ViiV Healthcare reports positive phase III study results of investigational, long-acting, injectable HIV-treatment regimen administered every two months

London, 22 August 2019 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive headline results from its global phase III ATLAS-2M study of the investigational, long-acting, injectable, 2-drug regimen (2DR) of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine for the treatment of HIV. The study was designed to demonstrate the non-inferior antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks (two months) compared to every four weeks (monthly) over a 48-week treatment period in adults living with HIV-1 infection whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.

The study met its primary endpoint, showing that the long-acting regimen of cabotegravir and rilpivirine, injected every two months, was non-inferior to cabotegravir and rilpivirine administered every month at Week 48. Non-inferiority was assessed by comparison of the proportions of participants with plasma HIV-RNA ≥ 50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48 (Intent-to-Treat Exposed [ITTE] population). Overall safety, virologic response and drug resistance results for the every-two-months injectable regimen were consistent with results from the phase III ATLAS study. 

About ATLAS-2M (NCT03299049)
The ATLAS-2M study is a phase III, randomised, open-label, active-controlled, multicentre, parallel-group, non-inferiority study designed to assess the non-inferior antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks compared to long-acting cabotegravir and rilpivirine administered every four weeks over a 48-week treatment period in 1,045 adults living with HIV-1.[1] Subjects were required to be virally-suppressed for six months or greater, on first or second regimen, with no prior failure. The primary outcome measure for the study is the proportion of participants with HIV-RNA ≥ 50 c/mL at Week 48 using the FDA Snapshot algorithm (Intent-to-Treat Exposed [ITT-E] population).

ATLAS-2M is part of ViiV Healthcare’s extensive and innovative clinical trial programme for 2-drug regimens. The study is being conducted at research centres in Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the United States.

For further information please see https://clinicaltrials.gov/ct2/show/NCT03299049.

About rilpivirine long-acting
Rilpivirine long-acting is an investigational, prolonged-release suspension for intramuscular injection being developed by Janssen Sciences Ireland UC and is not approved by regulatory authorities anywhere in the world.  

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.

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 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.

References:

1. Study evaluating the efficacy, safety, and tolerability of long-acting cabotegravir plus long-acting rilpivirine administered every 8 weeks in virologically suppressed HIV-1-infected adults. Available at: https://clinicaltrials.gov/ct2/show/NCT03299049. Last accessed 22 August 2019.