Gilead doubles down on HIV prevention, treatment amid Covid setbacks and awaiting FDA decision on long-acting candidate
Amid predictions of HIV advances unraveling during Covid, Gilead Sciences is doubling down on prevention, treatment options and on-the-ground community efforts, even as it awaits an FDA decision on its long-acting candidate.
Tomáš CihlářAt the AIDS 2022 conference beginning next week, Gilead will present new data and studies on HIV treatment Biktarvy and its long-acting PrEP and HIV candidate lenacapavir, but will also host a panel laying out the details — and importance — of community collaborations.
“Without a community, the scientific discoveries and breakthroughs remain just in publications and cannot be transitioned into clinical practice,” Tomáš Cihlář, Gilead SVP of research and virology, said.
Jared Baeten, Gilead’s VP of HIV clinical development, added, “It’s end to end in what we’re developing in treatment, prevention and cure and how we’re doing the clinical research, and then it also has huge community engagement in trying to make sure that the things we develop actually have the impact that we all want.”
Jared BaetenWhile data on Covid’s effect on HIV/AIDS aren’t fully in yet, an initial CDC report in May notes a 17% drop in HIV diagnosis in 2020 “likely due to disruptions in clinical care services, hesitancy in accessing health care services and shortages in materials for HIV tests” during the pandemic.
CDC director of its HIV/AIDS prevention division Demetre Daskalakis called 2020 “a lost year” in the HIV fight during an NBC interview after the CDC report was published.
“We don’t really know where HIV transmission is going to land, but it’s something that we obviously are concerned about,” he said.
Demetre DaskalakisBaeten agreed the Covid pandemic did have negative effects on both treatment and prevention of HIV from access to meds to economics — which makes new therapies, dosing options and education all the more important.
“Covid brings it home really strongly for us because it emphasizes that HIV treatment and prevention is just one part of an individual’s life that can be impacted by tons of things around them,” he said. “The larger social context, be it stigma and things that impact the ability to access therapy effectively or take it for the long term, as well as the close in day-to-day issues of food insecurity, family and other demands — Covid flows through all of those.”
Even before the pandemic, while HIV infections had leveled off and even declined by single-digit percentages, there were still many people with HIV who were not effectively virally suppressed, Baeten said. Along with that, only a “minority” of people who could benefit from pre-exposure prophylaxis (PrEP) were taking it. Public health estimates about 25% of eligible HIV-negative people are on PrEP.
Gilead is hoping to change that, currently awaiting a decision on its FDA application for its long-acting drug lenacapavir, resubmitted in June after it was handed a CRL in December, citing issues with the compatibility of the drug and borosilicate vials. If approved, lenacapavir will be the first HIV-1 capsid inhibitor on the market and would be the first med with a six-month dosing schedule for HIV and PrEP.
GSK’s ViiV Healthcare’s Cabenuva was the first long-acting HIV treatment regimen approved for monthly or every-two-month dosing for HIV treatment in January 2021, while ViiV’s Apretude was the first long-acting treatment approved for PrEP in December.
For Gilead, the longer-acting dosing of lenacapavir adds another option that’s greatly needed in the next steps to resolve the HIV epidemic.
“We’ve now established well that with a daily pill we’ve covered lots of people for prevention — and lots of people are still uncovered. So we need to innovate beyond that,” Baeten said. “It’s really about getting to the point where we can turn off the epidemic, right? And the only way to get there is to bump up the number of people who are covered with treatment and prevention.”
