ViiV Healthcare Announces First Phase II HIV Prevention Study Results for Investigational Long-acting Injectable Cabotegravir

London (ots/PRNewswire) -

ViiV Healthcare, the global specialist HIV company majority owned
by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today
presented positive results from the 41 week phase IIa ECLAIR study,
which evaluated the safety, tolerability, dosing and satisfaction
with the investigational, long-acting, injectable cabotegravir as
monotherapy for pre-exposure prophylaxis (PrEP) in HIV-uninfected
healthy adult males not at high risk of acquiring HIV.[1] Results
were presented at the Conference on Retroviruses and Opportunistic
Infections (CROI) in Boston.

(Logo: http://photos.prnewswire.com/prnh/20160223/336449LOGO )

Data from the study support the advancement of cabotegravir, an
integrase strand transfer inhibitor, to the next stage of development
as a potential drug for HIV prevention.[1] Adverse events (AEs)
during the injection phase occurred in 98% and 90% of cabotegravir
and placebo group participants, respectively.[1] Injection site pain
was the most frequently reported Grade 2-4 AE for those receiving
cabotegravir (59%, compared to 5% for placebo).[1]

The ECLAIR study randomised 127 HIV-uninfected participants to
cabotegravir or placebo (5:1) beginning with a safety assessment on
oral cabotegravir (30mg) or matching placebo tablet for four weeks,
followed by intramuscular injections of 800mg cabotegravir or placebo
(sterile saline solution) dosed once every 12 weeks for three
cycles.[1]

A majority of participants in the study reported satisfaction with
cabotegravir injections.[1] Following repeat injections, 67/91 (74%)
of participants favoured cabotegravir long-acting injections compared
to oral cabotegravir.[1]

"There are more than 36 million people worldwide living with HIV
today and, despite considerable progress made in the fight against
HIV, infections are still increasing in parts of the world.
Preventative measures like PrEP could play an important role in
reducing the number of new infections and help contribute to the goal
of ending the global AIDS epidemic," said John C Pottage, Jr, MD,
Chief Scientific and Medical Officer, ViiV Healthcare. "We are
encouraged by these first results from the ECLAIR study and look
forward to understanding the potential efficacy and broader safety
profile of cabotegravir in the PrEP setting as we move into phase III
development later this year."

The ECLAIR study also collected cabotegravir exposure data
throughout each 12-week dosing interval. Results showed drug
concentrations were lower than anticipated at the end of the dosing
interval in approximately two-thirds of participants.[1] As a result,
an alternative dosing strategy of 600mg intramuscular injections
every eight weeks is now under investigation as a means to optimise
cabotegravir dosing prior to future safety and efficacy studies.

Adverse events in ECLAIR

Adverse events (AEs) leading to withdrawal during the oral phase
(7/105) included three events of neutropenia, three events of
increasing blood creatine phosphokinase (CPK) and one event of
fatigue.[1] For participants who entered the injection phase, a
similar proportion (93% [87/94] for cabotegravir and 95% [20/21] for
placebo) completed all three injection cycles.[1] Self- reported
injection intolerability led to withdrawal in 4% (4/94) of
cabotegravir participants.[1] One participant in the placebo group
withdrew during the injection phase due to HIV seroconversion.[1]

The number of Grade 2-4 AEs on the cabotegravir arm was higher
compared to placebo during the injection phase (80% [75/94] for
cabotegravir vs 48% [10/21] for placebo).[1] Grade 2 AEs in the
injection phase not related to injection site pain included pyrexia
(fever) (7% [7/94] for cabotegravir subjects and 0% for placebo
subjects), injection site pruritus (itching) (6% [6/94] for
cabotegravir subjects and 0% for placebo subjects) and injection site
swelling (6% [6/94] for cabotegravir subjects and 0% for placebo
subjects).[1]

Additional supporting data from the ECLAIR study on the
satisfaction and acceptability of long-acting cabotegravir will be
presented at CROI later today.[2]

About HIV and PrEP

HIV stands for the Human Immunodeficiency Virus. Unlike some other
viruses, the human body cannot get rid of HIV, so once someone has
HIV they have it for life. There is no cure for HIV, but effective
treatment can control the virus so that people with HIV can enjoy
healthy and productive lives.

Pre-exposure prophylaxis (PrEP) is the use of antiretroviral
medicines by HIV-uninfected people before potential exposure to block
the acquisition of HIV.[3] Clinical trials of daily oral PrEP for
uninfected individuals have shown evidence of high levels of
effectiveness in men who have sex with men (MSM) and mixed levels in
women. Two regimens are currently approved for use: a daily
fixed-dose combination of tenofovir disoproxil fumarate (TDF) and
emtricitabine (FTC), and TDF alone.[4]

About cabotegravir

Cabotegravir is an investigational integrase strand transfer
inhibitor (INSTI) and analogue of dolutegravir. Cabotegravir is being
developed by ViiV Healthcare for the treatment and prevention of HIV
and is currently being evaluated as a once-daily oral tablet
formulation and as a long-acting nanosuspension formulation for
intramuscular (IM) injection.

About ECLAIR study

ECLAIR (Phase IIa Study to Evaluate the Safety, Tolerability and
Acceptability of Long Acting Injections of the HIV Integr ase
Inhibitor [cabotegravir] in HIV Uninfected Men) is a double-blind,
randomised, multi-centre US study in HIV-uninfected healthy adult
males not at high risk of acquiring HIV. It evaluated cabotegravir
long-acting injections as a candidate for HIV Pre-Exposure
Prophylaxis (PrEP).

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. Shionogi (TYO: 4507) 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 new HIV medicines, as well as support communities
affected by HIV. For more information on the company, its management,
portfolio, pipeline, and commitment, please visit
http://www.viivhealthcare.com

1. Markowitz M et al. ECLAIR: Phase 2A Safety and PK Study of
Cabotegravir LA in HIV Uninfected Men. Presented at the Conference on
Retroviruses and Opportunistic Infections (CROI) in Boston, 22-25
February, 2016. Abstract #106

2. Murray Miranda et al. Tolerability and Acceptability of
Cabotegravir LA Injection-results from ECLAIR Study. Presented at the
Conference on Retroviruses and Opportunistic Infections (CROI) in
Boston, 22-25 February, 2016. Abstract #471

3. World Health Organization (WHO). Guideline on when to start
antiretroviral therapy and on pre-exposure prophylaxis for HIV.
September 2015. Last accessed December 2015

http://apps.who.int/iris/bitstream/10665/186275/1/9789241509565_en
g.pdf?ua=1

4. World Health Organization (WHO). Consolidated guidelines on the
use of antiretroviral drugs for treating and preventing HIV
infection: What's new. November 2015. Last accessed December 2015

http://apps.who.int/iris/bitstream/10665/198064/1/9789241509893_en
g.pdf?ua=1

ots Originaltext: ViiV Healthcare
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Sébastien Desprez (UK)
+44 7920 567 707 Global Communications ViiV Healthcare / Marc Meachem
(US) +1 919 483 8756 US Communications ViiV Healthcare / UK Media
enquiries: Simon Steel +44 (0) 20 8047 5502 (London)
David Daley +44 (0) 20 8047 5502 (London) / US Media enquiries:
Kathleen Cuca +1 215 859 1922 (Philadelphia)
Mary Anne Rhyne +1 919 483 0492 (North Carolina)
Sarah Spencer +1 215 751 3335 (Philadelphia) / Analyst/Investor
enquiries: Ziba Shamsi +44 (0) 20 8047 5543 (London) / Tom Curry + 1
215 751 5419 (Philadelphia)
Gary Davies +44 (0) 20 8047 5503 (London)
James Dodwell +44 (0) 20 8047 2406 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)