Bictegravir Co-Formulation Maintained High Levels of Virologic Suppression in HIV
Serious adverse events were similar between the two regimens.
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SAN DIEGO – Among HIV-infected adults whose disease was virologically suppressed on a boosted protease inhibitor regimen, switching to bictegravir coformulated with emtricitabine/tenofovir alafenamide was safe and maintained high levels of virologic suppression, according to research presented at IDWeek 2017.
In this phase 3 study, researchers enrolled 577 adults (17% women, 26% black, median age 48 years) with HIV who had virologic suppression to receive bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg (n = 290) or continue their boosted protease inhibitor regimens (n = 287). At baseline, all patients were receiving a boosted protease regimen. Most were receiving emtricitabine/tenofovir disoproxil fumarate. The primary end point of the study was the proportion of patients who continued to have virologic suppression at 48 weeks (HIV-1 RNA ≥50 copies/mL).
At 48 weeks, the two groups had similar rates of patients whose disease was not virologically suppressed (1.7% vs 1.7%; P =1.0), which met the predefined criteria for noninferiority. Additionally, 92.1% of patients in the bictegravir group had HIV-1 RNA <50 copies/mL compared with 88.9% in the group that did not switch.
No participants in the bictegravir group developed resistance, whereas a drug-resistant mutation occurred in one participant who was receiving darunavir plus abacavir/lamivudine.
Serious adverse events were similar between the 2 regimens, with grade 3 or 4 adverse events occurring in 4% of patients in the bictegravir group and 6% of patients in the boosted protease inhibitor group. No participants in the bictegravir group discontinued because of renal complications or tubulopathy.
The study authors concluded that “adults switching to [bictegravir/emtricitabine/tenofovir alafenamide] from a boosted [protease inhibitor] maintained high rates of virologic suppression without resistance. [Bictegravir/emtricitabine/tenofovir alafenamide] was safe and well tolerated.”
With the exception of Godson Oguchi, MD, and Ellen Koenig, MD, the remaining authors have either received a consulting fee or are employed by Gilead. A full listing of disclosures can be viewed here.
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Daar E, DeJesus E, Ruane P, et al. Phase 3 randomized, controlled trial of switching to fixed-dose bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) from boosted protease inhibitor-based regimens in virologically suppressed adults: week 48 results. Presented at: IDWeek 2017; October 4-8, 2017; San Diego, CA. Oral Abstract LB-4.