European Commission authorises ViiV Healthcare Vocabria plus Rekambys for HIV treatment in adolescents

Harmony P. Garges, M.D., Chief Medical Officer at ViiV Healthcare, said, "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. As the only global pharmaceutical company 100% dedicated to HIV, we are committed to ensuring no person living with HIV – regardless of their age – is left behind, and the announcement is one more step towards realising this mission.”

The Marketing Authorisations are supported by week 24 data from the MOCHA study, (IMPAACT 2017, Study 208580), an ongoing Phase I/II multicentre, open-label, non-comparative study of the safety, tolerability and pharmacokinetics of cabotegravir and rilpivirine long-acting. Based on data from the study in 144 adolescents (aged at least 12 years and weighing 35kg or more), no new safety concerns were identified and 139 of 144 participants (96.5%) remained virologically suppressed (plasma HIV-1 RNA value <50 c/mL).

Ninety-nine percent of the MOCHA study participants (139/141) stated that they preferred injectable long-acting medicines over daily orals, mainly for the convenience and pill burden reduction; the most prominent components of pill burden reduction were decrease in adherence-related stress and increased privacy.

Cabotegravir and rilpivirine long-acting, under the brand name Vocabria + Rekambys, was approved by the EMA for the treatment of HIV-1 in adults who are virologically suppressed in December 2020.

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