Back HIV Prevention Pre-exposure (PrEP) Truvada PrEP for HIV Prevention Approved in European Union

Truvada PrEP for HIV Prevention Approved in European Union

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The European Commission, which has authority over new drug in the European Union, has approved Truvada (tenofovir/emtricitabine) for HIV pre-exposure prophylaxis or PrEP, Gilead Sciences announced this week. While this marketing authorization allows Truvada for PrEP to be sold throughout the EU, regulatory authorities in each country have the final say over whether to approve it and national health systems will decide whether to offer PrEP widely and pay for it.

The U.S. Food and Drug Administration approved Truvada for PrEP in July 2012, based in part on data from the iPrEx trial showing that once-daily Truvada reduced the risk of HIV infection among mostly gay and bisexual men by more than 90% if used consistently.

More recently, the U.K. Proud study of daily Truvada PrEP and the French Ipergay study of "on demand" PrEP before and after sex showed that both approaches reduced the risk of acquiring HIV by 86%.

In July the European Medicines Agency recommended that Truvada be approved for PrEP, but France had already decided last November to approve it and provide coverage under its national health insurance. Truvada PrEP is also currently approved in Australia, Canada, Kenya, Peru, and South Africa.

Below is an edited excerpt from a Gilead press release describing the European Commission approval in more detail.

European Commission Grants Marketing Authorization for Gilead’s Once-Daily Truvada For Reducing the Risk of Sexually Acquired HIV-1

Truvada is the First Antiretroviral Medicine to be Licensed in Europe for Pre-Exposure Prophylaxis, in Combination with Safer-Sex Practices, to Reduce the Risk of Sexually Acquired HIV-1 in Adults at High Risk

Foster City, Calif. -- August 22, 2016 -- Gilead Sciences, Inc.(Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for once-daily Truvada (emtricitabine 200 mg/tenofovir disoproxil 245 mg; FTC/TDF) in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. Truvada was approved by the European Medicines Agency in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults aged 18 years and over, and is currently the most prescribed antiretroviral medicine in Europe as part of combination therapy.

The marketing authorization allows for the marketing of Truvada for PrEP in all 28 countries of the European Union, subject to national regulatory authority approval of required pharmacovigilance materials in each country.

"In the past 30 years, we have seen significant progress in the way we treat HIV; however, infection rates have continued to rise. In 2014, we saw the highest number of newly diagnosed cases in the European Union ever recorded, with 94 percent of those with known cause transmitted through sexual contact," said Professor Jean-Michel Molina, MD, PhD, Hôpital Saint Louis in Paris and University of Paris 7. "Truvada for PrEP provides an additional prevention tool, which when used with safer-sex practices, will help uninfected adults at high risk of HIV protect themselves against the virus."

The marketing authorization is based on the results of two large placebo-controlled trials of Truvada, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the U.S. National Institutes of Health and the University of Washington, respectively. In these studies, the most commonly reported side effects included headache, stomach discomfort and weight loss. The incidence and types of side effects were consistent with Truvada’s safety and tolerability profile when used as part of an HIV treatment regimen.

"The approval of Truvada for PrEP represents an important step forward in addressing the incidence of HIV in Europe," said Norbert W. Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "When taken as directed and used in combination with other prevention strategies, Gilead believes Truvada for PrEP can have a meaningful impact on public health by helping to reduce HIV transmission rates across Europe."

Worldwide, clinical guidelines support the use of PrEP, in combination with other existing prevention measures such as condoms, to prevent the sexual transmission of HIV in adults at high risk of HIV infection. Truvada should not be used in individuals with unknown or positive HIV-1 status, as Truvada alone does not constitute a complete regimen for the treatment of HIV-1, and HIV-1 resistance mutations have emerged in individuals with undetected HIV-1 infection who are only taking Truvada.

In addition to the European Union, Truvada is also authorized for PrEP in Australia, Canada, Kenya, Peru, South Africa and the United States.

For important safety information for Truvada, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC, available from the EMA website at www.ema.europa.eu.

About Gilead

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

8/24/16

Source

Gilead Sciences. European Commission Grants Marketing Authorization for Gilead’s Once-Daily Truvada For Reducing the Risk of Sexually Acquired HIV-1. Press release. August 22, 2016.