The US Food and Drug Administration (FDA) recently granted approval for the use of Cabenuva (cabotegravir, rilpivirine) for use every two months. The approval expands the use of the first (and, to date, only) long-acting HIV treatment from 12 times to as few as six times a year for virologically suppressed patients diagnosed with HIV, without prior treatment failure or resistance to cabotegravir or rilpivirine.
Kimberly Smith, head of research and development at ViiV Healthcare, recently spoke with Outsourcing-Pharma about the treatment and how the six-times-a-regimen could benefit people living with the virus.
OSP: Please tell us some of the advantages of dosing every two months, rather than every month, with an HIV treatment.
KS: We believe that Cabenuva dosed every two months is the best possible choice but also acknowledge that some people living with HIV and HCPs may prefer once-monthly dosing. The initial FDA approval of Cabenuva (cabotegravir, rilpivirine), which happened just over a year ago on January 21, 2021, brought the first and only complete long-acting HIV treatment regimen to market; this was a major milestone, as we could offer people living with HIV who are virologically suppressed a completely new approach to care.
Since then, we have heard from the HIV community about the impact a long-acting treatment option has had and the importance of having a therapy that no longer requires daily oral pills. With this newly expanded label for Cabenuva, we now are able to reduce the frequency of dosing even further, to as few as six times a year.
Because Cabenuva has to be administered by a healthcare provider, fewer dosing days means fewer office visits to receive their injections. Ultimately, it’s up to the individual and their healthcare provider to determine which therapy is best for them.
OSP: Can you please share any other advantages Cabenuva might offer over other currently available HIV treatments?
KS: Some people living with HIV face challenges taking daily oral HIV therapy, and long-acting therapies provide a new option that significantly reduces the frequency of dosing. In the ATLAS-2M clinical trial, a global, Phase IIIb trial which was the basis of the expanded approval, approximately nine out of every 10 participants preferred Cabenuva dosed every two months compared to daily oral cabotegravir and rilpivirine taken as the oral lead-in per trial protocol. This underscores the interest in alternative dosing options and the need for innovative HIV therapies to address the variety of challenges people living with HIV may face relating to daily oral therapy, such as pill fatigue, self-stigma, and fear of disclosure.
At ViiV Healthcare, we take a unique approach to HIV and are focused on delivering effective solutions to care that meet the evolving needs of the HIV community. Offering different options, including regimens with less frequent dosing schedules, may help address unmet needs and allow for tailored treatment approaches for each person living with HIV.
OSP: Of the adverse events you mention, are any more common, more serious, or otherwise worth noting?
KS: The most common adverse event associated with Cabenuva was injection site pain/discomfort, which was primarily pain at the injection site and was experienced in roughly 75% of individuals over the 48-week study period.
However, the majority of ISRs were mild to moderate (Grade 1 or 2) and lasted for a median of three days. Importantly, despite the frequency of ISRs, they declined over time. Less than 1% of study participants discontinued as a result of injection site reactions. For full safety information, please see the prescribing information.
OSP: Do you have anything to add?
KS: As the only pharmaceutical company solely focused on HIV, ViiV Healthcare is committed to delivering a broad range of treatments that meet the needs of the HIV community to ensure no person living with HIV is left behind. We are proud that the expanded label for Cabenuva delivers on this commitment, and we are continuing to work on the next generation of innovative treatment options for people living with HIV.