ViiV Healthcare to present new data on long-acting regimens for HIV prevention and treatment, alongside pipeline advances at CROI 2021

Data presented will demonstrate the potential of new antiretroviral mechanisms of action and long-acting medicines that challenge the HIV treatment and prevention paradigm

London, 2 March 2021 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the presentation of 16 sponsored abstracts from its diverse portfolio of innovative pipeline and licensed HIV treatment and prevention options at the Conference on Retroviruses and Opportunistic Infections (CROI 2021), being held virtually 6-10 March.

Key data presentations will include:

  • ATLAS-2M 96-week findings for investigational long-acting cabotegravir and rilpivirine administered every 2-months for the treatment of HIV-1 in virologically suppressed adults, which build upon earlier 48-week efficacy and safety data, as well as an analysis of renal and bone outcomes from ATLAS and ATLAS-2M.1
  • Phase IIa proof-of-concept findings for the maturation inhibitor GSK3640254 (GSK’254), a novel, investigational, antiretroviral agent with a new mechanism of action that is being studied in adults living with HIV-1.2
  • Pharmacokinetic (PK) and resistance data from HPTN 083,* a study of investigational cabotegravir every 2-months for HIV prevention from HPTN 083 in men who have sex with men (MSM) and transgender women (TGW).3

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “The innovation powered by our research and development team strives to redefine what is possible in both HIV treatment and prevention. The findings that will be presented at CROI 2021 reflect this goal, with new data that further establish our leadership in long-acting therapies for HIV treatment and prevention, as well as proof-of-concept data from our early pipeline that explore a new mechanism of action maturation inhibitor. We look forward to sharing these findings during CROI 2021 with the HIV community.”

Key abstracts to be presented by ViiV Healthcare and study partners at CROI 2021:

Week 96 findings from the ATLAS-2M study evaluating investigational long-acting cabotegravir and rilpivirine administered every 2-months compared to once-monthly for the treatment of HIV-1: The ATLAS-2M study was designed to assess the non-inferiority and safety of long-acting cabotegravir and rilpivirine administered every 2-months compared to its once-monthly administration for treatment of HIV-1.4 The two-year findings to be presented at CROI 2021 will include cabotegravir and rilpivirine’s efficacy, safety and tolerability data, consistent with the previous 48-week data presentation.5

Week 48 renal and bone outcomes from investigational long-acting cabotegravir and rilpivirine administered every 2-months and once-monthly across ATLAS and ATLAS-2M for the treatment of HIV-1: The phase III development program of long-acting cabotegravir and rilpivirine was designed to demonstrate the regimen’s efficacy and safety when dosed once-monthly in ATLAS and every 2-months in ATLAS-2M for HIV treatment. Findings to be presented at CROI 2021 will provide further insights into renal and bone-specific outcomes among study participants.

PK and resistance data from the global HPTN 083* study evaluating cabotegravir as an investigational HIV prevention drug: The HPTN 083 study was designed to compare the efficacy and safety of every 2-month, long-acting, injectable cabotegravir to daily oral PrEP among MSM and TGW. Findings to be presented at CROI 2021 will provide additional information about seroconverters, PK, and resistance.4

Proof-of-concept findings from the phase IIa study of the maturation inhibitor GSK3640254 (GSK’254): The phase IIa proof-of-concept study was designed to evaluate the antiviral activity, safety, and tolerability of the once-daily maturation inhibitor GSK’254 in adults living with HIV-1.6 Findings to be presented at CROI 2021 will provide support for the continued study of this innovative investigational antiretroviral agent.2

The full list of ViiV Healthcare data to be presented at CROI 2021 is outlined below:

Abstract title

First Author

Presentation

Dolutegravir
Switching to DTG/3TC FDC is non-inferior to TAF-based regimens for 96 weeks: TANGO subgroup analyses

P Benson

Science Spotlight

Durable efficacy of DTG + 3TC in GEMINI-1&-2: Year 3 subgroup analyses 

C Orkin

Science Spotlight
Inflammatory and atherogenesis markers 148 weeks post-switch to DTG + RPV in SWORD-1/-2

J Libre

Science Spotlight

Association between newer antiretrovirals and increase in body mass index (BMI) in RESPOND

L Bansi-Matharu

Science Spotlight

Association between integrase strand transfer inhibitors and cardiovascular disease

B Neesgaard

Science Spotlight

Cabotegravir
Laboratory analysis of HIV infections in HPTN 083 (*ViiV/Division of AIDS, National Institutes of Health/HIV Prevention Trials Network collaborative study): Injectable CAB for PrEP

M Marzinke

Oral Presentation

Week 96 efficacy and safety of long-acting cabotegravir + rilpivirine every 2 months: ATLAS-2M

H Jaeger

Science Spotlight

Renal/bone outcomes after long-acting cabotegravir + rilpivirine in ATLAS + ATLAS-2M

P Benn

Science Spotlight

Cabotegravir population pharmacokinetic (PPK) simulation to inform Q2M strategies following dosing interruptions

K Han

Science Spotlight

Weight and lipid changes in phase 3 cabotegravir and rilpivirine long-acting trials

P Patel

Science Spotlight

Long-acting cabotegravir + rilpivirine in older adults: pooled phase 3 week 48 results

P Benn

Science Spotlight

Population PK modeling of every 2 months IM RPV LA for managing dosing interruptions in HIV-1 patients

S Rossenu

Science Spotlight

Fostemsavir
Reduced susceptibility to temsavir is not linked to IBA or MVC resistance

B Rose

Science Spotlight

Maturation Inhibitor (GSK‘254)
Phase IIa proof-of-concept trial of next-generation maturation inhibitor GSK3640254

C Spinner

Oral Presentation

GSK3640254 is a novel maturation inhibitor with an optimized virology profile

J Jeffrey

Science Spotlight

General
RCT of an online mental health intervention among older PLWH during COVID-19 pandemic

J Berko

Oral Presentation

The antiretroviral pregnancy registry: 30 years of monitoring for congenital anomalies

J Albano

Science Spotlight

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 aims are 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 https://www.gsk.com/en-gb/about-us

ViiV Healthcare
Media enquiries:

Melinda Stubbee

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+1 919 491 0831 (North Carolina)

+44 (0) 7341 079531 (London)

+1 919 605 4521 (North Carolina)

GSK enquiries:
Media enquiries:

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Tim Foley

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Analyst/Investor enquiries:

Sarah Elton-Farr

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James Dodwell

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Frannie DeFranco

+44 (0) 20 8047 5194 (London)

+44 (0) 7392 784784 (Consumer)

+44 (0) 20 8047 2406 (London)

+1 215 751 7002 (Philadelphia)

+1 215 751 4855 (Philadelphia)

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 "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principle risks and uncertainties” section of the Q4 Results and any impacts of the COVID-19 pandemic.

References

  1. Jaeger H, Overton E, Richmond G, et al. Week 96 efficacy and safety of cabotegravir + rilpivirine every 2 months: ATLAS-2M. Presented at Conference on Retroviruses and Opportunistic Infections (CROI) 2021.
  2. Spinner C, Felizarta F, Rizzardini G, et al. Phase IIa proof-of-concept trial of next-generation maturation inhibitor GSK3640254. Presented at Conference on Retroviruses and Opportunistic Infections (CROI) 2021.
  3.  Marzinke M, Grinsztejn B, Fogel J, et al. Laboratory analysis of HIV infections in HPTN 083: Injectable cabotegravir (CAB) vs daily, oral TDF/FTC for PrEP in MSM/TGW. Presented at Conference on Retroviruses and Opportunistic Infections (CROI) 2021.
  4.  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 September 2020.
  5.  Overton E, Richmond G, Rizzardini G, et al. Cabotegravir + rilpivirine every 2 months is noninferior to monthly. ATLAS-2M study. Presented at Conference on Retroviruses and Opportunistic Infections (CROI) March 2020.
  6. Clinical trials.gov. A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults. Available at: https://clinicaltrials.gov/ct2/show/NCT03784079. Accessed March 2021.