Today, ViiV Healthcare, in partnership with its shareholders GlaxoSmithKline, Pfizer Inc. and Shionogi Limited, formalized its collaboration with Janssen Sciences Ireland UC for phase III investigation and commercialization of the first long-acting injectable.
The two-drug formulation is a combination of cabotegravir (ViiV) and rilpivirine (Janssen) and is being investigated as an injectable maintenance treatment for people with HIV 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.”The two companies have been working together on the injectable treatment for several years.
In November, Phase IIb trials met its primary endpoint after just 32 weeks in the 96-week trial. Results showed the injectable formulation as being comparable to oral drug regimens in maintaining viral suppression.The Phase IIb trial evaluated the efficacy of administering the treatment every four weeks (94 percent) and every eight weeks (95 percent), both of which were comparable to patients using a three drug oral regimen.
Those receiving the 4-week dose reported more pain at the injection site that those on the 8-week dose.The daily adherence to current medication continues to serve as a barrier for some HIV-positive people to maintain viral suppression. If approved, ViiV and Janssen’s injectable treatment would allow for people with HIV to achieve higher viral suppression rates; improving the lives of people on treatment and driving down infection rates.The drug companies are expected to start Phase III trials to evaluate the safety and efficacy of the two-drug regimen in mid 2016.