Recently, ViiV Health announced that Health Canada has approved the company’s development of long-acting HIV-1 therapy Cabenuva to replace existing antiviral treatments in patients with HIV-1 virus has been suppressed. Cabenuva is the world’s first complete long-acting treatment to effectively suppress HIV-1 virus with just one shot per month.
It reduced the number of days patients received treatment per year from 365 to 12. The press release noted that this was the first time Cabenuva had been approved worldwide.
The use of antiviral “cocktail” therapy to treat HIV infection is one of the most important advances in the medical field over the past 25 years. There are already a variety of one-piece treatment programs that effectively control the proliferation of HIV-1 virus, so long as patients insist on taking daily medication, their life expectancy is not significantly different from that of healthy people. However, if the patient is unable to take the medicine daily for some reason, the virus in the body may not only re-emerge, but also increase the risk of developing drug resistance. Before the birth of the cure, daily medication remains a burden for many people living with HIV.
Cabenuva, developed by ViiV Healthcare, is a long-acting antiviral therapy for intramuscular injections. It consists of two active ingredients, rilpivirine and cabotegravir. Lipivirin is an oral non-nucleoside retrovirus ethnovirus inhibitor. Cabotwe is an integrated enzyme inhibitor that inhibits viral DNA from being integrated into the genome of human immune cells. This integration step is an indispensable step in the hiv virus replication process and is also an important cause of chronic infection.
Cabenuva’s approval is based on the results of two key Phase 3 clinical trials involving more than 1,100 patients in 16 countries. The results of two clinical trials, called ATLAS and FLAIR, were published this month in the New England Journal of Medicine (NEJM). The results showed that cabenuva, a monthly injection of buttock muscles, was comparable to the level of HIV-1 virus RNA in patients after 48 weeks of treatment compared to daily oral antiviral therapy. Health Canada also approved Cabotwe’s oral tablet, Vocabria, as an imported therapy prior to receiving Cabenuva long-acting therapy.
A questionnaire survey of some of the patients who participated in both clinical trials showed that 523 (98%) of the 532 patients who answered the questionnaire after 48 weeks of treatment were more likely to use Cabenuva, 9 (2%) preferred the original oral antiviral therapy, and 59 patients did not respond to the questionnaire.
“Today’s approval marks an important milestone in the treatment of HIV infection,” said Deborah Waterhouse, CEO of ViiV Healthcare. Cabenuva provides HIV-infected people with a treatment option that suppresses the virus 12 times a year and will positively affect their lives. “
Recently, ViiV Healthcare also announced that Cabenuva is injected every 8 weeks, compared with every 4 weeks of the treatment program, in the treatment of adult HIV-1 infection in the Phase 3 clinical trial, to achieve the non-disadvantage of the suppression of the virus standards. This means that this innovative treatment has the potential to further reduce the number of treatments for people living with HIV-1, to facilitate patients, and to improve compliance with medication.
Currently, this innovative therapy is under review by the European Medicines Agency (EMA). Although the application for a new drug (NDA) filed with the FDA was not approved at the end of last year, the FDA’s CRL did not raise any questions about the safety of the treatment, and the reasonfor for the failure to approve it was chemical manufacturing and control (CMC). ViiV Healthcare is working closely with the FDA to determine the next steps for new drug applications.
We expect this innovative treatment to be approved by more regulatory agencies around the world for the benefit of more people living with HIV-1.