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REG - GSK PLC - ViiV LAI superior to orals in adherence-challenged

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RNS Number : 8993D  GSK PLC  21 February 2024

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
(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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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described under
Item 3.D "Risk factors" in the company's Annual Report on Form 20-F for 2022,
and Q4 Results for 2023

 
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ViiV Healthcare Limited
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