You are now leaving GSK’s website

You are now leaving a GSK Website. By clicking this link, you will be taken to a website that is not owned or controlled by GSK, and GSK is not responsible for the content provided on that site.

Continue

Go back

Dovato

Product menu

PROVEN EFFICACY IN >36,000 PLHIV
INTRODUCING PASO DOBLE: THE LARGEST HEAD-TO-HEAD RCT OF DOVATO VS BIC/FTC/TAF[1]

DOVATO is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine

INTRODUCING PASO DOBLE: THE LARGEST HEAD-TO-HEAD RCT OF DOVATO VS BIC/FTC/TAF[1]

Paso Doble is a phase IV, randomised, open-label, multi-centre study comparing DOVATO (n=277) vs. BIC/FTC/TAF (n=276) as maintenance therapy in virologically suppressed people living with HIV without previous experience of DTG or BIC: 48-week results.[1]

The 48-week results were presented as an oral presentation at HIV Glasgow Conference November 2024. The study is not yet published.

PROVEN EFFICACY AND A HIGH BARRIER TO RESISTANCE VS. BIC/FTC/TAF, WITH FEWER MEDICINES[1]

DOVATO achieved non-inferior efficacy vs. BIC/FTC/TAF and, with 0 cases of treatment-emergent resistance across both arms at 48 Weeks.[1]

Snapshot outcomes in the intention-to-treat-exposed (ITT-E) population.

Proven efficacy and a high barrier to resistance vs. BIC/FTC/TAF, with fewer medicines[1]
Proven efficacy and a high barrier to resistance vs. BIC/FTC/TAF, with fewer medicines[1]

SWITCHING TO BIC/FTC/TAF LED TO STATISTICALLY SIGNIFICANT GREATER WEIGHT GAIN VS DOVATO[1]

Statistically significant difference in weight gain on BIC/FTC/TAF at 48 weeks: 0.92 KG (95% CI 0.17, 1.66; p=0.016)

Switching to BIC/FTC/TAF led to statistically significant greater weight gain vs DOVATO

Switching to BIC/FTC/TAF was associated with an 81% increased odds of clinically relevant weight gain vs. switching to DOVATO (>5% increase from baseline to Week 48) AOR 1.81 (95% CI 1.19, 2.76) p=0.006.[1]

HEAR FROM THE LEAD INVESTIGATOR, DR ESTEBAN MARTÍNEZ

Dr Esteban Martínez talks through the PASO DOBLE outcomes and the significance of the results.

  • Explore the study design

    PASO DOBLE had a two-arm switch design and was set up to assess the efficacy of DOVATO vs BIC/FTC/TAF through the maintenance of virologic suppression, as well as the difference in weight gain between arms.

    This study design chart shows TANGO was a Phase III, randomised, multicentre, parallel-group, non-inferiority switch study in more than 700 virologically suppressed patients. The study arms included DOVATO (DTG/3TC) and TAF-containing regimens (from baseline to Week 196).

  • Explore the baseline characteristics

    Baseline characteristics were similar between treatment arms.[1]

    Baseline characteristics of Tango

DOVATO has a comparable safety profile vs. BIC/FTC/TAF. [1] Drug-related adverse events reported in n=19/277 participants on DOVATO vs. n=27/276 participants on BIC/FTC/TAF. [1]

Is it time to reconsider the 2nd NRTI

SUPPORT YOUR PATIENT’S FUTURE NOW, WITH DOVATO

People living with HIV on effective treatment are living longer than ever before.[2] That is why it is important to recognise and consider the challenges that may impact them now and in their years ahead.

Michael

Miguel

Newly diagnosed

Photographer, looking to maintain his busy lifestyle.

Carlos

Carlos

Newly diagnosed

Coming to terms with his diagnosis, but is worried about the future

Nikki

Nikki

Treatment-experienced (virally suppressed on BIC/FTC/TAF)

Newly optimistic and considering her future goals.

Christopher

Christopher

Treatment-experienced (virally suppressed on BIC/FTC/TAF)

Recently turned 50 and managing other conditions.

PROVEN EFFICACY.[3,4,5]

HIGH BARRIER TO RESISTANCE.[3,4,5]

FEWER MEDICINES VS. 3-DRUG REGIMENS.[5]

proven efficacy

Proven efficacy across >45,000 people living with HIV.[3,6–9]

Read more

High Barrier

High barrier to resistance in data up to 5 years.[10–12]

Read more

medicine

Fewer medicines vs. 3-drug regimens. TDF, TAF, and ABC free[5]

Read More

3DR, 3-drug regimen; ABC, abacavir; ART, antiretroviral therapy; BIC, bictegravir; COBI, cobicistat; DDI, drug-drug interaction; EVG, elvitegravir; FTC, emtricitabine; NRTI, nucleoside/nucleotide reverse transcriptase inhibitor; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

†Primary endpoint: the proportion of participants with plasma HIV-1 RNA ≥50 c/mL with DOVATO vs BIC/FTC/TAF at Week 48 (FDA Snapshot; non-inferiority margin 4%)

*Confirmed virologic failure was defined as HIV-1 RNA ≥50 c/mL followed by a second consecutive HIV-1 RNA assessment ≥200 c/mL[1]

References:

  1. Ryan P, et al. AIDS 2024. Oral OAB3606LB
  2. The Antiretroviral Therapy Cohort Collaboration; Lancet 2017; 4(8): e349-e356
  3. Cahn P et al. AIDS 2022; 36(1): 39–48.
  4. Osiyemi O et al. Clin Infect Dis 2022; 75(6): 975–986
  5. DOVATO. Summary of Product Characteristics. April 2024.
  6. De Wit S et. J Acquir Immune Defic Syndr 2024. 96(2): 156—160.
  7. Rolle C et al. Open Forum Infect Dis 2023; 10(3): 1–9.
  8. Llibre J et al. Clin Infect Dis 2023; 76(4): 720–729.
  9. ViiV Healthcare. Data on File. REF-237004. 2024.
  10. Maggiolo F et al. BMC Infect Dis 2022; 22(1): 782.
  11. Ciccullo A et al. J Acquir Immune Defic Syndr 2021; 88(3): 234–237.
  12. Taramasso L et al. AIDS Patient Care STDS 2021; 35(9): 342–353.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255, or via the online patient safety reporting form at gsk.public.reportum.com.

Trademarks are owned by or licensed to the GSK group of companies.

Date of Preparation: April 2025 | PM-IE-DLL-WCNT-250004