powder for suspension (n=11) were also reported more frequently.
Distribution of Respondents by Provider Type

Conclusion
Our report suggests the unavailability of alternative ARVF has the potential to significantly impact patient care. Further research is needed to identify the root causes of this problem to determine specific solutions.

Disclosures
Milena M. Murray, PharmD, MSc, BCIDP, AAHIVP, Merck (Speaker’s Bureau)Theratechnologies (Other Financial or Material Support, Medical Advisory Board) Eric Farmer, PharmD, BCPS, AAHIVP, TheraTechnologies, Inc (Other Financial or Material Support, Medical Advisory Board)
893. Evaluating Weight Gain in Treatment-naïve, HIV-infected Patients Started on Antiretroviral Therapy
Authors: Chaudhry Nimra , Cani Eris , Raymond Lendelle , Park Tae , Kanter Timothy 
Published: December 2021

Abstract

Background
There is increasing evidence that integrase strand transfer inhibitors (INSTIs) are associated with more weight gain when compared to other antiretroviral (ART) classes. Thus, the primary objective of the study was to evaluate the difference in weight gain at 6 and 18 months among treatment-naïve patients started on an INSTI-based versus a non-INSTI-based ART regimen.

Methods
This was a retrospective cohort study of ART-naive adults who were initiated and maintained on INSTI and non-INSTI based regimens for at least 18 months at an HIV clinic in an inner-city hospital from January 2013 to June 2019. The non-INSTI-based regimens were darunavir (DRV) or rilpivirine (RPV)-based. Data collected included patient demographics, ART regimen, pre- and post-ART initiation weight in kilograms (kg), body mass index (BMI), CD4 count, and viral load. A two-tailed t-test was used to compare change in weight in INSTI-based versus non-INSTI-based regimens. Sub-group analyses were conducted using the ANOVA test.

Results
Out of 170 patients, 60% were initiated on an INSTI-based regimen, 7.1% on a DRV-based regimen, and 32.9% on a RPV-based regimen. Of the patients initiated on INSTI-based regimens, 73.5% were on elvitegravir (EVG),16.7% on dolutegravir, 8.8% on bictegravir, and 0.98% on raltegravir. The mean age at ART initiation was 38 years with majority of the patients described as Black. More male patients received an INSTI-based regimen compared to females (77.5% vs. 32%). The average change in weight at 6 and 18 months in the INSTI-based group vs non-INSTI-based group was +3.6 kg vs. +2.9 kg (95% CI -2.2-0.7, p=0.317) and +5.7 kg vs.+4.8 kg (95% CI -3.2-1.2, p=0.357) respectively. There was no significant average change in weight among the INSTI-based regimens (+3.6 kg), vs DRV (+5.3 kg), or RPV (+2.4 kg) based regimens at 6 months (p=0.108) and 18 months [(+5.7 kg) vs (+7.2 kg), vs (+4.3 kg) (p=0.186) respectively]. Among the INSTIs, EVG was associated with the highest increase in weight at both 6 and 18 months (+3.9 kg and +5.8 kg). Forty-six percent of patients in the INSTI group were on tenofovir alafenamide (TAF) while no patients received TAF in the non-INSTI groups.

Conclusion
When comparing INSTI-based to DRV or RPV-based regimens, there was no significant increase in average weight at 6 and 18 months.

Disclosures
All Authors: No reported disclosures
894. Trend of Transmitted Resistance Associated Mutations in People Living with HIV (PLWH) in a Large Southeastern U.S. Ryan White Clinic
Authors: Kavouklis Alisha , Ladak Amber F , Hamilton Caroline , Mims Annastesia , Askar Gina , Newman Cheryl 
Published: December 2021

Abstract

Background
Department of Health and Human Services (DHHS) guidelines recommend integrase strand transfer inhibitors (INSTIs) as the backbone of preferred initial antiretroviral (ART) regimens (1). Baseline mutation rates for the INSTI class is 0.8% compared with an overall rate of 19% for all ART classes, based on Centers for Disease Control and Prevention (CDC) U.S. data from 2013-16 (2). First-generation INSTIs (raltegravir and elvitegravir) have a lower genetic barrier to resistance compared with newer, second generation INSTIs (bictegravir and dolutegravir) (3, 4). DHHS guidelines do not currently recommend routine HIV genotypic resistance testing to INSTIs prior to ART initiation (1). Our study seeks to determine the current prevalence of transmitted INSTI and overall resistance in a large southeastern U.S. Ryan White clinic.

Methods
This was a single-center, retrospective analysis of treatment naïve PLWH presenting for care from January 1, 2017 to December 31, 2020. Of these, 164 had a baseline genotype performed by one of two commercially available assays – Vela Genomics or ViroSeq. Subsequent interpretations were based on Stanford HIV Drug Resistance Database.

Results
65 patients (39.6%) had at least one transmitted resistance associated mutation (RAMs). Of these, 24 (36.9%) had an INSTI RAM. Baseline PI, NRTI, and NNRTI RAMs declined during the four-year interval (2017-2020), while the rate of INSTI RAMs increased from 11.1% to 19%; all conferred resistance to the first generation INSTIs with one also conferring resistance to second generation INSTIs.
INSTI Resistance Associated Mutation Prevalence 2017-2020

Frequency of Antiretroviral Therapy Class Mutations Per Year

Trend of INSTI Mutations and Resistance Associated Mutations 2017-2020

Conclusion
Unlike the CDC data which showed the overall prevalence of INSTI RAM transmission rates during 2013-2016 to be 0.8%, our data suggests a higher rate of INSTI RAMs (14.6%) with overall ART RAM transmission of 39.6%. This increase in baseline resistance to the INSTI class, which occurred over time, mimics the historical development of RAMs seen in the earlier ART classes. Though suboptimal adherence in the population promotes development of RAMs, increased frequency of INSTI RAMs may be due to a lower barrier to resistance of first generation INSTIs. Should our observed trend continue, routine baseline INSTI resistance testing may need to be considered prior to ART initiation.

Disclosures
Cheryl Newman, MD, Gilead (Scientific Research Study Investigator)GSK/ViiV (Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Janssen (Scientific Research Study Investigator)Merck (Scientific Research Study Investigator)