A twice-yearly shot of the investigational antiretroviral medicine lenacapavir (Gilead Sciences) was associated with nearly a two-log drop in HIV viral load when paired with an optimized backbone antiretroviral regimen in people with resistance to multiple drug classes and few fully active treatment options.
This led Sharon Hillier, PhD, a researcher at the University of Pittsburgh, Pittsburgh, Pennsylvania, to call the results "small but pivotal" because they show activity. Most trials at this stage show negative results and end the program. But these suggest continuing.
"I was blown away," said Hillier, cochair of the Conference on Retroviruses and Opportunistic Infections 2021, who was not involved in the trial. And while the findings were limited by small numbers and interim analysis, Hillier added, "We need to keep our eye on the fact that this is amazing."
Lenacapavir binds to the conical capsid that encapsulates the HIV viral genome. If successful in larger phase 3 trials, it would be the first capsid inhibitor in HIV to come to market. It would also join fostemsavir (Rukobia) and ibalizumab (Trogarzo) as a new option for people with multiple drug resistance.
The phase 2/3 CAPELLA trial (NCT04150068) enrolled 72 heavily pretreated people living with HIV at trial sites in Canada, the US, the Dominican Republic, Japan, Taiwan, Thailand, France, Germany, Italy, Spain, and South Africa.
