Cabenuva is a treatment regimen with cabotegravir (Vocabria) and rilpivirine (Edurant), was approved by the US FDA on 21st January 2021. Cabotegravir is a tablet formulation and rilpivirine is an injectable formulation. Cabotegravir was also approved the same day by the US FDA. The approval of Cabenuva and Vocabria was granted to ViiV Healthcare.
It was approved as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults –
- to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen
- with no history of treatment failure and
- with no known or suspected resistance to either cabotegravir or rilpivirine
This is the first FDA-approved regiment for HIV-infected adult patients.
The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) before initiation of treatment with Cabenuva. Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed.
The most common adverse reactions with Cabenuva were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/milliliter).
Vocabria should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland UC, indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. It works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.
Cabotegravir is a integrase strand transfer inhibitor (INSTI), like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
This regimen provides an alternative strategy for effective HIV treatment. Cabenuva once-monthly injections showed comparable efficacy to daily oral antiretroviral treatment in maintaining viral suppression, which is first in the treatment paradigm.
Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen.