Clinical Data
At 160 weeks, 90% (104/115) and 83% (95/115) of the patients receiving the injectable regimen of cabotegravir and rilpivirine every eight and four weeks, respectively, remained virally suppressed. Of the patients on the oral comparator arm who elected to switch to the injectable regimen at Week 96, 97% (33/34) and 100% (10/10) remained virally suppressed on every eight- and four-week dosing schedule, respectively, at Week 160. Through Week 48, two patients developed protocol-defined virologic failure (PVDF) on the every-eight-week dosing arm, one with treatment-emergent, non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) resistance. No additional PVDF cases were observed on any arm between Week 48 and Week 160.

A majority of participants reported an injection site reaction (ISR) through Week 160, of which 85% were mild and 14% were moderate. Eighty-seven percent of ISRs resolved within seven days. ExcludingISRs, the most common adverse events (AEs) were nasopharyngitis (38%), diarrhoea (22%), and headache (22%). Three percent (3/115; Q8W) and 10% (12/115; Q4W) of patients had AEs leading to withdrawal or discontinuation and only 3/274 patients had ISRs leading to discontinuation through Week 160.