The following is a summary of “In-depth Analysis of the HIV Reservoir Confirms Effectiveness and Safety of Dolutegravir/Lamivudine in a Phase 4 Randomized Controlled Switch Trial (RUMBA)”, published in the September 2024 issue of Infectious Diseases by Scheerder et al.
The goal of minimizing the long-term effects of HIV treatment has led to research on 2-drug regimens (2DR), which prior studies have shown comparable to 3-drug regimens (3DR) in terms of viral control and safety.
Researchers conducted a retrospective study to investigate viral reservoirs, which were essential for the long-term safety of the regimens concerning HIV-1 DNA copies, HIV-1 RNA transcripts, and sustained immunological control.
They used the Rumba study, the 1st prospective randomized controlled trial, to assess the effect of switching from 3DR to 2DR on the viral reservoir. Participants with any stable 2nd generation INSTI-based 3DR regimen with HIV-1 RNA <50 copies/ml plasma for at least 3 months were randomized to switch to dolutegravir/lamivudine (DTG/3TC, N=89) or to switch or remain on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, N=45). Virological, immunological, and metabolic parameters were evaluated after 48 weeks.
The results showed no significant difference in the change over time in the mean number of intact HIV-1 DNA copies/million CD4+ T cells between patients receiving dolutegravir/3TC and those receiving bictegravir/f/TAF. No evidence was suggested that switching to dolutegravir/3TC increased the active reservoir of HIV-1 transcription, and no significant changes in pro-inflammatory cytokines or major immune cell subsets were observed. While there were minor and bidirectional changes in the exhaustion and activation of specific cellular subsets, metabolic outcomes were similar between the 2 treatment regimens.
They concluded dolutegravir/3TC was as safe as bictegravir/f/TAF based on viral control and in-depth investigations of the intact HIV-1 reservoir, HIV-1 transcription, and inflammatory markers.
Source: academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiae405/7748439
