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European Commission greenlights Gilead's Biktarvy for HIV-1

Published on 25/06/18 at 02:37pm

Good news for Gilead and HIV patients across the European Union today as the prominent pharma firm announced that its product Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) has been awarded marketing authorisation in the region from the European Commission for the treatment of HIV-1 infection.

The decision was supported by the findings of four currently ongoing Phase 3 studies examining a total of 2,415 treatment-naïve HIV-1 infected adult patients and virologically suppressed adult patients; Biktarvy met its primary endpoint in all four studies after 48 weeks.

In addition to these ongoing studies, Gilead is also pursuing dedicated trials in women, children and adolescent patients.

“To help support the long-term health of people living with HIV, it is crucial to have regimens that deliver durable viral suppression with a high barrier to resistance,” commented Professor Alan Winston, Professor of HIV and Genitourinary Medicine at Imperial College and Consultant Physician at St Mary’s Hospital in London. “In clinical trials through 48 weeks, BIC/FTC/TAF has shown high efficacy and zero resistance. With convenient dosing and few pre-screening or ongoing monitoring requirements, it has the potential to simplify treatment initiation, and follow-up over time.”

Dr Andrew Cheng, Gilead’s Chief Medical Officer, also remarked: “We are pleased to offer BIC/FTC/TAF, the latest innovation in our comprehensive HIV research and development program, which encompasses prevention, treatment and cure. The approval of BIC/FTC/TAF demonstrates our continued commitment to improving care for people living with HIV, and we look forward to working with health authorities across Europe to ensure that BIC/FTC/TAF is made widely available as soon as possible.”

Matt Fellows

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