ViiV Healthcare Submits Supplemental NDA for Expanded Use of Cabotegravir, Rilpivirine as HIV Treatment Every 2 Months
The sNDA seeks to expand the label of cabotegravir and rilipivirine to include dosing of every 2 months for the treatment of HIV-1 infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per milliliter) on a stable regimen.
ViiV Healthcare recently announced the submission of a supplemental New Drug Application (sNDA) to the FDA for the expanded use of cabotegravir and rilipivirine (Cabenuva, ViiV Healthcare) in the treatment of HIV.
The sNDA seeks to expand the label of cabotegravir and rilipivirine to include dosing of every 2 months for the treatment of HIV-1 infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per milliliter) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilipivirine.
The combination drug is a complete, long-acting regimen with 2 separate injectable medicines and was approved by the FDA in January 2021 as a once monthly treatment for HIV-1 infection in virologically suppressed adults. Prior to initiating treatment of cabotegravir and rilpivirine, oral dosing should be administered for approximately 1 month to assess the tolerability of each therapy, according to the press release.
“The submission of Cabenuva dosed every 2-months marks another meaningful step forward in our ongoing commitment to bring innovative HIV treatments to the community,” said Kimberly Smith, MD, MPH, head of research and development at ViiV Healthcare, in a press release. “This first-of-its-kind regimen reflects the evolving needs of people living with HIV, and, if this expanded use is approved, could allow adults living with HIV to maintain virologic suppression with six dosing days per year. At ViiV Healthcare, we will continue to advance new approaches to care as part of our mission of leaving no person living with HIV behind.”
The sNDA is based on results from the global phase 3b ATLAS-2M study, which showed the antiviral activity and safety of cabotegravir and rilpivirine administered every 2 months was non-inferior when compared to once monthly administration. Non-inferiority was determined by comparing the proportion of participants with plasma HIV-1 RNA less than or equal to 50 copies per milliliter using the FDA Snapshot algorithm at week 48, which showed the every 2 months arm and once monthly arm were similarly effective, according to the press release.
In addition, the study found that rates of virologic suppression, a key secondary endpoint, were similar, whether cabotegravir and rilpivirine was administered every 2 months or once monthly. Treatment with cabotegravir and rilpivirine was generally well-tolerated across both study arms. In the every 2-months arm, rates of serious adverse events (AEs) and withdrawals due to AEs were low and similar to those experienced in the once monthly arm.
ViiV Healthcare submits supplemental new drug application to us FDA for expanded use of cabenuva (cabotegravir, rilpivirine) as an hiv treatment for use every 2-months. ViiV Healthcare. https://viivhealthcare.com/en-us/us-news/us-articles/2021/viiv-healthcare-submits-supplemental-new-drug-application-to-us-fd-for-expanded-use-of-cabenuva/. Published February 24, 2021. Accessed March 11, 2021.