EACS 2023: Gilead shares real-world evidence for Biktarvy®

New real-world data from Gilead Sciences has revealed that its Biktarvy^® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) was found to be highly effective for a broad range of trial participants with HIV after three years of follow-up.

These findings presented at the 2023 European AIDS Conference (EACS 2023) were based on the ongoing Bictegravir Single Tablet Regimen (BICSTaR) study.

Specifically, this level of efficiency was reportedly found in 97 percent (58/60) of treatment-naïve and 97 percent (356/367) of treatment-experienced trial participants virologically suppressed (HIV-1 RNA <50 copies/mL; missing=excluded analysis). Additionally, there were no reports of treatment-emergent resistance.

“HIV affects a wide range of people so understanding a treatment’s efficacy and safety profile through real-world studies can help further inform HIV clinical care,” commented Dr Michael Sabranski, presenting author and physician at the ICH Study Center, Hamburg, Germany.

“The results presented at EACS complement the results observed in multiple Phase III clinical trials, which demonstrate the sustained efficacy, safety profile, and high barrier to resistance of Biktarvy,” stated Dr Fernando Bognar, Vice President of Global Medical Affairs for HIV at Gilead Sciences.

Mental health outcomes

Data for treatment-experienced participants with pre-existing symptoms of depression, anxiety or insomnia in BICSTaR were also presented at EACS 2023.

In this cohort of participants with HIV who were receiving comedications for pre-existing mental health impairments and switched their treatment to Biktarvy, viral loads were assessed at baseline and 24 months. The rates of virologic suppression remained high over the 24-month period.

No serious adverse events of depression, anxiety, or insomnia were reported.

In a missing=excluded analysis, 94 percent (88/94) of participants were virologically suppressed (HIV-1 RNA <50 copies/mL) at two years, the data found. Self-reported symptoms associated with depression, anxiety, or insomnia remained stable over the course of treatment with Biktarvy. Small, numerical increases in Mental Health Component Summary score and treatment satisfaction were reported in the data.

Virologic rebound

Additional research studies evaluating Biktarvy include a pooled analysis of nine Phase III randomised studies in treatment-naïve and virologically suppressed people with HIV who were restarting treatment with Biktarvy after experiencing virologic rebound.

Out of 3,772 participants, 2.5 percent experienced virologic rebound, resulting in 110 virologic rebound events. Excluding events where the outcome could not be evaluated due to the rebound occurring at the last assessment, the resuppression rate was 93 percent (91/98).

Gilead highlighted that the study found that most participants who experienced virologic rebound achieved viral resuppression within 30 days after regaining virologic control. Therefore, these findings support Biktarvy as a potential treatment option for these individuals.

Gilead’s complete HIV treatment

According to Gilead, Biktarvy is a complete HIV treatment that forms the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available. Beneficially, the treatment enables a once-daily dosing with or without food, with a limited drug interaction potential.

Biktarvy is currently indicated as a complete regimen for treating HIV type 1 (HIV-1) infection in US adults and paediatric patients weighing at least 14kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

First paediatric EC approval of HIV drug