The European Commission (EC) has authorised the use of ViiV Healthcare’s Vocabria (cabotegravir long-acting injections) plus Rekambys (rilpivirine long-acting injections) from Johnson & Johnson (J&J) for treating adolescents with human immunodeficiency virus type-1 (HIV-1).
The decision applies to individuals aged 12 and above, weighing a minimum of 35kg, who are virologically suppressed.
ViiV Healthcare chief medical officer Harmony Garges stated: "This authorisation for Vocabria + Rekambys is an important milestone for adolescents living with HIV across Europe who may prefer a long-acting HIV treatment that could address challenges with taking daily oral regimens and could better suit their individual needs.”
The authorisation is based on week 24 data from the ongoing Phase I/II trial, MOCHA, assessing the tolerability, pharmacokinetics and safety of the long-acting treatment combination.
A virological suppression of 96.5% was maintained with no new safety concerns observed, according to data from 144 subjects in the trial.
A significant majority - 99% of the study subjects - expressed a preference for the long-acting injectable treatment over daily oral medication.
Reasons included convenience and a decrease in pill burden, which translates to less adherence-related stress and more privacy for the individuals.
In December 2020, the combo was approved by the European Medicines Agency for use in virologically suppressed adults with HIV-1.
Vocabria tablets should be in combination with rilpivirine tablets, and healthcare professionals are advised to consult the prescribing information for Edurant (rilpivirine) for proper dosing.
The long-acting regimen minimises the number of doses required for HIV treatment, from 365 daily pills to as few as six injections per year.
In October 2023, the National Medical Products Administration of China approved the use of Vocabria in conjunction with Rekambys for treating HIV-1 infection.
A specialist HIV company, ViiV Healthcare is majority-owned by GSK while Shionogi and Pfizer are shareholders.
