The U.S. Food and Drug Administration has approved the first monthly, injectable treatment for HIV.
Cabenuva, developed by ViiV Healthcare, replaces the traditional daily pill regimen with two injections, administered every month.
The injections contain two different antiretrovirals — rilpivirine, from Johnson & Johnson’s Janssen, and the newly developed cabotegravir, from the GlaxsoSmithKline-owned ViiV.
“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,” Lynn Baxter, head of ViiV Healthcare in North America, said in a statement.
“Cabenuva reduces the treatment dosing days from 365 days to 12 days per year,” Baxter continued. “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.”
ViiV’s new treatment regimen requires potential patients to receive an oral dose of both drugs to assess tolerability.
It also requires them to be on a current antiretroviral regimen and to have achieved suppression of HIV viral loads — also known as being “undetectable,” because levels of the virus are so low that they cannot be detected in a standard blood test.
According to ViiV’s studies, which involved more than 1,100 patients from 16 countries, Cabenuva was “as effective in maintaining viral suppression as continuing a daily oral three-drug regimen,” when Cabenuva replaced daily pills with a once-monthly injection in the buttocks over a 48-week period.
ViiV also said that, of those who participated in their trials, 90% of patients preferred the once-monthly injection over their daily pill regimen.
Dr. David Wohl, professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill, said in a statement that the approval of ViiV was “truly meaningful” due to its enabling “a dramatic reduction in the frequency of dosing.”
Wohl said that the FDA’s approval of Cabenuva as a treatment for HIV “underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV.”
San Francisco-based nonprofit Positive Resource Center, which provides legal, workforce, and behavioral health services to those living with HIV/AIDS, praised the development and approval of Cabenuva. Brett Andrews, CEO of PRC, noted that it would free his clients from having to worry about their daily pill regimen.
“For years, many of our clients have struggled to manage their health while working to stabilize key aspects of their lives,” he said. “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.”
In addition to its use in Cabenuva, Viiv has previously found that bi-monthly injections of cabotegravir are more effective when used as PrEP than once-daily pills.
Sold under the brand name Truvada, PrEP — or pre-exposure prophylaxis — is a single, daily pill that uses antiretrovirals to help prevent HIV-negative people from contracting the virus.
While the pill is already up to 99% effective at preventing transmission of HIV, Viiv found that an injection of cabotegravir every two months was even more effective — 69% more — at preventing transmission.
It was so effective that Viiv ceased its clinical trials early and offered cabotegravir to those who had been given Truvada.
Last year, the FDA granted cabotegravir as PrEP “breakthrough therapy” designation, which helps the development of drugs that address serious or life-threatening medical conditions and expedites their review by the FDA.
Editor’s Note: This article has been updated to note that cabotegravir, not Cabenuva, is being researched for use as PrEP.
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