TOLERABILITY

TREATMENT-NAÏVE PATIENTS

GEMINI-1 GEMINI-2

Overall adverse events were comparable across both arms out of 144 weeks

Significantly lower rate of drug-related adverse events vs DTG + TDF/FTC at 144 weeks

 

This table  shows that the adverse  events  were comparable  across  both arms out to 3 years in GEMINI-1 and GEMINI-2.ms out to 3 years in GEMINI-1 and GEMINI-2.

Adapted from Cahn et al, 2020 1

Overall mean weight change from baseline to Week 144 was 3.7 kg with DTG + 3TC and 2.4 kg with DTG + TDF/FTC

DTG 50 mg + 3TC 300 mg used in the GEMINI studies. 

AE=adverse event. 

*The relative risk ratio (95% CI) for DOVATO vs DTG + TDF/FTC was 0.76 (0.63, 0.92).1 †Three deaths (acute myocardial infarction, n=1; Burkitt’s lymphoma, n=1; coronaryarterydisease, 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 regimen1

VIROLOGICALLY SUPPRESSED PATIENTS

TANGO

Overall Adverse Events Were Comparable Across Both Arms Out to 96 Weeks2

A tolerability profile you expect from DTG and 3TC

This table shows that the adverse events were comparable across both arms out to 96 Weeks2in TANGO.

Adapted from van Wyk et al, 2020 2

*1 patient was excluded for receiving a TDF-containing regimen instead of a TAF-containing regimen.2

†2 deaths (1 homicide and 1 unknown reason), both unrelated to treatment, occurred in the DOVATO arm.2

References

  1. Cahn P, Sierra Madero J, ArribasJR, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naïve adults with HIV-1 infection—3-year results from the GEMINI studies. Presented at: HIV Glasgow 2020; October 5-8, 2020; Virtual. Poster P018.
  2. van Wyk J, AjanaF, BisshopF, et al. Switching to DTG/3TC fixed-dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 96 weeks (TANGO study). Presented at: HIV Glasgow 2020; October 5-8, 2020; Virtual. Slides O441.

PM-GB-DLL-WCNT-210004 I April 2021