Gilead Sciences’ (GILD) Bictegravir is an integrase inhibitor under investigation in combination with TAF (tenofovir alafenamide) and FTC (emtricitabine) for the treatment of adult individuals with HIV-1.
Clinical trial results
In October 2017, Gilead Sciences presented the results of the phase-3, 48-week trial that evaluated safety and efficacy in switching a virologically suppressed HIV-1 infected adult patients from a multi-tablet regimen consisting a bPI (boosted protease inhibitor) to a fixed-dose combination of BIC (bictegravir 50 mg), FTC 200 mg, and TAF 25 mg regimen.
In the phase-3 trial, BIC/FTC/TAF regimen demonstrated non-inferiority, compared with bPI regimens. The BIC/FTC/TAF regimen also didn’t show treatment-emergent resistance at 48 weeks.
In the trial, at week 48, 92.1% of patients on BIC/FTC/TAF therapy arm had HIV-1 RNA less than 50c/mL compared with 88.9% of patients in the bPI therapy arm. No patients on BIC/FTC/TAF therapy arm showed any renal adverse effect. In the trial, 4% of the patients on BIC/FTC/TAF therapy showed grade-3 or -4 adverse effects, compared with 6% of patients on bPi therapy.
Gilead Sciences has already submitted a new drug application to the FDA (US Food and Drug Application) and the EMA (European Medicines Agency) for BIC/FTC/TAF therapy. The FDA has provided an action date of February 12, 2018.
Notably, the approval of BIC/FTC/TAF is expected to strengthen Gilead Sciences’ HIV franchise. GlaxoSmithKline and Pfizer have developed a joint venture ViiV Healthcare for the development and commercialization of HIV drugs. Gilead Sciences’ peers in HIV drug market include Johnson & Johnson (JNJ), Bristol-Myers Squibb (BMY), and GlaxoSmithKline (GSK). Notably, the SPDR S&P 500 ETF (SPY) invests ~0.49% of its total portfolio holdings in Gilead Sciences.