Table 1.
PRO instrument | Assessment | Timepoints measured | Pooled analysis |
---|---|---|---|
HIVTSQs/ca | Patient satisfaction with HIV treatment | Status version: maintenance baseline, week 4, week 24, week 44 Change version: week 48 | ✔ |
ACCEPT | Patient acceptance of treatment | Maintenance baseline, week 8, week 24, week 48 | ✔ |
PIN questionnaire | Perception of pain and injection site reactions | Week 5, week 41, week 48 | ✔ |
SF-12 | General health status and degree of mental health distress | Maintenance baseline, week 24, week 48 | ✖ |
Preference of HIV treatment (single question) | Patient preference for CAB + RPV LA vs. their current oral therapy | Week 48 | ✖ |
Reason for switch (single question) | Patient reasoning for switching to LA therapy from oral therapy for ATLAS study only | Week 52 | ✖ |
HAT-QoLb | Overall function and wellbeing. Only 3 out of 9 dimensions were assessed | Maintenance baseline, week 24, week 48 | ✖ |
Numeric Rating Scalec | Intensity of post-injection pain | Week 4, week 5, week 40, week 41 | ✖ |
ACCEPT Chronic Treatment Acceptance questionnaire, CAB cabotegravir, HAT-QoL HIV/AIDS-targeted quality of life, HIVTSQs/c HIV Treatment Satisfaction Questionnaire (status version)/(change version), LA long-acting, PIN Perception of Injection questionnaire, PRO patient-reported outcome, RPV rilpivirine, SF-12 12-Item Short Form Health Survey
aHIVTSQc only administered to participants receiving LA therapy
bNo meaningful differences between arms were reported with the three dimensions included in the phase 3 studies. Results are not discussed here
cConsistent with the PIN, numerical reduction in post-injection pain was reported in the Numeric Rating Scale over time. No significance testing was preplanned for this measure. Results are not discussed here