New Findings on Gilead’s Biktarvy Presented at AIDS 2020

Virtual Include Positive Switch Data in Older Adults

Gilead Sciences, Inc. (Nasdaq: GILD) today announced data demonstrating the safety and efficacy of the once-daily, single tablet regimen Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virologically suppressed adults ages 65 and older (n=140), including those with common comorbidities such as diabetes (22 percent), hypertension (55 percent), cardiovascular disease (24 percent), and dyslipidemia, which is an abnormal amount of lipids in the blood (59 percent). At 48 weeks, 92 percent of those who switched to Biktarvy maintained virologic suppression, achieving HIV RNA<50 copies/mL. Across the studies, Biktarvy was generally well tolerated. These data were evaluated as part of a pooled analysis of four international trials and will be presented during the 23rd International AIDS Conference (AIDS 2020: Virtual).

“As the number of older adults living with HIV grows, it’s critical to optimize therapy to fit the unique needs of this key population, including those with chronic conditions who may be on multiple medications,” said Moti Ramgopal, MD, FACP, FIDSA, Medical Director, Midway Immunology and Research Center. “By 2030, it is projected that up to 70 percent of people living with HIV will be 50 years or older, the majority of whom will have at least one other comorbidity. The data presented at AIDS 2020: Virtual showed that adults 65 years and older who switched to Biktarvy maintained viral suppression without a significant impact on lipid levels such as cholesterol, weight, or interactions with other drugs they may be taking for comorbidities.”

Gilead also announced a new data analysis from multiple studies evaluating drug resistance, including the first study to investigate a switch to Biktarvy in virologically suppressed study participants (n=565) in which some of the participants had a history of treatment failure or suspected pre-existing nucleoside reverse transcriptase inhibitor resistance (NRTI-R). The study showed infrequent and similar viral blips (when study participants experienced a temporary viral load at or above 50 copies/mL) among study participants switching to Biktarvy, as compared to the comparator arm. The results support further evaluation of whether the once-daily, single tablet regimen Biktarvy may potentially be an effective and well-tolerated option for adults with a history of treatment failure or pre-existing resistance. The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational.