CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

1108 Implementing Long-Acting Cabotegravir for HIV Preexposure Prophylaxis in a Large Urban HIV Clinic Christian Turner 1 , Gabriel Wagner 1 , Allan Pfeil 1 , Aaron Willcott 1 , Tyler Lonergan 1 , Lucas Hill 1 , Jill Blumenthal 2 1 University of California San Diego, La Jolla, CA, USA, 2 University of California San Diego, San Diego, CA, USA Background: Long-acting cabotegravir (CAB-LA) offers a novel HIV PrEP option for individuals unable to effectively take or tolerate oral PrEP and may expand access to PrEP to populations that have been difficult to reach. We describe the development of a CAB-LA program in a large urban HIV clinic and characterize the program's first patient cohort. Methods: The UC San Diego Owen Clinic is a Ryan White-funded HIV primary care clinic that also provides PrEP to over 400 patients. Starting in January 2021, individuals interested in initiating CAB-LA were referred to a PrEP pharmacist and a navigator for an insurance check and as-soon-as same-day initiation with on-site delivery of injection. Patients were included who initiated CAB-LA and had at least one follow-up injection. Demographic data were collected through EMR review, and reasons for discontinuation and missed doses were documented and continually reviewed. Logistic regression was performed to evaluate predictors of discontinuing CAB-LA. Results: Between 1/2021 and 6/2023, providers referred 215 patients to the CAB-LA program, and 162 patients (75%) received at least one injection. Median age was 31.5 (IQR 27, 39) among 48% White, 3% Black and 30% other race individuals with 40% (n=65) reporting Hispanic ethnicity. Ninety-one percent (n=148) identified as cisgender male, and 78% (n=126) reported previous oral PrEP use. Twenty-six (16%) discontinued therapy, with n=11 citing injection site reactions or pain caused by injection. Other reasons for discontinuation included moving or transferring care (n=4), change in HIV risk (n=3), insurance change (n=3), lost-to-follow up (n=3), and other side effects (n=2). Ninety patients were covered through pharmacy benefits (42 with Medicaid, 48 with private insurance), 46 through medical benefits, and 28 by a patient assistance program (PAP). Younger age (OR 1.05, 95% CI 1.01-1.11, p=0.049), having non-PAP coverage (OR 12.5, 95% CI 1.4-111.11, p=0.013), and missing an injection (OR 7.68, 95% CI 1.53-38.65, p=0.023) were associated with discontinuation of CAB-LA. Conclusion: We observed robust uptake of CAB-LA for HIV prevention among individuals with a clinical need or preference for non-oral PrEP. Most were prior oral PrEP users, highlighting the desire for choice among people who use PrEP for HIV prevention. Younger individuals, those without patient assistance program support and those who miss injection doses may need additional support to keep them engaged in CAB-LA. 1109 Preexposure Prophylaxis With Cabotegravir Long-Acting Injectable in the OPERA Cohort Anthony Mills 1 , Laurence Brunet 2 , Karam Mounzer 3 , Michael B. Wohlfeiler 4 , Kevin R. Frost 5 , Ricky K. Hsu 6 , Gerald Pierone 7 , Michael Sension 8 , Philip C. Lackey 9 , Jennifer S. Fusco 2 , Carolyn Brown 10 , Vani Vannappagari 10 , Michael Aboud 10 , Piotr Budnik 11 , Gregory P. Fusco 2 1 Men's Health Foundation, Los Angeles, CA, USA, 2 Epividian, Raleigh, NC, USA, 3 Philadelphia FIGHT, Philadelphia, PA, USA, 4 AIDS Healthcare Foundation, Miami, FL, USA, 5 amfAR, New York, NY, USA, 6 AIDS Healthcare Foundation, New York, NY, USA, 7 Whole Family Health Center, Vero Beach, FL, USA, 8 CAN Community Health, Sarasota, FL, USA, 9 Wake Forest University, Winston-Salem, NC, USA, 10 ViiV Healthcare, Durham, NC, USA, 11 ViiV Healthcare, London, United Kingdom Background: Cabotegravir long-acting (CAB LA) was approved as pre exposure prophylaxis (PrEP) for the prevention of HIV by the FDA on 20DEC2021. It is initiated with two 600mg injections given one month apart (initiation injections), followed by a 600mg injection every two months. We aimed to describe uptake of CAB LA for PrEP and injection patterns in routine clinical care in the US. Methods: Individuals ≥12 years old who received ≥1 CAB LA injection between 21DEC2021 and 31MAR2023 in the OPERA cohort were followed through 30JUN2023. Incomplete initiation was defined as the receipt of the first injection, with no additional injection within 68 days of the first. Discontinuation and non-adherence were assessed among complete initiators. Discontinuation was defined as ≥128 days without a CAB LA injection. Non-adherence consisted of ≥1 delayed or missed injection (see Table for definitions). Baseline characteristics were compared between adherent and non-adherent individuals. Multivariable logistic regression was used to assess predictors of non-adherence.

1107 First Case of HIV Seroconversion With Emergence of InSTI Resistance on CAB-LA PrEP in Routine Care Catherine A Koss 1 , Monica Gandhi 1 , Elias K. Halvas 2 , Hideaki Okochi 1 , Carolyn Chu 1 , David V. Glidden 1 , Lisa Georgetti Gomez 1 , Amy L. Heaps 2 , Amy A. Conroy 1 , Michael Tran 3 , Bhavna Chohan 4 , James Ayieko 5 , John W. Mellors 2 , Urvi M. Parikh 2 , for the SeroPrEP Study Team 1 University of California San Francisco, San Francisco, CA, USA, 2 University of Pittsburgh, Pittsburgh, PA, USA, 3 Men's Health Foundation, Los Angeles, CA, USA, 4 University of Washington, Seattle, WA, USA, 5 Kenya Medical Research Institute, Nairobi, Kenya Background: Long-acting cabotegravir (CAB-LA) PrEP is highly effective but delayed diagnoses and INSTI resistance were observed with incident infections in registrational trials. As CAB is scaled up, continued vigilance is needed to assess HIV acquisition, pharmacokinetics (PK), resistance, and ART outcomes after infections. We report the first case outside of trials, to our knowledge, of HIV infection on CAB with emergence of INSTI resistance. Methods: A 23-year old gender-nonbinary person, male at birth (on estradiol, spironolactone; BMI 19) with history of CAB PrEP use restarted CAB 6 months after discontinuation (Figure). On Day(D) 20 before CAB restart, HIV Ag/Ab was non-reactive (NR) and HIV RNA not detected (ND). Point-of-care HIV Ab was NR on the day of the 1st CAB injection (D0). On D28, when the 2nd CAB injection was given, the HIV Ag/Ab was reactive (index value 1.24), HIV RNA 451 c/mL. The patient enrolled in SeroPrEP, a study of breakthrough infections on PrEP across the U.S. Blood and hair samples were collected for sensitive diagnostic, PK and resistance assays. RNA below routine thresholds was quantified via single copy assay (SCA). INSTI mutations were identified by single genome sequencing (SGS) of full-length integrase, and compared to the partner's viral genotype (GenoSure PRime NGS). We measured CAB levels by LC-MS/MS in plasma and segmental hair analysis. Results: SGS of plasma HIV-1 RNA identified INSTI mutations Q148R in 2/24 and A128T in 1/24 sequences 2 days after diagnosis and the 2nd CAB injection (D30), while the commercial genotype failed (HIV RNA 410 c/mL). The partner's plasma viral genotype had no INSTI mutations, indicating CAB resistant variants arose after HIV infection and were selected by CAB in this case. Plasma from D42 (14 days post-diagnosis/8 days post-ART start [DRV/c/F/TAF]) was HIV-1 Ab reactive/ HIV-1 Ag NR (BioPlex 2200), HIV RNA 23 c/mL (SCA); CAB level 3.37 μg/mL. CAB levels in hair were 0.19 ng/mg 2 weeks pre-diagnosis and 0.95 ng/mg 3 weeks post-diagnosis and 2nd injection. HIV RNA was ND 1 month post-ART start. Conclusion: In this first case in routine care of HIV infection on CAB with emergence of INSTI resistance, infection likely occurred around the time of CAB reinitiation. CAB resistance emerged rapidly and was only detected by a sensitive research assay. This case highlights the value of RNA testing as close as possible to CAB start and the need to assess resistance, PK, and treatment outcomes to inform clinical and public health strategies.

Poster Abstracts

CROI 2024 359