GSK and ViiV Healthcare Secure European Commission Approval for Long-Acting HIV Treatment for Adolescents

(IN BRIEF) ViiV Healthcare has secured European Commission approval for its long-acting HIV treatment, Vocabria + Rekambys, for adolescents aged 12 and older. This approval offers a significant advancement in HIV care, providing an injectable treatment option that reduces the pill burden and improves patient convenience.

(PRESS RELEASE) LONDON, 1-Feb-2025 — /EuropaWire/ — In a significant development for HIV treatment, ViiV Healthcare, majority owned by GSK plc, has received approval from the European Commission for Vocabria (cabotegravir long-acting injections) in combination with Rekambys (rilpivirine long-acting injections) for adolescents aged 12 and older, who are living with HIV and weigh at least 35 kg. This approval marks the first long-acting injectable regimen for HIV treatment, offering a major leap forward in care for young patients.

Innovative HIV Treatment for Adolescents

Vocabria + Rekambys stands out as the only complete long-acting injectable treatment option for HIV. The European Commission’s approval stems from data supporting the regimen’s safety and efficacy in virologically suppressed adolescents. The approval addresses a crucial gap in treatment options for this age group, which, as of 2023, included 1.55 million young people living with HIV. This demographic often faces challenges with adherence to daily oral regimens, as well as lower reported treatment coverage and viral suppression rates compared to adults.

The long-acting injectable regimen dramatically reduces the treatment burden, requiring just six injections per year, compared to the 365 daily pills typically needed with oral treatments. This approach is proven to reduce the stigma and stress associated with adherence challenges, improving treatment outcomes and overall quality of life.

Positive Study Results and Widespread Preference

The approval is based on week 24 data from the MOCHA study, a Phase I/II clinical trial, which involved 144 adolescents. The study demonstrated that 96.5% of participants remained virologically suppressed after 24 weeks of treatment, with no new safety concerns identified. Remarkably, 99% of participants reported a preference for the long-acting injectable regimen over daily oral medications. The reduced pill burden and increased privacy were key factors contributing to this preference, offering young patients a more convenient and stress-free treatment option.

A Commitment to Advancing HIV Care

Dr. Harmony P. Garges, Chief Medical Officer at ViiV Healthcare, emphasized the significance of this approval: “Today’s milestone provides adolescents living with HIV across Europe with a much-needed treatment option. Our commitment to addressing the unique needs of young people continues, ensuring that no person, regardless of age, is left behind.”

Since its approval for adults in 2020, Vocabria + Rekambys has demonstrated significant potential in improving the management of HIV. ViiV Healthcare’s ongoing dedication to advancing treatment for people living with HIV aims to continue breaking barriers in the fight against the disease.

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 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.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q3 Results for 2024.

References

Adolescent HIV treatment. Available at: https://data.unicef.org/topic/hivaids/adolescent-hiv-treatment. Last accessed December 2024.
Ramgopal MN, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. Lancet HIV 2023;10(9):e566-e577
Scherzer J, et al. Perceptions of cabotegravir + rilpivirine long-acting (CAB+RPV LA) from people living with HIV (PLHIV) in the CARLOS study. IAS 2023, poster EPE0863.
Gaur A et al. Long-Acting Cabotegravir Plus Rilpivirine In Adolescents With HIV: Week 24 IMPAACT 2017(MOCHA) Study. CROI 2024, abstract 188. Available at: Long-Acting Cabotegravir Plus Rilpivirine In Adolescents With HIV: Week 24 IMPAACT 2017(MOCHA) Study – CROI Conference. Last accessed January 2025.
Lowenthal ED et al. IMPAACT 2017 Adolescent/Parent Experiences With LA Cabotegravir Plus Rilpivirine for HIV Treatment. CROI 2024, abstract 949. Available at: https://www.croiconference.org/abstract/impaact-2017-adolescent-parent-experiences-with-la-cabotegravir-plus-rilpivirine-for-hiv-treatment. Last accessed January 2025.

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SOURCE: GlaxoSmithKline plc

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