EMA has recommended the granting of marketing authorisations for two new antiretroviral (ARV) medicines, Rekambys (rilpivirine) and Vocabria injection (cabotegravir), to be used together for the treatment of patients with human immunodeficiency virus type 1 (HIV-1) infection. The two medicines are the first ARVs that come in a long-acting injectable formulation. This means that instead of daily pills, patients receive intramuscular injections monthly or every two months.
The combination of Rekambys and Vocabria injection is intended for maintenance treatment of adults who have undetectable HIV levels in the blood (viral load less than 50 copies/ml) with their current ARV treatment, and when the virus has not developed resistance to certain class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs) and integrase strand transfer inhibitors (INIs).
According to the World Health Organization (WHO) 38 million people were living with HIV worldwide in 2019. Over the last three decades, over 2.3 million people with HIV have been diagnosed and reported in the WHO European Region, including over 650,000 people in the EU/EEA. While there is no cure for HIV infection, ARV therapies can control the virus, help prevent transmission and prolong survival of patients.
The standard treatment for HIV-1 infection is a combination of ARV medicines from at least two different classes that need to be taken daily to suppress viral replication, increase number of CD4 cells (i.e. white blood cells that are important in helping to fight infections), and stop disease progression. For some HIV-infected people treated with a stable and effective daily combination of ARV medicines, the availability of a long-acting ARV that reduces the dosing frequency presents a significant improvement by increasing overall satisfaction with treatment and reducing the burden associated with daily pill taking.
Rekambys is an ARV of the NNRTI class of medicines that are used for the treatment of HIV-1 infection. It is a new long-acting formulation of rilpivirine that is already available as daily tablets (Edurant). Vocabria is a novel representative of the known pharmacological class of INIs. It contains cabotegravir, which is a new active substance.
Rekambys works together with Vocabria to block the ability of the virus to replicate. The long-acting injectable regimen does not cure HIV infection but helps reduce the amount of HIV, which targets the immune system, particularly the white blood cells, and keep it at a low level. This holds off damage to the immune system and the development of infections and diseases associated with acquired immune deficiency syndrome (AIDS).