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Clinical Trial
. 2022 Mar 4;14(3):524.
doi: 10.3390/v14030524.

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

Carmen Hidalgo-Tenorio  1 , Juan Pasquau  1 , David Vinuesa  2 , Sergio Ferra  3 , Alberto Terrón  4 , Isabel SanJoaquín  5 , Antoni Payeras  6 , Onofre Juan Martínez  7 , Miguel Ángel López-Ruz  1 , Mohamed Omar  8 , Javier de la Torre-Lima  9 , Ana López-Lirola  10 , Jesús Palomares  11 , José Ramón Blanco  12 , Marta Montero  13 , Coral García-Vallecillos  1
Affiliations
Clinical Trial

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

Carmen Hidalgo-Tenorio et al. Viruses. .

Abstract

Brief: 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.

Keywords: DOLAVI; HIV; dolutegravir; lamivudine; real-world data.

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Conflict of interest statement

The authors affirm that there were no conflict of interest in the conduct of the study.

Figures

Figure 1
Figure 1
Flowchart of patients treated with dolutegravir (DTG) plus lamivudine.
Figure 2
Figure 2
Time course of CD4 and viral load (baseline and weeks 4, 24, and 48 weeks).
Figure 3
Figure 3
Distribution of patient weight classification by BMI at baseline and weeks 4, 24, and 48.
See this image and copyright information in PMC

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