ViiV Healthcare presents positive 48-week data from phase III study showing every-two-month regimen of investigational long-acting, injectable cabotegravir and rilpivirine has similar efficacy to once-monthly dosing

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, presented positive 48-week data 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 met its primary endpoint at Week 48, showing that the antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks (two months) was non-inferior when compared to its administration every four weeks (monthly).

ATLAS-2M is being conducted in adults living with HIV-1 infection whose viral load is suppressed and whose virus is not resistant to cabotegravir or rilpivirine. These data were presented today 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: “We now have positive data showing the effectiveness and safety of a long-acting HIV treatment that is administered every two months. We also have patient preference data showing that study participants overwhelmingly preferred both the monthly and every-two-month long-acting regimens, over oral treatment. This two-drug regimen may provide an opportunity for people living with HIV who take daily medication to reduce their total treatment dosing days from 365 a year to six.”

In the global phase III ATLAS-2M study, non-inferiority was determined by comparing the proportion of participants with plasma HIV-1 RNA ≥ 50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48 (Intent-to-Treat Exposed [ITTE] population), which showed that the two-month arm (9/522 [1.7%]) and one-month arm (5/523 [1.0%]) were similarly effective (adjusted difference: 0.8%, 95% confidence interval [CI]: -0.6, 2.2). The study also found that rates of virologic suppression (HIV-1 RNA <50 c/mL), a key secondary endpoint for ATLAS-2M, were similar, whether the regimen of cabotegravir and rilpivirine was administered every two months (492/522 [94.3%]) or once monthly (489/523 [93.5%]) (adjusted difference: 0.8%, 95% CI: -2.1, 3.7).

Confirmed virologic failure (CVF) was defined as consecutive viral loads >200 copies per ml; eight participants in the every-two-month arm (8/522 [1.5%]) and two participants in the monthly arm (2/523 [0.4%]) developed CVF, respectively. On-treatment resistance-associated mutations to rilpivirine, cabotegravir, or both agents were found in five of eight instances of CVF in the two-month arm and both CVF instances in the one-month arm.

Treatment with cabotegravir and rilpivirine was generally well-tolerated across both study arms. In the two-month arm, rates of serious adverse events (SAEs) (27/522 [5.2%]) and withdrawals due to adverse events (AEs) (12/522 [2.3%]) were low and similar to those experienced in the one-month arm (SAEs: 19/523 [3.6%], withdrawals due to AEs 13/523 [2.5%]). Both treatment groups were similar with regards to severity and duration of injection site reactions (ISRs) experienced by participants, with 98% of ISRs described as mild or moderate (every-two-month: 2,464/2,507 [98.3%], monthly: 3,104/3,152 [98.5%]) with a median duration of three days). Out of 1,045 total participants, five participants in each arm (1.0%) withdrew for injection-related events over the 48-week study.

Ninety-eight percent of participants preferred the every-two-month, long-acting treatment over their daily, oral therapy. Patient preference data was measured using a single-item questionnaire at Week 48.

After switching to both long-acting arms (monthly and every-two-months), treatment satisfaction significantly improved for participants entering the study from daily oral standard of care regimen, and they favoured the every-two-month regimen compared to the monthly regimen at Week 48 (HIVTSQs mean change from baseline was 4.86 points (95% CI: 4.02, 5.69) for the every-two-month arm and 3.12 points (95% CI: 2.29, 3.95) for the monthly arm). For participants continuing on a long acting regimen from the ATLAS study, treatment satisfaction remained at very high levels throughout the study duration for both arms (Baseline and Week 48 mean HIVTSQ scores at around 62 out of 66 maximum points).

Turner Overton, M.D., Professor, Department of Medicine at the University of Alabama at Birmingham and ATLAS-2M Primary Investigator, said: “ATLAS-2M study participants expressed a clear preference for the two-month treatment option. This preference reinforces the desire for an option of a long-acting treatment.

“There is a need for more convenient, simplified treatments to help address challenges such as pill burden, pill fatigue, drug and food interactions, and stigma that detrimentally affect adherence for people living with HIV. The results from this study demonstrate the potential for an alternative to traditional daily, oral regimens.”

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 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 virologically 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-1 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 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.

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.

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