REG - GSK PLC - ViiV Healthcare announces Cabenuva positive data

GSKAnnouncement

23/02/2023 07:00

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RNS Number : 8272Q  GSK PLC  23 February 2023

ViiV Healthcare announces positive data demonstrating long-acting injectable
Cabenuva (cabotegravir, rilpivirine) is as effective as daily oral Biktarvy
(BIC/FTC/TAF) for the treatment of HIV-1

·    12-month findings from the SOLAR study showed that the
every-two-month regimen of CAB+RPV LA demonstrated non-inferior efficacy
compared to continuation of daily oral BIC/FTC/TAF

·    90% of participants who switched from BIC/FTC/TAF to CAB+RPV LA
preferred the complete long-acting regimen to daily pills

 

London, 23 February 2023 - ViiV Healthcare, the global specialist HIV company
majority owned by GSK, with Pfizer and Shionogi as shareholders, announced
yesterday positive 12-month findings from the SOLAR study. SOLAR is the first
head-to-head, Phase IIIb study of the first and only complete long-acting
injectable regimen Cabenuva (cabotegravir, rilpivirine [CAB+RPV LA]) compared
against complete daily oral regimen Biktarvy
(bictegravir/emtricitabine/tenofovir alafenamide  BIC/FTC/TAF ).

 

Study findings showed that CAB+RPV LA dosed every two months achieved the
primary endpoint of non-inferior virologic efficacy versus daily oral
BIC/FTC/TAF, while 90% of participants who switched to CAB+RPV LA from
BIC/FTC/TAF, and who completed a survey (n=425), preferred the long-acting
regimen. Switching to CAB+RPV LA from BIC/FTC/TAF during the SOLAR study was
efficacious, well-tolerated, and improved treatment satisfaction from baseline
based on adjusted HIV Treatment Satisfaction Questionnaire status version
scores (HIVTSQs). These data were presented at the 30
(https://www.croiconference.org/preliminary-agenda/) (th
(https://www.croiconference.org/preliminary-agenda/) ) Conference on
Retroviruses and Opportunistic Infections (CROI)
(https://www.croiconference.org/preliminary-agenda/) , being held in Seattle,
Washington.

 

Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said:
"The treatment needs of people living with HIV are changing, with ample
evidence on patient preference suggesting some people living with HIV can
experience challenges with taking daily oral treatment for HIV. It's essential
that people living with HIV have treatment options that can help alleviate
these burdens and we believe that complete long-acting regimens are here to
help address some of those challenges today. We are confident that
cabotegravir, as part of a complete long-acting regimen, is a cornerstone for
the long-acting treatment era in HIV medicine, as supported by its strong and
durable efficacy, safety, and by the fact that 90% of participants in this
study who completed a survey preferred a long-acting regimen after switching
from their daily oral pills."

 

In the SOLAR study, 670 participants who were virally supressed and taking
BIC/FTC/TAF were randomised 2:1 to switch to CAB+RPV LA administered every two
months (447 participants) or continue taking daily oral BIC/FTC/TAF (223
participants). The SOLAR study met its primary endpoint at Month 12, when
CAB+RPV LA demonstrated non-inferior efficacy versus daily oral BIC/FTC/TAF
based on the proportion of participants with HIV-1 RNA ≥50 c/mL using the
FDA Snapshot algorithm and a 4% non-inferiority margin (mITT-E; CAB+RPV LA:
5/447  1% , BIC/FTC/TAF: 1/223  <1% , adjusted difference: 0.7%, 95%
confidence interval [-0.7, 2.0]). The study found that rates of virologic
suppression (HIV-1 RNA <50 c/mL) were similar between treatment arms
(CAB+RPV LA: 403/447  90% , BIC/FTC/TAF: 207/223  93% , adjusted difference:
-2.7%, 95% confidence interval [-7.0, 1.7]). Non-inferior virologic outcomes
were confirmed in the ITT-E and Per Protocol (PP) analyses.

 

At the beginning of the study, 47% of participants reported always or often
experiencing one or more challenges with taking their daily therapy, including
"being worried about people unintentionally discovering their HIV status,"
"being worried about forgetting to take their HIV medication," or "feeling
that taking their HIV medication was an uncomfortable reminder of their HIV
status." Mean treatment satisfaction scores (HIVTSQs) improved significantly
at the conclusion of the study for participants taking CAB+RPV LA (+3.36)
compared to BIC/FTC/TAF (-1.59) from baseline (CAB+RPV LA: 57.88, BIC/FTC/TAF:
58.38) (p<0.001). 90% of participants who switched to CAB+RPV LA and
completed the survey, preferred long-acting therapy versus daily oral pills
(n=382/425), with the top five reasons for preferring long-acting therapy
being:

·    I don't have to worry as much about remembering to take HIV
medication every day

·    It is more convenient for me to receive injections every 2 months

·    I do not have to carry my HIV medication with me

·    I do not have to think about my HIV status every day

·    I do not have to worry about others seeing or finding my HIV pills

 

Confirmed virologic failure (CVF) was infrequent. Two participants (0.4%) in
the mITT-E analysis and one additional participant in the ITT-E analysis who
received CAB+RPV LA, developed CVF, with subsequent identification of
resistance-associated mutations (RAMs) to NNRTI and integrase inhibitors. No
participant in the BIC/FTC/TAF treatment arm developed CVF.

 

Treatment with CAB+RPV LA and BIC/FTC/TAF were both well-tolerated. With the
exclusion of injection site reaction (ISRs), adverse events (AEs) and serious
adverse events (SAEs) were comparable between arms, although drug-related AEs
were more frequent in the long-acting (the switch) arm (20% vs <1%). The
most commonly reported drug-related AEs in the LA arm were pyrexia (3%),
headache (2%), fatigue (2%), and diarrhoea (2%). In the BIC/FTC/TAF arm, the
two drug-related AEs reported were weight gain (<1%) and abnormal hepatic
function (<1%). Most ISRs in the long-acting arm were Grade 1 or 2 (98%)
and short lived (median 3 days), with few participants discontinuing due to
injection-related reasons (2%). More participants in the long-acting arm
withdrew due to AEs (6% vs <1%).

 

Moti N. Ramgopal of the Midway Immunology and Research Center, Fort Pierce,
Florida and Principal Investigator for SOLAR, said: "There are many people
living with HIV who are virally suppressed but experience challenges taking a
daily oral pill, including fears of accidentally disclosing their HIV status
due to discovery of their medicine. The SOLAR findings demonstrate that
CAB+RPV LA administered every two months is as effective as BIC/FTC/TAF, while
also addressing some important challenges associated with taking daily HIV
treatment. These findings raise the critical reminder that healthcare
providers who prescribe HIV medicines should identify and incorporate patient
preferences when making treatment recommendations, in addition to standard
efficacy and safety data, to ensure that people living with HIV have the best
treatment option for their needs."

 

ViiV Healthcare's cabotegravir in combination with rilpivirine, a product of
Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical
Companies of Johnson & Johnson, was co-developed as part of a
collaboration with Janssen and builds on ViiV Healthcare's industry-leading
long-acting portfolio that is centred on delivering innovative medicines for
the HIV community. The complete long-acting regimen of CAB+RPV LA is licensed
in Canada, USA and Australia under the brand name Cabenuva, and in Europe and
Japan as Vocabria (cabotegravir injection and tablets) and Rekambys
(rilpivirine long-acting injectable suspension). Additional findings and
analyses from the SOLAR study, including additional data on patient reported
outcomes, will be presented at future congresses.

 

About SOLAR

SOLAR (NCT04542070) is a Phase IIIb, randomised (2:1), open-label,
multicentre, non-inferiority (NI) study assessing switching virologically
suppressed adults to CAB+RPV LA (with/without oral lead-in  OLI ) dosed every
two months versus continuing BIC/FTC/TAF. The primary analysis was based on
the pre-specified modified intent-to-treat exposed (mITT-E) population (n=11
excluded from the ITT-E for major protocol deviations). The primary endpoint
was the proportion with plasma HIV-1 RNA ≥50 c/mL (FDA Snapshot, 4% NI
margin) at M11 (LA without oral lead-in)/M12 (LA with oral lead-in and
BIC/FTC/TAF). Other endpoints were the proportion with plasma HIV-1 RNA <50
c/mL (FDA Snapshot, -12% NI margin), incidence of confirmed virologic failure
(CVF; 2 consecutive HIV-1 RNA ≥200 c/mL), safety, tolerability, treatment
satisfaction (HIVTSQs), and preference.

 

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 is 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://viivhealthcare.com/en-us/media-center/news/press-releases/2023/february/viiv-healthcare-announces-positive-data.html)
.

 

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 www.viivhealthcare.com
(http://www.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/company
(https://www.gsk.com/en-gb/about-us/)

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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 in
the Company's Annual Report on Form 20-F for 2021, GSK's Q4 Results for 2022
and any impacts of the COVID-19 pandemic.

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GSK plc
 
ViiV Healthcare Limited
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                No. 06876960

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