• Vocabria + Rekambys (cabotegravir + rilpivirine) is the first and only
complete long-acting injectable for the treatment of HIV
• Ninety-nine percent of adolescents living with HIV preferred the long-acting
injectable to a daily oral regimen when given the option due to convenience
and pill burden reduction
• This Marketing Authorisation builds on company legacy of expanding access
to medicines for children and young people
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 today announced that the European Commission has
authorised 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 12 years of age and older and
weighing at least 35 kg who are virologically suppressed.
As of 2023, there were 1.55 million people aged 10 to 19 around the world living with HIV; people in this age bracket
typically have lower reported treatment coverage, adherence to treatment and viral suppression rates than older age
groups.1 Cabotegravir and rilpivirine long-acting reduces the number of doses needed for effective HIV treatment
from 365 daily pills to as few as six 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.2,3
Harmony P. Garges, M.D., Chief Medical Officer at ViiV Healthcare, 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.”
The Marketing Authorisations are 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).4
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.5
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.
About Vocabria
Vocabria (cabotegravir) injection is indicated - in combination with rilpivirine injection - for the treatment of Human
Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at
least 35kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without
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present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside
reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class.
Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection
in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed
(HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to,
and no prior virological failure with agents of the NNRTI and INI class for:
• oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria
injection plus long acting rilpivirine injection.
• oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.
Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the
prescribing information for Edurant (rilpivirine) tablets should also be consulted for recommended dosing.
Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg
prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets
About Rekambys
Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults and
adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA < 50
copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior
virological failure with, agents of the NNRTI and INI class.
Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for
cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or
without (direct to injection).
Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg
prolonged-release suspension for injection
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer
(NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who
are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a
deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to
deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected
by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit
viivhealthcare.com.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease
together. Find out more at gsk.com