2021-01-22| Trials & Approvals

Game-Changing Antiretroviral Regimen from ViiV Receives FDA Approval

by Daniel Ojeda
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On January 21st, ViiV Healthcare announced that their antiretroviral therapy Cabenuva had received FDA approval. Cabenuva is the first and only complete long-acting regimen for HIV treatment. The once-monthly injectable drug successfully suppresses viral replication in people living with HIV (PLWH). Cabenuva was as effective as a current treatment that requires daily administration.

If left untreated, infection with Human Immunodeficiency Virus (HIV) leads to the loss of immune cells and the body’s inability to fight infections, better known as the Acquired Immunodeficiency Syndrome (AIDS). First discovered in 1981, the disease has infected more than 75 million people, and more than 32 million people have died of AIDS-related complications.

Currently, there is still no cure for this disease. However, antiretroviral drug regimens can suppress the virus and prevent the development of AIDS. Some of the most common treatments include a daily oral three-drug regimen. For the 38 million living with HIV worldwide, the daily dosing frequency can be strenuous as they need to continue taking these medications for the rest of their lives. Therefore, there was an unmet need for new medications that can provide alternatives for managing this chronic infection.


ViiV Healthcare and Cabenuva

ViiV Healthcare is a company that solely focuses on developing treatments for HIV. It is primarily owned by GSK but also includes Pfizer Inc. and Shionogi Limited as shareholders. ViiV’s long-lasting injectable medication, Cabenuva, is the first antiretroviral treatment that does not require daily administration.

The efficacy of Cabenuva was tested in two randomized, open-label, controlled clinical trials that combined included 1,182 PLHW who were virologically suppressed. The results showed that Cabenuva was as effective as a three-drug daily regimen at maintaining viral suppression. More importantly, 9 out of 10 people preferred Cabenuva over their previous daily regimen.

Cabenuva consists of the monthly injection of two drugs, cabotegravir, and rilpivirine. The first is an investigational drug developed by ViiV, and the second is an FDA approved drug developed by Janssen Sciences. Cabotegravir prevents the virus from fusing its genome with the DNA of host cells, an essential step in the life of the virus. Rilpivirine acts by inhibiting the reverse transcriptase protein, which is an essential protein for viral replication. Together, the regimen successfully maintained the number of detectable viral RNA to less than 50 copies/mL.

Based on these results, the FDA approved two of ViiV’s therapies at the same time. First, the table formulation version of cabotegravir, and the second is injectable Cabenuva. The approved regimen consists of a month of oral cabotegravir and rilpivirine to ensure the combination is well tolerated. If tolerated, the patient then receives the extended-release injectable formulation.

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.”


Going One Step Further

One of the problems new medications can encounter in the clinic is the mental and clinical barriers of doctors, staff, and patients. To address these and identify ways to integrate Cabenuva in the clinical practices in the US, ViiV funded the “first-ever pre-approval implementation science study.”

The results demonstrate that there was a decrease in the perceived barriers to the implementation of this therapy. This shows that sometimes it is not enough to develop an effective treatment. Communication with doctors and patients is also essential for the adoption of new treatments.

By Daniel Ojeda, Ph.D.

Related Article: ViiV Healthcare’s Two Drug Regimen Shows Promising Results in HIV-1 Patients



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