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PROVEN EFFICACY IN >6,000 PLHIV

SALSA

ROBUST EFFICACY IN DIVERSE PATIENT POPULATIONS

NON-INFERIOR EFFICACY WITH NO INCREASED RISK OF VIROLOGICAL FAILURE vs CAR ARM[1]

Virological Outcomes at 48 Weeks                                           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.

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

Adapted from Llibre et al, 2021.[1]

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.

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

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

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.
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 Arms[3]

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

  • Study Design

    DOVATO vs DIVERSE REGIMENS IN ~500 VIROLOGICALLY SUPPRESSED PATIENTS

    Phase III, Randomised, Open-Label, Multicentre, Non-inferiority Switch Study[1]

    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).
    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

  • Baseline Characteristics

    A GLOBAL STUDY OF DIVERSE PATIENTS[1]

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

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

    Adapted from Rolle et al, 2021.[3]

A TOLERABILITY PROFILE YOU EXPECT FROM DOVATO

Adverse Events Leading to Withdrawal Were Similar Across Arms[1]

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

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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. 

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 www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline 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.