An Established Safety Profile for You to Consider for Your Patients

  • 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%)
      DOVATO
    (N=369), n (%)
    Drug-related AEs 21 (6%)
    Grades 2 to 5  
    Insomnia 4 (1%)
    Depression 2 (<1%)
    Constipation 2 (<1%)
    Weight increased 3 (<1%)
    Flatulence 2 (<1%)
    Nausea 0
    AEs leading to withdrawal 23 (6%)
      TAF-Containing Regimens
    (N=371), II n (%)
    Drug-related AEs 13 (4%)
    Grades 2 to 5  
    Insomnia 0
    Depression 1 (<1%)
    Constipation 1 (<1%)
    Weight increased 3 (<1%)
    Flatulence 0
    Nausea 2 (<1%)
    AEs leading to withdrawal 7 (2%)

    *1 participant was excluded for receiving a TDF-containing regimen instead of a TAF-containing regimen.1

    Drug-Related AEs and Discontinuation Rates Through 196 Weeks

    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 196.2,3

  • 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%)
    Drug-Related AEs DOVATO
    (N=716), n (%)
    All Grades 146 (20%)
    Grades 2 to 5 58 (8%)
    Participants reporting drug-related AEs (all Grades) with ≥2% frequency
    Headache 21 (3%)
    Nausea 14 (2%)
    Diarrhea 15 (2%)
    Insomnia 15 (2%)
    Fatigue 12 (2%)
    Anxiety 11 (2%)
    Dizziness 8 (1%)
    Discontinuation rates
    AEs leading to withdrawal 31 (4%)
    Drug-Related AEs DTG + TDF/FTC
    (N =717), n (%)
    All Grades 192 (27%)
    Grades 2 to 5 69 (10%)
    Participants reporting drug-related AEs (all Grades) with ≥2% frequency
    Headache 30 (4%)
    Nausea 40 (6%)
    Diarrhea 21 (3%)
    Insomnia 20 (3%)
    Fatigue 13 (2%)
    Anxiety 6 (<1%)
    Dizziness 14 (2%)
    Discontinuation rates
    AEs leading to withdrawal 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%)
    AEs DOVATO
    (n=149), n (%)
    Participants reporting drug-related AEs, all Grades 31 (21%)
    Participants reporting any drug-related AEs, Grades 2-5 14 (9%)
    Drug-related AEs (occurring in ≥2%)
    Nausea 7 (5%)
    Fatigue 6 (4%)
    Diarrhea 5 (3%)
    Headache 5 (3%)
    Insomnia 5 (3%)
    Worsening depression 3 (2%)
    Dizziness 3 (2%)
    AEs leading to withdrawal 6 (4%)
    Drug-related AEs leading to withdrawal* 6 (4%)
    Serious adverse events† 12 (8%)
    AEs BIKTARVY
    (n=73), n (%)
    Participants reporting drug-related AEs, all Grades 2 (3%)
    Participants reporting any drug-related AEs, Grades 2-5 1 (1%)
    Drug-related AEs (occurring in ≥2%)
    Nausea 0 (0%)
    Fatigue 0 (0%)
    Diarrhea 0 (0%)
    Headache 0 (0%)
    Insomnia 0 (0%)
    Worsening depression 0 (0%)
    Dizziness 0 (0%)
    AEs leading to withdrawal 1 (1%)
    Drug-related AEs leading to withdrawal* 0 (0%)
    Serious adverse events† 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 AEII 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 (6.9%) 27 (9.8%)
    AEs leading to withdrawal 1 (<1%) 2 (<1%)
    AEs DOVATO
    (n=277), n (%)
    Any AE‡ 207 (74.7%)
    Grade 3-4 AEs 3 (1.1%)
    Serious AEs 12 (4.3%)
    Drug-related AEs 19 (6.9%)
    AEs leading to withdrawal 1 (<1%)
    AEs BIKTARVY
    (n=276), n (%)
    Any AE‡ 216 (78.3%)
    Grade 3-4 AEs 10 (3.6%)
    Serious AEs 13 (4.7%)
    Drug-related AEs 27 (9.8%)
    AEs leading to withdrawal 2 (<1%)

    The most common drug-related AEs were not reported by the study investigators.

    IIMost 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

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, non-inferiority 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 antiretrovial 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-DLLWCNT240053 January 2025