ViiV Healthcare, a GSK company specialising in HIV treatments, has received the European Commission (EC) marketing authorisations for its treatment regimen for HIV-1 infection.
The regimen comprises ViiV’s Vocabria (cabotegravir), together with Johnson & Johnson’s (J&J) Rekambys (rilpivirine), both in long-acting injection formulation.
Vocabria works as an integrase strand transfer inhibitor (INSTI) to inhibit viral replication, by blocking its ability to integrate genetic material into human cells.
Rekambys is recommended to be always co-administered with a cabotegravir injection, and the treatment using the drug may be initiated regardless of oral lead-in.
EC indicated the regimen for the treatment of HIV-1 infection in adolescents, aged 12 years and above, and weighing at least 35 kg who are virologically suppressed.
In December 2020, the European Medicines Agency (EMA) approved cabotegravir plus rilpivirine long-acting regimen, under the brand name Vocabria + Rekambys.
The regimen was then indicated for adults with HIV-1, who are virologically suppressed.
ViiV Healthcare chief medical officer Harmony Garges 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 today’s announcement is one more step towards realising this mission.”
According to ViiV, cabotegravir and rilpivirine long-acting reduce the number of treatment doses from 365 daily pills to as few as six injectable treatments per year.
Also, the formulation helps address challenges associated with daily oral treatments, including stigma and adherence-related stress, observed in clinical and real-world studies.
EC marketing authorisation is supported by data from MOCHA, an ongoing, multicentre, open-label, non-comparative Phase ½ study.
MOCHA evaluated the safety, tolerability and pharmacokinetics of cabotegravir and rilpivirine long acting, in 144 adolescents, aged at least 12 years and weighing 35kg.
In the study, most participants preferred injectable long-acting medicines over daily orals and remained virologically suppressed, with no new safety concerns reported.
