Impact of Dolutegravir-based Regimen on Tolerance and Virologic Suppression, Compared to Non-dolutegravir Regimen among PLHIV in Southern Senegal

Abstract

Background: In 2020, Senegal began a transition to a Dolutgravir-based treatment as a first-line regimen in all new ART initiators in accordance with WHO recommendations. Aims: To determine the virological suppression and the tolerance on patients under a dolutegravir-based regimen by comparison with patients on a regimen without dolutegravir after at least 6 months of treatment. Materials and Methods: A cross-sectional study based on retrospective data (from January 2nd, 2017 to June 30th; 2022) involving 469 patients, 219 people were initiated with Dolutegravir regimen ART between Jan 2nd, 2020, and June 30th, 2022, and 250 patients treated using the old protocol (non-dolutegravir regimen). Patients who had received both the old protocol then switched to a DTG based regimen were excluded from the study. A single questionnaire was used to collect data. Sociodemographic, clinical and virological parameters and the last control of the virological load were analyzed with Stata 16 software. Descriptive statistics and univaried analysis were also carried-out. Results: In the dolutegravir regimen ART group, 161 (73, 52%) of 219 were women and 58 (26.48) were men. The median participant age was 43·0 years (IQR 33·0–53·0) and the median time on ART was 28·0 months (23·0–36·0). The dolutegravir-based regimen combined tenofovir, lamivudine and dolutegravir. 15 (6, 85 %) were receiving tuberculosis treatment at the time of ART initiation. The proportion of patients screened at an advanced clinical stage of AIDS (WHO stage 3 or 4) were 63, 47%. People initiated on dolutegravir were more likely to be retained in care at 12 months (100% vs. 95.20%; p=0.075) and having viral suppression (96.80%vs. 96.40% ; p=0,810) compared with those initiated on non-dolutegravir-based regimens but the difference was not statistically significant. Fewer patients presented side effects due to triple therapy in the dolutegravir-based regimen group compared to the non-dolutegravir group (2.74% vs. 3.20%; p=0.77). In the dolutegravir based regimen the side effects were mainly vomiting, insomnia, and dizziness. The mean gain weight was 6,7± 8,2 kilograms. For the non-dolutegravir regimen group, 195 (78.00%) were women. The median participants age was 43·0 years (IQR 34·0–53·0) and the median time on ART was 55·0 years (48·0–65·0) months. 18 (7, 20%) were receiving tuberculosis treatment at time of ART initiation. The therapeutic protocol combined TDF, lamivudine, Efavirenz in 225 cases (90%). A percentage of 59.20% patients were screened at an advanced clinical stage of AIDS (WHO Stage 3 and 4). In this group the side effects were mainly nausea and insomnia and the mean gain weight was 7,2 ± 6,2 kilograms. Conclusion: The results of our study show a high rate of viral suppression, and good tolerance of the dolutegravir-based regimen in a decentralized setting.