Gilead's new shell functional inhibitor lenspavir Phase 2/3 clinical end point!

On November 18, Gilead published the top-line results of the 2/3 clinical CAPELLA trial, which evaluated the efficacy and safety of the research-based, long-acting HIV-1 shell inhibitor lensavivir, which has been treated multiple times for HIV Type 1 (HIV-1) multiple drug-resistant infections.
study found that 88 percent of subjects treated with lensapavir (n=21/24) had a reduction in HIV-1 viral load by at least 0.5 log10 at the end of 14 days of functional monotherapy, compared with 17 per cent in the placebo group (n=2/12).
is expected to share long-term tracking data from CAPELLA study participants next year and plans to submit new drug approvals to regulators based on that data.
as part of a long-acting treatment programme, lenacapavir is used in therapy for HIV-1 infection in the same way as other antiretroviral drugs.
if approved, the drug would be the first HIV shell inhibitor to be used to treat HIV-1 infections.
In the CAPELLA study, 36 adult patients with multiple types of HIV resistance and viral load detected after the failure of the treatment programme were randomly assigned at a 2:1 scale and received oral lecapavir or placebo for 14 days in addition to continuing with previously failed treatments (functional monotherapy).
of the 24 people randomly assigned to the lensapavir group, the median baseline virus load was 4.2 log10 copies/mL, and 67% of the subjects had a CD4 count below 200/uL.
At the end of the 14-day treatment, the proportion of subjects receiving lenspavir with a reduction in viral load by at least 0.5 log10 copies/mL (primary endpoint) was statistically significant (88 percent vs. 17 percent, p.lt;0.0001) compared to placebo-added functional monotherapy.
addition, the average change in viral load in the lenacapavir group was statistically significant (-1.93 log10 copy/mL comparison-0.29 log10 copy/mL, p.lt;0001) compared to the placebo group.
In addition, lenacapavir was generally safe and well-to-do, with no serious adverse events associated with the study drug observed during the 14-day period, nor did the drug stop for any reason, including no adverse events.
the most common adverse events observed in this part of the study included swelling at the injection site (21%) and nods at the injection site (17%), most of which were grade 1 or 2.
after a 14-day functional monodrative treatment period, all subjects were subjected to an open label study by Lenacavavir to optimize the treatment.
the continuing duration of the CAPELLA study was to evaluate the subsuperfic dosing of Lenacavavir every six months, as well as the safety and stability of Lenacavavir, as well as the background scheme optimized in weeks 26 and 52.
results of the CAPELLA trial showed that lenacapavir led to a rapid decline in viral load in hiv-resistant patients who had been severely treated multiple times.
this clinical response can have important implications for individual patients and public health.
phase 1 clinical study data presented at the AIDS 2020 Conference supports the use of lenacapavir for HIV treatment and prevention every six months.
addition, on IDWeek 2020, Gilead announced the addition of a new research branch to assess the effectiveness of the use of lenacapavir every six months in women's AIDS prevention.
also plans to conduct a study of men who have sex with men and people with cross-cultural experiences, which is expected to start in mid-to-late 2021.
May 2019, the FDA approved lecapavir and other antiretroviral drugs in combination with breakthrough therapies for multidrrat patients who have underrated multiple times after HIV-1 infection.
source: Gilead's Lenacapavir Show Promise for Multidrug-Resistant HIV in Phase II/III Trial Original title: Long-acting treatment of HIV infection, Gilead's new shell function inhibitor lensapavir 2/3 clinical end!