The U.S. Food and Drug Administration (FDA) gave a greenlight for ViiV Healthcare’s Cabenuva. The drug, a combination of cabotegravir and rilpivirine, is a complete therapy for HIV-1 infection in adults who are virologically suppressed, which is defined as having HIV-1 RNA of less than 50 copies of the virus per milliliter on a stable treatment regimen, no history of treatment failure and no known or suspected resistance to either of the drugs in the combination. The shot is given as two intramuscular injections in the buttocks once a month at a specialist clinic.
ViiV Healthcare focuses on HIV and is majority-owned by GlaxoSmithKline (GSK), with Pfizer and Shionogi Limited as shareholders. Cabotegravir is a ViiV product marketed as Cabenuva, and rilpivirine is a Janssen product with a brand name Edurant. Janssen is a Johnson & Johnson company.
The approval was built on the Phase III ATLAS and FLAIR trials. These involved more than 1,100 patients from 16 countries. Before beginning treatment with Cabenuva, patients took oral doses of both cabotegravir and rilpivirine for about a month to determine if the patients could tolerate it.
In the trials, Cabenuva was as effective as a daily oral three-drug regimen. The once-a-month regimen was preferred by nine out of 10 patients over the daily oral therapy.
In addition to the ATLAS and FLAIR trials, ViiV sponsored the CUSTOMIZE clinical trial. This was the first-ever, pre-approval implementation science study developed to evaluate ways to integrate Cabenuva into U.S. clinical practices.
Cabotegravir is an integrated strand transfer inhibitor (INSTI). Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI).