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Initiating long-acting cabotegravir and rilpivirine in a real-world setting ' clinical characteristics and switch reasons from people living with HIV (PLHIV) and health care provider perspective in the German CARLOS cohort

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BACKGROUND: 2-monthly cabotegravir (CAB) + rilpivirine (RPV) long acting (LA) for HIV treatment offers a less frequent dosing alternative to daily oral antiretroviral therapy (ART). The CARLOS cohort is a non-interventional, multi-center, prospective study in PLHIV receiving CAB+RPV LA in routine care in Germany. Here we describe clinical characteristics and reasons for switching to LA therapy from a PLHIV and healthcare provider (HCP) perspective in a real-world setting.
METHODS: Clinical characteristics were collected from medical records. Reasons for switching were assessed through surveys administered at baseline.
RESULTS: Between May-Dec 2021,236 PLHIV initiated CAB+RPV LA across 19 sites in accordance with the SmPC. Median age was 42.5 (interquartile range (IQR);36.0-49.5), 95.3% (225/236) were male (Table1).
From the HCP perspective, the main reason (92.4%;n=218/236) for switching to CAB+RPV LA was 'patient wish' (Fig1). Among PLHIV, 'convenience' (62.8%;n=140/223) and 'pill fatigue' (52.5%;n=117/223) were the most often cited reasons for choosing LA therapy. Prior to switching, 23.1% (50/216) of PLHIV reported having been often/always 'worried about unintentional disclosure of their HIV status through oral therapy', 27.8% (n=60/216) often/always 'worried about forgetting daily ART' and 29.6% (64/216) often/always felt 'taking daily oral ART was an uncomfortable reminder of their HIV status'.
The majority of PLHIV (84.7%;n=200/236) were started with an oral lead-in (OLI) phase prior to the injectables. For those choosing no OLI, 'patient preference' was the main rationale provided (86.1%;n=31/36).
CONCLUSIONS: Switching to CAB+RPV LA in routine clinical care is primarily driven by patient choice with convenience and pill fatigue being the most often cited reasons for switching in this cohort.

Table 1. Baseline characteristics
Total
Observed data
Sex, male, % (n)
95.3 % (225)
236
Age, years, median (interquartile range; IQR)
42.5 (36.0-49.5)
236
Age categories <50; 50-65; >65, % (n)
75.0 % (177); 24.6 % (58); 0.4 % (1)
236
BMI '¥30 kg/m2, % (n)
10.5 % (19)
181
CD4 T-cell count, cells/µL, median (IQR)
714.5 (543 ' 986)
228
History of AIDS (CDC C), % (n)
7.6 % (18)
236
Time on ART, years (median, IQR)
8.1 (4.9-11.7)
210
Number of previous regimens '¥3, % (n)
43.2 % (102)
236