Background
Women represent ~20% of people with HIV in the US and may experience unique challenges with HIV treatment. Cabotegravir + rilpivirine long-acting (CAB+RPV LA) injectable, indicated for treatment experienced individuals with viral loads (VL) <50 copies/mL, is the first complete LA antiretroviral regimen approved for HIV-1 treatment. This study assessed clinical outcomes among virologically suppressed women receiving CAB+RPV LA in the OPERA cohort.
Methods
Women ≥18 years old with HIV who were virologically suppressed (VL <50 copies/mL) and received ≥1 CAB+RPV LA injection between 21JAN2021-31AUG2023 were followed from first injection until discontinuation, death, loss to follow-up or study end (29FEB2024). Individuals on monthly (Q1M) or every 2-month (Q2M) injection schedules were included. Complete initiation was defined as first 2 injections received ≤67 days apart. For Q1M schedules, on-time maintenance injections were 23-37 days after last injection, delayed were 38-52 days, missed were 53-67 days, and discontinuation was ≥68 days. For Q2M schedules, on-time maintenance injections were 53-67 days after last injection, delayed were 68-112 days, missed were 113-127 days, and discontinuation was ≥128 days. Confirmed virologic failure (CVF) was defined as 2 consecutive VLs ≥200 copies/mL or 1 VL ≥200 copies/mL followed by discontinuation within 4 months.
Results
Of 415 women observed, 264 (64%) were Black, 81 (20%) were Hispanic, 52 (13%) were transgender, 200 (48%) had a BMI of ≥30 kg/m2, median age was 43 (IQR: 34, 54), and median years since HIV diagnosis was 9 (IQR: 4, 18). A total of 381 (92%) completed initiation (293 [77%] on Q2M injections and 75 [20%] on Q1M injections at initiation) and were followed for a median of 12.4 (IQR: 7.2, 19.0) months (Table). At study end, 297 (78%) were on CAB+RPV LA. Among 340 women (89%) with known dosing schedules and ≥1 maintenance injection, 148 (43%) received all maintenance injections on-time, while 125 (37%) had ≥1 delayed maintenance injection and 42 (12%) had ≥1 missed maintenance injection. Among 372 women (98%) with ≥1 VL over follow-up, most maintained suppression (94% at last VL, 82% at all VLs) and 7 (2%) experienced CVF. Median absolute change in CD4 cell counts over follow-up was 40 cells/µL (IQR: -91, 152).
Conclusions
A diverse population of women with HIV was able to receive CAB+RPV LA on-time and remain suppressed in this real-world study. Confirmed virologic failure was infrequent in these antiretroviral experienced women.
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