Perspectives of people living with HIV-1 on implementation of long-acting cabotegravir plus rilpivirine in US healthcare settings: results from the CUSTOMIZE hybrid III implementation-effectiveness study

Cindy P Garris, Maggie Czarnogorski, Marybeth Dalessandro, Ronald D'Amico, Toyin Nwafor, Will Williams, Deanna Merrill, YuanYuan Wang, Larissa Stassek, Michael B Wohlfeiler, Gary I Sinclair, Leandro A Mena, Blair Thedinger, Jason A Flamm, Paul Benson, William R Spreen, Cindy P Garris, Maggie Czarnogorski, Marybeth Dalessandro, Ronald D'Amico, Toyin Nwafor, Will Williams, Deanna Merrill, YuanYuan Wang, Larissa Stassek, Michael B Wohlfeiler, Gary I Sinclair, Leandro A Mena, Blair Thedinger, Jason A Flamm, Paul Benson, William R Spreen

Abstract

Introduction: The CUSTOMIZE hybrid III implementation-effectiveness study evaluated implementation of once-monthly long-acting (LA) cabotegravir + rilpivirine in diverse US healthcare settings. Here, we report patient participant perspectives after 12 months in CUSTOMIZE.

Methods: CUSTOMIZE was a phase IIIb, 12-month study conducted from July 2019 to October 2020 at eight diverse US HIV clinics that enrolled virologically suppressed people living with HIV-1 (PLHIV) on a stable oral regimen to receive monthly cabotegravir + rilpivirine LA injections after a 1-month oral lead-in. Participants were administered quantitative surveys before injections at months 1 (baseline), 4 and 12. A randomly selected subset of participants was interviewed at baseline and month 12. Data collection at month 12 was completed by October 2020 (during the COVID-19 pandemic).

Results: At baseline, 109 and 34 participants completed surveys and interviews, respectively; 87% were male; 35% were Black or African American. All participants who remained in the study at month 12 (n = 102) maintained HIV-1 RNA <50 copies/ml; two participants withdrew due to injection-related reasons. Mean total scores measuring acceptability and appropriateness of cabotegravir + rilpivirine LA were high at baseline (4.5-4.6 out of 5) and month 12 (4.7-4.9). At month 12, 74% of participants reported nothing interfered with receiving LA injections; injection pain or soreness was the most common concern (15%). Time spent in the clinic and coming to the clinic for monthly injections was very or extremely acceptable after 12 months for most participants (93% and 87%, respectively), with 64% reporting having spent ≤30 minutes in the clinic for injection visits. At month 12, 92% of participants preferred LA injections to daily oral tablets (3%); 97% plan to continue LA treatment going forward. In month 12 interviews, 24 (77%) of 31 participants reported the COVID-19 pandemic did not impact their ability to receive treatment.

Conclusions: Once-monthly cabotegravir + rilpivirine LA was highly acceptable among PLHIV who were virologically suppressed on a stable antiretroviral regimen and interested in trying LA therapy, with few participants reporting challenges receiving LA injections. Implementation data from CUSTOMIZE suggest that monthly LA injections provide a convenient and appealing treatment option for PLHIV.

Trial registration: ClinicalTrials.gov NCT04001803.

Keywords: acceptability; antiretroviral therapy; appropriateness; integrase strand transfer inhibitor; non-nucleoside reverse transcriptase inhibitor; treatment satisfaction.

Conflict of interest statement

CPG, MC, MD, RD, TN, DM and WRS are employees of ViiV Healthcare and may own stock in GlaxoSmithKline. WW and YW are employees of and may own stock in GlaxoSmithKline. LS is an employee of Evidera, which receives funding from ViiV Healthcare for their work. MBW serves on the Janssen HIV Prophylactic Vaccine Advisory Board. GIS reports grants and personal fees from Janssen, ViiV Healthcare, and Merck and grants from Gilead Sciences. LAM reports grants and personal fees from Gilead Sciences, GlaxoSmithKline, ViiV Healthcare and MSD and grants from Janssen, Visby Medical, ThaiMed, Evofem Biosciences, SpeedDx Pty Ltd and Lupin Pharmaceutical outside of the submitted work. BT owns stock in ViiV Healthcare. JAF has served as a principal investigator for ViiV Healthcare. PB has nothing to disclose.

© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.

Figures

Figure 1
Figure 1
(a) Virologic outcomes at month 12 (modified Snapshot analysis with COVID‐19–related last observation carried forward) and (b) ISRs through month 12. Abbreviations: AE, adverse event; CAB, cabotegravir; ISR, injection site reaction; LA, long‐acting; RPV, rilpivirine. aOne death was reported due to diabetic ketoacidosis and drug abuse (both unrelated to study treatment). bReasons include withdrawn consent (n = 4), protocol deviation (n = 3) and physician decision (n = 1). cPatient participants receiving ≥1 injection. dCommon ISRs reported in >1% of total injections. eNo grade 4 or 5 ISRs were reported. fInjection site pain (n = 1) and injection site pain and injection intolerability (n = 1).
Figure 2
Figure 2
(a) Acceptability (AIM) and (b) appropriateness (IAM) of cabotegravir + rilpivirine LA injections over time and by COVID‐19 impact status at month 12. Both AIM and IAM were four‐item surveys that utilized a five‐point rating scale (1 = completely disagree to 5 = completely agree). Abbreviations: AIM, acceptability of intervention measure; CAB, cabotegravir; IAM, intervention appropriateness measure; LA, long‐acting; RPV, rilpivirine.
Figure 3
Figure 3
Participant‐reported (a) HIV‐1 treatment preference at months 4 and 12, and (b) level of satisfaction with cabotegravir + rilpivirine LA injections over time using the 12‐item HIVTSQs. The HIVTSQs items were rated on a scale of 0 to 6, where 0 = very dissatisfied and 6 = very satisfied. Abbreviations: HIVTSQs, HIV Treatment Satisfaction Questionnaire, status version; LA, long‐acting. aOne participant had missing data.
Figure 4
Figure 4
Participant‐reported (a) total time spent in the clinic/practice for each injection visit, (b) time spent in the exam room waiting for the injection, (c) acceptability of time spent in the clinic/practice for each injection visit and (d) acceptability of coming to the clinic/practice on a monthly basis for injection visits. aOne participant did not answer the question at month 12.
Figure 5
Figure 5
Participant‐reported perceived helpfulness of CUSTOMIZE toolkit resources at months 4 and 12. The bar graph indicates the proportion of participants who reported each resource as being very or extremely helpful in surveys.
Figure 6
Figure 6
Participant‐reported barriers to receiving cabotegravir + rilpivirine LA injections at months 4 and 12. Participants were asked to select all options that applied from a prespecified list of 11 factors or barriers, an “other” response option and a “nothing is interfering with getting this treatment” response option. Abbreviation: LA, long‐acting.
Figure 7
Figure 7
(a) Direct participant quotations from Consolidated Framework for Implementation Research–guided interviews at baseline and month 12, and (b) implementation results from the CUSTOMIZE study by Consolidated Framework for Implementation Research domain. Abbreviations: CNA, certified nursing assistant; LA, long‐acting.

References

    1. Cabenuva [prescribing information] . Research Triangle Park, NC: ViiV Healthcare; 2022.
    1. Panel on Antiretroviral Guidelines for Adults and Adolescents [Internet]. [cited 2022 Jan 4]. Available from:
    1. Swindells S, Andrade‐Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masia M, et al. Long‐acting cabotegravir and rilpivirine for maintenance of HIV‐1 suppression. N Engl J Med. 2020;. 382(12):1112–23.
    1. Orkin C, Arasteh K, Gorgolas Hernandez‐Mora M, Pokrovsky V, Overton ET, Girard PM, et al. Long‐acting cabotegravir and rilpivirine after oral induction for HIV‐1 infection. N Engl J Med. 2020;382(12):1124–35.
    1. Orkin C, Oka S, Philibert P, Brinson C, Bassa A, Gusev D, et al. Long‐acting cabotegravir plus rilpivirine for treatment in adults with HIV‐1 infection: 96‐week results of the randomised, open‐label, phase 3 FLAIR study. Lancet HIV. 2021;8(4):e185–96.
    1. Overton ET, Richmond G, Rizzardini G, Jaeger H, Orrell C, Nagimova F, et al. Long‐acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV‐1 infection (ATLAS‐2M), 48‐week results: a randomised, multicentre, open‐label, phase 3b, non‐inferiority study. Lancet. 2021;396(10267):1994–2005.
    1. Jaeger H, Overton ET, Richmond G, Rizzardini G, Andrade‐Villanueva JF, Mngqibisa R, et al. Long‐acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV‐1 infection (ATLAS‐2M), 96‐week results: a randomised, multicentre, open‐label, phase 3b, non‐inferiority study. Lancet HIV. 2021;8(11):e679–89.
    1. de Los Rios P, Okoli C, Castellanos E, Allan B, Young B, Brough G, et al. Physical, emotional, and psychosocial challenges associated with daily dosing of HIV medications and their impact on indicators of quality of life: findings from the Positive Perspectives Study. AIDS Behav. 2021;25(3):961–72.
    1. Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health. 2009;36(1):24–34.
    1. Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017;12(1):108.
    1. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4:50.
    1. Johnson K, Sawkin MT. Experiences to date with the logistical management of long‐acting cabotegravir and rilpivirine. Drugs Context. 2022;11.
    1. Rizzardini G, Overton ET, Orkin C, Swindells S, Arasteh K, Górgolas Hernández‐Mora M, et al. Long‐acting injectable cabotegravir + rilpivirine for HIV maintenance therapy: week 48 pooled analysis of phase 3 ATLAS and FLAIR trials. J Acquir Immune Defic Syndr. 2020;85(4):498–506.
    1. Margolis DA, Gonzalez‐Garcia J, Stellbrink HJ, Eron JJ, Yazdanpanah Y, Podzamczer D, et al. Long‐acting intramuscular cabotegravir and rilpivirine in adults with HIV‐1 infection (LATTE‐2): 96‐week results of a randomised, open‐label, phase 2b, non‐inferiority trial. Lancet. 2017;390(10101):1499–510.
    1. Centers for Disease Control and Prevention . Estimated HIV incidence and prevalence in the United States, 2014–2018 [Internet]. HIV Surveillance Supplemental Report 2020. [cited 2022 Jan 4]. Available from

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