European Commission authorises ViiV Healthcare Vocabria plus Rekambys for HIV treatment in adolescents
London: GSK plc has announced that ViiV Healthcare, the global HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, has announced that the European Commission has authorised Vocabria (cabotegravir long-acting injections) in combination with Johnson & Johnson’s Rekambys (rilpivirine long-acting injections) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed.
As of 2023, there were 1.55 million people aged 10 to 19 around the world living with HIV; people in this age bracket typically have lower reported treatment coverage, adherence to treatment and viral suppression rates than older age groups. Cabotegravir and rilpivirine long-acting reduces the number of doses needed for effective HIV treatment from 365 daily pills to as few as six injectable treatments per year and helps alleviate challenges with daily oral treatments, including stigma and adherence-related stress, in clinical trials and observed in real-world studies.
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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