GSK plc has announced that ViiV Healthcare, the global HIV-focused company majority owned by GSK with Pfizer and Shionogi as shareholders, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This recommendation supports marketing authorisation for Vocabria (cabotegravir long-acting injections) in combination with Rekambys (rilpivirine long-acting injections), developed by Johnson & Johnson Innovative Medicine. The treatment targets HIV-1 infection in adolescents aged 12 and older, weighing at least 35 kilograms, who are virologically suppressed.
This milestone is significant in addressing the needs of adolescents living with HIV, a group often underserved in HIV care. In 2023, approximately 1.55 million young people aged 10 to 19 globally were living with HIV. While advances in HIV treatment have transformed the condition into a manageable disease, many still face challenges with daily oral regimens. These challenges include difficulties with adherence, daily reminders of their diagnosis, and concerns about stigma and disclosure. Adolescents, in particular, report lower treatment coverage, adherence, and viral suppression rates compared to older age groups.
If approved, this expanded indication for cabotegravir and rilpivirine long-acting injections will represent the first complete, long-acting regimen available to adolescents with HIV. This development aims to address critical gaps in treatment access and adherence among younger populations.
Dr. Harmony P. Garges, Chief Medical Officer at ViiV Healthcare, emphasized the importance of this progress: “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 the potential to provide effective therapy while addressing the challenges many individuals face with daily oral treatments. This milestone underscores our commitment to providing innovative therapeutic options to young people and ensuring that no person living with HIV is left behind.”
The CHMP’s recommendation is based on week 24 data from the MOCHA study (IMPAACT 2017, Study 208580). This ongoing Phase I/II multicentre, open-label, non-comparative study evaluates the safety, tolerability, and pharmacokinetics of cabotegravir and rilpivirine long-acting injections in adolescents. The study enrolled 144 participants aged at least 12 years and weighing 35 kilograms or more. Results showed no new safety concerns, with 139 out of 144 participants (96.5%) maintaining virologic suppression (plasma HIV-1 RNA <50 c/mL) at week 24. Additionally, a survey conducted at the 24-week mark revealed that 99% of respondents (139 out of 141) preferred long-acting injectable treatments over daily oral regimens. Participants cited convenience and reduced treatment burden as primary reasons for their preference, with decreased adherence-related stress and increased privacy being significant factors.
The anticipated marketing authorisation from the European Commission is expected within the next few months. This approval would build on the initial EMA approval for cabotegravir and rilpivirine long-acting treatments under the brand names Vocabria and Rekambys, which were authorised in December 2020 for use in adults with HIV-1 who are virologically suppressed.
The availability of a long-acting injectable regimen for adolescents represents a transformative approach to HIV care. Long-acting treatments provide a solution to the adherence challenges associated with daily oral medications. By reducing the need for frequent dosing, these therapies can enhance the quality of life for individuals living with HIV. Adolescents, in particular, may benefit from the increased privacy and reduced stigma associated with long-acting options, helping them manage their condition more effectively and discreetly.
As HIV continues to disproportionately impact young populations worldwide, the approval of Vocabria and Rekambys for adolescents could significantly improve treatment outcomes. The MOCHA study results demonstrate the safety and efficacy of these long-acting injections, reinforcing their potential to address unmet needs in this vulnerable population.
ViiV Healthcare’s dedication to innovation in HIV care is evident in its mission to leave no person living with HIV behind. By developing therapies tailored to diverse patient needs, the company seeks to ensure equitable access to effective treatments for all individuals, regardless of age or circumstance. This positive CHMP opinion marks a step forward in achieving that vision, paving the way for improved therapeutic options for adolescents living with HIV across Europe.
With final authorisation anticipated soon, this breakthrough could reshape HIV care for younger populations, providing them with greater autonomy and a more manageable approach to their treatment. The expansion of cabotegravir and rilpivirine’s indication aligns with global efforts to close gaps in HIV care and improve health outcomes for those living with the virus.
