GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, has  announced that the Committee for Medicinal Products for Human Use (CHMP) of the Europe Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Vocabria (cabotegravir long-acting injections) in combination with Johnson & Johnson Innovative Medicine’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 young people aged 10 to 19 around the world living with HIV.¹ Advances in treatment mean HIV can be a manageable condition, but some people face challenges with taking daily oral regimens, including adherence, the daily reminder of HIV, and a fear of disclosure and associated stigma.²

This expanded indication for cabotegravir and rilpivirine long-acting, if approved, will mark the first time a complete, long-acting regimen is available for adolescents living with HIV, who have lower reported treatment coverage, adherence to treatment and viral suppression rates than older age groups.¹

Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said: "Today’s positive CHMP opinion is an important step towards bringing the first long-acting injectable regimen to adolescents living with HIV. Long-acting regimens have potential to provide effective HIV therapy and help address the challenges many people face taking daily oral regimens. This progress underscores our ongoing commitment to bringing more therapeutic options to young people as part of our mission to leave no person living with HIV behind.”

The positive opinion is 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) at week 24.³ Furthermore, 99% of participants asked at week 24 (139/141) stated that they preferred injectable long-acting medicines over daily orals, mainly for the convenience and burden reduction; the most prominent components of burden reduction were decrease in adherence-related stress and increased privacy.⁴

Marketing Authorisation from the European Commission is anticipated in the coming months. 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.