An Established Safety Profile for You to Consider for Your Patients

  • GEMINI 1 & 2

    Drug-Related AEs and Discontinuation Rates Through 144 Weeks (Pooled Analysis)1,2

    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

  • DOLCE

    Incidence of Adverse Events in Treatment-Naïve Participants on DOVATO Through Week 483

    AEs DOVATO
    (n=152), n (%)    		 Triple Therapy*
    (n =77), n (%)
    Participants with AEs (related to treatment, any Grade) 37 (24%) 21 (27%)
    Discontinuations due to treatment-related AEs 1 (1%) 1 (1%)
    Participants with SAEs 15 (10%) 9 (12%)
    SAEs (related to treatment) 2 (1%) 1 (1%)
    Deaths 4 (3%) 2 (3%)
    Deaths (related to treatment) 1 (1%)† 1 (1%)‡
    IRIS 9 (6%) 6 (8%)

    *Triple Therapy=DTG + TDF/XTC.

    †Unlikely related: pancytopenia + fever.

    ‡Possibly related: renal tubular acidosis + bronchopneumonia.

  • TANGO

    Drug-Related AEs and Discontinuation Rates Through 144 Weeks4

      DOVATO
    (N=369), n (%)    		 TAF-Containing Regimens
    (N=371),* n (%)
    Participants reporting any drug-related AEs, Grades 2 to 5 21 (6%) 13 (4%)
    Occurring in ≥0.5% of participants, Grades 2 to 5
    Insomnia 4 (1%) 0 (0%)
    Depression 2 (<1%) 1 (<1%)
    Constipation 2 (<1%) 1 (<1%)
    Weight increased 3 (<1%) 3 (<1%)
    Flatulence 2 (<1%) 0 (0%)
    Nausea 0 (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.

    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 196.2,5

  • DYAD

    Drug-Related AEs and Discontinuation Rates Through Week 486

    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).7
    †Included 1 drug-related SAE in the DOVATO arm (pancreatitis). All other SAEs were unrelated to the drug, and no fatal SAEs were observed.7

    Observational Extension Phase6

    Drug-Related AEs and Discontinuation Rates

    Drug-related AEs occurred in 42 (28%) participants on DOVATO and 4 (5%) participants on BIKTARVY.

    The most common drug-related AEs (occurring in ≥2%), in the DOVATO and BIKTARVY arms respectively, were:

    • Nausea; 8 (5%) vs 1 (1%)
    • Insomnia; 6 (4%) vs 1 (1%)
    • Fatigue; 6 (4%) vs 0 (0%)
    • Diarrhea; 6 (4%) vs 0 (0%)
    • Headache; 5 (3%) vs 0 (0%)
    • Weight gain; 4 (3%) vs 0 (0%)
    • Worsening depression; 3 (2%) vs 1 (1%)
    • Dizziness; 3 (2%) vs 0 (0%)
    • Nausea; 8 (5%) vs 1 (1%)
    • Insomnia; 6 (4%) vs 1 (1%)
    • Fatigue; 6 (4%) vs 0 (0%)
    • Diarrhea; 6 (4%) vs 0 (0%)
    • Headache; 5 (3%) vs 0 (0%)
    • Weight gain; 4 (3%) vs 0 (0%)
    • Worsening depression; 3 (2%) vs 1 (1%)
    • Dizziness; 3 (2%) vs 0 (0%)

    Drug-related AEs leading to withdrawal occurred in 11 (7%) participants on DOVATO and 0 participants on BIKTARVY.

    The single-switch, open-label nature of this study should be considered when assessing the number of drug-related AEs and withdrawals for DOVATO.7

  • PASO DOBLE

    Drug-Related AEs and Discontinuation Rates Through Week 968

    AEs DOVATO
    (n=277), n (%)    		 BIKTARVY
    (n=276), n (%)
    Any AE* 239 (86.3%) 243 (88.0%)
    Grade 3-4 AEs 13 (4.7%) 18 (6.5%)
    Serious AEs 23 (8.3%) 30 (10.9%)
    Drug-related AEs 21 (7.6%) 37 (13.4%)
    AEs leading to withdrawal 2 (0.7%) 4 (1.4%)

    *Most common AEs (>10% in either arm) through Week 48 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%).

AE=adverse event; DTG=dolutegravir; FTC=emtricitabine; IRIS=immune reconstitution inflammatory syndrome; SAE=serious adverse event; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate; XTC=lamivudine or emtricitabine.

References:

  1. 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
  2. Data on file, ViiV Healthcare.
  3. Figueroa MI, Brites C, Cecchini D, et al; DOLCE study group. Efficacy and safety of dual therapy with dolutegravir/lamivudine in treatment-naive persons with CD4 counts <200/mm3: 48-week results of the DOLCE study. Clin Infect Dis. 2025;ciaf415. doi:10.1093/cid/ciaf415
  4. 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
  5. 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
  6. Rolle C-P, Castano J, Nguyen V, Hinestrosa F, DeJesus E. Real-world efficacy, safety and persistence of dolutegravir/lamivudine vs. bictegravir/emtricitabine/tenofovir alafenamide among virologically suppressed adults with HIV--results from the 96-week observational extension phase of the DYAD study. Presented at: IDWeek 2025; October 19-22, 2025; Atlanta, GA. Abstract ID P-348.
  7. 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
  8. Masia M, Domingo P, Curran A, et al; PASO-DOBLE (GeSIDA 11720) Study Group. Virological non-inferiority and lower weight gain with DTG/3TC versus BIC/FTC/TAF: 96-week final results from the PASO-DOBLE (GeSIDA 11720) randomised, multicentre, open-label, non-inferiority trial. Abstract presented at: European AIDS Conference 2025; October 15-18, 2025. Slides RO3.8.LB.
  9. 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-DLLWCNT250022 March 2026