DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks)

Hidalgo-Tenorio, Carmen ; Pasquau, Juan ; Vinuesa, David ; Ferra, Sergio ; Terrón, Alberto ; Sanjoaquín, Isabel (Universidad de Zaragoza) ; Payeras, Antoni ; Martínez, Onofre J. ; López-Ruz, Miguel Á. ; Omar, Mohamed ; de la Torre-Lima, Javier ; López-Lirola, Ana ; Palomares, Jesús ; Blanco, José R. ; Montero, Marta ; García-Vallecillos, Coral

Resumen: Real-world data in naïve HIV-1 patients demonstrate that dolutegravir plus lamivudine in a multiple tablet regimen is effective, safe, and satisfactory; it causes moderately increasing weight and abdominal circumference and is administrable on a test-and-treat strategy. Background: Our objectives were to determine the real-life effectiveness and safety of DT with dolutegravir (50 mg/QD) plus lamivudine (300 mg/QD) in a multiple-tablet regimen (MTR) in naïve PLHIV followed up for 48 weeks and to evaluate the compliance and satisfaction of patients. Material and methods: An open, single-arm, multicenter, non-randomized clinical trial from May 2019 through September 2020 with a 48-week follow-up. Results: The study included 88 PLHIV patients (87.5% male) with a mean age of 35.9 years; 76.1% were MSM patients. The mean baseline CD4 was 516.4 cells/uL, with a viral load (VL) of 4.49 log10, and 11.4% were in the AIDS stage. DT started within 7 days of first specialist consultation in all patients and the same day in 84.1%; 3.4% had baseline resistance mutations (K103N, V106I + E138A, and V108I); 12.5% were lost to follow-up. At week 48, 86.3% had VL < 50 cop/uL by intention-to-treat analysis and 98.7% by per-protocol (PP) analysis. Virological failure (VF) was recorded in 1.1%, with no resistance mutation. One blip was detected in 5.2% without VF. Three reported anxiety, dizziness, and cephalgia, respectively, at week 4 and one reported insomnia at week 24; none reported adverse events at week 48. The mean weight was 4 kg higher at 48 weeks (p = 0.0001) and abdominal circumference 3 cm larger at 24 weeks (p = 0.022). No forgetfulness occurred in 98.7% of patients. Patient satisfaction was 90/100 at 4, 24, and 48 weeks. Conclusion: Real-world data demonstrate that dolutegravir plus lamivudine in MTR is effective, safe, and satisfactory, moderately increasing weight and abdominal circumference and administrable on a test-and-treat strategy.

Idioma: Inglés

DOI: 10.3390/v14030524

Año: 2022

Publicado en: VIRUSES-BASEL 14, 3 (2022), 524 [11 pp.]
ISSN: 1999-4915

Factor impacto JCR: 4.7 (2022)

Categ. JCR: VIROLOGY rank: 15 / 36 = 0.417 (2022) - Q2 - T2

Factor impacto CITESCORE: 7.1 - Immunology and Microbiology (Q2) - Medicine (Q1)

Factor impacto SCIMAGO: 1.29 - Infectious Diseases (Q1) - Virology (Q2)

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)