Table 3.
Randomized control trials demonstrating CAB-RPV efficacy, including subsets of older persons with HIV.
| Authors | Study name | Year published | Location(s) | Description | Median age (years) | Participants ≥50 years old | Subgroup analysis for older patients |
|---|---|---|---|---|---|---|---|
| ATLAS | Swindells et al. [42,62] | 2020, 2022 | Argentina, Australia, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden, USA (number of sites not specified) | Assessed noninferiority of long-acting CAB-RPV to oral ART in adults with treated, virologically suppressed HIV | 42.4 (range 18–82) | 162 (of 616 total) LAI-ART: 66 Oral ART: 96 | See Rizzardini et al. [102]; Benn et al. [46] |
| ATLAS-2M | Overton et al. [44] | 2021 | Compared efficacy and safety of 4weeks vs. 8 weeks dosing of CAB-RPV LAI-ART | 42 (IQR 34–50) | >25% of enrolled participants (of 1045 total) | See Rizzardini et al. [102]; Benn et al. [46] | |
| Chounta et al. [103] | 2021 | Analyzed patient-reported outcomes comparing participants’ experiences with monthly or every two-month LAI-ART dosing regimens. | Adjusted for age as a covariate | ||||
| FLAIR | Orkin et al. [43,61] | 2021, 2020 | Canada, France, Germany, Italy, Japan, the Netherlands, Russia, South Africa, Spain, UK, USA (108 sites) | Assessed noninferiority of long-acting CAB-RPV to daily oral ABC-DTG-3TC after oral lead-in for previously treatment-naïve patients | 34 (range 19–68) | 62 (of 566 total) LAI-ART: 33 Oral ART: 29 | See Rizzardini et al. [102]; Benn et al. [46] |
| LATTE-2 | Margolis et al. [63] | 2017 | USA, Canada, Spain, France, Germany (50 sites) | Comparing oral CAB plus abacavirlamivudine to CAB-RPV at 4-week dosing and 8-week dosing intervals for virologically unsuppressed adults | 35 (range 19–64) | Not specified (of 309 total) | No |
| Pooled analysis of ATLAS, FLAIR | Rizzardini et al. [102] | 2020 | Per ATLAS, FLAIR | Pooled analysis to determine LAI-ART efficacy at week 48, as well as safety, tolerability, and confirmed virologic failure. | LAI-ART: 38 (range 19–74); oral ART: 38 (range 18–82) | 224 (of 1184) LAI-ART: 99 Oral ART: 125 | No significant differences in viral suppression between PWH aged ≥ 50 years and <50 years at week 48 (supplemental Figure S3) |
| Pooled analysis of ATLAS, ATLAS-2M, FLAIR, | Benn et al. [46] | 2021 | Per ATLAS, FLAIR | Pooled analysis stratified by age ≥50 years and age <50 years to determine the efficacy, safety, adherence, and treatment satisfaction outcomes | NA | 399 (of 1850) LAI-ART: 274 Oral ART: 125 | PWH aged ≥50 years and <50 years had comparable rates of virologic suppression, adverse events, injection site reactions and severity, and changes in baseline treatment satisfaction compared to oral ART. |
| SOLAR | Ramgopal et al. [45] | 2023 | Not specified | Noninferiority study comparing switch from oral BIC/FTC/TAF to CAB-RPV LAI-ART every 8 weeks vs. continuing oral BIC/FTC/TAF in adults with virologically suppressed PWH | 37 (range: 18–74) | 128 (of 670 total) | No |
ART, antiretroviral therapy; LAI, long-acting injectables; PWH, people with HIV.