POLAR Study: Switch to Long-Acting Cabotegravir-Rilpivirine Every 2 Months Is Safe, Tolerable

A long-acting (LA) cabotegravir (CAB) and rilpivirine (RPV) injectable, administered every 2 months to treatment-experienced patients with HIV-1 infection, demonstrated durable virologic suppression and high levels of patient satisfaction over the first 12 months of the phase 2b POLAR study.

Results from the multicenter, open-label, LATTE rollover study were reported at the virtual ID Week 2020.

Eligible participants included virologically suppressed, HIV-positive adult LATTE participants who had completed ≥312 weeks of study, received once-daily oral CAB 30 mg + RPV 25 mg treatment, and had plasma HIV-1 RNA < 50 c/mL at screening. These participants, 97 in total, were offered a choice between switching to CAB LA+RPV LA every 2 months (Q2M) or switching to the oral fixed-dose combination of dolutegravir (DTG)/RPV once daily.

Proportion of participants with plasma HIV-1 RNA ≥ 50 c/mL after 12 months of therapy was the primary outcome, but investigators also sought to assess quality-of-life and patient satisfaction via questionnaires at day 1, month 6, and month 12.

Ninety participants chose CAB LA+RPV LA, while 7 selected oral DTG/RPV. Investigators reported no instances of HIV-1 RNA ≥ 50 c/mL or protocol defined virologic failure (confirmed plasma HIV-1 RNA > 200 c/mL) as of the 12-month mark. In the Q2M arm, the most common adverse events (AEs) besides injection-site reactions were nasopharyngitis (11%), upper respiratory tract infection (11%), diarrhea (10%), and pyrexia (10%). Two out of 90 participants in the Q2M arm reported AEs leading to withdrawal, and 5 out of 90 participants reported serious AEs (1 that was considered drug-related).

Of the 1534 injections administered over 12 months, 463 injection-site reactions were reported among participants (30%; all grade 1/2 [84%/16%]) and typically cleared after a median of 3 days.

Overall, 88% of participants who received long-acting therapy preferred CAB LA+RPV LA compared with oral treatment.

“CAB LA+RPV LA, administered Q2M, resulted in durable virologic suppression, an acceptable tolerability profile, and high levels of participant satisfaction over the first 12 months of treatment in POLAR,” investigators concluded.

The study, “Antiviral Activity and Safety of Long-acting Cabotegravir (CAB LA) Plus Long-acting Rilpivirine (RPV LA), Administered Every 2 Months (Q2M), in HIV-positive Subjects: Results from the POLAR Study,” was presented virtually at ID Week 2020.