Gilead’s Biktarvy proves non-inferior to standard care for HIV in Black and African American patients

pharmafile | October 22, 2020 | News story | Research and Development Biktarvy, Gilead, HIV, pharma 

Gilead has revealed promising new Phase 3 data reinforcing the non-inferiority of Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg) compared to standard care in treating Black and African American patients with HIV-1.

The 495 participants in the study self-identified as Black or African American and had failed to control their disease with treatments in the past or proved resistant to treatment. All participant HIV was virologically suppressed at the time of analysis.

Participants were randomised to switch to Biktarvy immediately, or to switch after 24 weeks receiving standard care, with both groups continuing treatment until week 48.

The findings supported the non-inferiority of Biktarvy to a standard regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) and a third agent.

After 48 weeks of treatment, 99% of patients receiving Biktarvy from the beginning of the study and 100% of those switching to the drug after 24 weeks were shown to maintain HIV-1 RNA levels of <50 copies/ml. Virologic suppression rates were found to be comparable regardless of preexisting drug resistance substitutions in participants.

Additional data from a 48-week extension study also revealed that, when taken once-daily, Biktarvy maintained virologic suppression in HIV patients with chronic haemodialysis.

“Black and African Americans in this country have the highest rates of new HIV infections every year compared to other races,” explained Dr Debbie P Hagins, Principal Investigator for the BRAAVE 2020 study Medical Director, CARE Centers of Southeast Georgia, Coastal Health District. “Adding to that burden are other inequalities such as lack of health insurance, difficulties navigating the healthcare system, and poverty; all of which contribute to higher rates of drug resistance.

“As drug resistance builds, treatment options become more limited, sometimes leading to less desirable, but often necessary, complicated treatment regimens. Again, lending itself to further adherence challenges,” she continued. “These data from BRAAVE 2020, a landmark study, designed with community input to understand specific treatment responses of Black and African Americans, show Biktarvy is an effective regimen for Black Americans, including those with a history of some drug resistance.”

Matt Fellows

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