Interest in and Preference for Long-acting Injectable Antiretroviral Therapy in the Era of Approved Cabotegravir/Rilpivirine among Reproductive-aged Women in the U.S. South

Among 103 reproductive-aged women with HIV in the U.S. South surveyed post-approval of long-acting injectable (LAI) cabotegravir/rilpivirine, nearly two-thirds reported willingness to try LAI antiretroviral therapy (ART). Most expressed preference for LAI over daily oral ART and had minimal concerns over potential LAI-ART use impacting reproductive health.Among 103 reproductive-aged women with HIV in the U.S. South surveyed post-approval of long-acting injectable (LAI) cabotegravir/rilpivirine, nearly two-thirds reported willingness to try LAI antiretroviral therapy (ART). Most expressed preference for LAI over daily oral ART and had minimal concerns over potential LAI-ART use impacting reproductive health

1486. The Association of Aging-related Comorbidity Burden and Quality of Life Among Women with and without HIV in the U.S

Abstract Background Women with HIV (WWH) are at higher and earlier risk of developing aging-related non-AIDS comorbidities (NACM) compared to those without HIV; however, the impact on health-related quality of life (QoL) is largely unknown. Methods We analyzed data from the Women’s Interagency HIV Study to evaluate the effect of comorbidity burden (total NACM of 10 assessed) on nine QoL domains and a summary QoL index (QoLI; measured by the MOS-HIV instrument). We included women followed on/after 2009 (when >80% of WWH reported antiretroviral therapy use) and ascertained covariates, NACM, and QoL through the last study visit by 03/2018. Unadjusted (HIV, age, NACM burden or prevalence separately), partially adjusted (unadjusted + all possible interaction terms) and adjusted (partially adjusted + covariates) linear regression assessed impact on QoL. Results Among 3036 women (2173 HIV+, 863 HIV-), median age was 50 (Q1-Q3 43-56) yrs, 66% were Black, 51% had annual income < $12K, and mean (sd) NACM burden was 3.4 (2.2). In unadjusted models, each additional NACM decreased the mean QoLI by -4.4 (95%CI -4.7,-4.1; p< 0.0001). Mean QoLI did not differ in WWH vs without HIV (68 vs 69, p=0.40) but decreased with older age (< 40, 40-49, 50-59, 60-69 yrs): 75 (95%CI 73,77), 71 (70,73), 65 (63,66), 63 (61,65), respectively (p< 0.0001). Unadjusted QoLI was negatively associated with each prevalent NACM (Table). NACM burden was associated with all nine QoL domains in unadjusted models: physical function, role function, energy/fatigue, social function, cognitive function, emotional well-being, health perception, pain, and perceived health index. In the partially adjusted model, the impact of NACM burden on QoLI was modified by age (p=0.02) but not HIV serostatus (p=0.40) (Figure). In covariate-adjusted models (race, BMI, cigarette, alcohol or crack use, menopausal status, socioeconomic status), NACM burden was associated with QoLI (p< 0.0001) but age and HIV did not modify this effect (age*HIV*NACM burden, p=0.83). Summary quality of life index and aging-related comorbidity burden by HIV serostatus and age Conclusion Among women with a high prevalence of multimorbidity, HIV, and health disparities, total comorbidity burden was associated with QoL, independent of age or HIV serostatus. Research is needed to optimize multimorbidity screening and prevention strategies in this population. Disclosures Lauren F. Collins, MD, MSc, Curio Science: Honoraria Igho Ofotokun, MD, MSc, FIDSA, Merck: Grant/Research Support Phyllis C. Tien, MD, MSc, Merck: Grant/Research Support Cyra Christina Mehta, PhD, MSPH, Merck: Grant/Research Suppor

A Patient Decision Aid (i.ARTs) to Facilitate Women\u27s Choice Between Oral and Long-Acting Injectable Antiretroviral Treatment for HIV: Protocols for its Development and Randomized Controlled Pilot Trial

BACKGROUND: Many women with HIV (WWH) have suboptimal adherence to oral antiretroviral therapy (ART) due to multilevel barriers to HIV care access and retention. A long-acting injectable (LAI) version of ART was approved by the US Food and Drug Administration in January 2021 and has the potential to overcome many of these barriers by eliminating the need for daily pill taking. However, it may not be optimal for all WWH. It is critical to develop tools that facilitate patient-provider shared decision making about oral versus LAI ART modalities to promote women\u27s adherence and long-term HIV outcomes. OBJECTIVE: This study will develop and pilot test a web-based patient decision aid called i.ART+support (i.ARTs). This decision aid aims to support shared decision making between WWH and their providers, and help women choose between oral and LAI HIV treatment. METHODS: The study will occur in 3 phases. In phase 1, we will utilize a mixed methods approach to collect data from WWH and medical and social service providers to inform i.ARTs content. During phase 2, we will conduct focus groups with WWH and providers to refine i.ARTs content and develop the web-based decision aid. In phase 3, i.ARTs will be tested in a randomized controlled trial with 180 women in Miami, Florida, and assessed for feasibility, usability, and acceptability, as well as to evaluate the associations between receiving i.ARTs and viral suppression, ART pharmacy refills, and clinic attendance. RESULTS: This study was funded in March 2021. Columbia University\u27s IRB approved the study protocols (approval number IRB-AAAT5314). Protocols for phase 1 interviews have been developed and interviews with service providers started in September 2021. We will apply for Clinicaltrials.gov registration prior to phase 3, which is when our first participant will be enrolled in the randomized controlled trial. This is anticipated to occur in April 2023. CONCLUSIONS: This study is the first to develop a web-based patient decision aid to support WWH choices between oral and LAI ART. Its strengths include the incorporation of both patient and provider perspectives, a mixed methods design, and implementation in a real-world clinical setting. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35646

Subclinical atherosclerosis across the menopausal transition in women with and without HIV

The menopausal transition is a pivotal time of cardiovascular risk, but knowledge is limited in HIV. We studied longitudinal carotid artery intima-media thickness (CIMT) in the Women's Interagency HIV Study (2004-2019; 979 women/3247 person-visits; 72% living with HIV). Among women with HIV only, those who transitioned had greater age-related CIMT progression compared to those remaining pre-menopausal (difference in slope=1.64 µm/year, p=0.002); and CIMT increased over time in the pre-transition (3.47 µm/year, p=0.002) and during the menopausal transition (9.41 µm/year, p<0.0001), but not post-transition (2.9 µm/year, p=0.19). In women with HIV, menopause may accelerate subclinical atherosclerosis as measured by CIMT

Aging-Related Comorbidity Burden Among Women and Men With or At-Risk for HIV in the US, 2008-2019

This cross-sectional study of US adults compares the burden of non-AIDS comorbidities between persons with HIV and those without by age and sex

Human Immunodeficiency Virus and Cardiac End-Organ Damage in Women: Findings From an Echocardiographic Study Across the United States

People with human immunodeficiency virus (HIV) have been reported to have increased risk of clinical and subclinical cardiovascular disease. Existing studies have focused on men and often have been uncontrolled or lacked adequate HIV-negative comparators. We performed echocardiography in the Women's Interagency HIV Study to investigate associations of HIV and HIV-specific factors with cardiac phenotypes, including left ventricular systolic dysfunction (LVSD), isolated LV diastolic dysfunction (LVDD), left atrial enlargement (LAE), LV hypertrophy (LVH), and increased tricuspid regurgitation velocity (TRV). Of 1654 participants (age 51 ± 9 years), 70% had HIV. Sixty-three (5.4%) women with HIV (WWH) had LVSD; 71 (6.5%) had isolated LVDD. Compared with women without HIV (WWOH), WWH had a near-significantly increased risk of LVSD (adjusted relative risk = 1.69; 95% confidence interval = 1.00 to 2.86; P = .051). No significant association was noted for HIV seropositivity with other phenotypes, but there was a risk gradient for decreasing CD4+ count among WWH that approached or reached significance for isolated LVDD, LAE, and LVH. WWH with CD4+ count <200 cells/mm3 had significantly higher prevalence of LAE, LVH, and high TRV than WWOH. There were no consistent associations for viral suppression or antiretroviral drug exposure. This study suggests that WWH have a higher risk of LVSD compared with sociodemographically similar WWOH, but their risk for isolated LVDD, LAE, LVH, and high TRV is increased only with reduced CD4+ count. Although these findings warrant replication, they support the importance of cardiovascular risk-factor and HIV-disease control for heart disease prevention in this population

CAGI, the critical assessment of genome interpretation, establishes progress and prospects for computational genetic variant interpretation methods

Background: The Critical Assessment of Genome Interpretation (CAGI) aims to advance the state-of-the-art for computational prediction of genetic variant impact, particularly where relevant to disease. The five complete editions of the CAGI community experiment comprised 50 challenges, in which participants made blind predictions of phenotypes from genetic data, and these were evaluated by independent assessors. Results: Performance was particularly strong for clinical pathogenic variants, including some difficult-to-diagnose cases, and extends to interpretation of cancer-related variants. Missense variant interpretation methods were able to estimate biochemical effects with increasing accuracy. Assessment of methods for regulatory variants and complex trait disease risk was less definitive and indicates performance potentially suitable for auxiliary use in the clinic. Conclusions: Results show that while current methods are imperfect, they have major utility for research and clinical applications. Emerging methods and increasingly large, robust datasets for training and assessment promise further progress ahead