SAFETY
TANGO: Drug-Related AEs and Discontinuation Rates Through 144 Weeks1
DOVATO (N=369), n (%) |
TAF-Containing Regimens (N=371),* n (%) |
|
|---|---|---|
| Grades 2 to 5 | ||
| Drug-related AEs (Grades 2 to 5) with ≥0.5% frequency | 21 (6%) | 13 (4%) |
| 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.1
TANGO: Drug-Related AEs and Discontinuation Rates Through 196 Weeks2,3
At Week 196 in the TANGO study, among participants who switched to DOVATO at Week 1 (Early Switch), 6% experienced at least one Grade 2-5 drug-related AE. For these Early-Switch patients, the most common drug-related AEs (all Grades, ≥2%) measured through Week 196 were weight increased (2%) and insomnia (2%). 7% experienced an AE leading to withdrawal through Week 196.
GEMINI 1 & 2: Drug-Related AEs and Discontinuation Rates Through 144 Weeks (Pooled Analysis)3,4
| Drug-related AEs | DOVATO (N=716), n (%) |
DTG + TDF/FTC (N =717), n (%) |
|---|---|---|
| All Grades | 146 (20%) | 192 (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
DYAD: Adverse Events Through Week 485
| AEs | DOVATO (n=149), n (%) |
BIKTARVY (n=73), n (%) |
|---|---|---|
| Participants reporting drug-related AEs, all Grades | 31 (21%) | 2 (3%) |
| Participants reporting any drug-related AEs, Grades 2-5 | 14 (9%) | 1 (1%) |
| Drug-related AEs (occurring in ≥2%) | ||
| Nausea | 7 (5%) | 0 (0%) |
| Fatigue | 6 (4%) | 0 (0%) |
| Diarrhea | 5 (3%) | 0 (0%) |
| Headache | 5 (3%) | 0 (0%) |
| Insomnia | 5 (3%) | 0 (0%) |
| Worsening depression | 3 (2%) | 0 (0%) |
| Dizziness | 3 (2%) | 0 (0%) |
| AEs leading to withdrawal | 6 (4%) | 1 (1%) |
| Drug-related AEs leading to withdrawal‡ | 6 (4%) | 0 (0%) |
| Serious adverse events§ | 12 (8%) | 4 (5%) |
‡Drug-related AEs leading to withdrawal included neuropsychiatric complaints (4), pancreatitis (1), and nausea (1).5
§Included 1 drug-related SAE in the DOVATO arm (pancreatitis). All other SAEs were unrelated to the drug, and no fatal SAEs were observed.5
PASO DOBLE: Adverse Events Through Week 486
| AEs | DOVATO (n=277), n (%) |
BIKTARVY (n=276), n (%) |
|---|---|---|
| Any AE‖ | 207 (74.7%) | 216 (78.3%) |
| Grade 3-4 AEs | 3 (1.1%) | 10 (3.6%) |
| Serious AEs | 12 (4.3%) | 13 (4.7%) |
| Drug-related AEs | 19 (16.9%) | 27 (9.8%) |
| AEs leading to withdrawal | 1 (<1%) | 2 (<1%) |
The most common drug-related AEs were not reported by the study investigators.
‖Most common AEs (>10% in either arm) per system organ class for DOVATO and BIKTARVY arms were, respectively: infections (36.8% and 45.3%), musculoskeletal disorders (19.5% and 18.5%), gastrointestinal disorders (17.3% and 10.5%), metabolism disorders (13.7% and 9.4%), and psychiatric disorders (9.7% and 13.4%).6
Please see Important Safety Information below for most common adverse reactions.
LEARN THE DOVATO DOSING INFORMATION
AE=adverse event; DTG=dolutegravir; FTC=emtricitabine; SAE=serious adverse event; 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, noninferiority TANGO randomized trial. Clin Infect Dis. 2022;75(6):975-986. doi:10.1093/cid/ciac036
2. De Wit S, Bonnet F, Osiyemi O, et al. Durable efficacy of switching from a 3- or 4-drug tenofovir alafenamide–based regimen to the 2-drug regimen dolutegravir/lamivudine in the TANGO study through week 196. J Acquir Immune Defic Syndr. 2024;96(2):156-160. doi:10.1097/QAI.0000000000003395
3. Data on file, ViiV Healthcare.
4. Cahn P, Madero JS, 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
5. Rolle C-P, Castano J, Nguyen V, Hinestrosa F, DeJesus E. Efficacy, safety, and tolerability of switching from bictegravir/emtricitabine/tenofovir alafenamide to dolutegravir/lamivudine among adults with virologically suppressed HIV: the DYAD study. Open Forum Infect Dis. 2024;11(10):1-10. doi:10.1093/ofid/ofae560
6. Ryan P, et al. Non-inferior efficacy and less weight gain when switching to DTG/3TC than when switching to BIC/FTC/TAF in virologically suppressed people with HIV (PWH): the PASO-DOBLE (GeSIDA 11720) randomized clinical trial. Abstract presented at: AIDS 2024; July 22-26, 2024; Virtual and Munich, Germany. Oral abstract OAB3606LB.
PMUS-DLLWCNT240067 October 2024
