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First Regimen Combining Long Acting Injectable Antiretrovirals; 32-Week LATTE 2 Study Results Presented at CROI
Cork, Ireland (ots/PRNewswire) - Intramuscular 2-drug maintenance therapy demonstrates comparable antiviral activity to daily oral 3-drug combination
Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, (Janssen) announced 32-week data from an ongoing phase IIb study. A regimen of two investigational long acting, intramuscular (IM) formulations of HIV medicines-Janssen's rilpivirine and ViiV Healthcare's cabotegravir-given together every 4 or 8 weeks-show comparable antiviral activity to 3-drug oral antiretroviral therapy (ART) (investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs). The full results of the study, named LATTE-2, co-funded by Janssen and ViiV Healthcare were presented at this year's Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, Massachusetts today.
The LATTE-2 study is investigating the safety and efficacy of 2-drug IM ART, relative to 3-drug oral ART when used to maintain viral suppression in HIV-1 infected adults.
Virologic responses (plasma HIV-1 RNA <50 c/ml by FDA snapshot analysis) for 309 patients at 32 weeks receiving two drug maintenance therapy with investigational long acting cabotegravir (CAB LA) and long acting rilpivirine (RPV LA) whether dosed every 8 weeks (Q8W, 95%) or every 4 weeks (Q4W, 94%) were comparable to the response observed in patients continuing with a three-drug oral regimen of investigational CAB + NRTIs (91%). Patients switching to CAB LA and RPV LA administered Q4W reported more adverse events (AEs) leading to withdrawal (5%; n=6) compared with those receiving an injection Q8W (2%; n=2) or those who continued on oral CAB + NRTIs (2%, n=1). The most common AE reported by patients was injection site pain (92% of injection recipients).
LATTE-2 (31LB) is a phase IIb, multicentre, parallel group, and open-label study which recruited ART-naïve HIV-infected adults. Enrolled patients who had a plasma HIV-1 RNA, <50 c/ml during 20-week Induction Period (IP) with daily oral CAB 30 mg + ABC/3TC were randomised 2:2:1 to IM CAB LA + RPV LA every four weeks, every 8 weeks, or remained on oral CAB + ABC/3TC (PO) in the Maintenance Period (MP). The primary endpoints evaluated antiviral activity by FDA snapshot algorithm, protocol defined virologic failure, and safety at 32 weeks in the MP.
If successfully developed and approved by regulatory authorities, this regimen could offer adult patients living with and treated for HIV an option to maintain viral suppression with 6 or 12 long acting injections of each drug per year.
"Through scientific advances, over the past two decades, HIV has moved from a death sentence to a manageable chronic disease," says Wim Parys, M.D., Vice President and Head of Research and Development Global Public Health, Janssen. "Results of the LATTE-2 study show that long acting injectable drug formulations may offer an important option for HIV maintenance therapy and we remain committed to developing such combinations as we enter phase 3 studies."
Driven by a purpose of caring, and remaining committed to the prevention, detection, education and treatment of HIV, Janssen has a long history in the global battle against HIV/AIDS. It is estimated that around 37 million people are currently living with HIV globally, with 2 million people becoming newly infected each year. As a company, Janssen has a deep commitment to HIV and the company's ultimate goal is to help all those living with the virus to achieve an undetectable viral load and have an improved quality of life with the aim of making HIV history.
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 (http://www.edurant.com/patients/important-safety-information), and talk to your healthcare professional to learn if EDURANT® is right for you.
Cabotegravir is an investigational integrase strand inhibitor (INSTI) and analogue of dolutegravir (TIVICAY®). Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a once-daily oral tablet formulation and as a LA nanosuspension formulation for intramuscular (IM) injection.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
Janssen Sciences Ireland UC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. At Janssen, we are dedicated to addressing some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. More information about Janssen can be found at: http://www.janssen.com.
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).
1. Margolis DA, González-García J, Stellbrink HJ, et al. Cabotegravir+rilpivirine as long-acting maintenance therapy: LATTE-2 week 32 results. Presentation at Conference on Retroviruses and Opportunistic Infections (CROI), Boston, MA, USA; 22-25 February 2016: abstract 31LB. 2. World Health Organization. HIV/AIDS Fact sheet N°360, updated November 2015. Available at: http://www.who.int/mediacentre/factsheets/fs360/en/. Last accessed February 2016.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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 and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in new product development, including uncertainty of clinical success and obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.