Biotechnology company Gilead Sciences (NASDAQ: GILD) has announced results from the phase 2/3 CAPELLA clinical trial evaluating the efficacy and safety of HIV-1 capsid inhibitor lenacapavir for the treatment of HIV infection in adults that were treated previously with other anti-viral drugs without adequate control of viral replication.
In the trial, 24 adults were administered oral lenacapavir and 14 were given a placebo for two weeks, after which levels of HIV in participants’ blood was assessed. The study found that, after 14 days of treatment, a greater proportion of lenacapavir-treated patients experienced viral load reduction of at least 0.5 log10 copies/mL from baseline as compared to those that received a placebo (88% vs. 17%, p<0.0001) and a greater change, on average, in the viral load (-1.93 log10 copies/mL vs. -0.29 log10 copies/mL, p<0.0001). Both outcomes demonstrated statistical significance.
While 88% of lenacapavir-treated patients (n=21/24) experienced at least a 0.5 log10 copies/mL reduction of viral load by the end of the treatment period, this outcome was achieved by only 17% of patients administered a placebo (n=2/12).
Senior Vice President and Virology Therapeutic Area Head at Gilead Sciences Diana Brainard, MD, stated, “Treatment options that address the complex needs of heavily treatment-experienced people living with multidrug resistant HIV remain a significant unmet need. Lenacapavir, a novel investigational capsid inhibitor that is being evaluated to be administered subcutaneously every six months, represents a potential substantial advance in the field of HIV treatment. We look forward to sharing data from longer-term follow-up of CAPELLA study participants next year and submitting these data for regulatory approval.”
Medical Director of the Orlando Immunology Center Edwin DeJesus, MD, FACP, FIDSA, stated, “There is an urgent and critical need for innovative treatment options for people living with HIV who have limited treatment options and are not able to maintain virologic suppression on their current therapy, whether from challenges adhering to a complex regimen or HIV mutations that cause drug resistance.”
“The initial CAPELLA trial results demonstrate that lenacapavir led to a rapid decline in viral load in heavily treatment-experienced people with multidrug resistance living with HIV. This clinical response could potentially have an important impact on individual patients and public health,” Dr. DeJesus continued.
If approved by the FDA, lenacapavir would be the first clinically available HIV-1 capsid inhibitor used to treat HIV-1 infection. The drug would likely be incorporated into a long-acting treatment regimen consisting of multiple anti-retroviral medications. Other therapies, including Gilead’s TLR7 agonist Vesatolimod, have also shown promise for the treatment of HIV.