DO-REAL - Observational Assessment of the Nation-Wide Roll-Out of Dolutegravir in Lesotho (Dolutegravir in Real Life in Lesotho; DO-REAL)

Background

Dolutegravir is a second-generation integrase strand transfer inhibitor with low side-effects and non-inferior or superior treatment outcomes for people living with HIV-1 when compared to other antiretroviral drugs currently in use in low-income countries. Though some cases have been described, HIV-1 resistance to dolutegravir is rare in clinical settings when dolutegravir is used as part of a combination therapy. The use of dolutegravir in first-line antiretroviral therapy (ART) regimens was recommended by the World Health Organisation in 2018 and was adopted by the Government of Lesotho in 2019. dolutegravir now forms part of the recommended first-line therapy for many ART-naïve patients in Lesotho. In addition, many patients on a non-dolutegravir-based first-line ART regimen are transitioning to a DTG-based regimen.

Objectives

The main goals of the Dolutegravir in Real Life in Lesotho (DO-REAL) are to i) assess virologic outcomes (viral suppression and potential drug resistance) and ii) assess any shifts in symptoms (general health, depressive symptoms, common HIV- or ART-related symptoms) upon routine transitioning to dolutegravir-based ART. Nested studies assess additional outcomes.

Methods

DO-REAL is a cohort study enrolling people living with HIV who are eligible to receive dolutegravir-based ART according to Lesotho guidelines in two hospital settings in Lesotho. Viral load testing is conducted on the day of initiating a dolutegravir-based regimen, as well as four, 12 and 24 months thereafter. In a post-hoc analysis, we will test for drug resistance in samples with viraemia. Furthermore, a subset of participants complete screenings for depression (PHQ-9), general health (SF-12), and HIV- or ART-related symptoms.

Funding

Swiss National Science Foundation (PCEFP3_181355)

Further Information

Project registration:

clinicaltrials.gov/ct2/show/NCT04238767

Publications:

Short-term virological outcomes: HIV Medicine, 10 October 2021

 

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Selected projects at this location:

Involved Regions: Africa
Involved Countries: Lesotho

Brown J.A, Nsakala B.L, Mokhele K, Rakuoane I, Muhairwe J, Urda L, Amstutz A, Tschumi N, Klimkait T, Labhardt N.D. Viral suppression after transition from nonnucleoside reverse transcriptase inhibitor- to dolutegravir-based antiretroviral therapy: A prospective cohort study in Lesotho (DO-REAL study). HIV Med. 2021(in press). DOI: 10.1111/hiv.13189

Contact

Jennifer Brown

Jennifer Brown
Postdoctoral Scientific Collaborator

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jennifer.brownswisstph.ch

Project Facts

Collaborating Institutions