London, 21 January 2021 — ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline, today announced that the US Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir and rilpivirine), the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. The approval represents a fundamental shift in how HIV can be treated, offering people living with the virus an alternative to daily oral antiretroviral therapy.
Cabenuva is provided as a co-packaged regimen of two injectable medicines — ViiV Healthcare's cabotegravir, an integrase strand transfer inhibitor (INSTI), and Janssen's rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI). The regimen is dosed once monthly, administered as two intramuscular injections in the buttocks during the same visit at a specialist clinic by a healthcare professional.
Who Is Eligible
Cabenuva is indicated for adults who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter) on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment with Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.
Lynn Baxter, Head of North America at ViiV Healthcare, described the approval as a paradigm shift:
"Today's FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year. At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission."
The Pivotal Trials: ATLAS and FLAIR
The approval of Cabenuva is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies, which together included more than 1,100 patients from 16 countries.
In both studies, Cabenuva was as effective in maintaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly once monthly throughout the 48-week study period. The ATLAS trial enrolled 616 participants across 13 countries, while FLAIR enrolled 566 participants across 11 countries, including research centers in South Africa — underscoring the global nature of the clinical evidence base.
The most common adverse reactions observed in clinical trial participants receiving Cabenuva were injection site reactions, pyrexia (fever), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. Serious adverse events occurred in 4% (24/591) of patients taking Cabenuva, and 3% (17/591) of adverse events led to withdrawal.
Patient Preference: A Striking Finding
In a pooled exploratory analysis of the Intent-to-Treat Exposed (ITT-E) population, 532 patients completed a single-item question at Week 48. The results were striking: 88% (523/591) preferred Cabenuva compared with 2% (9/591) who preferred their previous daily oral antiretroviral treatment. Nine out of ten patients preferred the long-acting injectable regimen over daily pills.
Dr. David Wohl, professor of medicine at the University of North Carolina Institute for Global Health and Infectious Diseases, said:
"Among the scientific community, we recognize the innovation behind Cabenuva is truly meaningful. Not only is it the first, complete long-acting regimen, which allows for a dramatic reduction in the frequency of dosing, but it also was preferred by most clinical trial participants when compared to their prior daily oral regimens. The FDA approval of Cabenuva underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV."
Implementation Science: The CUSTOMIZE Trial
To support the successful delivery of the once-monthly regimen, ViiV Healthcare sponsored the CUSTOMIZE trial — the first-ever pre-approval implementation science study to identify and evaluate approaches to integrate Cabenuva into clinical practices in the United States. Interim findings presented at the 23rd International AIDS Conference (AIDS2020) demonstrated that at four months, the majority of clinical staff participants continued to perceive the implementation of Cabenuva as highly acceptable, feasible, and appropriate for people living with HIV, with a substantial decrease in perceived barriers to implementation.
Brett Andrews, CEO of PRC, a San Francisco organization providing services for those affected by HIV/AIDS, spoke to the real-world impact:
"For years, many of our clients have struggled to manage their health while working to stabilize key aspects of their lives. Cabenuva will provide some people living with HIV greater freedom to pursue vocational, educational and other opportunities, like travel, without the need for daily oral medication management. A long-acting regimen is an innovation we have been waiting for."
A Broader Pipeline of Long-Acting HIV Innovations
The approval of Cabenuva for treatment was part of a broader wave of long-acting injectable HIV innovations. In December 2021, the FDA would go on to approve Apretude (cabotegravir extended-release injectable) for pre-exposure prophylaxis (PrEP) — the first injectable treatment for HIV prevention, offering an alternative to daily oral PrEP for people at risk of HIV acquisition.
Together, these approvals marked the beginning of a new era in HIV medicine, one in which long-acting injectable formulations could transform both treatment and prevention, reducing the burden of daily adherence and potentially improving outcomes for millions of people worldwide.
ViiV Healthcare announced it would begin shipping Cabenuva to wholesalers and specialty distributors in the United States in February 2021.
Sources
- ViiV Healthcare, "ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment," 21 January 2021
- Swindells S, et al. "Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression." New England Journal of Medicine, 382(12), 1112–1123, 2019
- Orkin C, et al. "Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection." New England Journal of Medicine, 382(12), 1124–1135, 2019
- US FDA, "FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention," December 2021
FIRAT Editorial Board
Institutional Research Desk · Foresight Institute of Research and Translation
The collective editorial and research translation board of FIRAT, synthesising peer-reviewed evidence, policy briefs, and division milestones across our seven foundational research pillars.
