ViiV Healthcare, majority-owned by GSK, with Pfizer and Shionogi Limited as shareholders, has announced detailed study results from its phase III programme evaluating the safety and efficacy of switching virologically suppressed patients from a three- or four-drug antiretroviral regimen to a two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC).
The HIV specialist said that use of dolutegravir and rilpivirine as a two-drug regimen for HIV-1 maintenance therapy is investigational and not approved anywhere in the world.
The dolutegravir and rilpivirine regimen achieved non-inferior viral suppression at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses of the SWORD 1 and SWORD 2 studies (current antiretroviral therapy (CAR). Virologic suppression rates were similar between treatment arms. The median duration of antiretroviral treatment was just over four years at the time of entry into the studies, the company explained.
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “The results from these studies may change our understanding of how HIV can be managed. For more than 20 years we thought that three or more drugs were required to maintain virologic suppression, but the SWORD studies provide compelling data that suppression may be maintained with a two drug regimen of dolutegravir and rilpivirine. These data mark an exciting first step towards making two drug regimens a reality in HIV treatment. We are planning regulatory submissions for this two-drug regimen as a single tablet in 2017.”
Detailed study results are being presented at the annual Conference on Retroviruses and Opportunistic Infections in Seattle.