The single tablet will contain Janssen’s non-nucleoside reverse transcriptase inhibitor rilpivirine (EDURANT®) and ViiV’s Integrase Inhibitor dolutegravir (TIVICAY®) as the sole active ingredients for the maintenance treatment of people living with human immunodeficiency virus (HIV).
The companies will further investigate development of this drug combination for pediatric use.
If successfully developed and approved by regulatory authorities, this treatment could offer people living with HIV who are virologically suppressed an option to switch from a standard three-drug therapy to a two-drug, nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiviral regimen.
“HIV remains a significant medical challenge, and our goal is to find new treatment regimens for patients,” says Paul Stoffels, Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman, Janssen. “We are pleased to collaborate with ViiV Healthcare in pursuing this shift in the HIV treatment paradigm and reaffirm our commitment to collaborate and develop new HIV treatments and fixed-dose regimens.”
Formulation and clinical development for the single tablet regimen will begin in the coming months.
Since the beginning of the HIV epidemic, almost 75 million people have been infected with the HIV virus.(1) It is estimated that 35 million people are living with HIV globally, with 2.5 million people becoming newly infected each year.(1, 2, 3)
Standard HIV-drug therapy contains three active components: a backbone of two NRTIs, plus either a non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI) or integrase inhibitor (INI).
- World Health Organization. Global summary of the AIDS epidemic. Available at: http://www.who.int/gho/hiv/en/. Last accessed June 2014.
- Hui Dy. Effects of HIV protease inhibitor therapy on lipid metabolism. Prog Lipid Res 2003;42(2):81-92.
- World Health Organization. Global summary of the AIDS epidemic. Available at: http://www.who.int/hiv/data/2012_epi_core_en.png . Last accessed June 2014.