ViiV Healthcare has kicked off a Phase III clinical trial programme to assess the safety and efficacy of a new combination maintenance therapy for adult patients with HIV.
The single tablet combines ViiV’s integrase inhibitor Tivicay (dolutegravir) with Johnson & Johnson’s non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine).
The Phase III programme is comprised of two replicate studies evaluating 48-week viral suppression in patients with HIV taking the therapy who were already virally suppressed on a three-drug regimen.
“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,” noted John Pottage, ViiV’s chief scientific and medical officer.
ViiV and J&J teamed up to study the combination of their drugs in April last year, in the hope of providing a new, effective option that will compete with Gilead Sciences’ blockbuster Atripla (efavirenz/emtricitabine/tenofovir).