Image credit: ViiV Healthcare
On January 31, the European Commission authorized ViiV Healthcare’s cabotegravir (Vocabria), long-acting injection, in combination with Johnson & Johnson’s rilpivirine (Rekambys),long-acting injections for the treatment of HIV in teens 12 years of age and older and weighing at least 35 kg (77.16 lbs) who are virologically suppressed.1
“This authorization 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,” ViiV Healthcare Chief Medical Officer Harmony Garges, MD, said in a statement.
Cabotegravir and rilpivirine long-acting injections reduces the number of doses needed for effective HIV treatment from 365 daily pills to as few as 6 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.
Cabotegravir and rilpivirine was approved by the EMA for the treatment of HIV-1 in adults who are virologically suppressed in December 2020.
Nearly 3 years ago, the combination injection was expanded in the US by the FDA for teens.
What You Need to Know
The European Commission has authorized ViiV Healthcare’s cabotegravir (Vocabria) and Johnson & Johnson’s rilpivirine (Rekambys) as a long-acting injectable HIV treatment for adolescents aged 12 and older, weighing at least 35 kg, who are virologically suppressed.
The long-acting injections reduce the need for 365 daily pills to as few as six injections per year, addressing challenges such as adherence-related stress, stigma, and privacy concerns, which were highlighted in clinical trials and real-world studies.
The authorization is based on data from the MOCHA study, which showed that 96.5% of participants remained virologically suppressed, and 99% of them preferred injectable treatment over daily oral regimens due to convenience and reduced pill burden.
Study Parameters
The Marketing Authorizations are supported by week 24 data from the MOCHA study, (IMPAACT 2017, Study 208580), an ongoing phase 1/2 multicenter, 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.
