In February 2018, ViiV Healthcare announced the start of a forty-eight-week phase III study designed to determine whether adults with HIV-1 who have achieved a suppressed viral load on a tenofovir alafenamide fumarate (TAF)-based regimen of at least three drugs are able to maintain that viral suppression after switching to a two-drug regimen (2DR) of dolutegravir (Tivicay) and lamivudine (Epivir). The TANGO study seeks to enroll approximately 550 adults with HIV-1, from clinical trial sites in North America, Europe, Australia, and Japan.
ViiV Healthcare hopes to explore how to reduce the number of drugs to which a patient is exposed without sacrificing the success achieved with three-drug regimens, the predominant method of treatment since the introduction of highly active antiretroviral therapy (HAART) twenty-plus years ago.
Successful viral suppression on a two-drug regimen could combat long-term toxicity by reducing patients’ intake of antivirals over a lifetime of treatment. TANGO will also quantify patient satisfaction as well as the efficacy, tolerability and safety of such a two-drug regimen.
John C. Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, said: “We are asking a simple question in the TANGO study—can virally suppressed people with HIV reduce the number of medicines in their HIV treatment regimen while maintaining viral suppression?… We believe that with its high barrier to resistance, dolutegravir has the right clinical profile to be a core part of 2DRs for the treatment of HIV-1 and look forward to seeing the results of TANGO in 2019.”
Regarding the two drugs to be tested in this study: Tivicay (dolutegravir) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This integration step in the HIV replication cycle is critical in establishing chronic infection, hence the importance of blocking integration. Epivir is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
ViiV Healthcare, majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, is a global specialist HIV company dedicated to delivering advances in treatment and care for people living with HIV.
—Reporting by Hank Trout
Hank Trout, Editor at Large, edited Drummer, Malebox, and Folsom magazines in the early 1980s. A long-term survivor of HIV/AIDS (diagnosed in 1989), he is a thirty-eight-year resident of San Francisco, where he lives with his fiancé Rick. Follow him on Twitter @HankTroutWriter.