SAFETY
TANGO: Drug-Related AEs and Discontinuation Rates Through 144 Weeks1
DOVATO (N=369), n (%) |
TAF-containing regimens (N=371),* n (%) |
|
|---|---|---|
| Participants reporting any drug-related AEs, Grades 2 to 5 | 21 (6%) | 13 (4%) |
Grade 2 to Grade 5 (occurring in ≥0.5% of participants) |
||
Insomnia |
4 (1%) | 0 |
Depression |
2 (<1%) | 1 (<1%) |
Constipation |
2 (<1%) | 1 (<1%) |
Weight Increased |
3 (<1%) | 3 (<1%) |
Flatulence |
2 (<1%) | 0 |
Nausea |
0 | 2 (<1%) |
| AEs leading to withdrawal | 23 (6%) | 7 (2%) |
*1 participant was excluded for receiving a TDF-containing regimen instead of a TAF-containing regimen.
GEMINI 1 & 2: Drug-Related AEs and Discontinuation Rates Through 144 Weeks (Pooled Analysis)2,3
| Drug-related AEs | DOVATO (N=716), n (%) |
DTG + TDF/FTC (N =717), n (%) |
|---|---|---|
| All Grades | 146 (20%) | 197 (27%) |
| Grades 2 to 5 | 58 (8%) | 69 (10%) |
| Participants reporting drug-related AEs (all Grades) with ≥2% frequency | ||
| Headache | 21 (3%) | 30 (4%) |
| Nausea | 14 (2%) | 40 (6%) |
| Diarrhea | 15 (2%) | 21 (3%) |
| Insomnia | 15 (2%) | 20 (3%) |
| Fatigue† | 12 (2%) | 13 (2%) |
| Anxiety | 11 (2%) | 6 (<1%) |
| Dizziness | 8 (1%) | 14 (2%) |
| Discontinuation rates | ||
| AEs leading to withdrawal | 31 (4%) | 33 (5%) |
†Includes fatigue, asthenia, and malaise.3
STAT: Drug-Related AEs and Discontinuation Rates at 48 Weeks4,5
DOVATO (N=131)‡ |
|
|---|---|
| Drug-related AEs | 8% |
| Drug-related AEs occurring in ≥2% of participants | |
| Diarrhea | 8% |
| Nausea | 7% |
| Headache | 9% |
| Depression | 7% |
| Drug-related AEs (Grades 2 to 5)§ | 2% |
| AEs leading to discontinuation of DOVATO | <1%‖ |
| Any SAE | 2%¶ |
‡The safety population is the same as the ITT–E—all enrolled participants who received at least 1 dose of DOVATO.
§All AEs were Grade 2.
ǁOne AE leading to discontinuation of DOVATO occurred (rash). The event resolved.
¶Two SAEs occurred (cellulitis and streptococcal bacteremia). No fatal SAEs occurred. AEs were coded using MedDRA v23.0.
LEARN THE DOVATO DOSING INFORMATION
AE=adverse event; DTG=dolutegravir; FTC=emtricitabine; ITT–E=intent-to-treat–exposed; MedDRA=Medical Dictionary for Regulatory Activities; SAE=serious adverse event; STAT=Study of Test and Treat; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate.
References:
1. Osiyemi O, De Wit S, Ajana F, et al. Efficacy and safety of switching to dolutegravir/lamivudine (DTG/3TC) versus continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with HIV-1: results through week 144 from the phase 3, non-inferiority TANGO randomized trial. Clin Infect Dis. 2022;75(6):975-986. doi:10.1093/cid/ciac036
2. Cahn P, Madero J, Arribas JR, et al. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naïve adults with HIV-1 infection. AIDS. 2022;36(1):39-48. doi:10.1097/QAD.0000000000003070
3. Data on file, ViiV Healthcare.
4. Rolle C-P, Berhe M, Singh T, et al. Dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV. AIDS. 2021;35(12):1957-1965. doi:10.1097/QAD.0000000000002979
5. Rolle C-P, Berhe M, Singh T, et al. Sustained virologic suppression with dolutegravir/lamivudine in a test-and-treat setting through 48 weeks. Open Forum Infect Dis. 2023;10(3):ofad101. doi:10.1093/ofid/ofad101
DLLWCNT230008 July 2023
