DOVATO demonstrated non-inferior efficacy vs. DTG + TDF/FTC through 144 weeks in treatment-naïve participants[2]
Primary endpoint: proportion of participants with plasma viral load <50 copies/mL at Week 48 (ITT-E population, FDA Snapshot analysis).[2]
DOVATO showed comparable virological outcomes to 3/4DRs including BIC/FTC/TAF at 96 weeks (ITT analysis)[5]
Adapted from Suárez-García I et al. 2025.[5]
Primary outcomes: the proportion of participants achieving HIV-RNA <50 copies/mL at 96 (±24) weeks after initiation of ART and the rates of virological failure after viral suppression.†,[5]
A well-established safety profile[3]
3DR, 3-drug regimen; 3/4DR, 3- or 4-drug regimen; 3TC, lamivudine; ABC, abacavir; ART, antiretroviral therapy; BIC, bictegravir; CI, confidence interval; COBI, cobicistat; DTG, dolutegravir; DRV, darunavir; FDA, United States Food and Drug Administration; FTC, emtricitabine; HBV, hepatitis B virus; ITT, intention-to-treat; ITT-E, intention-to-treat-exposed; RCT, randomised controlled trial; RWE, real-world evidence; SD, standard deviation; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
References:
- Figueroa M et al. Clin Infect Dis 2025. https://doi.org/10.1093/cid/ciaf415. [Epub ahead of print].
- Cahn P et al. AIDS 2022; 36(1): 39–48.
- DOVATO (dolutegravir/lamivudine) Summary of Product Characteristics (SmPC).
- Cahn P et al. Lancet 2019; 393(10167): 143–155.
- Suárez-García I et al. J Antimicrob Chemother 2025; 80(3): 682–691.
PM-GB-DLL-WCNT-250005 | February 2026
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