Thread by @fredhutch

Fred Hutch scientists are hailing “a true milestone” in last week’s FDA approval of the world’s first long-acting, injectable drug that can prevent HIV infection—as much as 90% more effective than taking a daily pill. bit.ly/3FOSWiF 1/9

Hutch biostatistician Dr. Deborah Donnell said this means “we now have a safe alternative to taking daily HIV prevention pills” like #Truvada, which already is nearly 100% effective—but only if you always remember to take your pills. bit.ly/3mCgEqs 2/9

“We think it could make a really big difference until we have a cure or a vaccine,” says Donnell, head of the data center that analyzed for (NC-based) @HIVptn results from its 2 key trials that proved the injectable drug, cabotegravir, worked well. bit.ly/3qx3z2O 3/9

Named a @aaas Fellow in 2020, Donnell has 25 years’ experience in design an analysis of #HIV prevention studies and collaborated on the 2 cabotegravir trials with @HIVptn and drugmaker @ViiVHC, whose FDA submission was approved Dec. 20. bit.ly/3HjTg95  4/9

The @NIH hopes a single injection every 2 months will reduce the ~35K new HIV infections each year in the U.S., especially for men who have sex w/ men, transgender people who have sex w/ women, and Black women disproportionately affected by HIV. bit.ly/3JsmlkD 5/9

“We really think the long-acting option for women in particular really could be a milestone in HIV prevention for women in Africa,” Donnell says. “Bimonthly injections give women control of HIV prevention, and injectable forms of prevention are familiar to women in Africa.” 6/9

The FDA decision was based on results of two large trials for which Donnell led data analysis. The goal of the trials was to see if the injectable drug worked as well as daily PreP pills. Instead, the trials showed cabotegravir worked better. 7/9

In the first trial, injectable drug reduced HIV risk 69% compared to Truvada among men and transgender women who have sex with men; in the second, among 3,444 African women, it reduced risk 90%.
wapo.st/3slaVJv 8/9

Last week’s FDA approval is the culmination of nearly a decade of work by a coalition of public and private research organizations, including the @gatesfoundation, to evaluate successful new approach to HIV prevention. bit.ly/3mGzfC2  9/9