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PROVEN EFFICACY IN >6,000 PLHIV

TANGO

NON-INFERIORITY IN ITT–E ANALYSIS VS TAF-CONTAINING REGIMENS AT 144 WEEKS

SUPERIOR EFFICACY IN PER-PROTOCOL SECONDARY ENDPOINT (HIV-1 RNA >50 C/ML) ANALYSIS[1]

Virological Outcomes At 144 weeks

This bar graph shows the virological outcomes at 144 weeks. DOVATO maintained non-inferiority with no increased risk of virological failure vs TAF-containing regimens.

ITT–E Snapshot analysis.

Adjusted Treatment Difference (95% CI)

This chart shows the adjusted treatment difference in proportion of patients with HIV-1 RNA ≥50 copies/mL (based on a 4% non-inferiority margin), which favours DOVATO.

Adapted from Osiyemi et al, 2022.[1]

  • 48-week primary endpoint (HIV-1 RNA ≥50 copies/mL): DOVATO 0.3% (1/369) vs TAF-containing regimens 0.5% (2/372)[2]

ITT–E=intent-to-treat–exposed.

EFFICACY CONFIRMED IN POST HOC ANALYSIS WITH MORE STRINGENT VIRAL LOAD (VL) MEASURES

Changes in Quantifiable and Non-quantifiable VL Levels by Baseline VL Category Through Week 144[3]

This bar graph shows the changes in quantifiable and non-quantifiable VL levels by baseline VL category through Week 144.
This bar graph shows the changes in quantifiable and non-quantifiable VL levels by baseline VL category through Week 144.
  • The proportion of patients with VL <40 copies/mL and target-not-detected (TND) at each visit was high and comparable across arms
  • The proportion of patients who maintained post baseline TND through Week 144 was comparable across arms
  • >90% of participants in the DOVATO arm with TND at baseline never had a VL ≥40 copies/mL
  • The frequency of blips* was low and similar across arms (5% DOVATO vs 7% TAF-containing regimens)

These long-term virology data continue to demonstrate the potency and durability of DOVATO compared with 3DRs in maintaining virological suppression.

VL=viral load.
*”Blips”, defined as VLs between 50 and 200 copies/mL with adjacent VL value of <50 copies/mL, are included in this category.
†Five participants with baseline VL <40 copies/mL in the DOVATO arm and 1 participant with baseline VL ≥50 copies/mL in TBR arm not presented due to no post baseline VL data.

DURABLE SUPPRESSION ACROSS DIVERSE VIROLOGICALLY SUPPRESSED PATIENTS

Virological Outcomes by Subgroup at 144 weeks[4]

This bar graph shows the virological outcomes by subgroup at 144 weeks.
This bar graph shows the virological outcomes by subgroup at 144 weeks.

Adapted from Scholten et al, 2021.[4]

*In all 8 Snapshot non-responders on DOVATO with baseline CD4+ T-cell count <350 cells/mm[3], Snapshot non-response occurred for non-virological reasons.

  • TANGO Study Design

    DOVATO VS TAF-CONTAINING REGIMENS IN MORE THAN 700 VIROLOGICALLY SUPPRESSED PATIENTS

    Phase III, Randomised, Non-Inferiority Switch Study[1]

    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).
    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).

    ITT–E=intent-to-treat–exposed

  • Baseline Characteristics

    CONFIDENCE IN TREATING A DIVERSE POPULATION[1]

    This table shows the baseline characteristics (including age, sex, race, ethnicity, CD4+ T-cell count and duration of prior ART) were similar across both treatment arms.
    This table shows the baseline characteristics (including age, sex, race, ethnicity, CD4+ T-cell count and duration of prior ART) were similar across both treatment arms.

    Adapted from Osiyemi et al, 2022.[1]

    *Historical resistance results (post hoc analysis) provided at screening were not included in the electronic case report form nor were they part of the locked database but are data on file that have been source verified and archived in the study trial master file.

A TOLERABILITY PROFILE YOU EXPECT FROM DOVATO

Rates of Adverse Events Were Comparable Between Arms From Week 48 to Week 144[1]

This table shows that the adverse events were comparable across both arms out to 144 weeks in TANGO.
This table shows that the adverse events were comparable across both arms out to 144 weeks in TANGO.

Adapted from Osiyemi et al, 2022.[1]

AE=adverse event.
*One participant was excluded for receiving a TDF-containing regimen instead of a TAF-containing regimen.[1]
 †All drug-related AEs through Week 96 were Grade 1 or 2; most drug-related AEs through Week 144 were Grade 1 or 2, except for 2 Grade 3 events (suicidal ideation and increased transaminases in the DTG/3TC group) and 1 Grade 4 event (angioedema in the TAF-containing regimen group). In the post Week 48 analysis of AEs, rates of drug-related AEs, serious AEs and AEs leading to discontinuation were similar between groups.[1]
‡Participants may have had ≥1 AE leading to withdrawal.[1]
§n=342 for both arms. Two drug-related serious AEs occurred through Week 144 (increased transaminases in the DTG/3TC group and angioedema in the TAF-containing group); 2 fatal AEs occurred in the DTG/3TC group through Week 96 (gunshot wound [homicide] and substance abuse [acute intoxication]), which were unrelated to study treatment; 1 additional fatal AE occurred in the DTG/3TC group through Week 144 (ischaemic hepatitis) and was unrelated to study treatment. 1 additional fatal AE occurred in the DTG/3TC group through Week 144 (ischaemic hepatitis) and was unrelated to study treatment. In the post Week 48 analysis of AEs, rates of drug-related AEs, serious AEs and AEs leading to discontinuation were similar between group.[1]

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References:

  1. Osiyemi O, De Wit S, Ajana F, et al. Efficacy and the 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;ciac036 and suppl 1-18. doi:10.1093/cid/ciac036
  2. van Wyk J, Ajana F, Bisshop F, et al. Efficacy and safety of switching to dolutegravir/lamivudine fixed-dose 2-drug regimen vs continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with human immunodeficiency virus type 1: phase 3, randomized, noninferiority TANGO study. Clin Infect Dis. 2020;71(8):1920-1929. doi:10.1093/cid/ciz1243
  3. Wang R, George N, Ait-Khaled M, et al. Low-level HIV-1 replication for DTG/3TC vs TAF-based regimen in TANGO through week 144. Presented at: Conference on Retroviruses and Opportunistic Infections; February 12-16, 2022; Virtual. Poster 484.
  4. Scholten S, Ajana F, Benson P, et al. Switching to DTG/3TC is non-inferior to continuing a TAF-based regimen at week 144: TANGO subgroup analyses. Presented at: 18th European AIDS Conference; October 27-30, 2021; London, England. Poster PE2/71.

October 2022 PM-GB-DLL-WCNT-220004

Prescribing Information

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GSK via the GSK Reporting Tool or on 0800 221441.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.