Biktarvy (bictegravir 50mg, emtricitabine 200mg, tenofovir alafenamide 25mg; Gilead) was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC/DTG/3TC) through 96 weeks of therapy, according to findings from an ongoing Phase 3 study presented at IDWeek 2018 in San Francisco.

The trial enrolled 629 treatment-naïve adults living with HIV-1 and randomized them to receive Biktarvy (N=314) or ABC/DTG/3TC (N=315) with matching placebos. Results at week 96 showed that 87.9% and 89.8% of patients in the Biktarvy and ABC/DTG/3TG groups, respectively, achieved HIV RNA <50 copies/mL (difference -1.9%; 95% CI: -6.9% to 3.1%, P=.45).

With regard to renal function, the median change in estimated glomerular filtration rate (eGFR) from baseline to Week 96 was significantly less with Biktarvy vs ABC/DTG/3TC (-7.8 mL/min vs -9.6 mL/min, P=.01); median changes in proteinuria were similar between both groups.

At Week 96, the mean changes from baseline in spine and hip bone mineral density in the Biktarvy arm were -0.71 and -1.13, respectively, vs -0.22 and -1.26 in the ABC/DTG/3TC group.

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“This study underscores the role of Biktarvy as a first-line treatment option for appropriate adults living with HIV who are new to therapy,” said David Wohl, MD, Professor of Medicine, Division of Infectious Diseases, the University of North Carolina at Chapel Hill and lead study author. “In addition, Biktarvy was shown to have less nausea with a similar bone and renal safety profile to the comparator through 96 weeks.”

Biktarvy is currently approved as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for ≥3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

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