Switching to Three-Drug Regimen Maintains HIV Suppression

TOPLINE:

Switching from a boosted protease inhibitor (bPI)–based regimen to bictegravir plus emtricitabine plus tenofovir alafenamide (B/F/TAF) maintained virological suppression over 48 weeks in patients with HIV who had preexisting resistance to nucleoside reverse transcriptase inhibitors (NRTIs), however with increased adverse events. 

METHODOLOGY:

• This phase 4 trial assessed the safety and efficacy of switching from a bPI-based regimen to B/F/TAF in virologically suppressed patients with HIV who had preexisting resistance to NRTIs.
• Overall, 72 patients (mean age, 55 years; 88.9% men) were randomly assigned to either continue a bPI-based regimen (delayed switch arm) or immediately switch to B/F/TAF (immediate switch arm).
• Participants in the immediate switch arm were followed-up for 48 weeks, whereas those in the delayed switch arm switched to B/F/TAF after 24 weeks and were followed-up for another 24 weeks.
• The primary endpoint was the percentage of participants maintaining virological suppression (HIV-1 RNA levels < 50 copies/mL) and absence of virological relapses (HIV-1 RNA levels ≥ 50 copies/mL) at week 24.
• Secondary outcomes included changes in various metabolic parameters at week 24, percentage of participants with virological suppression at week 48, occurrence of new treatment related mutations, and safety and tolerability of the new regimen over 48 weeks.

TAKEAWAY:

• At week 24, 100% of participants in the immediate switch arm and 97.4% in the delayed switch arm maintained virological suppression (95% CI, −2.4% to 7.5%); that persisted until week 48.
• Drug-related adverse events occurred in 30.3% vs 2.6% of participants in the immediate and delayed switch arms, respectively.
• The percentage of participants reporting adverse events after switching was comparable to that observed during the first 24 weeks in the immediate switch arm.
• At week 24, participants in the delayed switch arm had better values for overall metabolic parameters, whereas those in the immediate switch arm had improved lipid profiles but greater increases in A1c levels, body mass index, and weight.

IN PRACTICE:

“The regimen was safe and generally well tolerated in this small study. Carefully assessing the efficacy of B/F/TAF in individuals with more extensive NRTI resistance is warranted,” the authors wrote.

SOURCE:

This study was led by Collins Iwuji, Brighton and Sussex Medical School, University of Sussex, Brighton and Hove, United Kingdom. It was published online on February 10, 2025, in Virology Journal.

LIMITATIONS:

This study’s recruitment was affected by the COVID-19 pandemic, resulting in a smaller sample size than intended. Additionally, some participants in the delayed switch arm experienced delays in switching to B/F/TAF; however, procedures were implemented to ensure safe monitoring of patients without compromising study quality. 

DISCLOSURES:

This study was supported by an investigator award from Gilead Sciences. Some authors reported receiving honoraria, research grants, personal fees, speaker fees, and lecture fees from various pharmaceutical and healthcare companies. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.