Viral suppression

BRENTFORD, U.K.—There are about 34 million people living with HIV/AIDS across the world, and HIV treatment is a continuing and persistent effort. Currently, a stabilized patient receives three drugs daily, but an effort is being made to see if this can be reduced to two.

According to GlaxoSmithKline (GSK), the two new drugs are lamivudine, a nucleoside analog given the brand name Epivir, and dolutegravir, an integrase strand transfer inhibitor (INSTI) that will be marketed as Tivicay. An INSTI stops HIV virus production by keeping the viral DNA from entering the nucleus of the patient’s T cells. Lamivudine is available in branded and generic forms, and Tivicay is approved in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.

Both drugs were created by ViiV Healthcare, a company founded in 2009 by the pharma giants GlaxoSmithKline and Pfizer, joined by Shionogi Ltd. in 2012. The companies got together following a long-term collaboration on the joint development of several novel integrase inhibitors.

ViiV Healthcare regards its mission in beating the disease as dedicating itself to providing advances in treatment and care for people living with HIV. According to the company website, “ViiV Healthcare is 100 percent dedicated to HIV medicines and research and completely focused on people affected by HIV/AIDS. Scientists are 100 percent dedicated to finding new ways to limit the impact of HIV on the people living with the virus and understanding how best to prevent and treat the disease.”

As Dr. John C Pottage Jr., chief scientific and medical officer of ViiV Healthcare, explained, “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 [two-drug regimens] for the treatment of HIV-1, and look forward to seeing the results of TANGO in 2019.”

TANGO refers to the Phase 3 randomized, parallel group clinical trial now underway with 550 HIV patients, which will compare the new drugs’ performance with the existing three-drug treatment for 96 weeks. TANGO will attempt to enroll about 550 adults with HIV-1, from clinical trial sites in North America, Europe, Australia and Japan. If the new drugs prove superior, patients receiving the current therapy will be switched over in 48 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.

ViiV’s current portfolio of 12 HIV treatments accounted for annual sales of £2.3 billion in 2015, giving the company the financial stability to “take a sustainable, long-term view when investing in our pipeline of new medicines.” The staff of more than 700 people works in 15 countries. The company extends its geographical reach even further because of its relationship with GSK to establish a presence in more than 65 countries around the world. ViiV maintains it is equipped to move quickly in response to the needs of the HIV community and has launched numerous access initiatives to help deliver on World Health Organization/UNAIDS goals to reach all those who need treatment.

The company actively participates in community-based initiatives to combat HIV. One of them, established in 1992, is the Positive Action program that supports vulnerable communities around the world. The company typically works with non-governmental organization and community-based organization partners to deliver sustainable projects at a grassroots level in communities facing the most severe challenges of HIV and AIDS. Additionally, ViiV works with pharmaceutical and biotechnology companies, individuals, academic institutions and not-for-profit organizations to respond to the HIV epidemic. Scientists are focused on finding new ways to limit the impact of HIV and finding new medicines to improve outcomes for people living with HIV.