Demonstration Project of Long-Acting Antiretroviral Therapy in a Diverse Population of People With HIV

Gandhi, Monica; Hickey, Matthew D.; Imbert, Elizabeth; Grochowski, Janet R.; Mayorga-Munoz, Francis; Szumowski, John D.; Oskarsson, Jon; Shiels, Mary; Sauceda, John A; Salazar, Jorge D.; Dilworth, Samantha E.; Nguyen, Jennifer; Glidden, David V.; Havlir, Diane V.; Christopoulos, Katerina

doi:10.7326/m23-0788

Cited by 41 publications

(19 citation statements)

References 20 publications

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“…Two patients were initiated on CAB/RPV in collaboration with the San Francisco General Hospital HIV Clinic (“Ward 86”) and have earlier data captured in previously published demonstration projects. 14,15 After a mean of 9.67 months since initiating LA-ART (SD: 8.30; range: 1–24 months), 17 of 18 (94%) patients achieved or maintained virologic suppression (Fig. 1), 3 of whom transitioned to the 8-week CAB/RPV dosing interval.…”

Section: Resultsmentioning

confidence: 99%

“…13 CAB/RPV is currently FDA-approved only for patients with baseline HIV virologic suppression—reflecting the characteristics of participants in clinical trials upon which regulatory approval was based. 8–10 However, real-world demonstration projects at academic medical centers have suggested that CAB/RPV may provide robust virologic suppression even among patients with baseline HIV viremia who have experienced challenges adhering to oral ART, 14–17 although data from compassionate use settings have been more mixed. 18…”

Section: Introductionmentioning

confidence: 99%

“…Such a “direct-to-inject” approach for providing LA antiretrovirals at 4- and 8-week intervals or even less frequently to patients with baseline viremia opens possibilities for innovative treatment methodologies that may mitigate structural barriers to medication adherence and provide strategic benefit to PEH and people who use drugs. 7,14–16 While recent qualitative studies demonstrate significant interest in the use of LA antiretrovirals among these populations, they also highlight logistical concerns, including needs for delivery within community-based settings and alternative care sites. 19,20 To date, no published studies have evaluated the feasibility of administering LA-ART or LA-PrEP in homeless health centers or community-based clinics designated to serve patients known to have a high burden of comorbid substance use and mental illness.…”

Section: Introductionmentioning

confidence: 99%

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Feasibility of Implementing a Low-Barrier Long-Acting Injectable Antiretroviral Program for HIV Treatment and Prevention for People Experiencing Homelessness

Mehtani,

Strough,

Strieff

et al. 2024

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background: Long-acting (LA) antiretrovirals may provide meaningful benefit to people who use drugs and people experiencing homelessness (PEH) who face disproportionate structural and psychosocial barriers in adhering to daily oral HIV antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP), but their use in these populations has not been studied. Setting: The Maria X. Martinez Health Resource Center is a low-barrier (e.g., no appointment) community-based clinic serving San Francisco PEH. Methods: A multidisciplinary care model with robust monitoring and outreach support was developed to provide LA-ART and LA-PrEP to eligible patients experiencing difficulties adhering to oral antiretrovirals. Feasibility was assessed by evaluating rates of HIV viremia and on-time injections among patients receiving LA antiretrovirals over the first 24 months of program implementation. Results: Between November 2021 and November 2023, 33 patients initiated LA-ART or LA-PrEP (median age, 37 years; 27% transgender/non-binary; 73% non-White; 27% street homeless; 52% sheltered homeless; 30% with opioid use disorder; 82% with methamphetamine use disorder). Among 18 patients with HIV, 14 initiated LA-ART injections with detectable viremia (median CD4 count, 340 cells/mm3; mean log10 viral load, 3.53; standard deviation [SD], 1.62), eight had never previously been virally suppressed, and all but one achieved or maintained virologic suppression (mean, 9.67 months; SD, 8.30). Among 15 LA-PrEP patients, all remained HIV-negative (mean, 4.73 months; SD, 2.89). Of 224 injections administered total, 8% were delayed >7 days. Discussion: The implementation of LA antiretrovirals is feasible in low-barrier, highly supportive clinical settings serving vulnerable PEH. Expansion of such programs will be critical to Ending the HIV Epidemic.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Feasibility of Implementing a Low-Barrier Long-Acting Injectable Antiretroviral Program for HIV Treatment and Prevention for People Experiencing Homelessness

Mehtani,

Strough,

Strieff

et al. 2024

JAIDS Journal of Acquired Immune Deficiency Syndromes

Self Cite

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“…Interestingly, even among viremic adult patients in a real-world cohort, high rates of virologic suppression were observed with IM-LA CAB/RPV (with the same rate of failure as in registrational clinical trials of 1.5%) [87].…”

Section: Long-acting Antiretroviralsmentioning

confidence: 85%

Gen Z and HIV—Strategies for Optimizing the Care of the Next Generation of Adolescents Living with HIV

Dufour,

Fougère,

Goetghebuer

et al. 2023

Viruses

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The management of adolescents living with HIV represents a particular challenge in the global response to HIV. The challenges specific to this age group include difficulties engaging and maintaining them in care, challenges with transition to adult care, and limited therapeutic options for treatment-experienced patients, all of which have been jeopardized by the COVID-19 pandemic. This paper summarizes some of the challenges in managing adolescents living with HIV, as well as some of the most recent and innovative therapeutic approaches in this population.

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“…The potential benefits and risks of LAI CAB/RPV for individuals with detectable viremia and/or a history of missed doses of oral ART is a topic of ongoing study and debate. Promising data on the potential role for LAI CAB/RPV in the setting of viremia have been published in case reports, case series, and one open-label demonstration study, though national guidelines still advise against prescribing this option in the setting of viremia [2–6]. The findings from SCOLTA indicate that there are clinical instances in which LAI CAB/RPV may be the optimal ART choice in the setting of low-level viremia, and greater detail and understanding of the cases in which this option was selected despite viremia would benefit the field.…”

mentioning

confidence: 99%

Early adopters of long-acting injectable cabotegravir/rilpivirine: what lessons can we learn?

Wood,

Kumarasamy

2024

Aids

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Demonstration Project of Long-Acting Antiretroviral Therapy in a Diverse Population of People With HIV

Cited by 41 publications

References 20 publications

Feasibility of Implementing a Low-Barrier Long-Acting Injectable Antiretroviral Program for HIV Treatment and Prevention for People Experiencing Homelessness

Feasibility of Implementing a Low-Barrier Long-Acting Injectable Antiretroviral Program for HIV Treatment and Prevention for People Experiencing Homelessness

Gen Z and HIV—Strategies for Optimizing the Care of the Next Generation of Adolescents Living with HIV

Early adopters of long-acting injectable cabotegravir/rilpivirine: what lessons can we learn?

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