GSK's HIV asset ViiV launches major new study

ViiV Healthcare, the specialist HIV company majority owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, announced the start of a major study on Thursday.

The company said the phase III study was 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 of dolutegravir (TIVICAY) and lamivudine (EPIVIR).

It said the TANGO study would seek to enrol approximately 550 adults with HIV-1, from clinical trial sites in North America, Europe, Australia, and Japan.

ViiV said HIV care remained a long-term prospect for those living with the disease, requiring lifelong adherence to treatment.

Since the introduction of highly active antiretroviral therapy 20 years ago, HIV treatment regimens had predominantly included three antiretroviral drugs.

The company said it was now 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.

“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?,” asked ViiV Healthcare chief scientific and medical officer John C Pottage, Jr.

“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 company said the TANGO trial was 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.

It said TANGO would 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 was following the GEMINI studies' investigation of the 2DR of dolutegravir and lamivudine in treatment-naïve patients with HIV-1.

Results from those trials were anticipated later this year.

It was the second announcement from ViiV on Thursday, after it earlier announced it was launching litigation against Gilead Sciences, claiming the company had infringed on its patents in the US and Canada.