Cabenuva (cabotegravir and rilpivirine)
Cabenuva is a complete antiretroviral regimen comprising Vocabria (cabotegravir) and Edurant (rilpivirine) for the treatment of HIV-1 infection in adult patients with virologically stable and suppressed viral load.
ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK), Pfizer, and Shionogi, developed Cabenuva.
Cabenuva is a long-lasting extended-release (ER) injectable suspension, whose complete dose is administered with two gluteal intramuscular injections, one for cabotegravir and the other for rilpivirine.
The drug is available as 2mL and 3mL dosing kits with two injectable medicines. Each kit comprises cabotegravir as a white to light pink, free-flowing ER injectable suspension in 200mg / mL strength and rilpivirine as a white to off-white ER injectable suspension in 300mg / mL strength.
ViiV Healthcare submitted a new drug application (NDA) for a two-drug regimen of cabotegravir and rilpivirine to the US Food and Drug Administration (FDA) in April 2019, while a marketing authorisation application (MAA) for the combination was submitted to the European Medicines Agency (EMA) in July 2019.
In December 2019, the company received a complete response letter (CRL) from the FDA citing safety concerns related to chemistry manufacturing and controls (CMC) and the safety profile of the drugs.
Cabenuva received approval from Health Canada in March 2020 and is under evaluation by the regulatory authorities in Switzerland and Australia.
In November 2020, the FDA granted breakthrough therapy designation to cabotegravir for HIV pre-exposure prophylaxis (PrEP).
Human immunodeficiency virus (HIV) destroys cells that aid the body in combating infection, rendering it more susceptible to other pathogens and diseases.
The disease spreads through infected body fluids of a person infected with HIV, most often through either casual intercourse (sex without a condom or measures to avoid or treat HIV) or through the sharing of injection drug equipment. If left untreated, HIV leads to AIDS (acquired immunodeficiency syndrome) disease.
The symptoms include fatigue, chills, rash, mouth ulcers, night sweats, muscle aches, fever, swollen lymph nodes and sore throat.
Cabotegravir acts as an integrase strand transfer inhibitor. It blocks HIV integrase by attaching to the active integrase site and inhibiting the retroviral deoxyribonucleic acid (DNA) integration stage, which is necessary for the HIV replication cycle.
Rilpivirine is a diarylpyrimidine non-nucleoside reverse transcriptase inhibitor of HIV-1.
Approval of Cabenuva by Health Canada comes from the results of two pivotal phase three clinical studies, Antiretroviral Therapy as Long-Acting Suppression (ATLAS) and First Long-Acting Injectable Regimen (FLAIR), which together enrolled more than 1,100 patients from 16 countries.
The drug safety profile was based on 48-week analyses of pooled data from the two studies.
Patients previously treated with antiretroviral regimen were enrolled in ATLAS, while those enrolled in FLAIR were antiretroviral treatment-naive but were previously treated with a dolutegravir (INSTI)-containing regimen for 20 weeks.
In clinical studies, randomised patients received either Cabenuva or remain on their antiretroviral regimen. The patients receiving Cabenuva intramuscularly once in a month showed similar efficacy to those continuing their daily, oral antiretroviral regimens to maintain viral suppression throughout the 48 weeks.
Approximately 88% of the patients preferred Cabenuva, while just 2% preferred their previous antiretroviral regimen in a single-item question survey performed in 532 patients at week 48.
The most common adverse events reported in the patients in the two studies were injection site reactions, high body temperature, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, rash and diarrhoea.
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