ViiV Healthcare has started a phase III clinical trial program to evaluate the safety and efficacy of dolutegravir (Tivicay) and rilpivirine (Edurant) as maintenance therapy for adult patients with HIV. The phase III program 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 already have 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 program 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.
SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate 148-week, randomized, 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 enroll approximately 500 patients across 13 countries and aims to enroll meaningful numbers of patients from groups underrepresented in HIV clinical studies, such as women and people over 50 years of age. The primary endpoint is proportion of patients with plasma HIV-1 RNA