Switching to Gilead's Biktarvy proves non-inferior in HIV patients

Gilead has unveiled findings from two Phase 3 studies into the efficacy of switching to its three-drug combo Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) from a range of regimens.

In the first study examining 563 participants, Biktarvy was found to be statistically non-inferior to a regimen of abacavir, dolutegravir, and lamivudine (ABC/DTG/3TC) in virologically suppressed adult HIV patients. After 48 weeks of treatment, 1.1% of those receiving Biktarvy demonstrated HIV-1 RNA ≥50c/mL, compared to 0.4% of those receiving ABC/DTG/3TC. Additionally, 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

Biktarvy also demonstrated a lower incidence of mild to moderate side-effects at 8% compared to 16% with ABC/DTG/3TC, and lipid profiles did not change upon switching to Gilead’s therapy.

"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," commented Dr Jean-Michel Molina, lead investigator and Head of the Infectious Diseases Department, Hospital Saint Louis, Paris. "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."

In the second study, comprising 470 virologically supressed women with HIV, Biktarvy was again found to be non-inferior to a boosted protease inhibitor or boosted elvitegravir-containing regimen. After 48 weeks, 1.7% of patients in both treatment arms showed HIV-1 RNA ≥50 c/mL, with 95.7% of patients in the Biktarvy arm showing HIV-1 RNA <50 c/mL, compared to 95.3% of those on their baseline regimen.

"In this study, women who switched to Biktarvy maintained high levels of viral suppression, comparable to those who remained on a baseline regimen of either Genvoya, Stribild or ATV+RTV+FTC/TDF, and none of the participants on Biktavy developed treatment-emergent resistance," explained Dr Cissy Kityo, Deputy Executive Director of Uganda’s Joint Clinical Research Centre and lead investigator on the study. "Conducting this women-only study on an international scale helps to further demonstrate that Biktarvy may be appropriate for a wide range of people living with HIV." 

No treatment-emergent resistance was observed in either study. According to the Gilead, additional trials are ongoing to evaluate the efficacy of Biktarvy in women and adolescents and children with HIV.

Dr Norbert W Bischofberger, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer remarked on the data: "The data presented at CROI this week, in addition to previously reported studies in both treatment-naïve and virologically suppressed adult patients, further demonstrate that Biktarvy may be appropriate for a wide range of people living with HIV who are either new to treatment or who choose to switch regimens[…]Following the recent approval of Biktarvy in the United States, we look forward to working to expand the availability of this novel therapy to patients around the world.

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