DOVATO

SAFETY

Chart showing insomnia, depression, constipation, weight gain, flatulence, and nausea to be most common adverse events in TANGO trial

TANGO: Drug-Related AEs and Discontinuation Rates Through 144 Weeks1

 

DOVATO

(N=369), n (%)

TAF-Containing Regimens

(N=371),* n (%)
Drug-related AEs 21 (6%) 13 (4%)
Grades 2 to 5    
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.

TANGO: Drug-Related AEs and Discontinuation Rates Through 196 Weeks2,3

At Week 196 in the TANGO study among patients 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)2,4

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.2

STAT: Drug-Related AEs and Discontinuation Rates at 48 Weeks5,6

 

 

DOVATO (N=131)‡
Drug-related AEs 8%
Drug-related AEs occurring in ≥2% of participants
Diarrhea 2%
Nausea 2%
Rash 2%
Headache 2%
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.

One 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

CONTINUE

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, noninferiority TANGO randomized trial. Clin Infect Dis. 2022;75(6):975-986. doi:10.1093/cid/ciac036

2. Data on file, ViiV Healthcare.

3. De Wit S, Bonnet F, Osiyemi O, et al. Durable efficacy of switching from a 3-/4-drug tenofovir alafenamide (TAF)-based regimen to the 2-drug regimen dolutegravir/lamivudine (DTG/3TC) in the TANGO study through week 196. Presented at: HIV Drug Therapy Glasgow; October 23-26, 2022; Virtual and Glasgow, Scotland. Slides MO41.

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, 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

6. 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

DLLWCNT240012 March 2024