Login Register Cart 0
Generic placeholder image

Current HIV Research

Editor-in-Chief

ISSN (Print): 1570-162X
ISSN (Online): 1873-4251

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Short-term Neuropsychiatric and Body Weight Changes in Patients Switching From EVG/Cobi/FTC/TAF to BIC/FTC/TAF (PreEC/RIS69)

Author(s): Juan Tiraboschi*, Paula Prieto, Maria Saumoy, Ana Silva, Arkaitz Imaz, Sofía Scevola, Guillem Fernandez, Antonio Navarro, Camila Piatti and Daniel Podzamczer

Volume 20, Issue 3, 2022

Published on: 15 July, 2022

Page: [251 - 254] Pages: 4

DOI: 10.2174/1570162X20666220608160335

Price: $65

Abstract

Background: We report NP, clinical and laboratory changes in patients switching from EVG/Cobi/FTC/TAF to BIC/FTC/TAF in clinical practice.

Methods: A group of subjects switching from EVG/Cobi/FTC/TAF to BIC/F/TAF was prospectively followed. A validated sleep quality questionnaire (Pittsburgh Sleep Quality Index), as well as the Hospital Anxiety and Depression Scale (HADS), were administered after 4 weeks from the treatment switch. Adverse events, side effects and discontinuation were recorded at weeks 4 and 24. Pretreatment switch and week 24 body weight and laboratory data were compared.

Results: A total of 96 virologically suppressed patients (86% male) were included. All patients received EVG/Cobi/FTC/TAF at least 1 year before the treatment switch. Median (IQR) nadir CD4 was 367 (263). The most common comorbidities were dyslipidemia, HTA and diabetes, 26%, 14% and 7%, respectively. Depression was reported by 8%. Five patients discontinued BIC/FTC/TAF before week 4 due to intolerance (2 insomnia, 1 headache and 2 GI symptoms). No changes in sleep quality, anxiety and depression outcomes were observed at week 4 (p = 0.1, p = 0.1 and p = 0.3, respectively). After 6 months, the median body weight change was statistically significant (0.6 kg, p = 0.003). All patients maintained HIV suppression.

Conclusion: Except in a few cases, sleep quality, anxiety and depression symptoms remain stable in HIV virologically suppressed patients on EVG/Cobi/FTC/TAF who switch to BIC/F/TAF. NPAEs are mild and tend to occur in those with previous neuropsychiatric symptoms. Weight gain tends to be small but statistically significant. Long-term follow-up in “real-life” cohorts would be needed to confirm these findings.

Keywords: INSTI, neuropsychiatric, body weight, sleep quality, bictegravir, integrase.

« Previous Next »
Graphical Abstract

[1]
Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. 2021. Available from: https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines (Accessed on March 2, 2021).
[2]
Hoffmann C, Llibre JM. Neuropsychiatric adverse events with dolutegravir and other integrase strand transfer inhibitors. AIDS Rev 2019; 21(1): 4-10.
[http://dx.doi.org/10.24875/AIDSRev.19000023] [PMID: 30899113]
[3]
Venter WDF, Moorhouse M, Sokhela S, et al. Dolutegravir plus two different prodrugs of tenofovir to treat HIV. N Engl J Med 2019; 381(9): 803-15.
[http://dx.doi.org/10.1056/NEJMoa1902824] [PMID: 31339677]
[4]
McCann K, Moorhouse M, Sokhela S, et al. The ADVANCE clinical trial: Changes from baseline to week 96 in DXA-assessed body composition in TAF/FTC +DTG compared to TDF/FTC+DTG, and TDF/FTC/EFV. 17th European AIDS Conference. Basel. 2019.
[5]
Hoffmann C, Welz T, Sabranski M, et al. Higher rates of neuropsychiatric adverse events leading to dolutegravir discontinuation in women and older patients. HIV Med 2017; 18(1): 56-63.
[http://dx.doi.org/10.1111/hiv.12468] [PMID: 27860104]
[6]
Wohl D, Clarke A, Maggiolo F, et al. Patient-reported symptoms over 48 weeks among participants in randomized, double-blind, phase iii non-inferiority trials of adults with HIV on co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus co-formulated abacavir, dolutegravir, and lamivudine. Patient 2018; 11(5): 561-73.
[http://dx.doi.org/10.1007/s40271-018-0322-8] [PMID: 29956087]
[7]
Hoffmann C, Schewe K, Fenske S, et al. Short-term neuropsychiatric tolerability of bictegravir combined with emtricitabine/tenofovir alafenamide in clinical practice. Antivir Ther 2020; 25(2): 83-90.
[http://dx.doi.org/10.3851/IMP3351] [PMID: 32235038]
[8]
Stellbrink HJ, Reynes J, Lazzarin A, et al. Dolutegravir in antiretroviral-naive adults with HIV-1: 96-week results from a randomized dose-ranging study. AIDS 2013; 27(11): 1771-8.
[http://dx.doi.org/10.1097/QAD.0b013e3283612419] [PMID: 23807273]
[9]
Clotet B, Feinberg J, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet 2014; 383(9936): 2222-31.
[http://dx.doi.org/10.1016/S0140-6736(14)60084-2] [PMID: 24698485]
[10]
Sax PE, Erlandson KM, Lake JE, et al. Weight gain following initiation of antiretroviral therapy: Risk factors in randomized comparative clinical trials. Clin Infect Dis 2019; ciz999.
[http://dx.doi.org/10.1093/cid/ciz999] [PMID: 31606734]

Rights & Permissions Print Cite
Article Metrics
11
© 2024 Bentham Science Publishers | Privacy Policy