ABSTRACT
Background. Cabotegravir + Rilpivirine Long Acting (CAB+RPV LA) every 2 months is a recommended regimen in European and US treatment guidelines for PLWH with virological suppression and no known resistance to CAB or RPV. CARISEL, an implementation study, is the first study where all participants switched from standard oral therapy to 2 monthly CAB+RPV. Key clinical and implementation secondary endpoints are reported. Methods. This single arm study enrolled virologically-suppressed PLWH to receive CAB+RPV LA 2-monthly at 18 clinics in 5 EU countries, conducted from Sept 2020-Feb 2022. Clinics with no prior experience with CAB+RPV LA were preferentially selected. Sites were randomized to standard implementation (Arm-S) or enhanced implementation (Arm-E) which included additional implementation strategies. Proportion of participants with plasma HIV-1 RNA >=50c/mL and < 50c/mL at Month 12 (FDA Snapshot algorithm, ITT-E) were reported. Adverse events, COVID-related events, clinic visit length, and safety were analyzed by implementation arm. Results. 72% of clinics (13/18) had no experience with CAB+RPV LA at study start. 430 enrolled and treated participants were included with 25% female, 18% black, and a mean baseline age of 44 yrs (30% > 50 years). At Month 12, 87% of participants maintained virologic suppression in each implementation arm (Table 1) and 1 participant (1/430;0.23%) in Arm-E experienced confirmed virologic failure. Grade 1-2 AEs were reported in Arm-E:99% vs Arm-S: 97%;Grade 3-4 drug-related AEs reported in Arm-E: 4%, Arm-S: 8%. ISRs were reported in 86% of participants;98% were mild or moderate, median duration of 3 days and a low proportion of participants discontinued treatment due to ISR (6%). Total time in clinic decreased more in Arm-E than Arm-S;visit length varied by country (Table 2). COVID was diagnosed in 16% of participants. COVID-19 related protocol deviations reported in 3% of participants. There were no discontinuations and no snapshot failures due to COVID-19. Conclusion. Regardless of implementation arm, CAB+RPV LA was a highly effective and well tolerated, consistent with clinical outcomes in the Phase 3 clinical program. Clinic visit lengths varied by country and decreased over time. COVID-19 did not lead to treatment disruption or study discontinuation. (Table Presented).
ABSTRACT
Background: Older adults (≥50 y) living with HIV (OALWH) may experience elevated levels of depression, anxiety, and loneliness. Online mindfulness lessons have the potential to ameliorate these problems and enhance access, especially during the COVID-19 pandemic. The objective of this randomized controlled trial was to determine the effectiveness of online mindfulness lessons in reducing feelings of depression, anxiety, and loneliness among OALWH. Methods: The study was conducted between May and August 2020. Individuals with any degree of self-reported loneliness at baseline were eligible to participate. Outcomes of interest included depression, measured using the Center for Epidemiologic Studies Depression Scale (CES-D-10), anxiety measured using the Generalized Anxiety Disorder (GAD-7), and loneliness measured using both the Three-item Loneliness Scale (3IL) and a Daily Diary that asked “How lonely do you feel today?” Two sample t-tests were used to compare group scores at follow-up. Results: Of 214 participants who were randomized, the mean (SD) age was 60.4 (5.9) years, 89% were male, 69% were white, and 74% were gay or lesbian. At the end of the 25-day intervention, the intervention group demonstrated reduced levels of depression (2.6 point improvement;p<0.01), and reduced levels of anxiety (1.5 point improvement;p=0.03) compared to the control group (Table 1). Among the subset of participants with elevated baseline depression scores (defined as CES-D-10 ≥ 8), the between-group improvement in depression scores was greater (4.2 point improvement;p<0.01). Similarly, among the subset of participants with elevated baseline anxiety scores (defined as GAD-7 ≥ 5), the between-group improvement in anxiety scores was greater (2.4 point improvement;p<0.01). Loneliness improved significantly, as indicated by the Daily Diary, for those with at least moderate loneliness at baseline (0.7 point improvement;p<0.01). Conclusion: This randomized controlled trial is the first to show that a series of brief, online mindfulness audio lessons improves mental health outcomes among OALWH who report some degree of loneliness. For many patients, this intervention may offer emotional relief, particularly with regard to depression and anxiety, even in the face of the COVID-19 pandemic.