ViiV Healthcare presents positive long-term data from phase III study demonstrating efficacy and safety of cabotegravir and rilpivirine, its investigational, long-acting, injectable treatment regimen in adults living with HIV-1

Issued: London, UK

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, presented 96-week data from its global phase III FLAIR study of the investigational, long-acting, injectable, 2-drug regimen of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine for the treatment of HIV. The study demonstrated that the 2DR of once-monthly cabotegravir and rilpivirine continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC) at Week 96. These data were presented at the 2020 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, Massachusetts.

Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare, said: “Our focus on creating innovative treatment options for people living with HIV is further supported by these long-term findings of a long-acting injectable HIV treatment regimen. The efficacy and safety data of cabotegravir and rilpivirine at 96 weeks, as well as a high level of treatment satisfaction for the long-acting regimen, further encourage us as we work to bring this treatment option to people living with HIV.”

Week 96 results from the global phase III FLAIR study continued to build on the previously reported non-inferiority of long-acting cabotegravir and rilpivirine to daily oral Triumeq at Week 48. At Week 96, long-acting cabotegravir and rilpivirine demonstrated non-inferiority to Triumeq as measured by the proportion of participants with plasma HIV-1 RNA ≥ 50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 96 (cabotegravir + rilpivirine: 9/283 [3.2%], Triumeq 9/283: [3.2%], adjusted difference: 0.0%, 95% CI: -2.9, 2.9). The study found that rates of virologic suppression (HIV-1 RNA <50 c/mL) at Week 96 were similar between treatment arms (cabotegravir + rilpivirine: 245/283 [86.6%], Triumeq: 253/283 [89.4%], adjusted difference: -2.8%. 95% CI: -8.2, 2.5).

No new confirmed virologic failure (CVF) was reported between Week 48 and Week 96 among individuals who received long-acting cabotegravir and rilpivirine. One participant in the Triumeq arm developed CVF at Week 64 with no treatment-emergent resistance.

Treatment with cabotegravir and rilpivirine was generally well-tolerated, with similar rates of severe adverse events (SAEs) (cabotegravir + rilpivirine: 24/283 [8.4%], Triumeq: 22/283 [7.8%]) and AEs leading to withdrawal (cabotegravir + rilpivirine: 12/283 [4.2%], Triumeq: 4/283 [1.4%]) between both treatment arms. Of the participants who received cabotegravir and rilpivirine injections, 88 percent (246/278) reported an injection site reaction (ISR) at some point through Week 96. A majority of injections did not result in an ISR being reported, with a total of 12,552 injections administered during the 96-week study period resulting in 3,100 ISR events.  Nearly all ISRs (99.4%) were mild or moderate (mild: 2,730/3,100, moderate: 352/3,100), with a median duration of three days and the frequency of these events decreasing over time. Six participants (2.1%) withdrew for injection-related events.

At Week 48, 90.8% of FLAIR participants preferred the long-acting regimen to their previous, oral treatment and expressed a high level of treatment satisfaction. At Week 96, participants continued to demonstrate a statistically significant higher level of treatment satisfaction compared with participants on daily oral Triumeq based on the HIV Treatment Satisfaction Questionnaire (HIVTSQs) mean difference of total scores (between group difference in adjusted mean change from baseline: 2.3 points, 95% CI (1.1, 3.5), p<0.001).

Chloe Orkin, M.D., Consultant Physician and Clinical Professor at Queen Mary University of London and FLAIR principal investigator, said, “Seeing the longer-term data is really exciting. It confirms that the long-acting, two-drug regimen of cabotegravir and rilpivirine has maintained its efficacy and has the potential to be a generally well-tolerated alternative to the standard-of-care, daily, oral pill. For some people living with HIV, reducing their dosing schedules from 365 days per year to 12 may be a realistic option in the future.”

This investigational, long-acting, injectable regimen is being co-developed as part of a collaboration with Janssen Sciences Ireland UC and is not approved by regulatory authorities anywhere in the world.

About FLAIR (NCT02938520)

FLAIR includes 566 men and women living with HIV and is being conducted at research centres in Canada, France, Germany, Italy, Japan, the Netherlands, Russia, South Africa, Spain, the United Kingdom, and the United States.

FLAIR is a phase III, randomised, open-label, multicentre, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of intramuscular, long-acting, injectable cabotegravir and rilpivirine in virologically suppressed adults living with HIV, following 20 weeks of induction therapy with Triumeq. The primary endpoint for FLAIR is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure, Intent-to-Treat Exposed [ITT-E] population).

For further information please see https://clinicaltrials.gov/ct2/show/NCT02938520.

About cabotegravir

Cabotegravir is an investigational integrase inhibitor (INI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV. It is being evaluated as a long-acting formulation for intramuscular injection and also as a once-daily oral tablet for use as a lead-in, to establish the tolerability of cabotegravir prior to long-acting injection.

About rilpivirine long-acting

Rilpivirine long-acting is an investigational, prolonged-release suspension for intramuscular injection being developed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is not approved by regulatory authorities anywhere in the world.

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/about-us.

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 2019.