June 25, 2018
European Commission Grants Marketing Authorization for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection
– In Clinical Trials, Biktarvy Demonstrated High Efficacy and Zero Resistance Through 48 Weeks –
“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,” said Professor
Today’s decision is supported by data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a population of 2,415 participants. BIC/FTC/TAF met its primary objective at 48 weeks in all four studies.
Through 48 weeks, no participants in any of the four studies failed BIC/FTC/TAF with treatment-emergent virologic resistance, no participants discontinued BIC/FTC/TAF due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome. The most common adverse reactions in patients taking BIC/FTC/TAF were diarrhea, nausea and headache.
“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,” said
Additional studies not included in the marketing authorization application are also ongoing, including dedicated studies in women, and in adolescents and children.
BIC/FTC/TAF was approved by the
For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Today, it’s estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s generic manufacturing partners.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that physicians may not see the benefits of prescribing BIC/FTC/TAF for
the treatment of HIV-1 infection and the possibility of unfavorable
results from additional clinical trials involving BIC/FTC/TAF. These
risks, uncertainties and other factors could cause actual results to
differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these forward-looking
statements. These and other risks are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended
Full European Summary of Product Characteristics for Biktarvy and Descovy are available from the EMA website at www.ema.europa.eu.
Biktarvy, Descovy, Gilead and the Gilead logo are trademarks of
For more information on
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Gilead Sciences, Inc.
Sung Lee, +1 650-524-7792
Ryan McKeel, +1 650-377-3548
Stephen Head, +44 (0)7768 705945