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).

The opinion by EMA’s human medicines committee (CHMP) is based on data from three phase 3 randomised, open-label, multicentre clinical trials with HIV-infected, treatment naïve (i.e. never taken ARV therapies) or successfully treated men and women aged 18 years or older. These studies demonstrated the safety and efficacy of Rekambys and Vocabria regimen when administered every four or eight weeks. Because the levels of the active substances fall slowly, it is even more important than with standard ARV medicines that patients adhere to the dosing schedule of Rekambys and Vocabria to avoid the risk of the virus developing resistance.

As for all medicines, a risk management plan (RMP) will ensure rigorous safety monitoring of the medicines once authorised across the EU. Further efficacy and safety data will be collected through a prospective cohort study and a real-world five-year drug utilisation study. The results will be included in post-marketing safety reports.

The most common side effects observed in clinical trials with the injectable regimen Rekambys and Vocabria include injection site reactions followed by headache, pyrexia, nausea, fatigue, asthenia, myalgia and dizziness.

The opinion adopted by the CHMP at its October 2020 meeting is an intermediary step on Rekambys and Vocabria’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.

Posted on the EMA website on 16 October 2020