Biktarvy Found to Be Non-Inferior to Abacavir-Containing Regimen in Phase 3 Study

Biktarvy was approved by the Food and Drug Administration in February 2018
Biktarvy was approved by the Food and Drug Administration in February 2018

Results from a 48-week Phase 3 study evaluating HIV patients who switched to treatment with Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; Gilead) found this combination therapy to be statistically non-inferior to a regimen containing abacavir, dolutegravir, and lamivudine (600mg/50mg/300mg) (ABC/DTG/3TC).

Study 1844 included 563 virologically-suppressed adults with HIV taking a regimen of ABC/DTG/3TC; these patients were randomized to continue a once-daily fixed-dose combination of ABC/DTG/3TC or to switch to Biktarvy. At Week 48, 1.1% of patients treated with Biktarvy and 0.4% of patients treated with ABC/DTG/3TC had HIV-1 RNA ≥50c/mL (difference: 0.7%; 95% CI –1.0% to 2.8%, P=0.62); 93.6% of patients in the Biktarvy arm and 95.0% of patients in the ABC/DTG/3TC arm had HIV-1 RNA <50c/mL.

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Treatment with Biktarvy was also associated with a numerically lower incidence of mild to moderate study drug-related adverse events  (8% vs.16%, P=0.006; all grades) and no treatment-emergent resistance. Moreover, there were no renal adverse events leading to discontinuation in either group. Lipid profiles remained the same after switching to Biktarvy; bone mineral density changes from baseline were similar between both groups.

“In this study, Biktarvy maintained high rates of virologic suppression and demonstrated a high barrier to resistance through 48 weeks of treatment, findings that have been consistently observed across all Phase 3 studies of the regimen,” said Jean-Michel Molina, MD, Head of the Infectious Diseases Department, Hospital Saint Louis, Paris, France and lead study investigator. “In addition, people taking Biktarvy experienced fewer drug-related adverse events compared to participants in the comparator arm, a consideration for physicians and their patients who choose to switch HIV treatments.”

Biktarvy was approved by the Food and Drug Administration (FDA) in February 2018. The combination product is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50c/mL) on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

For more information visit Gilead.com.