ViiV’s two-drug regimen gets EU approval for HIV-1

pharmafile | May 22, 2018 | News story | Manufacturing and Production, Sales and Marketing EMA, EU, Europe, HIV, Juluca, ViiV Healthcare, pharma 

ViiV Healthcare has announced that its HIV therapy Juluca (dolutegravir/rilpivirine) has been awarded marketing authorisation in the EU from the European Commission, making it the first available two-drug regimen, daily single pill solution for the type 1 of the virus (HIV-1).

Specifically, the authorisation covers its use in virologically supressed adult patients who have been 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. It is estimated that the approval will provide a new treatment option for around 810,000 HIV patients across Europe.  

Supporting data from two Phase 3 studies showed that the drug combo proved non-inferior to traditional three- and four-drug regimens in maintaining virologic suppression over the course of 48 weeks.

Juluca is a combination of J&J’s non-nucleoside reverse transcriptase inhibitor Edurant and ViiV’s own integrase inhibitor Tivicay. ViiV itself is majority owned by UK pharma giant GlaxoSmithKline, while both Pfizer and Shionogi also hold shares in the firm.

“We are delighted to be able to provide dolutegravir with rilpivirine in a once-daily two-drug regimen for PLHIV. ViiV Healthcare is committed to delivering innovative advances to meet the unmet needs of PLHIV and our robust clinical research programme has the potential to revolutionise how we care for PLHIV for the long-term,” commented Dr John C Pottage Jr, ViiV’s Chief Scientific and Medical Officer. “With the advent of Juluca, we have found a way to reduce the number of antiretrovirals whilst maintaining the efficacy of the traditional 3-drug regimen. This is already being recognised by the European AIDS Society (EACS 2017) guidelines recommending a dolutegravir and rilpivirine regimen as a switch option for virologically suppressed patients.”

ViiV CEO Deborah Waterhouse added: “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 to manage their HIV.”

Matt Fellows

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