By Seun Adeuyi
In a new historic feat, the The food and Drug Administration (FDA) of the United States (US) has approved cabenuva, which consists of rilpivirine (Janssen) and cabotegravir (ViiV Healthcare), for treating HIV-1 infection in adults.
This is said to be the first once-monthly, long-acting injectable (LAI) to be approved for the treatment of HIV.
For its administration, a provider would conduct a once-monthly administration that would consist of 2 individual intramuscular injections in the buttocks.
In a press release, Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said, “With the approval of cabenuva, we’re proud to bring a new treatment option to people living with HIV that removes the burden of taking a daily pill.
“While much more remains to be done to make HIV history, today’s milestone reminds us how far medical innovation has come since the first reported cases of the virus almost 40 years ago.”
The FDA approved rilpivirine and cabotegravir based on 2 recent studies, the phase 3 Antiretroviral Therapy as Long-Acting Suppression (ATLAS) study and First Long-Acting Injectable Regimen (FLAIR) study.
Both studies had approximately 1100 patients from 16 countries included in the cohorts and demonstrated the efficacy of the treatment as a daily, oral 3-drug regimen that was able to maintain viral suppression during a 48-week period.