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- For the majority of patients in the DOVATO arm, the introduction of 2 new antiretrovials may have contributed to the differences in
drug-related AEs grade 2 to grade 5.
Tolerability
Treatment-Naïve Patients
Significantly Lower Rate of Drug-Related Adverse Events vs DTG + TDF/FTC at 3 years¹
Overall adverse event profiles were comparable at 144-weeks¹
Adapted from Cahn et al, 2020.¹
DTG 50mg + 3TC 300mg 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
┼4 deaths occurred overall and were considered unrelated to the study drug regimen: 3 deaths in the DTG + 3TC group (acute myocardial infarction, n=1; Burkitt's lymphoma, n=1; coronary artery disease, n=1; 1 death of unknown cause occurred in the DTG + TDF/FTC group.¹
Virologically Suppressed Patients
Overall Adverse Events Were Comparable Across Both Arms at 96-Weeks²
- For the majority of patients in the DOVATO arm, the introduction of 2 new antiretrovials may have contributed to the differences in drug-related AEs grade 2 to grade 5.
Adapted from van Wyk et al, 2020.²
AE = Adverse Event
*1 participant was excluded for receiving a TDF-containing regimen instead of a TAF-containing regimen.
┼2 deaths (1 homicide and 1 unknown reason), both unrelated to treatment, occurred in the DOVATO arm²
References:
- Cahn P, Sierra Madero J, Arribas JR, 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.
- 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 (TBR) in maintaining virologic suppression through 96 weeks (TANGO study). Presented at: HIV Glasgow 2020; October 5-8, 2020; Virtual. Slides O441.
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.
Dovato is a registered trade mark of the ViiV Healthcare group of companies or its licensor.
Date of preparation: September 2023 PM-IE-DLL-WCNT-200020
