Table 2:
Phase 3 trials of cabotegravir and rilpivirine for the treatment of HIV6
| Participant characteristics | Regimens | Primary endpoint* difference (95% CI) | Final published data* difference | |
|---|---|---|---|---|
| ATLAS7,8 | Virologically suppressed, ART-experienced adults with HIV | Oral PI, NRTI, or INSTI with a two-NRTI backbone vs oral lead-in of cabotegravir 30 mg/day plus rilpivirine 25 mg/day for 4 weeks, followed by 600 mg of long-acting cabotegravir intramuscularly plus 900 mg long-acting rilpivirine intramuscularly once on week 4, followed by 400 mg long-acting cabotegravir intramuscularly plus 600 mg long-acting rilpivirine intramuscularly every 4 weeks beginning at week 8 | Week 48: 0·6% (−1·2 to 2·5) | Week 96: 100% (23 of 23) in long-acting arm and 97% (28 of 29) in switch arm had HIV-1 RNA <50 copies per mL† |
| ATLAS-2M9,10 | Virologically suppressed (HIV-1 RNA <50 copies per mL) participants who completed the ATLAS trial | Long-acting cabotegravir 400 mg intramuscularly plus long-acting rilpivirine 600 mg intramuscularly every 4 weeks vs long-acting cabotegravir 600 mg intramuscularly plus long-acting rilpivirine 900 mg intramuscularly every 8 weeks | Week 48: 0·8% (−0·6 to 2·2) | Week 124: 1·0% (95% CI −0·6 to 2·4) |
| FLAIR11,12 | ART-naive adults with HIV | All participants inducted on oral dolutegravir, abacavir, and lamivudine daily for 20 weeks then randomly assigned to continue or switch to oral lead-in of cabotegravir 30 mg daily plus rilpivirine 25 mg daily for 4 weeks followed by long-acting cabotegravir 600 mg intramuscularly plus long-acting rilpivirine 900 mg intramuscularly once at week 4 followed by long-acting cabotegravir 400 mg intramuscularly plus long-acting rilpivirine 600 mg intramuscularly every 4 weeks beginning at week 8 | Week 48: −0·4% (−2·8 to 2·1) | Week 124: 450 (82%) of 551 had HIV-1 RNA <50 copies per mL‡ |
INSTI=integrase strand transfer inhibitor. NRTI=nucleoside or nucleotide reverse transcriptase inhibitor. NNRTI=non-nucleoside reverse transcriptase inhibitor. PI=protease inhibitor. All trials were phase 3, randomised, multicentre, open-label, non-inferiority trials.
Endpoint was HIV-1 RNA of 50 copies per mL or less, unless indicated.
52 participants continued long-acting therapy (long-acting arm) or were randomised to oral ART but who chose to switch to long-acting therapy (switch arm); these participants were included in the week 96 analysis for which the primary endpoint was the proportion of patients with HIV-1 RNA <50 copies per mL.
At week 100, participants originally assigned to the oral therapy comparator group were offered the option to switch to long-acting cabotegravir with rilpivirine; 111 chose a direct-to-inject option without an oral lead-in whereas 121 opted for the oral lead-in, 110 in the direct-to-inject group (99%; 95% CI 97–100%) and 113 in the oral lead-in group (93%; 95% CI 89–98%) had an HIV-1 RNA of less than 50 copies per mL at week 124.