EC Greenlights ViiV Healthcare and J&J’s HIV-1 Combo for Adolescents

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced today that the European Commission has authorised the use of 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 aged 12 years and older, weighing at least 35 kg, who are virologically suppressed.

This approval marks a significant advancement in HIV treatment for adolescents, a demographic that faces unique challenges in managing the condition. As of 2023, an estimated 1.55 million people aged 10 to 19 worldwide are living with HIV. This age group typically reports lower treatment coverage, adherence rates, and viral suppression compared to older populations.

The long-acting injectable regimen of cabotegravir and rilpivirine reduces the annual number of doses required for effective HIV treatment from 365 daily pills to as few as six injections per year. This innovative approach addresses key barriers to adherence, such as stigma and the stress associated with daily oral treatments, as demonstrated in clinical trials and real-world studies.

Dr. Harmony P. Garges, Chief Medical Officer at ViiV Healthcare, commented:

“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.”

The Marketing Authorisations are supported by data from the MOCHA study (IMPAACT 2017, Study 208580), an ongoing Phase I/II multicentre, open-label, non-comparative study evaluating the safety, tolerability, and pharmacokinetics of cabotegravir and rilpivirine long-acting injections. The study involved 144 adolescents aged 12 years and older, weighing at least 35 kg. At week 24, no new safety concerns were identified, and 139 out of 144 participants (96.5%) remained virologically suppressed, with a plasma HIV-1 RNA value of less than 50 copies/mL.

Notably, 99% of MOCHA study participants (139/141) expressed a preference for long-acting injectable treatments over daily oral medications, citing convenience and reduced pill burden as primary reasons. Participants highlighted the decrease in adherence-related stress and increased privacy as significant benefits of the injectable regimen.

Cabotegravir and rilpivirine long-acting, marketed as Vocabria + Rekambys, were first approved by the European Medicines Agency (EMA) in December 2020 for the treatment of HIV-1 in virologically suppressed adults. This latest authorisation extends its use to adolescents, offering a transformative treatment option for younger patients.

About Vocabria and Rekambys

Vocabria (cabotegravir) is indicated, in combination with rilpivirine injection, for the treatment of HIV-1 infection in adults and adolescents (aged 12 years and older, weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen. It is also available in tablet form for short-term use, including as an oral lead-in to assess tolerability before transitioning to long-acting injections.

Rekambys (rilpivirine) is indicated, in combination with cabotegravir injection, for the same patient population. It can be initiated with or without an oral lead-in phase.

For full safety information, healthcare professionals are advised to consult the Summaries of Product Characteristics for Vocabria and Rekambys.

About ViiV Healthcare

ViiV Healthcare, established in November 2009 by GSK and Pfizer, with Shionogi joining as a shareholder in 2012, is solely dedicated to advancing HIV treatment and care. The company focuses on delivering innovative medicines and supporting communities affected by HIV.

About GSK

GSK is a global biopharmaceutical company committed to uniting science, technology, and talent to combat disease. For more information, visit gsk.com.

For further details on ViiV Healthcare’s portfolio and pipeline, visit viivhealthcare.com.


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