Tivicay (dolutegravir)+Edurant(rilpivirine) enter Phase III trial for HIV maintenance therapy-Viiv +Janssen

ViiV Healthcare 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.

SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate 148-week, randomised, open-label, non-inferiority studies to assess the antiviral activity and safety of a two-drug regimen of DTG + RPV compared with current antiretroviral therapy. Each study seeks to enrol approximately 500 patients across 13 countries and aims to enrol meaningful numbers of patients from groups underrepresented in HIV clinical studies, such as women and people over 50 years of age.

Comment: The intention is to provide a new, effective option that will compete with Gilead Sciences’ blockbuster Atripla (efavirenz/emtricitabine/tenofovir).