HIV Specialist - March 2021 - 3

NEWS

I NFOR M AT ION FOR H I V CA RE PROV I DERS

IN
THE

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 announced the

will continue to advance new approaches

effective (adjusted difference: 0.8%, 95%

submission of a supplemental New Drug

to care as part of our mission of leaving no

confidence interval [CI]: -0.6, 2.2). The study

Application (sNDA) to the US Food and Drug

person living with HIV behind. "

also found that rates of virologic suppression

Administration (FDA) for the expanded use

The sNDA is based on results from the

(HIV-1 RNA <50 c/mL), a key secondary

of Cabenuva (cabotegravir, rilpivirine). The

global phase IIIb ATLAS-2M study, which

endpoint, were similar, whether Cabenuva

sNDA seeks to expand Cabenuva's label

showed the antiviral activity and safety of

was administered every 2-months (492/522

to include every 2-months dosing for the

Cabenuva administered every 2-months

[94.3%]) or once monthly (489/523 [93.5%])

treatment of HIV-1 infection in virologically

was non-inferior when compared to once

(adjusted difference: 0.8%, 95% CI: -2.1, 3.7).

suppressed adults (HIV-1 RNA less than

monthly administration.Non-inferiority was

Treatment with Cabenuva was generally well-

50 copies per milliliter [mL]) on a stable

determined by comparing the proportion of

tolerated across both study arms. In the every

regimen, with no history of treatment failure,

participants with plasma HIV-1 RNA ≥ 50 copies

2-months arm, rates of serious adverse events

and with no known or suspected resistance

per milliliter (c/mL) using the FDA Snapshot

(SAEs: 27/522[5.2%]) and withdrawals due to

to either cabotegravir or rilpivirine. Cabenuva

algorithm at Week 48 (Intent-to-Treat Exposed

adverse events (AEs: 12/522 [2.3%]) were low

is a complete long-acting regimen with

[ITTE] population), which showed that the

and similar to those experienced in the once

two separate injectable medicines, ViiV

every 2-months arm (9/522 [1.7%]) and once

monthly arm (SAEs: 19/523 [3.6%], withdrawals

Healthcare's cabotegravir and rilpivirine,

monthly arm (5/523 [1.0%]) were similarly

due to AEs 13/523 [2.5%]).

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.
Kimberly Smith, M.D., MPH, Head of
Research & Development at ViiV Healthcare,
said: " Today's submission of Cabenuva dosed
every 2-months marks another meaningful
step forward in our ongoing commitment
to bring innovative HIV treatments to the
community. 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

About ATLAS-2M (NCT03299049)
THE ATLAS-2M STUDY is an ongoing phase IIIb, randomized, open-label,
active-controlled, multicenter, parallel-group, non-inferiority study designed to
assess the non-inferior antiviral activity and safety of long-acting cabotegravir and
rilpivirine administered every eight weeks (2-months, 3mL dose of each medicine)
compared to every four weeks (once monthly, 2mL dose of each medicine) over a
48-week treatment period in 1,045 adults living with HIV-1.2 Subjects were required to
be virologically suppressed for six months or greater, on first or second antiretroviral
regimen, with no prior virologic failure. The primary outcome measure for the study
was the proportion of participants with HIV-1 RNA ≥ 50 c/mL at Week 48 using the
FDA Snapshot algorithm (Intent-to-Treat Exposed [ITT-E] population).
ATLAS-2M is part of ViiV Healthcare's extensive and innovative clinical trial program
and is being conducted at research centers in Australia, Argentina, Canada, France,
Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the
United States.
For further information please see https://clinicaltrials.gov/ct2/show/NCT03299049.

dosing days per year. At ViiV Healthcare, we

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3
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HIV Specialist - March 2021

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