Study meets primary endpoint, comparing efficacy of an investigational once a month injectable two-drug regimen to the standard of care daily, three-drug regimen
Full results from the studies will be presented at an upcoming scientific meeting
CORK, Ireland, Aug. 15, 2018 -- The Janssen Pharmaceutical Companies of Johnson & Johnson today confirmed positive topline results from the global, Phase III Antiretroviral Therapy as Long-Acting Suppression (ATLAS) study of the first investigational long-acting injectable two-drug regimen (2DR) for the treatment of HIV-1.
The ATLAS study results showed long-acting rilpivirine (Janssen Sciences Ireland UC) and cabotegravir (ViiV Healthcare), 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.1,2
"These results offer new evidence that suggest this investigational, two-drug, once a month dosing regimen may reduce the impact of treatment on people's lives," said Wim Parys, M.D., Head of R&D, Global Public Health, Janssen Pharmaceutica N.V. "This novel approach would signify a much-needed treatment evolution for people living with HIV, moving from dosing 365 days a year to just 12 times per year."
The ATLAS study was designed to establish whether HIV-1-infected adult participants with current viral suppression on a daily oral regimen comprised of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent (standard of care), remained suppressed upon switching to the novel, two-drug long-acting regimen of rilpivirine and cabotegravir.[i]
Full results of the ATLAS study co-funded by Janssen and ViiV Healthcare will be presented at an upcoming scientific meeting. Topline results from FLAIR, a second pivotal trial designed to evaluate the investigational long-acting, injectable regimen of rilpivirine and cabotegravir in people living with HIV, are also expected later this year.
This novel regimen is being co-developed as part of a collaboration with ViiV Healthcare.
About ATLAS (NCT02951052)i
The ATLAS study is part of Janssen's ongoing R&D commitment to develop transformational medicines.
The study includes 618 men and women living with HIV-1 and are being conducted at research centres in Argentina, Australia, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden, and the United States.
ATLAS is a phase III, open-label, active-controlled, multicentre, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of long-acting, injectable rilpivirine and cabotegravir dosed once per month compared to continuation of current ART of two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI). The primary endpoint for ATLAS is the proportion of participants with plasma HIV-1 RNA ≥50 copies per milliliter [c/mL] using 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/NCT02951052.
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for the treatment of HIV in combination with other antiretrovirals and is being developed by Janssen Sciences Ireland UC in a long-acting formulation (Rilpivirine LA). Rilpivirine LA is an investigational injectable nanoparticle suspension for intramuscular injection which is not approved by regulatory authorities anywhere in the world.
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 and is currently being evaluated as a long-acting, nanosuspension formulation for intramuscular injection and also as a once-daily oral tablet for induction prior to long-acting injection.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us at @JanssenGlobal.
Janssen Sciences Ireland UC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.
Delivering Sustainable Impact in Global Public Health
Combatting HIV is an important component of Johnson & Johnson's long-standing legacy of commitment and partnership to improve global public health for individuals, families and communities worldwide. Janssen supports this commitment with groundbreaking science and innovative strategies to improve access to medicines, foster collaborations, and support public health solutions to sustainably advance health care worldwide. Through Johnson & Johnson's global public health organization, the company aims to deliver integrated evidence-based solutions to address comprehensive health needs and deliver meaningful and enduring impact in three core focus areas: HIV, maternal and child health, and extensively drug-resistant (XDR)- and Multidrug-resistant (MDR)- tuberculosis (TB).
Notice to Investors Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding rilpivirine and development of potential preventive and treatment regimens for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Sciences Ireland UC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," in the company's most recently filed Quarterly Report on Form 10-Q, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson.
1,2 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