EU nod for ViiV/Janssen's two-drug HIV regimen

Juluca is comprised of ViiV’s dolutegravir, an integrase strand transfer inhibitor, and Janssen’s rilpivirine 25mg, a non-nucleoside reverse transcriptase inhibitor.

The once-daily pill can be used to treat HIV-1 infection in adults who are virologically suppressed 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.

A pooled analysis of data from the SWORD studies showed Juluca to be non-inferior to traditional three and four drug regimens in maintaining virologic suppression through 48 weeks in HIV positive adults, paving the way for its approval.

The most commonly reported (>5 percent) adverse events in the dolutegravir+rilpivirine arm were nasopharyngitis, headache, diarrhoea and upper respiratory tract infection.

The approval of 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," said Deborah Waterhouse, chief executive of ViiV Healthcare.

"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 to manage their HIV."

Juluca was approved in the US last November.

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