GSK744 (Cabotegrevir)/Rilpivirine Long-Acting Injectable Maintenance Therapy Phase 3 Study Start Date Announced - ViiV Healthcare to progress collaboration with Janssen to develop the first long-acting, two drug injectable regimen for treatment of HIV
first long-acting, two drug injectable regimen for treatment of HIV
London, UK, 7 January 2016 - ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders, today formalised its collaboration with Janssen Sciences Ireland UC (Janssen) for the phase III investigation and commercialisation of the long-acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) for the treatment of HIV-1 infection. The long-acting formulations of cabotegravir (CAB LA) and rilpivirine (RPV LA) are being investigated as an injectable maintenance treatment for patients who have achieved viral suppression.
"As a company committed to innovation in the field of HIV, this agreement with Janssen will enable us to progress the development of the first long-acting, injectable two drug regimen," said Dominique Limet, CEO, ViiV Healthcare. "If successful, this regimen would offer people living with HIV who have achieved viral suppression an alternative option to the standard oral daily, three drug therapy."
While HIV is now considered a chronic manageable condition for most individuals, there are remaining treatment challenges that continue to impact the lives of people living with HIV; which may include tolerability, safety, dosing schedules, drug interactions and adherence. ViiV Healthcare is committed to investigating new treatment options that may help to address some of these challenges with the aim of providing healthcare professionals with alternative treatment options for appropriate patients.
As part of this agreement and as announced at the GSK R&D day (3 November 2015), the two companies expect to start a phase III programme to evaluate the efficacy, safety and tolerability of the long-acting, two drug injectable regimen in mid-2016.
This is the second development agreement with Janssen. In June 2014 both companies entered into an agreement to develop and commercialise a single-tablet combining ViiV Healthcare's integrase strand transfer inhibitor (INSTI), dolutegravir (Tivicay®) and Janssen's non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (EDURANT®). A phase III clinical trial programme to evaluate the safety and efficacy of both medicines as maintenance treatment of HIV-1 infection began in May 2015. These agreements build on ViiV Healthcare's strategy to collaborate with other companies, institutions and not-for-profit organisations to contribute to the understanding and management of HIV.
HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives. The current standard of care in HIV involves a combination of at least three oral antiretroviral (ARV) drugs taken daily: two non-nucleoside reverse transcriptase inhibitors (NRTIs), plus either a non-nucleoside reverse transcriptase inhibitor, protease inhibitor (PI) or integrase strand transfer inhibitor (INSTI).
Cabotegravir is an investigational integrase strand transfer 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 long-acting nanosuspension formulation for intramuscular (IM) injection.
Rilpivirine (EDURANT®) is a once daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of human immunodeficiency virus (HIV-1) infection in combination with other antiretroviral agents in antiretroviral treatment-naïve adult patients with a viral load ≤ 100,000 HIV RNA copies/mL.
Rilpivirine was developed by Janssen. Rilpivirine is approved in US and EU as EDURANT® as a single agent tablet dosed at 25mg taken once a day and is always taken with a meal. The overall safety profile of rilpivirine is based on phase III clinical studies. Rilpivirine is also available in the United States (US) and the European Union as part of a once daily fixed dose antiretroviral combination with Gilead Sciences Inc's tenofovir disoproxil fumarate and emtricitabine. This combination, is known as COMPLERA® (US) or EVIPLERA®. The most common side effects of EDURANT® include: depression, headache, trouble sleeping (insomnia) and rash.
Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Tivicay is approved in over 90 countries across North America, Europe, Asia, Australia, Africa and Latin America.
Tivicay is a registered trademark of the ViiV Healthcare group of companies.
Important Information about Tivicay® (dolutegravir)
FDA Indication and Usage: TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Use of TIVICAY in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R.
Important Safety Information for Tivicay® (dolutegravir)
Contraindication: TIVICAY is contraindicated (1) in patients with previous hypersensitivity reaction to dolutegravir, and (2) in patients receiving dofetilide (antiarrhythmic) due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events.
Hypersensitivity Reactions: Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in 1% or fewer subjects receiving TIVICAY in Phase 3 clinical trials. Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reaction develop, (including but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, oral blisters or lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing.) Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy. Delay in stopping treatment with TIVICAY or other suspect agents after the onset of hypersensitivity may result in a life-threatening reaction. TIVICAY is contraindicated in patients who have experienced a hypersensitivity reaction to dolutegravir.
Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Coinfection: Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY are recommended in patients with underlying hepatic disease such as hepatitis B or C.
Fat Redistribution: Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy.
Immune Reconstitution Syndrome: During the initial phase of treatment, immune reconstitution syndrome can occur, which may necessitate further evaluation and treatment. Autoimmune disorders have been reported to occur in the setting of immune reconstitution; the time to onset is more variable and can occur many months after initiation of treatment.
Adverse Reactions: The most commonly reported (≤2%) adverse reactions of moderate to severe intensity in treatment naïve adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).
Drug Interactions: Co-administration of TIVICAY with drugs that are strong inducers of UGT1A1 and/or CYP3A4 may result in reduced plasma concentrations of dolutegravir and require dose adjustments of TIVICAY.
- TIVICAY should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral iron supplements, oral calcium supplements, or buffered medications.
- Consult the full Prescribing Information for TIVICAY for more information on potentially significant drug interactions, including clinical comments.
Pregnancy: Pregnancy category B. TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.
Breastfeeding: Breastfeeding is NOT recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.
Paediatric Patients: Safety and efficacy of TIVICAY has not been established in children younger than 12 years old, or weighing <40 kg, or in INSTI-experienced paediatric patients with documented or clinically suspected INSTI resistance.
Please visit the following link for the full US prescribing and patient information: https://www.viivhealthcare.com/media/58599/us_tivicay.pdf.
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. Shionogi (TYO: 4507) 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 new HIV medicines, 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 the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, 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.
Sebastien Desprez (UK)
+44 7920 567 707
Marc Meachem (US)
+1 919 483 8756