Gilead Sciences has received approval from the US Food and Drug Administration (FDA) to expand the indication of Biktarvy for treating HIV in individuals with suppressed viral loads and pre-existing resistance.
Biktarvy is a combination of bictegravir 50mg, emtricitabine 200mg and tenofovir alafenamide 25mg tablets (B/F/TAF).
In 2018, the combination drug got its first FDA approval for the treatment of HIV-1 infection.
The latest expanded indication pertains to treating individuals with HIV who are known or suspected to have M184V/I resistance, which is a prevalent form of treatment resistance.
According to Gilead Sciences, HIV treatment resistance, once developed, remains permanent and irreversible, potentially limiting future treatment options for individuals living with HIV.
The M184V/I resistance mutation has been detected in a significant proportion, ranging from 22% to 63% of people with HIV (PWH) exhibiting pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across different HIV subtypes.
The updated labelling is backed by Study 4030, which assessed the efficacy, safety, and tolerability of Biktarvy in a diverse population of individuals with HIV-1, with or without pre-existing NRTI resistance, including those carrying the M184V/I mutation.
Study 4030 was a Phase 3 randomised, double-blinded trial involving virologically suppressed adults with HIV-1 who were initially on a regimen of dolutegravir (DTG) + either emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF).
Participants were evenly randomised 1:1 to switch to Biktarvy involving 284 patients or DTG+F/TAF, featuring 281 patients.
Among participants receiving Biktarvy, 47 individuals had HIV-1 with pre-existing M184V/I resistance substitutions. The primary endpoint was the proportion of participants with HIV RNA ≥ 50 copies/mL at Week 48.
Eighty-nine percent of participants with M184V/I remained suppressed and 11% did not have virologic data at the Week 48 time point.
None of the participants with M184V/I who received Biktarvy and had virologic data had HIV RNA ≥ 50 copies/mL at Week 48.
Additionally, at Week 48, the proportion of subjects with HIV-1 RNA ≥ 50 copies/mL was 0.4% in the Biktarvy group and 1.1% in the DTG+F/TAF group/
Furthermore, there were no cases of treatment-emergent resistance to Biktarvy, regardless of known or suspected pre-existing M184V/I resistance, in the final resistance analysis population.
Biktarvy now stands as the first and sole integrase strand transfer inhibitor (INSTI)-based single-tablet regimen endorsed by the FDA and recommended by the US Department of Health and Human Services (DHHS) guidelines for people living with HIV achieving viral suppression with M184V/I resistance.
Gilead Sciences HIV clinical development vice president Jared Baeten said: “Clinical data have established Biktarvy as a long-term HIV treatment option for a broad range of PWH. With this label update, healthcare providers have a better understanding of the efficacy of Biktarvy in an underserved segment of PWH.
“Thanks to decades of therapeutic improvements, PWH may live longer, healthier lives, but treatment needs remain. Treatment resistance is one such area.
“We are committed to a person-centered approach to HIV treatment research that not only advances continuous scientific innovations to help address public health needs, but also maximises long-term outcomes for PWH.”
