ViiV Healthcare initiates Phase III trial to evaluate dolutegravir and rilpivirine in HIV patients

First programme to evaluate dual HIV maintenance therapy with dolutegravir and rilpivirine

ViiV Healthcare today announced the start of a Phase III clinical trial programme to evaluate the safety and efficacy of dolutegravir (Tivicay®) and rilpivirine (Edurant®) as maintenance therapy for adult patients with HIV. The Phase III programme comprises two replicate studies evaluating 48 week viral suppression with a two drug regimen combining an integrase inhibitor (dolutegravir) and a non-nucleoside reverse transcriptase inhibitor (rilpivirine) in patients with HIV who have already achieved viral suppression with a three drug regimen.

"As HIV care becomes an increasingly long term consideration, patients and clinicians are seeking to balance efficacy and side effects of treatment. We are able to attain initial viral suppression with a standard three drug regimen and the question is whether we can maintain viral suppression with two drugs instead of three." said Dr John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare. "An interesting part of this Phase III programme is the inclusion of measures of the patient experience -- we're looking at health-related quality of life and adherence to treatment, in addition to the primary efficacy and safety endpoints."

In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson announced a partnership to investigate the potential of combining dolutegravir and rilpivirine in a single-tablet in order to expand the treatment options available to people living with HIV (ViiV Healthcare announces new collaboration with Janssen).