Issued: 6 March 2024, London
UK
ViiV
Healthcare announces interim data at CROI indicating superior
efficacy of long-acting injectable HIV treatment Cabenuva (cabotegravir + rilpivirine)
compared to daily oral therapy in individuals living with HIV who
have adherence challenges
London, 06 March 2024 - ViiV
Healthcare, the global specialist HIV company majority owned by
GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today
announced data from a planned interim analysis of the LATITUDE
phase III trial, indicating that their long-acting injectable
antiretroviral treatment (ART) for HIV, Cabenuva (cabotegravir + rilpivirine),
demonstrated superior efficacy in maintaining viral load
suppression compared to daily oral therapy in individuals with a
history of ART adherence challenges.
The data were presented by the
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other
Infections (ACTG) network at the Conference on Retroviruses and
Opportunistic Infections (CROI), in Denver, Colorado.
Kimberly Smith, MD, MPH, Head of
Research & Development at ViiV Healthcare said,
"It's estimated that one-third of people living
with HIV in the United States struggle with maintaining viral
suppression. The findings of the LATITUDE study show that
long-acting injectable cabotegravir + rilpivirine could be
important for some people in this group, giving them another option
to help keep their virus under control and improve their health.
Further, since we know that individuals whose virus is undetectable
don't transmit to sexual partners, this could be an important
contribution to ending the HIV epidemic."
LATITUDE is a phase III, randomised,
open-label study. Participants received comprehensive and
incentivised adherence support while taking guideline-recommended,
three-drug regimen oral ART, including dolutegravir and
bictegravir-based regimens, to achieve viral suppression. Those who
achieved viral suppression were eligible to randomise to staying on
oral standard of care (SOC) regimens or switch to long-acting
injectable cabotegravir + rilpivirine (LA-ART) dosed
monthly.
During the randomised phase of the
study, 146 participants received monthly LA-ART and 148 continued
on SOC. The primary endpoint was a comparison of regimen failure,
defined as a combination of virologic failures (VF) and regimen
discontinuations, between arms. 24.1% of participants on LA-ART
experienced regimen failure compared to 38.5% on SOC {difference
-14.4 (98.75% CI -29.8%, -0.8%)}.
Although the primary endpoint did
not meet the strict predefined stopping criterion for the interim
analysis, key secondary endpoints of virologic failure (7.2% LA-ART
vs. 25.4% SOC {difference -18.2% (98.75% CI-31.1%, -5.4%}) and
treatment-related failure (9.6% LA-ART vs 26.2% SOC {difference
-16.6% (98.75% CI -29.9%, -3.3%)} favoured the LA-ART regimen. The
study's Data Safety Monitoring Board (DSMB) considered the totality
of all the study endpoints together and concluded that the evidence
indicated superior efficacy of long-acting ART over daily oral
standard of care. The DSMB recommended that all eligible
participants should be offered long-acting injectable cabotegravir
+ rilpivirine.
The rate of adverse events (AEs) was
similar in both arms. Three participants in the LA-ART arm had
serious injection site reactions (ISR) and one participant
discontinued due to an ISR. Two confirmed virologic failures in
each arm had new resistance associated mutations (RAMS), including
at least two new integrase inhibitor RAMs in both LA-ART
participants.
The LATITUDE (Long-Acting Therapy to
Improve Treatment Success in Daily Life) study is ongoing across 31
sites in the U.S. including Puerto Rico, implemented through ACTG.
The median age of study participants was 40 years old; 40 percent
of participants were male, 64 percent were Black/African American,
17 percent were Hispanic, 5 percent were transgender, and 14
percent currently or previously used injection drugs. The study is
sponsored and funded by the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of
Health, and is being conducted by ACTG, with additional support
from the National Institute of Mental Health, the National
Institute on Drug Abuse, ViiV Healthcare and the Janssen
Pharmaceutical Companies of Johnson & Johnson.
About Cabenuva (cabotegravir +
rilpivirine)
Cabenuva is
indicated as a complete regimen for the treatment of HIV-1
infection in adults to replace the current antiretroviral regimen
in those who are virologically suppressed (HIV-1 RNA <50 c/ml)
on a stable antiretroviral regimen with no history of treatment
failure and with no known or suspected resistance to either
cabotegravir or rilpivirine.
The complete regimen combines the
integrase strand transfer inhibitor (INSTI) cabotegravir, developed
by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse
transcriptase inhibitor (NNRTI) developed by Janssen Sciences
Ireland Unlimited Company. Rilpivirine tablets are approved in the
US as a 25mg tablet taken once a day to treat HIV-1 in combination
with other antiretroviral agents in antiretroviral treatment-naïve
patients 12 years of age and older and weighing at least 35kg with
a viral load ≤100,000 HIV RNA c/ml.
INSTIs inhibit HIV replication by
preventing the viral DNA from integrating into the genetic material
of human immune cells (T-cells). This step is essential in the HIV
replication cycle and is also responsible for establishing chronic
disease. Rilpivirine is an NNRTI that works by interfering with an
enzyme called reverse transcriptase, which stops the virus from
multiplying.
Trademarks are owned by or licensed to the ViiV Healthcare group of
companies.
Please consult the full Prescribing
Information.[1]
About ACTG
ACTG is the world's largest and longest running clinical trials
network focused on HIV and other infectious diseases and the people
living with them. It is funded by NIAID and collaborating NIH
Institutes. Founded in 1987, ACTG conducts research to improve the
management of HIV and its comorbidities; develop a cure for HIV;
and innovate treatments for tuberculosis, hepatitis B, and emerging
infectious diseases. It comprises thousands of dedicated
researchers, staff, and community members who are pursuing research
into novel treatments and cures for infectious diseases at hundreds
of locations across four continents, with the ultimate goal of
advancing science that meaningfully impacts the lives of the people
we serve.
About ViiV Healthcare
ViiV Healthcare is a global
specialist HIV company established in November 2009 by GSK (LSE:
GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in
treatment and care for people living with HIV and for people who
are at risk of acquiring HIV. Shionogi became a ViiV shareholder in
October 2012. The company's aims are to take a deeper and broader
interest in HIV and AIDS than any company has done before and take
a new approach to deliver effective and innovative medicines for
HIV treatment and prevention, as well as support communities
affected by HIV.
For more information on the company,
its management, portfolio, pipeline, and commitment, please visit
viivhealthcare.com.
About GSK
GSK is a global biopharma company
with a purpose to unite science, technology, and talent to get
ahead of disease together. Find out more at gsk.com.
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GSK cautions investors that any
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those made in this announcement, are subject to risks and
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those described under Item 3.D "Risk factors" in the company's
Annual Report on Form 20-F for 2023.
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