ViiV Healthcare announces the Marketing Authorisation of the first complete long-acting injectable HIV treatment in Europe

·         Marketing Authorisation granted by European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets)

• New treatment can enable people living with HIV to reduce the days they receive treatment from 365 to 12 or 6 per year
• The long-acting injectable regimen was preferred by majority of clinical trial patients who tried the treatment over their previous daily oral therapy

London, 21 December 2020 – ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, announced the authorisation of Vocabria (cabotegravir injection and tablets) in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the European Union, for the treatment of HIV-1 infection in adults who are virologically suppressed.[i] Cabotegravir injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults 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. This authorisation represents the first time people living with HIV in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase.

Dr Antonio Antela, University Hospital, Santiago de Compostela, Spain, said: “Daily antiretrovirals have transformed the lives of people living with HIV. However, taking daily medication can pose challenges for some people; it may act as a constant reminder of HIV or be a cause of fear that their HIV status will be disclosed. Following the oral initiation phase to assess the tolerability of the medicines, cabotegravir and rilpivirine injections could reduce the number of days of treatment per year from 365 down to 12 for the once-monthly, or 6 for the once every 2-months dosing regimen, representing a paradigm shift in how we are able to treat and manage the condition. The long-acting regimen of cabotegravir and rilpivirine was as effective as treatment with current daily antiviral therapy in the clinical trials in maintaining viral suppression, is generally well tolerated, and could change the treatment experience for some people living with HIV that may have challenges with daily HIV therapies.”

Outlining the need for a less frequent dosing regimen, the largest global HIV patient-reported outcomes study to date conducted by ViiV Healthcare, Positive Perspectives Wave 2, found that when participants were asked about their treatment aspirations and attitudes towards innovative medications, 55% (n=1306/2389) would prefer not having to take medication every day, as long as their HIV stays suppressed.[ii] In addition, 58% (n=1394/2389) noted that taking daily HIV medication acts as a constant reminder of HIV in their lives, while up to 38% (n=906/2389) of participants reported anxiety around the fact that taking daily treatment could increase the chances of revealing their HIV status to others.[iii]

Deborah Waterhouse, CEO, ViiV Healthcare, said: “At ViiV Healthcare, we push the boundaries to provide new treatment options that will help make a difference to people’s lives. We saw from the patient reported outcomes in our pivotal clinical trials that approximately 9 out of 10 people who switched to the long-acting regimen preferred this over their previous daily oral tablets.^{[iv],[v],[vi]} It will potentially change the treatment experience for some people living with HIV by removing the need for daily HIV tablets. We are committed to pursuing innovative research to meet the diverse needs of the HIV community, and we won’t stop until we have more ways to treat, and hopefully one day cure, HIV.”

Marketing Authorisation is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies, which included more than 1,200 participants from 16 countries.[iv]^,[v],[vi] Cabotegravir and rilpivirine are co-administered as two intramuscular (IM) injections in the buttocks by a Healthcare Professional at the same appointment.

ViiV Healthcare’s cabotegravir in combination with Janssen’s rilpivirine was co-developed as part of a collaboration with Janssen and builds on ViiV Healthcare’s industry-leading portfolio that is centered on delivering innovative medicines for the HIV community. 

This announcement marks the second marketing authorisation of the long-acting regimen of cabotegravir and rilpivirine, with once-monthly dosing licensed by Health Canada under the brand name Cabenuva for the treatment of HIV-1 infection in adults who are virologically stable and suppressed. In July, ViiV Healthcare resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine to the US Food and Drug Administration (FDA), and further regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide. 

[i]  Vocabria EU Summary of Product Characteristics.

[ii] De Los Rios P, Okoli C, Castellanos C et al.  Treatment aspirations and attitudes towards innovative

medications among people living with HIV in 25 countries. Popul. Med. 2020;2(July):23

[iii] De Los Rios P, Okoli C, Castellanos C et al. Physical, Emotional and Psychosocial Challenges Associated with Daily Dosing of HIV Medications and Their Impact on Indicators of Quality of Life: Findings from the Positive Perspectives Study. AIDS and Behavior. 2020

[iv] Swindells S, Andrade-Villanueva J-F, Richmond G, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med. DOI: 10.1056/ NEJMoa1904398

[v] Orkin C, Arasteh K, Hernandez-Mora MG, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. N Engl J Med. DOI: 10.1056/ NEJMoa1909512

[vi] Overton ET et. al. Cabotegravir and rilpivirine every 2 months is non inferior to monthly: ATLAS-2M study. Presented at CROI 2020: Available at: https://www.croiconference.org/abstract/cabotegravir-rilpivirine-every-2-months-is-noninferior-to-monthly-atlas-2m-study/. Accessed September 2020