New Findings on Gilead’s Biktarvy Presented at AIDS 2020

Virtual Include Positive Switch Data in Older Adults - Seite 2

Biktarvy is indicated in the United States as a complete regimen for the treatment of HIV-1 infection in adults or pediatric patients weighing at least 25 kg who have no antiretroviral (ART) treatment history. While it is also indicated for adults and pediatric patients weighing at least 25 kg who are virologically suppressed and on a stable antiretroviral regimen, these people must have no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Please see below for U.S. Important Safety Information for Biktarvy, including a Boxed Warning on the risk of post-treatment acute exacerbation of hepatitis B.

“These data presented at AIDS 2020: Virtual further reinforce the potential of Biktarvy for use in a wide range of people living with HIV, including those with treatment resistance, older adults and those with certain common chronic conditions,” said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. “At Gilead, we are focused on continuing to advance the scientific understanding of HIV treatment in a way that will have a truly meaningful impact on the daily lives of those affected by the epidemic, from young children to the growing number of older adults who are living longer, healthier lives with HIV.”

Key abstracts for HIV treatment data presented at AIDS 2020: Virtual include:

Oral Presentation OAB0403: Pooled Analysis of 4 International Trials of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged 65 or Older Demonstrating Safety and Efficacy: Week 48 Results

A pooled analysis of four international trials (Studies 1844, 1878, 4030 and 4449) of virologically suppressed (HIV-1 RNA<50 copies/mL), treatment-experienced adults 65 years and older evaluated the efficacy and safety of switching to Biktarvy. The primary endpoint was HIV-1 RNA<50 copies/mL at week 48 as defined by the U.S. Food and Drug Administration Snapshot algorithm. Across the studies, 140 study participants with a median age of 68 years were evaluated; 14 percent were female, and 88 percent were white. Medical history at baseline was significant for diabetes (22 percent), hypertension (55 percent), cardiovascular disease (24 percent), and dyslipidemia, which is an abnormal amount of lipids in the blood (59 percent).