CABENUVA approved by the FDA as first long-acting HIV regimen

The U.S FDA has given the green light to Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment.

Cabenuva is provided as a joint package of two injectable medications – ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine. The marketing authorisation holder for CABENUVA In the U.S. is ViiV Healthcare, a global specialist HIV company majority-owned by GSK, with Pfizer and Shionogi as shareholders. ViiV Healthcare plans to begin shipping Cabenuva to wholesalers and distributors in the US in February 2021.

Dosed once monthly, Cabenuva is an option to replace the current antiretroviral (ARV) regimen in virologically suppressed adults on a stable regimen, with no history of treatment failure or resistance to either cabotegravir or rilpivirine, to maintain viral suppression with 12 dosing days per year.

Lynn Baxter, Head of North America, ViiV Healthcare, said:

“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.”

Basis of the Cabenuva approval

Cabenuva’s approval is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies, which included more than 1,100 patients from 16 countries. Before starting 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 found to be 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.

In both studies, the most common adverse reactions (Grades 1 to 4) observed in less than 2% of the trial participants were injection site reactions, pyrexia, 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.

In the pivotal studies, Cabenuva was preferred by nine out of 10 patients over their previous daily oral therapy. Patient preference data was collected from clinical trial participants who received Cabenuva, but the results were descriptive 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, commented:

“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.”

The first-ever pre-approval implementation science study

ViiV Healthcare has sponsored the CUSTOMIZE trial to support the successful delivery of the once-monthly regimen to people living with HIV (PLHIV). This is 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 International AIDS Conference AIDS2020 have demonstrated that at four months, most of the clinical staff participants continued to think of the implementation of Cabenuva as highly acceptable, feasible and appropriate for PLHIV. Moreover, 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.”

About Cabenuva (cabotegravir, rilpivirine)

Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no prior history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Cabenuva is administered as two intramuscular injections (cabotegravir and rilpivirine) in the buttocks during a single visit at a specialist clinic.

The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Rilpivirine is approved in the US as a 25mg tablet taken once-a-day for the treatment of HIV-1 in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35-kg with a viral load ≤ 100,000 HIV RNA copies/mL.

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.

About the phase III ATLAS and FLAIR studies

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. The primary endpoint for ATLAS is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure, ITT-E population). Trial participants were required to be virally suppressed for six months or greater, on first or second regimen, with no prior failure.

ATLAS includes 616 men and women living with HIV and is being conducted at research centers in Argentina, Australia, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden, and the United States.

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). The primary endpoint for FLAIR is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure, ITT-E population).

FLAIR includes 566 men and women living with HIV and is being conducted at research centers in Canada, France, Germany, Italy, Japan, the Netherlands, Russia, South Africa, Spain, the United Kingdom, and the United States.

Original Source – Press Release 21/01/21 –

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