Weight and Metabolic Changes With Long-Acting Cabotegravir and Rilpivirine or Bictegravir/Emtricitabine/Tenofovir Alafenamide

Abstract

Background: Modest weight and lipid changes have been observed in cabotegravir plus rilpivirine long-acting (CAB + RPV LA) phase 3/3b studies. The SOLAR study included standardized evaluations of weight and metabolic changes in people living with HIV switching to CAB + RPV LA dosed every 2 months (Q2M) vs. continuing bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).

Setting: Phase 3b, randomized, open-label study conducted in 118 centers across 14 countries.

Methods: Participants (n = 687) were randomized 2:1; 454 switched to CAB + RPV LA Q2M and 227 continued BIC/FTC/TAF. Participants who started lipid-modifying agents or underwent cosmetic procedures were excluded. We analyzed changes in body weight, body mass index (BMI), waist circumference (WC), hip circumference (HC), waist-to-height ratio (WHtR), waist-to-hip ratio (WHR), muscle mass, body fat, and proportion with insulin resistance or metabolic syndrome at 1 year.

Results: Median (interquartile range) change in body weight from baseline was -0.40 kg (-2.95 to +2.10) and +0.05 kg (-2.30 to +1.95) in the LA and BIC/FTC/TAF arm, respectively. Median (interquartile range) changes in WC and HC were +0.06 cm (-4.50 to 4.00) and +0.00 cm (-4.00 to 3.97) in the LA arm, and +1.14 cm (-3.00 to 5.09) and +0.13 cm (-3.10 to 4.00) in the BIC/FTC/TAF arm. There were no clinically relevant changes in WHtR, WHR, or the proportion with metabolic syndrome or insulin resistance in either arm.

Conclusions: Standardized changes in weight, BMI, and body composition were minor and similar between participant switching to CAB + RPV LA Q2M or continuing BIC/FTC/TAF, with no clinically relevant changes in metabolic syndrome or insulin resistance.

Trial registration: ClinicalTrials.gov NCT04542070.

FIGURE 1.

Median (IQR) changes in weight through Month 12*†. *Any anthropometric data for participants who started lipid-modifying agents or underwent cosmetic procedures (including procedures of the torso/thighs [excluding the face and neck] but not limited to liposuction/liposculpture/implants) during the study were nonevaluable. Postbaseline values were nonevaluable for any participant who received lipid-modifying agents 12 weeks before study start. †For 1 participant, baseline weight was erroneously recorded in pounds vs. kilograms, resulting in an incorrect weight of 138.8 kg being recorded vs. ∼63.0 kg; this was retained as originally recorded to maintain database consistency. ‡Median (IQR) weight (kg) at baseline: CAB + RPV LA Q2M (n = 409), 81.3 (70.70, 91.80); BIC/FTC/TAF (n = 203), 79.0 (69.40, 91.70). §CAB + RPV LA Q2M: M2, n = 148; M4, n = 387; M6, n = 378; M12, n = 356. ¶BIC/FTC/TAF: M2, n = 197; M4, n = 199; M6, n = 196; M12, n = 184.

FIGURE 2.

Median (IQR) changes in BMI through Month 12*†. *Any anthropometric data for participants who started lipid-modifying agents or underwent cosmetic procedures (including procedures of the torso/thighs [excluding the face and neck] but not limited to liposuction/liposculpture/implants) during the study were nonevaluable. Postbaseline values were nonevaluable for any participant who received lipid-modifying agents 12 weeks before study start. †For 1 participant, baseline weight was erroneously recorded in pounds vs. kilograms, resulting in an incorrect weight of 138.8 kg being recorded vs. ∼63.0 kg; this was retained as originally recorded to maintain database consistency. ‡Median (IQR) BMI (kg/m²) at baseline: CAB + RPV LA Q2M (n = 409), 26.01 (23.21, 29.26); BIC/FTC/TAF (n = 203), 25.28 (23.56, 29.58). §CAB + RPV LA Q2M: M2, n = 148; M4, n = 387; M6, n = 378; M12, n = 356. ¶BIC/FTC/TAF: M2, n = 197; M4, n = 199; M6, n = 196; M12, n = 184.

FIGURE 3.

Median (IQR) changes in WC through Month 12 by treatment regimen*. *Any anthropometric data for participants who started lipid-modifying agents or underwent cosmetic procedures (including procedures of the torso/thighs [excluding the face and neck] but not limited to liposuction/liposculpture/implants) during the study were nonevaluable. Postbaseline values were nonevaluable for any participant who received lipid-modifying agents 12 weeks before study start. †Median (IQR) WC at baseline (cm): CAB + RPV LA Q2M (n = 408), 90.35 (82.20, 100.98); BIC/FTC/TAF (n = 198), 90.00 (81.30, 101.00). ‡CAB + RPV LA Q2M: M2, n = 146; M4, n = 385; M6, n = 374; M12, n = 352. §BIC/FTC/TAF: M2, n = 194; M4, n = 195; M6, n = 193; M12, n = 180.

FIGURE 4.

Median (IQR) changes in HC through month 12 by treatment regimen*. *Any anthropometric data for participants who started lipid-modifying agents or underwent cosmetic procedures (including procedures of the torso/thighs [excluding the face and neck] but not limited to liposuction/liposculpture/implants) during the study were nonevaluable. Postbaseline values were nonevaluable for any participant who received lipid-modifying agents 12 weeks before study start. †Median (IQR) HC at baseline (cm): CAB + RPV LA Q2M (n = 408), 99.00 (92.00, 106.00); BIC/FTC/TAF (n = 198), 97.0 (90.00, 106.68). ‡CAB + RPV LA Q2M: M2, n = 146; M4, n = 385; M6, n = 374; M12, n = 352. §BIC/FTC/TAF: M2, n = 194; M4, n = 195; M6, n = 193; M12, n = 180.