Therapy Areas: AIDS & HIV
ViiV Healthcare Submits Supplemental New Drug Application to US FDA for Expanded Use of Cabenuva as an HIV Treatment for Use Every 2-Months
24 February 2021 - - US-based specialist HIV company ViiV Healthcare has submitted a supplemental New Drug Application to the US Food and Drug Administration for the expanded use of Cabenuva (cabotegravir, rilpivirine), the company said.

The sNDA seeks to expand Cabenuva's label to include every 2-months dosing for the treatment of HIV-1 infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

Cabenuva is a complete long-acting regimen with two separate injectable medicines, ViiV Healthcare's cabotegravir and rilpivirine, a product of Janssen Sciences Ireland UC.

The medication 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 Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.

The sNDA is based on results from the global phase IIIb ATLAS-2M study, which showed the antiviral activity and safety of Cabenuva 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 ≥ 50 copies per milliliter using the FDA Snapshot algorithm at Week 48 (Intent-to-Treat Exposed [ITTE] population), which showed that the every 2-months arm (9/522 [1.7%]) and once monthly arm (5/523 [1.0%]) were similarly effective (adjusted difference: 0.8%, 95% confidence interval [CI]: -0.6, 2.2).

The study also found that rates of virologic suppression (HIV-1 RNA
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