Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M)

Vasiliki Chounta (), Edgar T. Overton, Anthony Mills, Susan Swindells, Paul D. Benn, Simon Vanveggel, Rodica Solingen-Ristea, Yuanyuan Wang, Krischan J. Hudson, Mark S. Shaefer, David A. Margolis, Kimberly Y. Smith and William R. Spreen
Additional contact information
Vasiliki Chounta: ViiV Healthcare
Edgar T. Overton: University of Alabama at Birmingham
Anthony Mills: Men’s Health Foundation
Susan Swindells: University of Nebraska Medical Center
Paul D. Benn: ViiV Healthcare
Simon Vanveggel: Janssen Pharmaceutica NV
Rodica Solingen-Ristea: Janssen Pharmaceutica NV
Yuanyuan Wang: GlaxoSmithKline
Krischan J. Hudson: ViiV Healthcare
Mark S. Shaefer: ViiV Healthcare
David A. Margolis: ViiV Healthcare
Kimberly Y. Smith: ViiV Healthcare
William R. Spreen: ViiV Healthcare

The Patient: Patient-Centered Outcomes Research, 2021, vol. 14, issue 6, No 13, 849-862

Abstract: Abstract Background Advances in HIV-1 therapeutics have led to the development of a range of daily oral treatment regimens, which share similar high efficacy rates. Consequently, more emphasis is being placed upon the individual’s experience of treatment and impact on quality of life. The first long-acting injectable antiretroviral therapy for HIV-1 (long-acting cabotegravir + rilpivirine [CAB + RPV LA]) may address challenges associated with oral treatment for HIV-1, such as stigma, pill burden/fatigue, drug–food interactions, and adherence. Patient-reported outcomes (PROs) collected in an HIV-1 clinical trial (ATLAS-2M; NCT03299049) comparing participants’ experience with two dosing regimens (every 4 weeks [Q4W] vs. every 8 weeks [Q8W]) of CAB + RPV LA are presented herein. Methods PRO endpoints evaluated through 48 weeks of therapy included treatment satisfaction (HIV Treatment Satisfaction Questionnaire [HIVTSQ]), treatment acceptance (“General Acceptance” domain of the Chronic Treatment Acceptance [ACCEPT®] questionnaire), acceptability of injections (Perception of Injection [PIN] questionnaire), treatment preference (questionnaire), and reasons for switching to/continuing long-acting therapy (exploratory endpoint; questionnaire). Participants were randomized 1:1 to receive CAB + RPV LA Q8W or Q4W. Results were stratified by prior CAB + RPV exposure in either preplanned or post hoc analyses. Results Overall, 1045 participants were randomized to the Q8W (n = 522) and Q4W (n = 523) regimens; 37% (n = 391/1045) had previously received CAB + RPV in ATLAS. For participants without prior CAB + RPV exposure, large increases from baseline were reported in treatment satisfaction in both long-acting arms (HIVTSQ status version), with Q8W dosing statistically significantly favored at Weeks 24 (p = 0.036) and 48 (p = 0.004). Additionally, improvements from baseline were also observed in the “General Acceptance” domain of the ACCEPT questionnaire in both long-acting arms for participants without prior CAB + RPV exposure; however, no statistically significant difference was observed between arms at either timepoint (Week 24, p = 0.379; Week 48, p = 0.525). Significant improvements (p

Date: 2021
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DOI: 10.1007/s40271-021-00524-0

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