Reactions to the FDA approval of bictegravir, emtricitabine, and tenofovir alafenamide as fixed-dose combination therapy for patients with HIV.
Frank J. Palella, MD: The fixed-dose combination, single-tablet regimen of the second-generation integrase inhibitor bictegravir, along with the NRTI [nucleoside reverse transcriptase inhibitor] tenofovir alafenamide, which is the bone- and kidney-friendlier version of tenofovir, along with emtricitabine, or FTC, is a good development in that it’s the first time we have a second-generation integrase inhibitor with a substantial barrier to the emergence of resistance. It’s not easy for HIV to become resistant to bictegravir, which is very important when we talk about treating patients in rapid-start scenarios where we might not know whether they already have some resistance. We need to have a regimen that has a substantial barrier to resistance.
This regimen has that type of drug, along with the kidney- and bone-friendly version of tenofovir and FTC. It’s a very effective regimen for first-line therapy, as well as for persons who are undertaking a stable switch. This means they’re already virally suppressed on an older regimen, but they and their provider are seeking to switch them to a more modern therapy that could be better tolerated that will be at least as effective and easy to adhere to in terms of 1 pill once a day.
The efficacy and potency against other gold standards has been shown in randomized controlled trials and the tolerability, both in terms of patient symptoms and the avoidance of kidney or bone adverse effects, has been testified to. It’s a very well tolerated, adherable, effective therapy across diverse patient types, stages of HIV, and demographics, and it’s effective in people who have preexisting comorbidities, including substantial kidney function impairment. The availability of Biktarvy has been a welcome 1 for both providers and patients.
Transcript edited for clarity.