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SALSA Efficacy

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ROBUST EFFICACY IN DIVERSE PATIENT POPULATIONS

Non-Inferiority Maintained With No Increased Risk of Virological Failure1

Adjusted Treatment Difference (95% CI)

This bar graph shows the virological outcomes at 48 weeks. DOVATO maintained non-inferiority with no increased risk of virological failure vs continued current regimens.

Virological Outcomes at 48 Weeks

This bar graph shows the virological outcomes at 48 weeks. DOVATO maintained non-inferiority with no increased risk of virological failure vs continued current regimens.

Adapted from Llibre et al, 2021.1

ITT–E Snapshot analysis.
ITT–E=intent-to-treat–exposed.

VIROLOGICAL OUTCOMES BY SUBGROUP ARE CONSISTENT WITH OVERALL EFFICACY RESULTS

Virological Outcomes by Subgroup at Week 48 (Snapshot Analysis; ITT–E)2

This bar graph shows the virological outcomes by subgroup at 48 weeks for DOVATO vs continued current regimens.

Adapted from Taylor et al, 2021.2

EFFICACY REINFORCED AT 48 WEEKS WITH MORE STRINGENT VIRAL LOAD MEASURES

Proportion of Patients With <40 copies/mL and TND at Last Available On-treatment Was High and Comparable Across Arms3

This bar graph shows that <40 copies/mL and TND proportions were similar across arms.

Adapted from Underwood et al, 2022.3

  • This post hoc analysis looked at the more stringent viral load measures of <40 copies/mL and TND in a subpopulation of the SALSA study

  • papers icon Study Design

    DOVATO vs DIVERSE REGIMENS IN ~500 VIROLOGICALLY SUPPRESSED PATIENTS

    Phase III, Randomised, Open-Label, Multicentre, Non-inferiority Switch Study1

    This study design chart shows SALSA was a Phase III, randomised, open-label, multicentre, non-inferiority switch study in ~500 virologically suppressed patients. The study arms included DOVATO (DTG/3TC) and continued current regimens (from baseline to Week 48).

    ITT–E=intent-to-treat–exposed

  • file icon Baseline Characteristics

    A GLOBAL STUDY OF DIVERSE PATIENTS1

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

    Adapted from Llibre 2021 et al, 2021. 1

    *Includes tenofovir disoproxil succinate (DOVATO, n=1; CAR, n=3).

A TOLERABILITY PROFILE YOU EXPECT FROM DTG AND 3TC

ADVERSE EVENTS LEADING TO WITHDRAWAL WERE SIMILAR ACROSS ARMS1

This table shows that the adverse events were comparable across both arms out to 48 weeks in SALSA.

Adapted from Llibre et al, 2021.1

AE=adverse event; SAE=serious adverse event.

References:

  1. Llibre JM, Alves Brites C, Cheng C-Y, et al. Switching to the 2-drug regimen of dolutegravir/lamivudine (DTG/3TC) fixed-dose combination is noninferior to continuing a 3-drug regimen through 48 weeks in a randomized clinical trial (SALSA). Presented at: International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual. Slides OALB0303.
  2. Taylor S, Andrade-Villanueva J, Kaplan R, et al. Switching to DTG/3TC is non-inferior to continuing current antiretroviral regimen at week 48: SALSA subgroup analyses. Presented at: 18th European AIDS Conference; October 27-30, 2021; London, England. Poster PE2/72.
  3. Underwood M, Osiyemi O, Rubio R, et al. Archived resistance and response to <40 c/mL and TND—DTG/3TC FDC at week. 48 in SALSA. Presented at: Conference on Retroviruses and Opportunistic Infections; February 12-16, 2022; Virtual. Poster 481.

Dovato is a registered trade mark of the ViiV Healthcare group of companies or its licensor.

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.

Date of Preparation: March 2024
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