TIDMGSK
RNS Number : 1721N
GlaxoSmithKline PLC
18 May 2020
Issued: 18 May 2020, London UK - LSE announcement
Global HIV prevention study to stop early after ViiV
Healthcare's long-acting injectable formulation of cabotegravir
dosed every two months shows higher efficacy than daily oral
PrEP
-- Interim analysis from HPTN 083 study shows investigational,
long-acting injectable cabotegravir (CAB LA) administered every two
months is 69% more effective than daily pills in preventing HIV
acquisition
-- Participants who were in the daily oral
emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg
(FTC/TDF) tablet arm of the study will be offered CAB LA
London, 18 May 2020 - ViiV Healthcare, the global specialist HIV
company majority owned by GSK, with Pfizer Inc. and Shionogi
Limited as shareholders, today announced the interim analysis of
the HIV Prevention Trials Network (HPTN) 083 study evaluating the
safety and efficacy of investigational, long-acting, injectable
cabotegravir for HIV prevention. In the study cabotegravir was
found to be 69% more effective (95% CI 41%-84%) in preventing HIV
acquisition in men who have sex with men (MSM) and transgender
women who have sex with men when compared to the current standard
of care, daily oral emtricitabine/tenofovir disoproxil fumarate 200
mg and 300 mg (FTC/TDF) tablets. The study achieved its primary
objective of non-inferiority with the difference approaching
superiority in favour of cabotegravir, pending final analysis.
The HPTN 083 study, with approximately 4,600 participants across
more than 40 sites in North and South America, Asia, and Africa, is
one of the first-ever clinical trials to directly compare two
active prevention agents. In a planned interim review, the
independent Data and Safety Monitoring Board (DSMB) found the study
data clearly indicated that long-acting injectable cabotegravir was
highly effective at preventing HIV in the study population. Among
the 50 people in the trial who acquired HIV, 12 were randomised to
the long-acting cabotegravir arm and 38 were randomised to the
daily, oral FTC/TDF arm. This translated to an HIV incidence rate
of 0.38% (95% confidence interval [CI] 0.20%-0.66%) in the
cabotegravir group and 1.21% (95% CI 0.86%-1.66%) in the FTC/TDF
group. Adherence to oral FTC/TDF was high, based on a random subset
sampling that detected tenofovir (> 0.31 ng/ml) in 87% of all
samples tested. Despite this high level of adherence to oral
therapy, long-acting cabotegravir was 69% (95% CI 41%-84%) more
effective than FTC/TDF in preventing HIV acquisition in the study
population.
Myron S. Cohen, M.D., Co-Principal Investigator of the HPTN and
the Yeargan-Bate Distinguished Professor of Medicine, Microbiology
and Immunology and Epidemiology at the University of North Carolina
(UNC) at Chapel Hill, said: "Each year, an estimated 1.7 million
people are newly diagnosed with HIV. To lower that number, we
believe more prevention options are needed in addition to currently
available oral tablets for daily use. If approved, a new injectable
agent, such as long-acting cabotegravir administered every two
months, could play an important role in reducing HIV transmission
and helping to end the HIV epidemic."
Safety was similar in the two groups. Most participants in the
cabotegravir group (80%) reported pain or tenderness at the
injection site, compared to only 31% of those in the FTC/TDF arm,
who received placebo injections. Discontinuation due to injection
site reactions or injection intolerance in the cabotegravir arm of
the study was 2% and there were no discontinuations due to ISRs in
the FTC/TDF arm.
Following review of these findings, the DSMB recommended the
blinded, randomised portion of the study be stopped early and
results released. Participants who were in the FTC/TDF arm will be
offered CAB LA and participants in the CAB LA arm will continue to
receive it. Participants who do not want to receive CAB LA will be
offered FTC/TDF until the end of the originally planned blinded
component of the study. The DSMB decision was approved by the U.S.
National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health (NIH), the study sponsor.
The HPTN 083 study enrolled HIV-negative men who have sex with
men and transgender women who have sex with men, participants
considered at risk for HIV acquisition. Two-thirds of study
participants were under 30 years of age, and 12% were transgender
women. Half of the participants in the United States identified as
black or African American.
"These study results demonstrate that long-acting injectable
cabotegravir dosed every two months can successfully reduce HIV
acquisition in at-risk MSM and transgender women," said Kimberly
Smith, M.D., Head of Research & Development at ViiV Healthcare.
"We are thrilled with the results not only because of the high
efficacy of cabotegravir but also because we have demonstrated high
efficacy in a study that adequately represents some of the
populations most disproportionately impacted by HIV -- black MSM in
the US, young MSM globally and transgender women," she said.
"We continue to be focused on the completion of the companion
HPTN 084 study, which will give us important information about the
effectiveness of cabotegravir in women. New options are needed for
HIV prevention that offer an effective alternative to daily oral
PrEP. If approved, this long-acting injectable has the potential to
be a game-changer for HIV prevention by reducing the frequency of
dosing from 365 days to six times per year."
HTPN 083 was jointly funded by the U.S. NIAID, part of the NIH,
and ViiV Healthcare, and was conducted by the HPTN. Study product
was provided by ViiV Healthcare and Gilead Sciences.
The DSMB also reviewed data from HPTN 084, which began a year
later than HPTN 083, and recommended that it continue as planned.
To date, more than 3,000 sexually active women in seven African
countries have enrolled in HPTN 084, which is co-funded by NIAID,
ViiV Healthcare and the Bill & Melinda Gates Foundation.
Detailed results from HPTN 083 will be presented at an upcoming
scientific meeting. ViiV Healthcare plans to use the data from HPTN
083 for future regulatory submissions. Cabotegravir has not yet
been approved for the treatment or prevention of HIV as a single
agent by regulatory authorities anywhere in the world.
About HPTN 083 (NCT02720094)
The HPTN 083 study is a phase IIb/III double blind study
designed to evaluate the safety and efficacy of long-acting
injectable cabotegravir for HIV prevention administered every eight
weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg). Each
participant was to receive a maximum of three years of blinded
study medication. The study opened to enrolment in November 2016.
HPTN 083 was conducted in approximately 4,600 men who have sex with
men and transgender women who have sex with men at research centres
in Argentina, Brazil, Peru, United States, South Africa, Thailand
and Vietnam.
For further information on HPTN 083 please visit
https://clinicaltrials.gov/ct2/show/NCT02720094 .
About HPTN 084 (NCT03164564)
The HPTN 084 study is a phase III double blind safety and
efficacy study designed to evaluate the safety and efficacy of the
long-acting injectable cabotegravir for HIV prevention administered
every eight weeks compared to daily oral FTC/TDF tablets (200
mg/300 mg) in 3,200 women who are at increased risk of HIV
acquisition. HPTN 084 opened to enrolment in November 2017 and is
being conducted at research centres in Botswana, Kenya, Malawi,
South Africa, Eswatini, Uganda and Zimbabwe.
For further information please see
https://clinicaltrials.gov/ct2/show/NCT03164564
About HIV Prevention Trials Network (HPTN)
The HIV Prevention Trials Network (HPTN) is a worldwide
collaborative clinical trials network that brings together
investigators, ethicists, community members and other partners to
develop and test the safety and efficacy of interventions designed
to prevent the acquisition and transmission of HIV. The National
Institutes of Health (NIH), the National Institute of Mental Health
(NIMH) and the National Institute on Drug Abuse (NIDA) co-fund the
HPTN. The HPTN has collaborated with more than 85 clinical research
sites in 19 countries to evaluate new HIV prevention interventions
and strategies in populations that bear a disproportionate burden
of infection. The HPTN research agenda - more than 50 trials
ongoing or completed with over 161,000 participants enrolled and
evaluated - is focused primarily on the use of antiretroviral drugs
(antiretroviral therapy and pre-exposure prophylaxis); and
integrated strategies including interventions for substance abuse,
particularly injection drug use; behavioural risk reduction
interventions and structural interventions. For more information,
visit hptn.org.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established
in November 2009 by GlaxoSmithKline (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 becoming
infected with HIV. Shionogi joined in October 2012. The company's
aim is to take a deeper and broader interest in HIV/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 www.viivhealthcare.com.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com.
Inside information
The information contained in this announcement is inside
information. If you have any queries on this, then please contact
Victoria Whyte GSK Company Secretary (responsible for arranging the
release of this announcement) at GSK House Brentford, Middlesex,
TW8 9GS on +44 208 047 5000.
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 2019
and any impacts of the COVID-19 pandemic.
ViiV Healthcare Media
enquiries: Melinda Stubbee +1 919 491 0831
Audrey Abernathy +1 919 605 4521
GSK Global Media enquiries: Simon Steel +44 (0) 20 8047 5502
Kristen Neese
+1 804 217 8147
Analyst/Investor enquiries: Sarah Elton-Farr +44 (0) 20 8047 5194
Danielle Smith +44 (0) 20 8047 0932
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Jeff McLaughlin +1 215 751 7002
Frannie DeFranco +1 215 751 4855
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