People who took daily oral cabotegravir and Edurant (rilpivirine) for years and switched to the regimen’s long-acting injectable equivalent, ViiV Healthcare’s Cabenuva (cabotegravir/rilpivirine), with an undetectable viral load all still had a fully suppressed virus a year later in a recent trial.
The vast majority of these individuals reported they preferred the injectable regimen, which was dosed every two months and requires a clinic visit.
Twelve-month findings from the Phase IIb POLAR study were presented at the virtual IDWeek meeting. ViiV announced the results in a press release.
The study included 97 people with a fully suppressed viral load who rolled over after spending at least six years with a fully suppressed viral load thanks to daily oral cabotegravir and Edurant in the Phase II LATTE trial.
In POLAR, the participants were offered the chance to switch to injectable Cabenuva or daily oral Juluca (dolutegravir/rilpivirine).
Ninety (93%) of the participants opted to receive Cabenuva, while seven (7%) chose Juluca. A year later, all those who opted for Cabenuva had maintained a viral load below 200.
Cabenuva was generally well tolerated. Six percent (5 of 90) of the participants who opted for the injectable regimen experienced serious adverse health events, one of which was considered related to treatment.
Seventy-eight percent (70 of 90) of those on Cabenuva reported at least one injection site reaction. Of all the injections the participants received during the first 12 months of POLAR, 30% (463 of 1,534) led to a reported injection site reaction. All these reactions were mild (84%) or moderate (16%). They lasted three days on average.
Otherwise, the most common adverse health events were the common cold (11% experienced this), upper respiratory tract infections (11%), diarrhea (10%) and fever (10%). Two participants (2%) experienced adverse health events that led them to withdraw from the study.
At the 12-month mark, 88% of those who chose to receive Cabenuva preferred the injectable regimen to oral HIV treatment. The most commonly cited reasons for this preference were increased convenience (69% reported this) and the reduced frequency of dosing (57%).
Cabenuva has been approved in Canada, but the U.S. Food and Drug Administration (FDA) has expressed concerns about the drug’s manufacturing process. ViiV has reported that it is working with the FDA to address these concerns.