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PMUS-DLLWCNT240044 July 2024 Produced in USA.
A Breadth of Data Across Multiple Clinical Trials1-7*†
DOVATO vs BIKTARVY
See data from 2 head-to-head trials comparing efficacy and safety6,7
Fewer Medicines
DOVATO is a complete, booster-free, single-tablet regimen for your patients
*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. 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
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AE=adverse event; CI=confidence interval; CVW=confirmed virologic withdrawal; DTG=dolutegravir; FTC=emtricitabine; TAF=tenofovir alafenamide; TCR=TAF-containing regimen; TDF=tenofovir disoproxil fumarate.
References:
1. Cahn P, Madero JS, Arribas JR, et al. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naïve adults with HIV-1 infection. AIDS. 2022;36(1):39-48. doi:10.1097/QAD.0000000000003070
2. Cahn P, Madero JS, Arribas JR, et al; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019;393(10167):143-155. doi:10.1016/S0140-6736(18)32462-0
3. van Wyk J, Ajana F, Bisshop F, et al. Efficacy and safety of switching to dolutegravir/lamivudine fixed-dose 2-drug regimen vs continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with human immunodeficiency virus type 1: phase 3, randomized, noninferiority TANGO study. Clin Infect Dis. 2020;71(8):1920-1929. doi:10.1093/cid/ciz1243
4. Osiyemi O, De Wit S, Ajana F, et al. Efficacy and safety of switching to dolutegravir/lamivudine (DTG/3TC) versus continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with HIV-1: results through week 144 from the phase 3, noninferiority TANGO randomized trial. Clin Infect Dis. 2022;75(6):975-986. doi:10.1093/cid/ciac036
5. De Wit S, Bonnet F, Osiyemi O, et al. Durable efficacy of switching from a 3- or 4-drug tenofovir alafenamide–based regimen to the 2-drug regimen dolutegravir/lamivudine in the TANGO study through week 196. J Acquir Immune Defic Syndr. 2024;96(2):156-160. doi:10.1097/QAI.0000000000003395
6. Rolle C-P, Castano J, Nguyen V, Hinestrosa F, DeJesus E. Efficacy, safety, and tolerability of switching from bictegravir/emtricitabine/tenofovir alafenamide to dolutegravir/lamivudine among adults with virologically suppressed HIV: the DYAD study. Open Forum Infect Dis. 2024;11(10):1-10. doi:10.1093/ofid/ofae560
7. Ryan P, et al. Non-inferior efficacy and less weight gain when switching to DTG/3TC than when switching to BIC/FTC/TAF in virologically suppressed people with HIV (PWH): the PASO-DOBLE (GeSIDA 11720) randomized clinical trial. Abstract presented at: AIDS 2024; July 22-26, 2024; Virtual and Munich, Germany. Oral abstract OAB3606LB.
PMUS-DLLWCNT240061 October 2024
