Issued: 21 February 2024, London
UK
LATITUDE phase III interim trial data indicates ViiV
Healthcare's long-acting injectable HIV treatment Cabenuva (cabotegravir + rilpivirine)
has superior efficacy compared to daily therapy in individuals
living with HIV who have adherence challenges
· Data Safety Monitoring Board (DSMB) for ACTG study recommends
study be modified to stop randomisation and to give participants
receiving daily oral therapy the option to transition to
long-acting injectable therapy
· Full data set to be presented at an upcoming scientific
conference
London, 21
February 2024 - ViiV Healthcare, the global specialist HIV company
majority owned by GSK, with Pfizer Inc. and Shionogi Limited as
shareholders, today announced results from an interim analysis of
the LATITUDE phase III trial, indicating 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 interim data indicating the
superiority of long-acting therapy compared to daily oral therapy
in individuals who have difficulty taking pills for HIV every day
is a remarkable outcome," said Kimberly Smith, MD, MPH, Head of R&D at
ViiV Healthcare. "There are many reasons why people may find
it challenging to stay on daily oral treatment and the LATITUDE
study shows cabotegravir and rilpivirine injectable treatment can
help them keep their virus suppressed, which benefits their overall
health. Optimising therapy for all people living with HIV,
including those with adherence challenges, is critical to the
effort to end the HIV epidemic."
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
Advancing Clinical Therapeutics Globally for
HIV/AIDS and Other Infections (ACTG), a
global NIH-funded clinical trials network focused on HIV and other
infectious diseases. Participants with challenges taking daily oral
ART as prescribed and evidence of viremia were screened to ensure
the HIV in their blood was not resistant to the study drugs and
that they met other health and safety criteria. Once enrolled, they
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. They were then randomised to receive long-acting
injectable ART (cabotegravir +
rilpivirine) every four weeks or to
continue taking daily oral ART.
Last week, the DSMB performed a
planned interim review. They 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.
There are many factors that can influence a person's ability to
take medicine every day, including access to health care or health
insurance, affordability, unstable housing, stigma and fear of
having their HIV status disclosed. Lack of consistent adherence is
a common reason why some people living with HIV have difficulty
maintaining undetectable viral loads.
LATITUDE 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:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Cabenuva/pdf/CABENUVA-PI-PIL-IFU2-IFU3.PDF
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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