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US FDA approves ViiV Healthcare’s Cabenuva for HIV treatment

London
Saturday, January 23, 2021, 12:00 Hrs  [IST]

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi Limited as shareholders, announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.

Cabenuva is provided as a co-pack with two injectable medicines — ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine — dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment of 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, ViiV Healthcare said, “This US 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 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 that included more than 1,100 patients from 16 countries. Prior to initiating treatment with Cabenuva, oral dosing of cabotegravir and rilpivirine (lead-in) was administered for approximately one month to assess the tolerability of each therapy. In these studies, Cabenuva was as effective in maintaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly in the buttocks once a month throughout the 48-week study period.

Cabenuva was preferred by nine out of 10 patients over their previous daily oral therapy in these pivotal studies. Patient preference data was collected from clinical trial participants who received Cabenuva. In a pooled exploratory analysis of this Intent-to-Treat Exposed (ITT-E) population, 532 patients completed a single-item question at week 48 (59 patients did not) and 88% (523/591) preferred Cabenuva compared with two percent (9/591) who preferred their previous ARV treatment. The results were descriptive in nature and are not intended to imply clinical significance.

Dr. David Wohl, professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill 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 US 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.”

To support the successful delivery of the once-monthly regimen to people living with HIV (PLHIV), 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 US. Interim findings presented at 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 PLHIV, and clinical staff had a substantial decrease in what they thought would be barriers to implementation of the injectable regimen.

Brett Andrews, CEO of PRC said, “PRC provides legal, workforce and behavioral health services for those affected by HIV/AIDS in San Francisco. 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.”

The New Drug Application for Vocabria (cabotegravir) 30 milligram (mg) oral tablets was also approved by the FDA. Vocabria is indicated, in combination with rilpivirine tablets, as a complete regimen for short-term treatment of HIV-1 infection in adults who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as an oral lead-in to assess tolerability of cabotegravir prior to initiating Cabenuva and as an oral therapy for patients who will miss planned injection dosing of Cabenuva.

INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.

ATLAS (NCT02951052) is a phase III, open-label, active-controlled, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of long-acting, injectable cabotegravir and rilpivirine dosed every four weeks compared to continuation of current oral ARV of two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase inhibitor (INI), NNRTI, or protease inhibitor (PI) among virally suppressed individuals.

FLAIR (NCT02938520) is a phase III, randomized, open-label, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of intramuscular, long-acting, injectable cabotegravir and rilpivirine in virologically suppressed adults living with HIV, following 20 weeks of induction therapy with Triumeq (abacavir/dolutegravir/lamivudine).

 

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