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Issue: November 2017
October 10, 2017
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Bictegravir with F/TAF noninferior to boosted PI regimens in HIV

Issue: November 2017
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SAN DIEGO — Switching to an HIV regimen containing bictegravir was virologically noninferior to remaining on stable boosted protease inhibitor-based regimens in a recent phase 3 trial.

The bictegravir-containing regimen was also a safe alternative to the others, researchers said.

Previous trials have shown that bictegravir with emtricitabine/tenofovir alafenamide (F/TAF) is effective, study researcher Eric S. Daar, MD, chief of the division of HIV medicine at the Harbor-UCLA Medical Center and professor of medicine at the David Geffen School of Medicine at UCLA, said during a presentation.

Bictegravir is a novel, potent integrase strand transfer inhibitor with a high in vitro barrier to resistance and low potential for drug-drug interactions and is coformulated in a single tablet regimen with emtricitabine/tenofovir alafenamide for once-daily dosing,” Daar said.

In their study, Daar and colleagues included a total of 577 virologically suppressed adults with HIV on a boosted protease inhibitor (bPI)-based regimen with two nucleoside reverse-transcriptase inhibitors. Of those, 287 were randomly assigned to continue their existing bPI-based regimens consisting of boosted atazanavir or darunavir plus abacavir/lamivudine (ABC/3TC) or emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).

The other 290 patients switched to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) once daily.

The median patient age was 48 years, and approximately 85% were receiving FTC/TDF at screening.

At 48 weeks, 1.7% of patients in each study arm had HIV RNA of 50 c/mL or more.  In addition, 92.1% of patients receiving B/F/TAF had HIV RNA less than 50 c/mL, compared with 88.9% of those receiving a bPI-based regimen.

No patient receiving B/F/TAF developed resistance to the study drugs, discontinued treatment due to renal problems or experienced tubulopathy, the researchers said.

“B/F/TAF was well-tolerated and adverse events were comparable between study arms, with the exception of mild headaches that occurred more frequently in the B/F/TAF arm,”
Daar said. “But these tended to be relatively mild, transient and low grade.”

Darunavir is sold under the brand name Prezista (Janssen), FTC/TDF is sold under the brand name Truvada (Gilead Sciences), F/TAF is sold under the brand name Descovy (Gilead Sciences) and atazanavir is sold under the brand name Reyataz (Bristol-Myers Squibb). – by Joe Green

Reference:

Daar E, et al. Abstract LB-4. Presented at: IDWeek; Oct. 4-8, 2017, San Diego.

Disclosures: Daar reports working as a consultant for and receiving consulting fees from Bristol-Myers Squibb; working as a paid consultant, grant investigator and scientific advisor for, and receiving research support and consulting fees from, Gilead Sciences, Janssen, Merck and ViiV Healthcare; and working as a consultant and scientific advisor for, and receiving consulting fees from, Teva Pharmaceuticals. Please see the study for all other authors’ relevant financial disclosures.