FDA approves Juluca, allowing virologically suppressed HIV patients to reduce the number of antiretrovirals

ViiV Healthcare, a HIV specialist company (majority) owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, on Wednesday said that the US Food and Drug Administration (FDA) has approved Juluca, indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral (ART) regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

Juluca is the first 2-drug regimen (2DR) comprising dolutegravir 50mg (ViiV Healthcare), an integrase strand transfer inhibitor and rilpivirine 25mg (Janssen Therapeutics, Division of Janssen Products LP), a non-nucleoside reverse transcriptase inhibitor.

Deborah Waterhouse, CEO ViiV Healthcare said this approval is the start of a new era in HIV treatment. “We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”

The company said that this FDA approval is based primarily upon data from two pivotal phase III clinical trials, SWORD-12 and SWORD-2,2 which showed the 2-drug regimen achieved non-inferior viral suppression (HIV-1 RNA less than 50 copies per mL) at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies (CAR 485/511 [95%], dolutegravir + rilpivirine 486/513. Virologic suppression rates were similar between treatment arms. Drug related adverse events and adverse events leading to withdrawal occurred in low frequencies in both arms of the study, but more frequently in the investigational arm.

John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, said that, based on the fundamental principle that no one should have to take more medicines than necessary, ViiV Healthcare has put in place a comprehensive 2-drug regimen research and development programme built around the characteristics of dolutegravir. Pottage said that the new 2-drug regimen Juluca, once-daily, single pill, now provides people living with HIV who are virologically suppressed, the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen.

Image. A red ribbon is put on the sleeves of a man by his friend to show support for people living with HIV during a program to raise awareness about AIDS on World AIDS Day in Kathmandu December 1, 2013. World AIDS Day is observed annually on December 1. According to the Government of Nepal, Ministry of Health and Population, National Center for AIDS and STD Control, the estimated number of people living with HIV is around 48,600 in Nepal. REUTERS/Navesh Chitrakar (NEPAL – Tags: HEALTH SOCIETY) – RTX15ZGI