Long-acting Injectable Antiretroviral Therapy Research Articles

Characterizing long-acting injectable antiretroviral therapy eligibility and initiation at a safety net academic medical center in the southeastern United States.

Background: Long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) extends dosing intervals from daily to every 8weeks. Equitable implementation requires anticipating and addressing barriers to use. We described LAI-CAB/RPV eligibility and initiation among persons with HIV (PWH) receiving care at a Southeastern US academic medical center. Methods: We included PWH ≥18years, in care 01/01/2020-12/31/2021, and participating in the UNC CFAR HIV Clinical Cohort. We characterized LAI-CAB/RPV eligibility, compared those with and without recent detectable viral load (VL), and described clinical outcomes on LAI-CAB/RPV. Results: Among 1672 PWH, 425 (25.4%) had LAI-CAB/RPV drug-resistance. Among 1238 LAI-eligible PWH, 8.9% had detectable VL. Median age was 53 (interquartile range 40, 61), 54.6% were non-Hispanic Black, and 73.6% male. Over one-third lived >50 miles from clinic, one-fifth were uninsured, and 7.4% reported hazardous alcohol use. Gaps in care (prior 12-month) were more common among PWH with detectable VL versus suppressed (23.1% vs 13.9%, p = 0.03). 6/47 initiated LAI-CAB/RPV had detectable VL prior to injection; >95% sustained suppression and those with detectable VL had a rapid decline in viremia. Conclusions: Three-quarters of PWH were eligible for LAI-CAB/RPV, but equitable implementation may require addressing challenges such as distance to care, inconsistent care engagement, and other comorbid conditions, particularly for PWH with viremia.

Innovations in HIV Prevention and Treatment: The Future of HIV Care

The Human Immunodeficiency Virus (HIV) continues to pose a significant global health challenge, despite substantial progress in treatment and prevention. This review explored recent innovations in HIV prevention and treatment, highlighting advancements such as long-acting pre-exposure prophylaxis (PrEP), long-acting injectable antiretroviral therapy (ART), and emerging research into potential cures. It also examined integrated care approaches, digital health innovations, and innovative financing models that are shaping the future of HIV care. The review synthesized recent research, evaluated the impact of these innovations, and discussed future directions to advance global health goals. The methodology for this review involved a comprehensive analysis of current literature, clinical trial data, and expert opinions to provide a holistic overview of how these advancements are transforming HIV care and addressing existing challenges. Keywords: HIV Innovations, Prevention Strategies, Long-Acting ART, Integrated Care Models, Digital Health Technologies.

Patient and clinic staff perspectives on the implementation of a long-acting injectable antiretroviral therapy program in an urban safety-net health system

BackgroundLong-acting injectable cabotegravir plus rilpivirine (LAI CAB/RPV) has several potential benefits over daily oral formulations for HIV treatment, including the potential to facilitate long-term adherence and reduce pill fatigue. We aimed to assess facilitators of and barriers to LAI CAB/RPV implementation and delivery through the perspectives of physicians and clinical staff, and the experiences of LAI CAB/RPV use among people living with HIV (PLWH) at a Ryan-White supported safety-net clinic in North Texas.MethodsWe conducted semi-structured interviews with recruited clinic staff (physicians, nurses, and support staff) involved with LAI CAB/RPV implementation and PLWH who switched to LAI CAB/RPV and consented to participate in individual interviews. Data were collected from July to October 2023. Our interview guide was informed by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM), and Proctor Implementation Outcomes frameworks. Qualitative data were analyzed using a rapid qualitative analysis approach to summarize key themes.ResultsWe recruited and interviewed 15 PLWH who transitioned to LAI CAB/RPV and 11 clinic staff serving these patients. PLWH conveyed that emotional and informational support from family or a trusted clinician influenced their decision to switch to LAI CAB/RPV. PLWH also reported that injectable treatment was more effective, convenient, and acceptable than oral antiretroviral therapy. Clinic staff and physicians reported that staff training, pharmacist-led medication switches, flexible appointments, refrigeration space and designated room for injection delivery facilitated implementation. Clinic staff cited medication costs, understaffing, insurance prior authorization requirements, and lack of medication access through state drug assistance programs as critical barriers.ConclusionsOur study offers insights into real-world experiences with LAI usage from the patient perspective and identifies potential strategies to promote LAI CAB/RPV uptake. The barriers to and facilitators of LAI CAB/RPV program implementation reported by clinic staff in our study may be useful for informing strategies to optimize LAI CAB/RPV programs.

Who wants long-Acting injectable antiretroviral therapy? Treatment preferences among adults with HIV in Florida

ABSTRACT Long-acting injectable (LAI) antiretroviral therapy (ART) is available to people with HIV (PWH), but it is unknown which PWH prefer this option. Using the Andersen Behavioral Model this study identifies characteristics of PWH with greater preference for LAI ART. Cross-sectional data from the Florida Cohort, which enrolled adult PWH from community-based clinics included information on predisposing (demographics), enabling (transportation, income), and need (ART adherence <90%) factors. ART preference was assessed via a single question (prefer pills, quarterly LAI, or no preference). Confounder-adjusted multinomial logistic regressions compared those who preferred pills to the other preference options, with covariates identified using directed acyclic graphs. Overall, 314 participants responded (40% non-Hispanic Black, 62% assigned male, 63% aged 50+). Most (63%) preferred the hypothetical LAI, 23% preferred pills, and 14% had no preference. PWH with access to a car (aRRR 1.97 95%CI 1.05–3.71), higher income (aRRR 2.55 95%CI 1.04–6.25), and suboptimal ART adherence (aRRR 7.41 95% CI 1.52–36.23) were more likely to prefer the LAI, while those who reported having no social network were less likely to prefer the LAI (aRRR 0.32 95% CI 0.11–0.88). Overall LAI interest was high, with greater preference associated with enabling and need factors.

Challenges towards an AIDS-free generation in Africa and Asia.

To review the latest data on prevention of HIV vertical transmission in Asia and Africa and discuss strategic directions to achieve an AIDS free generation by 2030. Progress in vertical transmission elimination efforts in Africa and Asia have stalled in the last decade, with 130 000 new infections in 2022. Main causes of vertical transmissions vary; in Asia-Pacific due to its low-burden, thus low testing coverage, but high overall vertical transmission rates, in South and East Africa due to new HIV infections during pregnancy and breast/chestfeeding, whereas in Western and Central Africa due to low antiretroviral therapy (ART) coverage. Long-acting injectable ART and neutralizing antibodies for treatment and prevention show promise in supporting efforts to further reduce vertical transmissions. Integrated and more accessible pre- and postnatal care is needed to achieve an AIDS-free generation. Much can be implemented to address existing HIV service gaps; including strengthening of HIV prevention services for youth and women of childbearing age and pregnant people, early detection and treatment, and the delivery of integrated services that can reach and retain pregnant and postpartum people living with HIV in care.

Perinatally Acquired HIV: Viral Evolution and its Implications for Adolescents

This literature review explores the implications of viral evolution on the health outcomes of adolescents with perinatally acquired HIV, offering recommendations for enhancing public health practices. Since the emergence of HIV in the 1980s, perinatal transmission from parent to child has become increasingly prevalent in developing countries. Antiretroviral therapy (ART) has greatly improved the life expectancy of children with perinatally acquired HIV, allowing them to reach adolescence. ART plays a critical role in suppressing HIV and reducing the risk of transmission. Nevertheless, low adherence or lack of treatment can lead to viral evolution and drug resistance, posing significant threats to adolescents. Challenges faced by adolescents with perinatally acquired HIV are multifaceted, including increased viral evolution and difficulties in adhering to ART. The impact of stigma, behavioral factors, and social and familial dynamics contribute to low adherence rates. Global inequities and systems-level challenges further complicate the situation, particularly in resource-limited settings. Adequate public health infrastructure and innovative approaches, such as long-acting injectable ART, are imperative to address these structural barriers and reduce drug resistance among adolescents. Comprehensive data collection and longitudinal studies are needed to understand the long-term consequences of perinatally acquired HIV and its impact on viral evolution. A multidisciplinary approach involving healthcare providers, virologists, and social scientists is crucial to meeting global HIV goals and addressing the specific needs of this vulnerable population.

Engagement in Care, Awareness, and Interest in Long-Acting Injectable Anti-Retroviral Therapy

Long Acting Injectable (LAI) therapy to treat HIV is an alternative to daily oral medications. The success of early roll-out of LAI to eligible patients requires a better understanding of patients’ awareness and interest in this novel therapy. We administered an electronic survey to patients attending an urban HIV clinic in the US South. Eligible participants were 18 + years old with a most recent HIV-1 viral load < 200 copies/ml, without any evidence of genotypic resistance to LAI components or chronic hepatitis B. Survey recipients were asked about current treatment, engagement in care, and knowledge of LAI. Between January-April 2023, 480 patients were screened; 319 were eligible, and 155 (49%) completed the survey. The majority (119, 77%) were aware of, and 87 (56%) were interested in LAI. In regression analysis, only age was associated with interest in LAI (OR 0.95, 95% CI 0.92,0.99). Among proposed benefits of injectables, ease of travel without pills, lack of daily pill-taking, and fewer medication interactions were most appealing. Among proposed concerns with injectables, higher cost and insurance coverage of the new medicine were most worrisome. A large majority of people with HIV (PWH) are aware of the newest treatment available, and just over half of our sample expressed interest in LAI. Older age was associated with lower interest in LAI. LAI is appealing for its convenience, privacy, and avoidance of drug interactions, while the increased costs associated with LAI need to be addressed.

Long-acting injectable ART to advance health equity: a descriptive analysis of US clinic perspectives on barriers, needed support and programme goals for implementation from applications to the ALAI UP Project.

Approval of the first long-acting injectable antiretroviral therapy (LAI ART) medication heralded a new era of HIV treatment. However, the years since approval have been marked by implementation challenges. The "Accelerating Implementation of Multilevel Strategies to Advance Long-Acting Injectable for Underserved Populations (ALAI UP Project)" aims to accelerate the systematic and equitable delivery of LAI ART. We coded and analysed implementation barriers according to the Consolidated Framework for Implementation Research (CFIR) domains, desired resources and programme goals from questionnaire short-answer responses by clinics across the United States responding to ALAI UP's solicitation to participate in the project between November 2022 and January 2023. Thirty-eight clinics responded to ALAI UP's solicitation. The characteristics of LAI ART as an innovation (cost, complexity of procurement, dosing interval, limited eligibility) precipitated and interacted with barriers in other CFIR domains. Barriers included obtaining coverage for the cost of medication (27/38 clinics) (outer setting); need for new workflows and staffing (12/38) and/or systems to support injection scheduling/coordination (16/38), transportation and expanded clinic hours (13/38) (inner setting); and patient (10/38) and provider (7/38) education (individuals). To support implementation, applicants sought: technical assistance to develop protocols and workflows (18/38), specifically strategies to address payor challenges (8/38); additional staff for care coordination and benefits navigation (17/38); opportunities to share experiences with other implementing clinics (12/38); patient-facing materials to educate and increase demand (7/38); and support engaging communities (6/38). Clinics' LAI ART programme goals varied. Most prioritized delivering LAI ART to their most marginalized patients struggling to achieve viral suppression on oral therapy, despite awareness that current US Food and Drug Administration approval is only for virally suppressed patients. The goal for LAI ART reach after 1 year of implementation ranged from ≤10% of patients with HIV on LAI ART (17/38) to ≥50% of patients (2/38). Diverse clinic types are interested in offering LAI ART and most aspire to use LAI ART to support their most vulnerable patients sustain viral suppression. Dedicated resources centred on equity and relevant to context and population are needed to support implementation. Otherwise, the introduction of LAI ART risks exacerbating, not ameliorating, health disparities.

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.

"I Feel Like I Don't Even Have HIV Anymore"-Facilitators, Barriers, and Experience regarding Use of Long-Acting Injectable Antiretroviral Therapy Among Persons with HIV in North Carolina.

As access to long-acting injectable antiretroviral therapy (LAI ART) expands, understanding patient perceptions and experiences around LAI should inform equitable scale-up and effective implementation strategies. This study used qualitative research design relying on semi-structured interviews conducted among persons with HIV (PWH) who were either virally suppressed on oral treatment (n = 11) or had received at least one dose of injectables (n = 7). Approximately half of participants identified as male (10/18) and most identified as African American (17/18). Among participants on oral ART, many described the prospect of injectable treatment as likely convenient and discreet, relieving the stress of remembering to take daily pill. Nearly all had heard of LAI ART prior to the interview, often from television or internet commercials. Most were excited about less frequent dosing, though expressed concern about the logistics involved in coming to clinic every two months. Many expressed uncertainties regarding the relative effectiveness of LAI ART compared with oral therapy and were wary of potential pain related to injections. In contrast, all persons on LAI ART described injection-site soreness as manageable. In addition to acknowledging the convenience of every-two-month injections, some persons receiving LAI ART expressed relief by lifting the emotional stress of taking a daily-pill that reminded them of their HIV positive status. Emerging clinical trial data supports the individual and public health benefits of LAI ART, regardless of prior viral-suppression; our work adds to a growing body of literature demonstrating the potential psychological benefits associated with this novel treatment modality for PWH regardless of recent viral-suppression.

Patient Attitudes Toward Self- or Partner-, Friend-, or Family-Administered Long-acting Injectable Antiretroviral Therapy: A Mixed-Methods Study Across 3 Urban Human Immunodeficiency Virus Clinics.

Long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) offers a novel drug delivery option for persons with human immunodeficiency virus (PWH) but requires administration every 4 or 8 weeks by a medical professional. To facilitate LAI antiretroviral therapy (ART) scale-up, we evaluated patient interest in alternative administration approaches via a mixed-methods, serial cross-sectional study across 3 US HIV clinics. We surveyed PWH (December 2021 to May 2022) on appeal of self- or partner/friend/family-administered LAI-CAB/RPV; multivariable ordinal logistic regression explored associated characteristics. To contextualize survey results, we thematically analyzed semi-structured interview data collected from PWH (August 2020 to July 2021) on attitudes toward out-of-clinic LAI-ART administration. Among 370 surveyed PWH (median age, 46 years; 26% cisgender female, 59% Black, 56% sexual minority, 34% housing instability), self-administering LAI-CAB/RPV appealed to 67%. PWH who were White (adjusted odds ratio [aOR], 3.30 [95% confidence interval {CI}, 1.42-7.64]), stably housed (aOR, 2.16 [95% CI, 1.30-3.59]), or gay/bisexual (aOR, 1.81 [1.14-2.89]) were more likely to endorse self-administration. Fewer PWH (60%) reported partner/friend/family administration as appealing; adjusted models revealed similar sociodemographic preferences for this outcome. In 72 interviews, PWH noted that acceptability of out-of-clinic LAI-ART administration was qualified by convenience, prior injection experience, and potential fear of self-inflicted pain, dependence on others, and/or HIV disclosure. In a multisite sample of PWH, self- and, to a lesser extent, partner/friend/family-administration of LAI-CAB/RPV appealed to most; however, was less appealing among populations more impacted by health disparities. Innovative LAI-ART delivery options could free up in-clinic resources to focus scale-up among marginalized populations.

Long-Acting Injectable ART in Practice: A Mixed Methods Implementation Study Assessing the Feasibility of Using LAI ART in High Risk Populations and At Alternative Low Barrier Care Sites.

Long-acting injectable (LAI) antiretroviral therapy (ART) has the potential to change the lives of people living with HIV (PLWH). To ensure equitable access to new treatment modalities, we examined the feasibility and acceptability of administering Cabotegravir Rilpivirine Long Acting (CAB/RPV LA) to individuals who experience challenging social determinants of health (SDoH) and struggle with adherence to traditional oral ART. Quantitative and qualitative data were used to assess feasibility of utilizing ART at alternative clinic. Data were collected on individuals eligible to receive CAB/RPV LA at an alternative street-based clinic and on individuals receiving CAB/RPV LA at a traditional HIV clinic. After 6 months, participants were interviewed about their experience. Providers involved in the implementation were also interviewed about their experiences. Only one participant (out of 5) who received CAB/RPV LA at the alternative clinic received consistent treatment, whereas 17 out of 18 participants receiving CAB/RPV LA at the traditional clinic site were adherent. Participants and providers believed that LAI had potential for making treatment adherence easier, but identified several barriers, including discrepancies between patients' desires and their lifestyles, impact of LAI on interactions with the medical system, risk of resistance accompanying sub-optimal adherence, and need for a very high level of resources. While LAI has major potential benefits for high-risk patients, these benefits must be balanced with the complexities of implementation. Despite challenges that impacted study outcomes, improving treatment outcomes for PLWH requires addressing SDoH and substance use.

Acceptability of Long-Acting Injectable Antiretroviral Therapy Among People with HIV Receiving Care at Three Ryan White Funded Clinics in the United States

Understanding the acceptability of long-acting injectable antiretroviral therapy (LAI-ART) among people with HIV (PWH), especially priority populations, is essential for effective implementation. We conducted semi-structured interviews with patients in three Ryan White-funded HIV clinics in San Francisco, Chicago, and Atlanta. We employed maximal variation sampling across age, gender, race, ethnicity, and time living with HIV and oversampled for individuals with suboptimal clinical engagement. An 8-step hybrid deductive and inductive thematic analysis approach guided data analysis. Between August 2020 and July 2021, we conducted 72 interviews. Median age was 46 years; 28% were ciswomen, 7% transwomen, 44% Black/African-American and 35% Latinx, 43% endorsed a psychiatric diagnosis, 35% were experiencing homelessness/unstable housing, and 10% had recent substance use. Approximately 24% were sub-optimally engaged in care. We observed a spectrum of LAI-ART acceptability, ranging from enthusiasm to hesitancy to rejection. We also characterized four emergent orientations towards LAI-ART: innovator, pragmatist, deliberator, and skeptic. Overall, the majority of participants expressed favorable initial reactions towards LAI-ART. Most approached LAI-ART pragmatically, but acceptability was not static, often increasing over the course of the interview. Participants considered their HIV providers as essential for affirming personal relevance. HIV stigma, privacy concerns, and medical mistrust had varied impacts, sometimes facilitating and other times hindering personal relevance. These findings held across priority populations, specifically young adults, cis/trans women, racial/ethnic minorities, and individuals with suboptimal clinical engagement. Further research is needed to explore the transition from hypothetical acceptance to uptake and to confirm the actual benefits and drawbacks of this treatment.

Off-label use of long-acting injectable antiretroviral therapy: A Single Center Retrospective Review of Youth Living with HIV with detectable HIV RNA starting Injectable Therapy.

Nineteen youth living with HIV (YLWH) opted for injectable cabotegravir and rilpivirine without oral lead in and without achieving an undetectable HIV viral load (VL) for the 3 months prior to initiation. All achieved undetectable status within 3 months (3 injections) and maintained an undetectable status through 6-12 months of therapy.

Patient Education and Decision Support for Long-Acting Injectable HIV Antiretroviral Therapy: Protocol for Tool Development and Pilot Testing with Ryan White HIV/AIDS Program Medical Case Management Programs in New York.

Long-acting injectable (LAI) HIV antiretroviral therapy (ART) presents a major opportunity to facilitate and sustain HIV viral suppression, thus improving health and survival among people living with HIV and reducing the risk of onward transmission. However, realizing the public health potential of LAI ART requires reaching patients who face barriers to daily oral ART adherence and thus can clinically benefit from alternative treatment modalities. Ryan White HIV/AIDS Program Part A medical case management (MCM) programs provide an array of services to address barriers to HIV care and treatment among economically and socially marginalized people living with HIV. These programs have demonstrated effectiveness in improving engagement along the continuum of care, but findings of limited program impact on durable viral suppression highlight the need to further innovate and hone strategies to support long-term ART adherence. This study aims to adapt and expand Ryan White MCM service strategies to integrate LAI ART regimen options, with the larger goal of improving health outcomes in the populations that could most benefit from alternatives to daily oral ART regimens. In 3 phases of work involving patient and provider participants, this study uses role-specific focus groups to elicit perceptions of LAI versus daily oral ART; discrete choice experiment (DCE) surveys to quantify preferences for different ART delivery options and related supports; and a nonrandomized trial to assess the implementation and utility of newly developed tools at 6 partnering Ryan White HIV/AIDS Program Part A MCM programs based in urban, suburban, and semirural areas of New York. Findings from the focus groups and DCEs, as well as feedback from advisory board meetings, informed the design and selection of the tools: a patient-facing, 2-page fact sheet, including frequently asked questions and a side-by-side comparison of LAI with daily oral ART; a patient-facing informational video available on YouTube (Google Inc); and a patient-provider decision aid. Implementation outcomes, measured through provider interviews, surveys, and service reporting, will guide further specification of strategies to integrate LAI ART options into MCM program workflows. The study was funded in late April 2021 and received approval from the institutional review board in May 2021 under protocol 20-096. Focus groups were conducted in late 2021 (n=21), DCEs ran from June 2022 to January 2023 (n=378), and tools for piloting were developed by May 2023. The trial (May 2023 through January 2024) has enrolled >200 patients. This study is designed to provide evidence regarding the acceptability, feasibility, appropriateness, and utility of a package of patient-oriented tools for comparing and deciding between LAI ART and daily oral ART options. Study strengths include formative work to guide tool development, a mixed methods approach, and the testing of tools in real-world safety-net service settings. Clinicaltrials.gov NCT05833542; https://clinicaltrials.gov/study/NCT05833542. DERR1-10.2196/56892.

Long-Acting Injectable Antiretrovirals for HIV Treatment: A Multi-Site Qualitative Study of Clinic-Level Barriers to Implementation in the United States.

Long-acting injectable antiretroviral therapy (LAI ART) has the potential to address adherence obstacles associated with daily oral ART, leading to enhanced treatment uptake, adherence, and viral suppression among people living with HIV (PLWH). Yet, its potential may be limited due to ongoing disparities in availability and accessibility. We need a better understanding of the organizational context surrounding the implementation of LAI ART, and to inform its widespread rollout, we conducted 38 in-depth interviews with medical and social service providers who offer HIV care at private and hospital-based clinics across six US cities. Our findings highlight real-world implementation barriers outside of clinical trial settings. Providers described ongoing and anticipated barriers across three stages of LAI ART implementation: (1) Patient enrollment (challenges registering patients and limited insurance coverage), (2) medication delivery (insufficient personnel and resources), and (3) leadership and management (lack of interprofessional coordination and a lack of programming guidelines). Providers described how these barriers would have a disproportionate impact on under-resourced clinics, potentially exacerbating existing disparities in LAI ART access and adherence. Our findings suggest strategies that clinic leadership, policymakers, and other stakeholders can pursue to promote rapid and equitable LAI ART implementation in clinics across the United States. Resource and staffing investments could support clinics to begin, sustain, and scale up LAI ART delivery; additionally, the establishment of guidelines and tools could facilitate wider adoption of LAI ART across clinical settings. These efforts are crucial to promote resourced, standardized, and equitable implementation of LAI ART and maximize its potential to help end the HIV epidemic.

"What Is the Benefit?": Perceptions and Preferences for Long-Acting Injectable Antiretroviral Therapy Among People Living With HIV.

Long-acting injectable antiretroviral therapy (LA-ART) expands treatment options for people living with HIV (PLWH). This qualitative study characterizes LA-ART awareness, perceptions, and preferences among PLWH engaged in HIV care. From 2019 through 2021, we conducted semistructured in-depth interviews with 71 PLWH sampled from three clinics in three U.S. settings (North Carolina, Washington, DC, Massachusetts). Transcripts were analyzed using narrative and thematic techniques. Participant mean age was 46 years (range 24-72); most were cisgender men (55%) and virally suppressed (73%). Most participants had not heard of LA-ART and reacted with a mix of excitement and cautiousness. Potential LA-ART benefits included easier adherence, privacy, and effectiveness; concerns included effectiveness, side effects, costs, and increased clinic visits. Participants appreciated that LA-ART could support achieving and sustaining viral suppression. To inform their decision, participants wanted more information and convenient access and administration. Findings indicated that a shared decision-making approach and economic and logistical support for PLWH could facilitate LA-ART uptake.

1609. Engagement in Care, Awareness, and Interest in Long-Acting Injectable Anti-Retroviral Therapy

Abstract Background Long Acting Injectable (LAI) therapy to treat HIV is now a viable alternative to daily oral medications. The success of early roll-out of LAI to eligible patients requires a better understanding of patients’ awareness and interest in this novel therapy. Methods We administered an electronic survey to patients attending an urban HIV clinic in the US South (Duke University). Eligible participants were 18+ years old with a most recent HIV-1 viral load &amp;lt; 200 copies/ml, without any evidence of genotypic resistance to LAI components or chronic hepatitis B. Survey recipients were asked questions on their current treatment, their awareness and interest in LAI, and were asked to rate common benefits and concerns associated with LAI. After probing awareness of LAI, patients were provided further details on LAI for consideration for the rest of the survey. The survey also included the 3-item Brief Index of Engagement in HIV Care, a patient-reported measure of engagement in HIV care that has predicted future retention in care outcomes. Results Between January-April 2023, 480 patients were screened; 319 were found to be eligible, and 159 (50%) completed the survey. 73% were male; 44% Black, 7% Latinx; mean age was 49. The majority (119, 76%) were aware of injectable treatments, and 87 (56%) were interested in LAI. Among proposed benefits of injectables, ease of travel without pills, fewer medication interactions, and lack of daily pill-taking were most appealing. Among proposed concerns with injectables, out of pocket cost and insurance coverage of the new medicine were most worrisome. Black patients were more likely to be interested in LAI, and interested patients tended to be younger, single, and more recently diagnosed with HIV. Overall, patients surveyed were highly engaged in care (Mean 4.5/5, SD: 0.5)., but engagement was not predictive of awareness or interest in LAI. This table summarizes and compares the key patient characteristics between the patients who rated themselves interested or not interested in LAI Conclusion As we roll out LAI in real world settings, it will be helpful to characterize which patients are most interested in order to optimize uptake and benefit. Ease of travel without pills, not having to remember daily doses, and fewer medication interactions were the most appealing reasons, while concerns about both insurance coverage and out of pocket cost will need to be addressed. Disclosures Mehri McKellar, MD, Gilead Sciences, Inc: Grant/Research Support

1585. The Annual Cost per Newly Virally-Suppressed Person with HIV in Those Starting Long-Acting Injectable Antiretroviral Therapy with Detectable Viremia in a Safety-Net Clinic in San Francisco

Abstract Background Long-acting injectable cabotegravir/rilpivirine (CAB/RPV-LA) holds promise to effectively treat people with HIV (PWH) who are unable to achieve or maintain viral suppression on oral antiretroviral therapy (ART). Methods We employed standard micro-costing techniques to identify the resources and associated annual costs to provide CAB/RPV-LA to those initiating it with detectable viremia at San Francisco General Hospital’s Ward 86 clinic, accounting for q4week vs. q8week injections. Through structured interviews with service providers and administrators, we elicited the time in minutes for each staff member to perform each task, using mid-points for ranges. Person-minutes were applied to the personnel compensation rate to derive the total personnel cost per person. One-time costs required for CAB/RPV-LA initiation were distributed over 29.3 years, the expected average duration of treatment. We used the Medi-Cal reimbursement rate for the cost of CAB/RPV-LA and a literature-based estimate of other medical care costs of treating people with viral suppression to derive the total variable cost of CAB/RPV-LA treatment from the payer’s perspective. This result was adjusted by the viral suppression success rate at Ward 86 (96.5%) to derive the cost per new virally-suppressed PWH. We deducted the cost of standard ART and medical care to derive the incremental cost per additional virally suppressed PWH. Costs were adjusted to 2022 dollars. Results The annual variable cost of providing CAB/RPV-LA was $36,511, $35,252 for CAB/RPV-LA medication and $1,259 for other variable costs, mainly personnel. Including other medical care costs yielded a total annual medical care cost of $43,945 per newly virally-suppressed person. Deducting the cost of standard care, $42,276, from this sum suggests an incremental annual variable cost for CAB/RPV-LA of $1,668 per newly virally-suppressed person. If the cost of CAB/RPV-LA were reduced slightly, e.g. to 90% of current cost, CAB/RPV-LA would generate net savings of $1,985. Table 1 Annual Cost of Providing CAB/RPV-LA and Cost per Newly Suppressed Person with HIV Conclusion We found that the additional cost per newly-suppressed PWH was $1,668. CAB/RPV is likely to be highly cost-effective for this population. Modest reductions in CAB/RPV-LA price could render it cost-saving from a health care payer perspective. Disclosures Jonathan Colasanti, MD, MSPH, DKB MED LLC: Honoraria|Prime Education LLC: Advisor/Consultant Katerina Christopoulos, MD, MPH, Gilead Sciences: Advisor/Consultant

The New Era of Long-Acting Antiretroviral Therapy: When and Why to Make the Switch.

Despite the availability of safe and effective oral combination antiretroviral therapy, barriers to maintaining viral suppression remain a challenge to ending the HIV epidemic. Long-acting injectable antiretroviral therapy was developed as an alternative to daily oral therapy. This review summarizes the current literature on the efficacy of long-acting cabotegravir plus rilpivirine for the treatment of HIV-1, reasons to switch to injectable therapy, and barriers to switching. Long-acting cabotegravir plus rilpivirine is safe and effective in maintaining HIV-1 virologic suppression. Ideal candidates for switching to long-acting cabotegravir plus rilpivirine are virologically suppressed on oral regimens with good adherence and no history of virologic failure or baseline resistance. Indications to switch to injectable therapy include patient preference, the potential for improved adherence, and avoidance of adverse effects. Implementation research is needed to assess and overcome system barriers. Long-acting cabotegravir plus rilpivirine is a novel alternative to oral antiretrovirals, with the potential to improve adherence and quality of life in people with HIV.