Long-acting CAB/RPV injections have a similar weight and lipid profile to dolutegravir-based oral ART

A new pooled analysis from ATLAS-2M and FLAIR report that long-acting cabotegravir (CAB) and rlpivirine (RPV) injections have a similar weight gain and lipid profile to oral dolutegravir-based ART. [1]

Approximately 30% of participants on each regimen moved up a BMI category at week 96 compared to baseline. Lipid profiles were similar between groups.

Data were pooled from participants that received LA CAB+RPV (Q4W/Q8W; n=937) or ABC/DTG/3TC (QD; n=283). Median age was 37 years (range: 18 to 83) and baseline BMI was 24.7 (IQR: 21.8 to 28.6). At baseline 49% of those receiving LA and 40% on daily therapy were obese.

Other demographics included being female (23%), trans women (n=6), 17% were Black or African American and 5% were Asian. Median CD4 counts were 607 cells/mm³ (IQR: 411 to 849) and 453 cells/mm³ (IQR: 323 to 604) for the CAB/RPV and ABC/DTG/3TC groups, respectively. Co-medications included anti-hypertensives (n=22), anti-diabetes (n=23), statins (n=92) and SSRIs (n=47).

Between weeks 48 and 96 median BMI increased for those on Q8W (from +0.4 to +0.6 kg/m2), Q4W (from 0.4 to 0.5 kg/m2) and QD regimens (from 0.5 to 0.6 kg/m2) that contained DTG. Across the same period, median weight increased by 0.5 kg (+1.3 to 1.8 kg), 0.6 kg (+1.0 to +1.6 kg) and 0.5 kg (+1.5 to 2.0 kg) for Q8W, Q4W and QD regimens, respectively. Weight gain of ≥10% was reported for 12% of participants on LA therapy and 13% of those on daily therapy.

Disaggregated data indicated that being Black, female or aged >50 was associated with weight gain. Lipid parameters were not significantly altered at week 96. Overall, there was little difference between the weight gain and lipid profiles for daily vs LA therapy.

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The most important information about this presentation is that dolutegravir is included in the comparison arm which was associated with increased weight in the ADVANCE and other studies.

As in those studies, this is related to race and gender and is highest in Black women.

This means that people using long-acting injectable ART also need to be carefully monitored for weight gain.

Research into the management options to reduce or reverse this are urgently needed.

References
1. Patel P et al. Week 96 weight and lipid changes from baseline among participants receiving cabotegravir + rilpivirine long-acting or comparator therapy in the ATLAS-2M and FLAIR studies. AIDS 2022 (Montreal). 29th July to 2nd August.