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

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.

Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIV

“…Viruses 2022, 14, 2626 2 of 10 Two-drug regimens (2DRs) have been studied as a means of minimizing short-and longterm antiretroviral (ARV) toxicity in naive or ARV-experienced patients [3]. They include the combination of lamivudine and dolutegravir (DTG), which achieved excellent outcomes in clinical trials in naive [4][5][6] and treatment-experienced patients [7][8][9]. A 2DR with rilpivirine (RPV) plus DTG demonstrated the same effectiveness in treatment-experienced patients as that obtained with three-drug regimens (3DRs) in two clinical trials, SWORD 1 and 2, which found no risk of increased resistance and improvements in renal function and bone metabolism [10].…”

Real-World Effectiveness of Dolutegravir/Lamivudine in People With HIV-1 in Test-and-Treat Settings or With High Baseline Viral Loads: TANDEM Study Subgroup Analyses

“…Results from the test-and-treat subgroup in TANDEM are in alignment with those from the phase 3b test-and-treat STAT clinical trial, in which 82% of participants in the ITT-E missing = failure analysis achieved virologic suppression at week 48. In a single-arm, multicenter, prospective trial in Spain, 76 (86%) of 88 treatment-naive people initiating DTG + 3TC within 1 week of initial consultation achieved HIV-1 RNA < 50 copies/ml at week 48 [ 19 ]. In a retrospective analysis of the REDOLA cohort in Spain, 111 (84%) of 132 treatment-naive people initiating DTG/3TC without availability of baseline resistance testing results had HIV-1 RNA < 50 copies/ml at week 96 [ 20 ].…”

“…An observational study of treatment-naive individuals in China who initiated DTG/3TC reported that 96% of 22 people with baseline viral loads ≥ 500,000 copies/ml achieved HIV-1 RNA < 50 copies/ml at week 48 [ 21 ]. In a single-arm, multicenter, prospective trial in Spain that included 17 treatment-naive individuals with baseline viral loads > 100,000 copies/ml, 14 (82%) achieved HIV-1 RNA < 50 copies/ml at week 48 [ 19 ]. Lastly, in a retrospective analysis of the REDOLA cohort in Spain, 39 (87%) of 45 people with baseline viral loads ≥ 100,000 copies/ml had HIV-1 RNA < 50 copies/ml at week 96 [ 20 ].…”

Effectiveness and tolerability of dolutegravir/lamivudine for the treatment of HIV-1 infection in clinical practice

“…Two other cohorts have assessed this rapid treatment approach. At 48 weeks after starting first-line ART, Hidalgo-Tenorio et al found an effectiveness of 86% among 88 patients who started dolutegravir/lamivudine in the first week after their first specialist consultation, 8 and Cabello et al found an effectiveness of 85% among 135 patients, 72% of whom did not have the results of resistance testing available at the start of treatment; 7 neither cohort compared dolutegravir/lamivudine treatment effectiveness with 3DRs.…”