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gemini 1
gemini 2

Within the GEMINI studies, overall AE profiles were similar; however, there was a lower risk of Drug-related AEs in the DTG +3TC group at week 96. 1

Any drug related AE, grades 2-5 and AEs leading to withdrawal were higher in the Dovato arm vs the TAF-containing regimen arm. This is expected since the majority of patients were switching to a new regimen after suppression on their previous regimen for approx. 3 years (median).

Overall adverse events

Adapted from Cahn et al, 2019. 1

*The relative risk ratio (95% CI) For Dovato vs DTG+ TDF/FTC was 0.78 (0.64,0.95). 1

3 deaths (acute myocardial infarction, n=1; Burkitts's lymphoma, n=1; coronary artery disease, n=1); 1 in GEMINI-1 and 2 in GEMINI-2; all were in the DOVATO group and were considered unrelated to the study drug regimen. 1

  • Minimal changes in overall mean weight. Change from baseline was +3.1 kg in the DOVATO arm and +2.1 kg in the DTG+TDF/FTC arm. 1

METABOLIC BIOMARKERS vs A TDF-CONTAINING REGIMEN AT 96 WEEKS

Bone

Changes in bone turnover biomarkers

SIGNIFICANTLY FAVOUR

DOVATO vs DTG + TDF/FTC 1

Renal

Changes in renal function biomarkers

SIGNIFICANTLY FAVOUR

DOVATO vs DTG + TDF/FTC 1

AEs due to renal and urinary disorders were comparable across both arms. 3

TC-HDL ratio

CHANGES IN TC/HDL RATIO

A statistically greater reduction in TC/HDL ratio occurred in the DTG+TDF/FTC arm vs DOVATO, however there was also an improvement in the DOVATO arm. 1

Tango

In the TANGO study, overall adverse events were comparable across both arms at 48 weeks 2

Any drug related AE, grades 2-5 and AEs leading to withdrawal were higher in the Dovato arm vs the TAF-containing regimen arm. This is expected since the majority of patients were switching to a new regimen after suppression on their previous regimen for approx. 3 years (median).

Adverse event profiles
Adapted from van Wyk et al, 2019. 1
**1 fatal AE occurred (homicide) in the DOVATO arm. No serious AEs were drug related. 2
  • Minimal changes in overall mean weight. Change from baseline was ≈0.8 kg over 48 weeks in both treatment arms. 1

METABOLIC BIOMARKERS AT 48 WEEKS

TC-HDL ratio

INCREASED PROPORTIONS OF PATIENTS WITH OPTIMAL TC/HDL RATIO (<3.5)

Classified by NCEP category as 'Green' (<3.5) in the Dovato arm, while remaining constant in the TAF-containing regimen arm vs baseline 2

Bone

MINIMAL CHANGES

in bone turnover biomarkers in both treatment arms 2

Renal

MINIMAL CHANGES

in renal function biomarkers in both treatment arms 2 ††

References:

  1. Cahn P, Sierra Madero J, Arribas J, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naïve adults with HIV-1 infections: 96-week results from the GEMINI studies, Presented at: International AIDS Conference; July 21-24, 2019; Mexico City, Mexico, Slides WEAB0404LB.
  2. van Wyk J, Ajana F, Bisshop F, et al. Switching to DTG/3TC fixed-dose combination (FDC) is non-inferior to continuing a TAF-based regimen in maintaining virologic suppression through 48 weeks (TANGO study). Presented at: International AIDS Conference; July 21-24, 2019; Mexico City. Slides WEAB0403LB.
  3. Data on file. GEMINI-1 and GEMINI-2 96-week renal and urinary disorders/adverse events; REF-31232. ViiV Healthcare group of companies. Research Triangle Park, NC.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

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