New Single-Pill HIV Treatment Approved in Europe

Juluca from ViiV Healthcare is the first 2-drug regimen offered in a once-daily pill.

Patients with Human Immunodeficiency Virus (HIV) must deal with the infection their entire lifetimes. While there is no cure, medicines have been developed that help patients control the virus, making the disease chronic but treatable.

ViiV Healthcare (majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders) and Janssen Sciences Ireland UC (part of the Janssen Pharmaceutical Companies of Johnson & Johnson) formed a collaboration in June 2014 to evaluate the possibility of developing a combination drug based on two successful HIV medicines – dolutegravir from ViiV and rilpivirine from Janssen – as a single pill. The resultant drug – Juluca (dolutegravir/rilpivirine) – is a 2-drug regimen, single pill that combines the integrase inhibitor (INI) dolutegravir (50mg), with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (25mg). It is designed to be taken once per days as a complete HIV regimen for people living with HIV who are virologically suppressed.

Juluca was approved by the US Food and Drug Administration in November 2017 as as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of dolutegravir/rilpivirine.

Recently, the European Commission granted marketing authorization for Juluca for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor. The approval follows the positive Opinion from the European Medicines Agency’s (EMA) Committee for Human use of Medicinal Products (CHMP) on March 22, 2018. 

Noted Deborah Waterhouse, CEO ViiV Healthcare: “The European Commission Decision for Juluca is very positive news for people living with HIV (PLHIV) across Europe, who will now have the opportunity to maintain their viral suppression with a complete treatment regimen composed of only two drugs within a single-pill. Thanks to advances in treatment, many PLHIV who are on therapy are living longer, with near-normal life expectancies. We listened to their concerns about the potential long-term effects of being on treatment for decades, and have developed a solution aligned with a preference to streamline care by taking fewer antiretrovirals.”

 

Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.