HIV franchise growth and prevention

“That's very insightful. Right? We are currently looking into the different study designs, right? We have not commented exactly on what we're planning on doing at this point in time. But you're absolutely right, there are different study designs that you can utilize and potentially a PK-based approach is a possibility that we're discussing.”

“Our base business, excluding Veclury, grew 4% from the first quarter of 2024, primarily driven by growth in our HIV business.”

“HIV sales were up 6% year over year, with Biktarvy up 7%, highlighting our demand-led volume growth that was offset in part by the expected headwinds associated with the Part D redesign.”

“In HIV, we are now only weeks away from the anticipated FDA decision on twice-yearly lenacapavir for PrEP. We remain on track for the June 19 PDUFA date with the potential launch in the US immediately following.”

“As a reminder, this is one of up to nine potential HIV products we are targeting before the end of 2033, building on Gilead Sciences, Inc.'s decades of leadership in HIV innovation.”

“As a reminder, we have no major LOEs until the end of 2033 and expect to drive top-line growth over time across all three of our therapeutic focus areas of virology, oncology, and inflammation.”

“Overall, the HIV treatment market continues to grow in line with our expectations, of 23% annually.”

“HIV prevention continues to represent the significant majority of Descovy sales, and growth this quarter was driven by broader awareness, growing unrestricted access, and associated pricing favorability, as well as focused commercial execution that contributed to approximately 16% US PrEP market growth year over year.”

“Growing awareness and adoption of HIV prevention is encouraging ahead of our upcoming potential US launch of lenacapavir for PrEP.”

“Building on our deep expertise and success of HIV launches and with strong engagement across the board from community leaders to healthcare providers, our teams are ready to build awareness, drive adoption, and overall, deliver a seamless customer experience.”

“Lenacapavir plus BNABs has already received breakthrough therapy designation from FDA, and these phase two data further underscore the potential for this combination to be the first complete twice-yearly treatment regimen for virologically suppressed people with HIV.”

“We think that LEN for PrEP is really well positioned there.”

“We do believe though that despite this, we feel we're incredibly well-positioned because of the transformative nature of lenacapavir to build access across the different channels that and we're prepared to do that.”

“Think that number will definitely continue to grow quite rapidly, especially with the acceleration. I think it will accelerate with the launch of lenacapavir and I think that number could be quite exponential as you think about the next ten years or so.”

“The combinations of doravirine and enzlotrovir is the first complete two-drug regimen without an integrase strand transfer inhibitor to demonstrate comparable efficacy and safety to the three-drug insti-based regimen Biktarvy.”

“Based on its potent antiviral properties and barrier to resistance, it is our ambition that ezlotrovir will serve as a novel anchor medicine across multiple two-drug treatment regimens, providing new daily and weekly options for people living with HIV.”

“So as you highlight, we are really excited about islatravir because we really think it is a next-generation nucleoside analog. So it leverages a unique mechanism of translocation inhibition that gives it high potency and a high degree of resistance.”

“I think there will be an excitement of having a two-drug combo without an Insty backbone.”