EU approves long-acting HIV treatment for adolescents

BELGIUM – The European Commission (EC) has approved the use of ViiV Healthcare’s Vocabria (cabotegravir long-acting injections) combined with Rekambys (rilpivirine long-acting injections) from Johnson & Johnson for treating HIV-1 in adolescents.

This approval applies to individuals aged 12 and older, who weigh at least 35kg and are virologically suppressed.

Harmony Garges, Chief Medical Officer at ViiV Healthcare, expressed the significance of this milestone, stating, “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 approval is supported by data from the ongoing Phase I/II MOCHA trial, which evaluated the tolerability, pharmacokinetics, and safety of this long-acting treatment.

After 24 weeks, the trial showed that 96.5% of participants maintained virological suppression, and no new safety concerns were identified.

One of the standout findings from the study was the overwhelming preference for long-acting injections among participants.

Nearly 99% of the 144 adolescents involved said they preferred the injections over daily pills. They highlighted the convenience, reduced stress related to medication adherence, and the increased privacy that comes with fewer doses.

This new injectable combination marks a significant advancement in HIV treatment by reducing the burden of daily medication. Instead of 365 pills a year, patients can now manage their condition with as few as six injections annually.

The long-acting Vocabria and Rekambys combo was first approved for use in virologically suppressed adults with HIV-1 by the European Medicines Agency in December 2020.

In October 2023, China’s National Medical Products Administration also approved this combination for treating HIV-1.

Healthcare professionals prescribing this regimen are advised to refer to the prescribing information for Edurant (rilpivirine) for proper dosing. Vocabria tablets should be used alongside rilpivirine tablets when transitioning to the injectable form.

ViiV Healthcare, the company behind this innovative treatment, is a specialist in HIV care. It is majority-owned by GSK, with Shionogi and Pfizer as shareholders.