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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
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IDWeek 2020 Oct 21-25 virtual
Reported by Jules Levin
abstract
Background: Long-acting (LA) cabotegravir (CAB) and rilpivirine (RPV) injectable suspensions have demonstrated efficacy in phase III studies. POLAR assessed antiviral activity and safety of CAB LA+RPV LA, administered every 2 mos (Q2M), in HIV-1 infected, antiretroviral therapy-experienced adults who completed LATTE and received once-daily oral CAB30mg+RPV25mg treatment.
Methods: POLAR is a phase IIb, multicenter, open-label, rollover study in 97 virologically suppressed, HIV-infected adults. LATTE participants who completed ≥312 weeks on study, with plasma HIV-1RNA< 50c/mL at screening, were eligible for POLAR and offered the option to switch to CAB LA+RPV LA Q2M or to the oral fixed dose combination of dolutegravir (DTG)/rilpivirine (RPV) once daily, for continued maintenance of HIV-1RNA suppression. 90 participants chose CAB LA+RPV LA and 7 participants chose oral DTG/RPV. The primary outcome measure was proportion of participants with plasma HIV-1RNA≥50c/mL after 12 mos (M12) of therapy. Safety and laboratory measures were assessed throughout the study. Participants selecting LA treatment completed satisfaction and quality-of-life questionnaires at Day 1, M6, and M12.
Results: At M12, no participant had HIV-1RNA≥50c/mL or protocol defined virologic failure (confirmed plasma HIV-1RNA > 200c/mL). Excluding injection-site reactions (ISRs), nasopharyngitis (11%), upper respiratory tract infection (11%), diarrhea (10%), and pyrexia (10%) were the most commonly reported adverse events (AEs) in the Q2M arm. 10% (9/90) of Q2M participants reported AEs ≥grade 3; 0 were drug related. 2% (2/90) of Q2M participants had AEs leading to withdrawal. 6% (5/90) of participants reported serious AEs (1 considered drug-related). Over 12 mo, 1534 injections were administered; 463 ISRs were reported (30%; all grade 1/2 [84%/16%]); resolution of ISRs occurred after a median of 3 days. Minimal changes in lab parameters were observed in participants across 12 mo. 88% of participants who received LA therapy preferred CAB LA+RPV LA vs oral therapy.
Conclusion: 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 mo of treatment in POLAR.
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