*In a pooled analysis from GEMINI 1 & 2, identical, Phase 3, randomized, double-blind to Week 96 (open-label Week 96 to Week 144), noninferiority trials in treatment-naïve adults with HIV-1 (≥18 years old), the proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 (primary endpoint) was 91% vs 93% for the DOVATO (N=716) and DTG + TDF/FTC (N=717) arms, respectively (treatment difference: -1.7% [95% CI; -4.4%, 1.1%]). In GEMINI 1 & 2, CVW occurred in 21 participants (12 for DOVATO, 9 for DTG + TDF/FTC) at 144 weeks. Among all trial participants, 1 in the DOVATO arm developed treatment-emergent resistance. CVW was defined as either virologic nonresponse (a decrease in plasma HIV-1 RNA of <1 log₁₀ copies/mL by Week 12, with subsequent confirmation, unless plasma HIV-1 RNA is <200 copies/mL or confirmed plasma HIV-1 RNA ≥200 copies/mL on or after Week 24) or virologic rebound (confirmed rebound in plasma HIV-1 RNA levels to ≥200 copies/mL after prior confirmed suppression to <200 copies/mL). The most common (≥2%) drug-related adverse events (all Grades) in the DOVATO arm (N=716) and DTG + TDF/FTC arm (N=717), respectively, were headache (3%, 4%), nausea (2%, 6%), diarrhea (2%, 3%), insomnia (2%, 3%), fatigue (including fatigue, asthenia, and malaise [2%, 2%]), anxiety (2%, <1%), and dizziness (1%, 2%). 4% and 5% of participants, respectively, experienced adverse events that led to withdrawal.^1,2

^†TANGO is a Phase 3, noninferiority trial in virologically suppressed (HIV-1 RNA <50 copies/mL) adults with HIV-1 in which all participants were on a TCR and stable for >6 months. The proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48 (primary endpoint) was <1% vs <1% for the DOVATO (N=369) and TCR (N=372) arms, respectively (treatment difference: -0.3% [95% CI; -1.2%, 0.7%]). Patients in the TAF-containing regimen were switched to DOVATO at Week 148 if HIV-1 RNA <50 copies/mL (Late Switch). In TANGO, no treatment-emergent resistance was detected through Week 196. Only participants meeting CVW criteria (1 for DOVATO, 3 for TCR) were evaluated for treatment-emergent resistance. CVW was defined as HIV-1 RNA ≥50 copies/mL followed by a second consecutive HIV-1 RNA ≥200 copies/mL. At Week 144, the most common (≥0.5%) drug-related adverse events (Grades 2-5) in the DOVATO arm (n=369) and TCR arm (n=371), respectively, were insomnia (1%, 0), depression (<1%, <1%), constipation (<1%, <1%), weight increase (<1%, <1%), flatulence (<1%, 0), and nausea (0, <1%). 6% and 2% of participants, respectively, experienced adverse events that led to withdrawal. At Week 196 among patients who switched to DOVATO at Week 1 (Early Switch), 6% experienced at least one Grade 2-5 drug-related AE. For these Early-Switch patients, the most common drug-related AEs (≥2%) measured at Week 196 were weight increase (2%) and insomnia (2%). 7% experienced an AE leading to withdrawal at Week 196.^3-5