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 noninferior to a regimen containing abacavir, dolutegravir, and lamivudine (600mg/50mg/300mg) (ABC/DTG/3TC), according to a study presented CROI 2018, held March 4-7 in Boston, Massachusetts.1,2

Study 1844 included 563 virologically-suppressed adults with HIV taking a regimen of ABC/DTG/3TC; these patients were randomly assigned 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%, =.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.

Treatment with Biktarvy was also associated with a numerically lower incidence of mild to moderate study drug-related adverse events  (8% vs 16%, =.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 in 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.”

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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.

References

  1. Gilead presents results from phase 3 study evaluating patients who switched to Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) from regimen containing abacavir, dolutegravir and lamivudine [press release]. Foster City, California. Published March 5, 2018. Accessed March 7, 2018.
  2. Molina J-M, Ward D, Brar I, et al. Switch to Bictegravir/F/TAF from DTG and ABC/3TC. Presented at: CROI 2018. Boston, MA; March 4-7, 2019. Abstract 22.

This article originally appeared on MPR