ViiV Healthcare 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.
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.
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering advances in treatment and care for people living with HIV. Shionogi 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.