Patient-Reported Outcomes in ATLAS and FLAIR Participants on Long-Acting Regimens of Cabotegravir and Rilpivirine Over 48 Weeks
Open Access
- 23 May 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in AIDS and Behavior
- Vol. 24 (12), 3533-3544
- https://doi.org/10.1007/s10461-020-02929-8
Abstract
The phase 3 ATLAS and FLAIR studies demonstrated that maintenance with Long-Acting (LA) intramuscular cabotegravir and rilpivirine is non-inferior in efficacy to current antiretroviral (CAR) oral therapy. Both studies utilized Patient-Reported Outcome instruments to measure treatment satisfaction (HIVTSQ) and acceptance (ACCEPT general domain), health status (SF-12), injection tolerability/acceptance (PIN), and treatment preference. In pooled analyses, LA-treated patients (n = 591) demonstrated greater mean improvements from baseline than the CAR group (n = 591) in treatment satisfaction (Week 44, + 3.9 vs. +0.5 HIVTSQs-points; p < 0.001) and acceptance (Week 48, +8.8 vs. +2.0 ACCEPT-points; p < 0.001). The acceptability of injection site reactions (PIN) significantly improved from week 5 (2.10 points) to week 48 (1.62 points; p < 0.001). In both studies, ≥ 97% of LA group participants with recorded data preferred LA treatment compared with prior oral therapy. These results further support the potential of a monthly injectable option for people living with HIV seeking an alternative to daily oral treatment.Keywords
Funding Information
- ViiV Healthcare
- Janssen Pharmaceuticals
This publication has 40 references indexed in Scilit:
- Adherence to Highly Active Antiretroviral Therapy (HAART): A Meta-AnalysisAIDS and Behavior, 2011
- Rituximab in patients with primary progressive multiple sclerosis: Results of a randomized double‐blind placebo‐controlled multicenter trialAnnals of Neurology, 2009
- Assessing health-related quality of life among coronary patients: SF-36 vs SF-12Public Health, 2009
- Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI©) questionnaireHealth and Quality of Life Outcomes, 2009
- Differential adherence to combination antiretroviral therapy is associated with virological failure with resistanceAIDS, 2008
- Validation of the Revised 10-Item HIV Treatment Satisfaction Questionnaire Status Version and New Change VersionValue in Health, 2006
- The Short Form—12 and the measurement of health status in patients with cerebral aneurysms: performance, validity, and reliabilityJournal of Neurosurgery, 2005
- Abacavir Compared to Protease Inhibitors as Part of HAART Regimens for Treatment of HIV Infection: Patient Satisfaction and Implications for AdherenceAIDS Patient Care and STDs, 2005
- A 12-Item Short-Form Health SurveyMedical Care, 1996
- The MOS 36-ltem Short-Form Health Survey (SF-36)Medical Care, 1992