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Cabotegravir plus Rilpivirine: First Approval

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posted on 2020-06-03, 21:21 authored by Anthony Markham
Compliance with Ethical Standards

Funding: The preparation of this review was not supported by any external funding.

Conflict of interest: During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Anthony Markham is a contracted employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found here


A regimen comprising extended release injectable suspensions of cabotegravir and rilpivirine for concurrent administration (CABENUVA™) is being developed by ViiV Healthcare and Janssen Pharmaceutica (Janssen) as a complete regimen for HIV infection. Based on the results of the ATLAS and FLAIR trials, the regimen was recently approved in Canada for the treatment of HIV-1 infection in adults to replace current antiretroviral therapy in patients who are virologically stable and suppressed. This article summarizes the milestones in the development of co-packaged cabotegravir and rilpivirine leading to this first approval.

© Springer Nature Switzerland AG 2020


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