Today ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced the start of a phase III study designed to establish if adults with HIV-1 with current virologic suppression on a tenofovir alafenamide fumarate (TAF)-based regimen of at least three drugs are able to maintain viral suppression upon switching to a two-drug regimen (2DR) of dolutegravir (TIVICAY) and lamivudine (EPIVIR). TANGO will seek to enrol approximately 550 adults with HIV-1, from clinical trial sites in North America, Europe, Australia, and Japan.
HIV care is a long-term prospect for those living with the disease, requiring life-long adherence to treatment. Since the introduction of highly active antiretroviral therapy 20 years ago, HIV treatment regimens have predominantly included three antiretroviral drugs., ViiV Healthcare is looking to the future and exploring how HIV treatment could evolve to reduce the number of drugs to which a patient is exposed, while maintaining the level of efficacy achieved with three-drug regimens.
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? If the data show the answer to be yes, this may allow healthcare providers to address issues of long-term toxicity by reducing exposure to antiviral agents over a lifetime of treatment. 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.”
The TANGO trial is designed to demonstrate the non-inferior antiviral activity of switching to dolutegravir and lamivudine compared to continuation of a TAF-based regimen over 48 weeks in virologically suppressed subjects. TANGO will characterise patient satisfaction as well as the long-term antiviral activity, tolerability and safety of a 2DR of dolutegravir and lamivudine through to 96 weeks.
The TANGO study follows the GEMINI studies’ investigation of the 2DR of dolutegravir and lamivudine in treatment-naïve patients with HIV-1. Results from those trials are anticipated later this year.
TIVICAY and EPIVIR are trademarks owned by or licensed to the ViiV Healthcare group of companies.
SOURCE: GlaxoSmithKline
Filed Under: Drug Discovery
