Gilead Sciences announced on Saturday new results from its continuing Phase 2 and Phase 3 CAPELLA clinical trial that is investigating the use of lenacapavir, the biopharmaceutical company’s drug that may help people living with multi-drug resistant HIV.
Lenacapavir is an injection for patients to take every six months. Researchers found that after Week 26, lenacapavir, taken with antiretrovirals, suppressed HIV in those that had not been previously responding to such treatment, according to a press release.
The results were presented at the 11th International AIDS Society Conference on HIV Science.
“Despite the advances in treating HIV infection, there remains an unmet need for treatment options for people who struggle with multi-drug resistance. As a physician, it’s frustrating to have limited options for these patients who are at greater risk of progressing to AIDS,” said Dr. Jean-Michel Molina, professor of infectious diseases at the University of Paris.
In the CAPELLA study, 72 individuals participated.
“The CAPELLA results are exciting as they demonstrate that an undetectable viral load is achievable in a patient population that has typically had challenges with viral suppression over the course of their journey living with HIV,” said Molina. “New, long-acting options in development, like lenacapavir, are critical to changing the clinical landscape, and I’m encouraged that lenacapavir can potentially help improve clinical outcomes.”
Gilead has applied for U.S. Food & Drug Administration approval. If the drug is approved, it will be the only one of its kind.
“Lenacapavir is a breakthrough innovation in HIV research. If approved, it has the potential to become a cornerstone of future long-acting HIV regimens,” said Frank Duff, senior vice president and virology therapeutic area head at Gilead Sciences.
“Scientific advances are a key to helping end the HIV epidemic,” Duff said. “Our researchers are committed to addressing the unmet needs of people living with HIV, including the exploration of different dosing intervals that may coincide with regularly scheduled visits with healthcare providers.”
In a separate study called CALIBRATE, lenacapavir and emtricitabine/tenofovir alafenamide were used together, some research participants saw a viral suppression rate of 94 percent. More studies are required to have conclusive findings.