Table 7.
Second Generation INSTIs: Selected drug-related adverse events after week 48 recorded in 2% or more patients in either treatment group
| Dolutegravir | Bictegravir | Cabotegravir | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SPRING-2a | SINGLE | GEMINI-1 and -2b – Pooled Analysis | GS-US-380–1489a | GS-US-380–1490a | FLAIR and ATLAS – Pooled Analysis | ||||||||
| Adverse reaction | DTG n = 411 | RAL n = 411 | DTG n = 414 | EFV n = 419 | DTG/3TC n = 716 | DTG and FTC/ TDF n = 717 | DTG n = 315 | BIC n = 314 | DTG n = 325 | BIC n = 320 | CAB n = 591 | CAR n = 591 | |
| Diarrhea | 11% | 11% | 17% | 18% | 9% | 11% | 13% | 13% | 12% | 12% | – | – | |
| Nausea | 14% | 13% | 14% | 14% | 4% | 7% | 23% | 10% | 9% | 8% | 3% | 1% | |
| Vomiting | – | – | 5% | 5% | – | – | 5% | 4% | – | – | – | – | |
| Fatigue | 5% | 4% | 13% | 12% | - | - | 9% | 6% | 8% | 6% | 5% | < 1% | |
| Upper respiratory infection | 6% | 6% | 9% | 10% | 8% | 6% | 11% | 6% | 7% | 5% | – | – | |
| Dizziness | 6% | 6% | 9% | 35% | – | – | – | – | 1% | 2% | 2% | < 1% | |
| Headache | 12% | 12% | 13% | 13% | 10% | 10% | 14% | 11% | 12% | 13% | 4% | < 1% | |
| Insomnia | 5% | 4% | 15% | 10% | 4% | 6% | 6% | 4% | 4% | 5% | – | – | |
| Depression | 5% | 3% | 6% | 6% | – | – | – | – | – | – | - | – | |
| Rash | – | – | 3% | 14% | – | – | – | – | – | – | 2% | 0% | |
| Pyrexia | – | - | - | - | - | - | – | – | – | – | 8% | 0% | |
| Injection site reactions | – | – | – | – | – | - | – | – | - | – | 83% | 0% | |
| Discontinuations due to drug-related clinical adverse events | 2% | 2% | 2% | 10% | 1% | 1% | 1% | 0% | < 1% | 2% | 80% | – | |
| References | [92] | [93] | [96] | [97] | [98] | [99, 100] | |||||||
Dash (-) indicates that information regarding this adverse effect was not reported in the study results or was reported as < 2% for both groups
3TC lamivudine, BIC bictegravir, CAB cabotegravir, CAR current antiretroviral regimen, DTG dolutegravir, EFV efavirenz, FTC emtricitabine, RAL raltegravir, RPV rilpivirine, TDF tenofovir disoproxil fumarate
aAdverse events reported as adverse events with ≥ 5% incidence in either group
bAdverse events reported as adverse events with ≥ 4% incidence in either group