ViiV Healthcare announced positive headline results from its global, phase III ATLAS study of a long-acting, injectable two-drug regimen (2DR) for the treatment of HIV. ATLAS (Antiretroviral Therapy as Long-Acting Suppression) was designed to establish if HIV-1-infected adult participants who had maintained viral suppression for at least six months, on a daily oral regimen comprised of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, maintained similar rates of viral suppression upon switching to the investigational, two-drug, long-acting, injectable regimen of cabotegravir and rilpivirine, compared with continuing the three-drug oral regimen.
The study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to a standard of care, daily, oral three-drug regimen at Week 48. The injectable treatment regimen met the primary endpoint for non-inferiority (the proportion of participants with plasma HIV-1 RNA ≥50 copies per milliliter [c/mL] using the FDA Snapshot algorithm at Week 48). Overall safety, virologic response and drug resistance results for the injectable regimen were consistent with results from the phase II LATTE and LATTE-2 studies.[i],[ii]
Detailed results from the study will be presented at an upcoming scientific meeting. Headline results from FLAIR, a second pivotal trial designed to evaluate a long-acting, injectable regimen of cabotegravir and rilpivirine in treatment-naïve individuals, are expected later this year.[iii]
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.
Notes to editors
The ATLAS study is part of ViiV Healthcare’s innovative clinical trial programme for two-drug regimens. The study includes 618 men and women living with HIV and is being conducted at research centres in Argentina, Australia, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden, and the United States.
About EDURANT® (Rilpivirine)
EDURANT® (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in patients:
- Who have never taken HIV medicines before, and
- Who have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL. Your healthcare professional will measure your viral load
EDURANT® should be taken in combination with other HIV medicines. Your healthcare professional will work with you to find the right combination of HIV medicines.
It is important that you remain under the care of your healthcare professional during treatment with EDURANT®
EDURANT® is not recommended for patients less than 12 years of age.
EDURANT® does not cure HIV infection or AIDS. You should remain on your HIV medications without stopping to ensure that you control your HIV infection and decrease the risk of HIV-related illnesses. Ask your healthcare professional about how to prevent passing HIV to other people.
Please read Important Safety Information below, and talk to your healthcare professional to learn if EDURANT® is right for you.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer 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 as a shareholder 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.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com/about-us.
[i] Margolis D A et al. Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised phase 2b dose-ranging trial. The Lancet Infectious Diseases. Published online July 2015. Available at: http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(15)00152-8/abstract
[ii] Margolis, D. et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2):96-week results of a randomised, open-label, phase 2b, non-inferiority trial. The Lancet. July 2017. Published online: http://dx.doi.org/10.1016/S0140-6736(17)31917-7 Last accessed August 2018
[iii] Study to evaluate the efficacy, safety, and tolerability of long-acting intramuscular cabotegravir and rilpivirine for maintenance of virologic suppression following switch from an integrase inhibitor in HIV-1 infected therapy naïve participants. Available at: https://clinicaltrials.gov/ct2/show/NCT02938520?term=FLAIR+Cabotegravir&rank=1. Last accessed August 2018