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

PR63555

LONDON, Feb. 25, 2016 /PRNewswire=KYODO JBN/ --

     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_eng.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_eng.pdf?ua=1

Source: ViiV Healthcare