DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV:

Summary

The hypothesize that DTG/3TC will be non-inferior to BIC/FTC/TAF with a 4% margin in virologically suppressed HIV-infected patients. The study will allow claiming for Superiority. Assuming that both DTG and BIC may lead to similar weight gains (approximately 1 kg after 48 weeks) in virologically suppressed HIV-infected patients and that TAF may induce a further weight gain (approximately 1 kg after 48 weeks), also hypothesize that switching to BIC/FTC/TAF may lead to greater weight gain than switching to DTG/3TC over 48 weeks. This trial is a Phase IV, open-label, randomized multicentre clinical trial evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virological suppression in HIV patients.

Timeline

Start

2021-07-14

Primary completion

2024-02-20

Completion

2025-03-13

Outcome

Met primary endpoint

paper The difference in the proportion of participants with HIV RNA ≥50 copies per mL between the dolutegravir and lamivudine group (six [2%] of 277) and bictegravir, emtricitabine, and tenofovir alafenamide group (two [1%] of 276) was 1·4% (95% CI -0·5 to 3·4; p=0·16), showing non-inferiority. PMID 40489982 ↗

release “The results from PASO DOBLE show that Dovato demonstrated non-inferior efficacy compared to Biktarvy” viivhealthcare.com ↗

Publications

• Ryan P, Blanco JL, Masia M, Garcia-Fraile L, Crusells MJ, Domingo P, Curran A, Guerri-Fernandez R, Bernal E, Bravo J, Revollo B, Macias J, Tiraboschi JM, Montejano R, Amador C, Torralba M, Merino D, Diaz-Brito V, Galindo MJ, Ferra S, Villoslada A, Losa JE, Fanjul FJ, Perez-Stachowski X, Peraire J, Portilla J, de la Fuente S, Duenas C, Vazquez MJ, Di Gregorio S, Esteban H, Gil P, de Miguel M, Alejos B, Martinez E; PASO-DOBLE study group. Maintenance therapy with dolutegravir and lamivudine versus bictegravir, emtricitabine, and tenofovir alafenamide in people with HIV (PASO-DOBLE): 48-week results from a randomised, multicentre, open-label, non-inferiority trial. Lancet HIV. 2025 Jul;12(7):e473-e484. doi: 10.1016/S2352-3018(25)00105-5. Epub 2025 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bictegravir	Small molecule	50 mg	Oral
Subject	Dolutegravir	Other / unclassified	50 mg	Oral
Subject	Lamivudine	Other / unclassified	300 mg	Oral
Comparator	emtricitabine	Other / unclassified	200 mg	Oral
Comparator	tenofovir alafenamide	Small molecule	25 mg	Oral

Indications