Long-acting CAB + RPV: safety, efficacy, and discontinuation risks in ODOACRE cohort

Purpose: Real-world data on long-acting
(LA) cabotegravir (CAB) and rilpivirine (RPV) durability,
safety, and discontinuation risk are limited. We present
findings from a large multicenter cohort, focusing ondiscontinuation rates and metabolic/immunologic
changes over time.
Method: All people with HIV (PWH) initiating LA-CAB/
RPV in six Italian centers were included. Data ondemographics, clinical information and laboratory
parameters at baseline and after 12 and 24 months were
collected. The primary endpoint was cumulative probability
of all-cause treatment discontinuation (TD).
Kaplan-Meier estimates were used to assess TD probability,
and Cox models to assess associated risk factors.
Results: Three hundred thirty-six PWH were included,
mostly males (79.3%), with a mean age of 48.3 years
(main features in Table 1). The total follow-up was 8,783
person-months.
Overall, 43 PWH discontinued treatment (Figure 1).
The cumulative probability of TD was 10.0% (95% CI:
7.4%–13.5%) and 11.3% (95% CI: 8.5%–14.9%) at 12 and
24 months, respectively. Discontinuation due to virological
failure (VF) was 1.9% at both 12 and 24 months. Injection
site reactions (ISRs) led to discontinuation in 3.5% of
cases, while 2.2% of people stopped treatment based on
personal decision by 12 months, rising to 2.9% at
24 months (Figure 2).
Cox analysis did not identify any significant association
between baseline variables and overall discontinuation or
VF. However, depression was significantly associated
with personal-driven decision to stop treatment (HR:
3.63, 95%CI: 1.03–12.88).
We observed a CD4/CD8 ratio increase (Table 2) and an
improvement of renal function, especially in those previously
treated with bictegravir or dolutegravir. HDL
increased modestly, while LDL, total cholesterol, triglycerides, and liver function tests did not change over
12 months (Table 2).
Conclusions: In this real-life cohort, LA-CAB+RPV
demonstrated sustained virologic effectiveness and tolerability.
Appropriate user selection remains critical to optimize
durability and outcomes of such therapeutic
approach.