Long-acting Injectable Antiretroviral Therapy Research Articles

Patient attitudes towards self- or partner-, friend-, or family-administered long-acting injectable antiretroviral therapy: a mixed-methods study across three urban HIV clinics

Abstract Background Long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) offers a novel drug-delivery option for persons with HIV (PWH), but requires administration every 4-or-8-weeks by a medical professional, thus increasing demand for clinical services amid workforce shortages. Methods With the goal of facilitating LAI-antiretroviral therapy (ART) scale-up, we evaluated patient interest in alternative administration approaches via a mixed-methods, serial cross-sectional study across three U.S. urban HIV clinics. From 12/2021-05/2022, we surveyed PWH on appeal of self- or partner/friend/family-administered LAI-CAB/RPV; multivariable ordinal logistic regression explored characteristics associated with appeal. To contextualize survey results, we thematically analyzed semi-structured interview data collected from PWH between 08/2020-07/2021 on attitudes towards out-of-clinic LAI-ART administration. Results Among 370 surveyed PWH (median age 46 years, 26% cis-female, 59% Black, 56% sexual minority, 34% housing instability), self-administering LAI-CAB/RPV appealed to 67%. PWH who were White (aOR 3.30 [95%CI 1.42,7.64]), stably housed (aOR 2.16 [1.30,3.59]) or gay/bisexual (aOR 1.81, [1.14,2.89]) had higher odds of endorsing self-administration as appealing. Slightly fewer PWH (60%) reported partner/friend/family-administration as appealing; adjusted models revealed similar sociodemographic preferences for this outcome. In 72 interviews, PWH noted 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. Conclusions In a multisite sample of PWH, self- and to a lesser extent partner/friend/family-administration of LAI-CAB/RPV appealed to the majority, however, appeal was greater for populations less impacted by health disparities. Innovative LAI-ART delivery options could potentially 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.

Likelihood of trying long-acting injectable antiretroviral therapy (LAI ART) among women with HIV in nine sites across the United States

Likelihood of trying long-acting injectable antiretroviral therapy (LAI ART) among women with HIV in nine sites across the United States

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 46years; 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 < 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.

Implementing long-acting injectable antiretroviral treatments in Senegal: issues, challenges and conditions for introducing them. Qualitative study with healthcare providers and patients

ABSTRACT Long-acting injectable antiretroviral therapy (LAI-ART) can offer people living with HIV (PLWH) a promising alternative to daily oral therapy. This article highlights the issues, challenges and conditions related to introducing LAI-ART into the social lives of PLWH and HIV-care practices in Senegal. Semi-structured interviews were conducted with 42 PLWH in two hospital care units in Dakar and with 13 healthcare providers and 6 peer educators. Interviews were transcribed, thematically coded and analysed using a cross-sectional approach. We found three key issues. First, simplifying living with HIV: PLWH respondents perceive LAI-ART as an opportunity to ease the burden associated with taking tablets. This enthusiasm may however be qualified by an ambivalent relationship with injections and is subject to certain conditions. Second, certain constraints linked to the medicalisation of care are to be anticipated, including the obligation to go to the hospital every two months for injections. These findings foreshadow the new management work for medical follow-up expected to fall on PLWH and caregivers. Third, the challenges of introducing LAI-ART in Senegal are to ensure adequate organisation of care and supply and sustainability of the program. These results clarify how to implement programs to introduce LAI-ART into real life in the West African context.

Perceptions of Long-Acting Injectable Antiretroviral Therapy Among People Living with HIV Who Use Drugs and Service Providers: a Qualitative Analysis in Rhode Island.

Long-acting injectable antiretroviral therapy (LAI-ART) is a novel method to deliver HIV treatment, and the first regimen was approved in the USA in 2021. LAI-ART may mitigate barriers to oral treatment adherence, but little is known about LAI-ART perceptions among people living with HIV (PLWH) who use drugs, despite these populations facing greater barriers to treatment retention and ART adherence. We assessed LAI-ART perceptions and implementation considerations among PLWH who use drugs and health and ancillary service providers in Rhode Island. Data was collected from November 2021 to September 2022, and include in-depth interviews with 15 PLWH who use drugs and two focus groups with HIV clinical providers (n = 8) and ancillary service providers (n = 5) working with PLWH who use drugs. Data were analyzed thematically, with attention paid to how levels of structural vulnerability and social-structural environments shaped participants' LAI-ART perceptions and the HIV care continuum. Willingness to consider LAI-ART was impacted by HIV outcomes (e.g., viral suppression) and previous experiences with oral regimens, with those on stable regimens reluctant to consider alternative therapies. However, LAI-ART was seen as potentially improving HIV outcomes for PLWH who use drugs and enhancing people's quality of life by reducing stress related to daily pill-taking. Recommendations for optimal implementation of LAI-ART varied across participants and included decentralized approaches to delivery. HIV care delivery must consider the needs of PLWH who use drugs. Developing patient-centered and community-based delivery approaches to LAI-ART may address adherence challenges specific to PLWH who use drugs.

Perspectives on long-acting injectable HIV antiretroviral therapy at an alternative care site: a qualitative study of people with HIV experiencing substance use and/or housing instability

IntroductionAdherence to daily oral antiretroviral therapy (ART) and regular clinic appointments can be challenging for individuals who experience adverse social determinants of health. Long-acting injectable ART administered outside of traditional clinic settings may be a promising solution to adherence barriers, but additional research is needed to assess patients’ perspectives. This study assessed perspectives of people living with HIV (PLWH) who had difficulty with adherence to traditional HIV care models and evaluated feasibility and acceptability of receiving a long-acting ART injection at a location outside of a traditional HIV clinic to address barriers to HIV care.MethodsQualitative interviews (n = 26) were conducted with PLWH who had experienced barriers to adherence. Participants were referred to the study by staff from Project Trust, a drop in harm reduction and sexually transmitted infection/HIV clinic. The interviews were conducted between May and November 2021. Interviews were recorded, professionally transcribed, coded, and analyzed qualitatively using the integrated-Promoting Action on Research Implementation in Health Services framework.ResultsWe identified 6 main themes regarding the acceptability of receiving a long-acting injection to treat HIV, and the acceptability and feasibility of receiving injections at an alternative care site. Participants specified that they: (1) have a general understanding about their HIV care and the importance of ART adherence, (2) prefer a long-acting injection over a daily pill regimen, (3) expressed concerns about injection safety and efficacy, (4) had specific logistical aspects around the delivery of long-acting injections, including location of injection administration, that they believed would improve their ability to adhere, (5) have confidence that they can become undetectable and then complete the oral lead-in required to begin receiving the injection, and (6) see potential barriers that remain a concern for successful adherence to long-acting injections.ConclusionTo better treat HIV among people who are living with challenging social determinants of health, interventions that include a long-acting injection in a non-traditional care setting may prove to be a promising treatment option.

Factors Associated with Preferences for Long-Acting Injectable Antiretroviral Therapy Among Adolescents and Young People Living with HIV in South Africa

Long-acting injectable anti-retroviral therapy (LAART) may overcome barriers to long-term adherence and improve the survival of adolescents and young people living with HIV (AYLHIV). Research on the acceptability of LAART for this age-group is limited. We asked 953 AYLHIV about their preferred (theoretical) ART mode of delivery (pill, injectable, or other) in 2017–2018, before LAART was available or known to AYLHIV in South Africa. One in eight (12%) AYLHIV preferred LAART over single or multiple pill regimens. In multivariate analyses, six factors were associated with LAART preference: medication stock-outs (aOR = 2.56, 95% CI 1.40–4.68, p = 0.002), experiencing side-effects (aOR = 1.84, 95% CI 1.15–2.97, p = 0.012), pill-burden (aOR = 1.88, 95% CI 1.20–2.94, p = 0.006), past-year treatment changes (aOR = 1.63, 95% CI 1.06–2.51, p = 0.025), any HIV stigma (aOR = 2.22, 95% CI 1.39–3.53, p ≤ 0.001) and recent ART initiation (aOR = 2.02, 95% CI 1.09–3.74, p = 0.025). In marginal effects modelling, 66% of adolescents who experienced all factors were likely to prefer LAART, highlighting the potential high acceptability of LAART among adolescents and young people living with HIV struggling to adhere and have good HIV treatment outcomes. Adolescent boys who reported high ART pill burden were more likely to prefer LAART than their female peers in moderation analyses, suggesting that LAART may be particularly important to improve treatment outcomes among male AYLHIV as they become older. Adding LAART to existing treatment options for AYLHIV, particularly higher risk groups, would support AYLHIV to attain and sustain viral suppression—the third 95, and reduce their risk of AIDS-related mortality.

Long-acting injectable antiretroviral therapy: will it change the future of HIV treatment?

The treatment of human immunodeficiency virus (HIV) has greatly advanced over the past few decades from complex regimens, with high toxicities, multiple daily dosing, and incomplete viral suppression to more simplified, highly effective, daily oral regimens. Although these advancements greatly improved access and tolerability, the need for daily antiretroviral (ARV) administration remained until recently. With long-acting (LA) injectable ARV options emerging, patients may choose how they want to receive treatment. By eliminating the barrier of daily medication adherence, LA injectable ARV formulations have the potential to not only improve health outcomes for the individual, but also the community by reducing HIV transmission. At the time of this writing cabotegravir/rilpivirine (LA-CAB/RPV) is the only LA injectable ARV regimen approved as a complete regimen for the treatment of HIV in adults and adolescents (⩾35 kg and ⩾12 years of age) who are virologically suppressed. However, additional studies of LA-CAB/RPV in expanded populations, and of other LA ARVs, are underway. The goal of this article was to summarize clinical data and review pertinent clinical considerations for the use of LA-CAB/RPV in the management of HIV.

1253. Acceptability and feasibility of long-acting injectable antiretroviral therapy for persons who inject drugs in Vietnam: using the Consolidated Framework on Implementation Research to identify determinants and inform implementation strategies

Abstract Background Long-acting injectable antiretroviral therapy (LAI) is an exciting alternative to daily oral ART. Less frequent dosing afforded by LAI may be especially pertinent for persons who inject drugs (PWID), who experience more HIV-related mortality largely driven by inadequate ART adherence. We used the Consolidated Framework on Implementation Research (CFIR) to characterize determinants of LAI implementation, focusing on use among PWID, in Hanoi, Vietnam. Methods We conducted in-depth interviews with HIV-infected PWID, ART providers, and policymakers using purposive sampling, recruiting respondents with diverse ART experience from public HIV/ART clinics and national regulatory agencies. Participants were briefed regarding LAI ART, including administration, effectiveness, side effects, and dosing frequency. Data were coded and analyzed using thematic analysis. Results We interviewed 19 PWID, 14 providers, and five policymakers (February-November, 2021). We identified recurrent themes in CFIR domains. Intervention: All informants were excited about LAI, citing convenience and discrete dosing as major facilitators. Surprisingly, provider concerns, including more frequent clinic visits and injection reactions, were rarely voiced by PWID who described monthly injections as similar to current visit frequency and cited “high pain tolerance.” Outer: Providers and policymakers were eager to offer patients ART choice but were divided as to if LAI distribution should proceed with sub-population prioritization. Inner: Providers described personnel and clinic logistic concerns but were confident these could be addressed. Individual: Providers were motivated and confident in their ability to deliver LAI. Process: Transitions to new ART and provision of COVID-19 vaccines were frequently invoked by providers and policymakers as interventions informing LAI implementation. FigureDeterminants of LAI ART implementation in Vietnam using the domains of the Consolidated Framework on Implementation Research Conclusion Using CFIR, we identified multiple determinants of LAI implementation in Vietnam. Stakeholders agreed that LAI was feasible and acceptable. Medication tolerance and efficacy concerns highlight the importance of patient and provider education. Areas where stakeholders diverge should be considered in designing LAI implementation strategies. Disclosures Joseph J. Eron, MD, Adagio Therapeutics: data safety monitoring committee|Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Glaxo Smith Kline: Advisor/Consultant|Merck: Advisor/Consultant|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support.

Patient preferences and health state utilities associated with the treatment process of antiretroviral therapy for people living with HIV

PurposePeople living with HIV (PLHIV) have reported challenges associated with daily oral antiretroviral therapy (ART), including missed doses, negative psychological impact, and difficulty remaining discreet while at home or traveling. Recently approved long-acting injectable (LAI) ART may help eliminate these concerns. The purpose of this study was to examine patient preferences and estimate health state utilities associated with oral and LAI treatment for ART.MethodsFour health state vignettes were developed based on published literature, clinician interviews, and a pilot study. All vignettes included the same description of HIV, but differed in treatment regimens: (A) single daily oral tablet, (B) two daily oral tablets, (C) injections once monthly, and (D) injections every two months. PLHIV in the UK reported their preferences and valued the health states in time trade-off utility interviews.ResultsThe sample included 201 PLHIV (83.1% male; mean age = 44.9y). The health states frequently selected as most preferable were D (n = 119; 59.2%) and A (n = 75; 37.3%). Utility differences among health states were relatively small, which is typical for treatment process utilities (mean utilities: A, 0.908; B, 0.905; C, 0.900; D, 0.910). Statistically significant differences in utility were found for one vs. two tablets and injections every month vs. every two months (p < 0.001). Participants’ quotations highlight the wide range of reasons for treatment process preferences.ConclusionsCurrent results indicate that many PLHIV would prefer LAI ART. The reported utilities may be useful in economic modeling comparing oral vs. LAI ART.

Tenofovir use is associated with a decreased risk of hepatocellular carcinoma among men with HIV irrespective of coinfection status

Tenofovir is recommended as part of the first-line antiretroviral therapy (ART) to treat people living with HIV (PLWH) with HBV coinfection. However, the effects of tenofovir-containing ART on hepatocellular carcinoma (HCC) risk among PLWH with/without chronic hepatitis virus infections remain unclear. This study included 23,838 PLWH. All of them were males aged ≥20 years and followed prospectively during 2000-2017. Four major nationwide registries - the Human Immunodeficiency Virus surveillance database, Taiwan Cancer Registry, Death Certification System, and National Health Insurance Database - were applied to define ART and comorbidities and ascertain newly diagnosed HCC. Tenofovir-containing ART was identified through prescription records. Cox proportional hazards models were used to determine the association of tenofovir use with HCC incidence. HCC incidence was lower among ever users of tenofovir than among never users (24.2 and 85.7 per 100,000 person-years, respectively). Ever users had significantly reduced HCC risk (adjusted hazard ratio 0.20, 95% CI 0.13-0.31). The effect of tenofovir use on reduced risk for HCC consistently favored never users across many prespecified subgroups, including HBV or HCV coinfection (p <0.05). The findings were consistent in subgroups of PLWH diagnosed with HIV before tenofovir's approval and in those born before the nationwide roll-out of neonatal HBV vaccination. Our findings underscore the need for randomized controlled trials of tenofovir in combination with long-acting injectable ART regimens to assess its safety and efficacy in PLWH, particularly in those with HBV or HCV coinfection. Tenofovir's effect on the risk of hepatocellular carcinoma (HCC) among people living with HIV with hepatitis B or C coinfection remains under investigated. This nationwide prospective cohort study, comprising 23,838 men living with HIV, showed that tenofovir-containing antiretroviral therapy was associated with reduced risk of HCC (adjusted relative risk: 0.20, 95% CI 0.13-0.31), which was consistently observed across many prespecified subgroups. The effect of tenofovir use on HCC risk should be further investigated in PLWH, particularly following the development of long-acting injectable ART regimens.

Barriers to Uptake of Long-Acting Antiretroviral Products for Treatment and Prevention of HIV in Low- and Middle-Income Countries (LMICs).

Long-acting injectable antiretroviral therapy (LA ART) has been found to be non-inferior to daily oral ART in phase 3 clinical trials and is poised to soon enter routine clinical care. This treatment modality has the potential to address many barriers to daily oral ART adherence among people living with human immunodeficiency virus (HIV) and for HIV Pre-Exposure prevention. Data from the Patient Reported Outcomes (PROs) showed high rates of satisfaction, acceptability, tolerability and preference for the LA regimen, compared with the daily oral treatment. Once LA ART is available, access and uptake will be limited because of current knowledge gaps in the use of these agents and multiple challenges many specific to low-income and middle-income countries, where the epidemic is most concentrated and HIV prevention and treatment options are limited. These gaps will lead to multiple systems-level and individual-level barriers to implementation. Anticipating and addressing these gaps and barriers will help fulfill the promise of these agents against the pandemic.