ViiV Healthcare has 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]
The 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; reducing the days they receive treatment from 365 to 12 or 6 per year.
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]
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.
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.”
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.”
[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