WASHINGTON (AP) — Federal health regulators have delayed a decision on whether to approve the first pill shown to prevent HIV infection, the drug's manufacturer says.
Gilead Sciences disclosed Friday that the Food and Drug Administration will take three more months to review its application for Truvada, after the company submitted additional materials to the agency earlier this month.
In May, a panel of experts recommended approval of the daily pill for healthy people who are at high risk of contracting HIV, including gay and bisexual men. The vote was nonbinding, though the FDA often follows the group's advice.
Gilead said it submitted updated information on its planned safety materials for patients and doctors using the drug. The FDA typically extends its reviews after receiving such information.
The FDA is now expected to rule by Sept. 14, the company said in a statement.
Gilead Sciences Inc., based in Foster City, Calif., has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication is a combination of two older HIV drugs, Emtriva and Viread.
Truvada made headlines in 2010, when government researchers showed it could actually prevent people from contracting HIV when used as a precautionary measure. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. Last year another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.
An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. AIDS causes the body's immune system to break down, leading to infections which are eventually fatal. Gay and bisexual men account for the majority of cases — nearly two-thirds.
Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval would allow Gilead Sciences to formally market its drug for that use.
But Truvada's groundbreaking preventive ability has exposed stark disagreements on prevention among those in the HIV community. While Truvada's supporters say the drug is an important new option to stop the spread of AIDS, critics worry that the drug could give users a false sense of security and encourage risky behavior.
Groups including the AIDS Healthcare Foundation have asked the FDA to reject the new indication, saying it could reduce use of condoms, the most consistently reliable prevention against HIV.
The number of new HIV infections in the U.S. has held steady for 15 years at about 50,000 per year. With no vaccine in sight and an estimated 240,000 HIV carriers unaware of their status, most doctors and patients say new methods are needed to fight the spread of the virus.
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This Week’s Celebrity Instagrams (10/15-10/21)
31 photos Launch gallery
1. Just a NY girl with BIG dreams....
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2. HAPPY CHILDREN=QUALITY PARENTING. We don't always see eye to eye on everything and that's normal. We're human beings. But we come together and do it right for what's important, the kids. We are not enemies, we are parents. And we are parents 1st. S/O to @monyettashaw for making Mason's bday memorable. S/O to @itscrystalsmith at home taking care of our other lil' Prince. ❤️❤️❤️ THIS IS WHAT CO-PARENTING LOOKS LIKE. #Blessed #Happy #AboveTheDrama #BiggerThanUs
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3. So happy to finally be able to share with you all that I’m the new Global Brand Ambassador for @Revlon! Follow my day on RevlonSnaps. Yay! Choose Love, Everybody! #RevlonXCiara #chooselove #ad
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4. Glam on point!!!@makeupbymotoko & @shaylinjoneshair #easybreezy @lifetimetv #beachesmovie #january2017 😘
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5. ✨True love ✨📸: @jessiemarrerophotography
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7. Today was not easy..but by the grace of God we all got through it. Words cannot express our gratitude for all of your Prayers, Positive thoughts and Support for us throughout the years. Tommy will be missed but most certainly never forgotten...And PLEASE don't ask "Where's Martin?.." he was there too...just not in this picture. Lol! God bless you all.. #LoveConquersAll #MartinShow
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9. West coast get ready for #RockyHorror. I will be live tweeting again. #letsdothetimewarpagain
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10. #THEKEYS pre order yours now ... Available everywhere #NOV22 #WeTheBest 🔑🔑🔑🔑🔑🔑🔑🔑🔑🔑🔑🔑🔑🔑🔑🔑🔑🔑🔑🔑
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11. We about to ROCK at #KCABlackBall!! All for our life-changing effort to end 🌎 AIDS.
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12. Today's #SNAPJACK is brought to you by @yazzthegreatest 😂😂😂💋💋💋
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13. Damn girl you kinda old to be headed to the Go Go. You coming in at the age they leaving. LMAO
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14. Daddy daycare B-Boxin with @acewellstucker @shopraisingace
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15. #FBF Naviyd & URV "LIL MONSTERS"
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16. HAPPY BIRTHDAY TO ONE OF THE BIGGEST LEGENDS IN OUR HIPHOP HISTORY! @snoopdogg CONTINUED BLESSING AND LOVE FAMILY!!!!! REAL OG!
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17. Thank you for a beautiful night VSU! Let's do it again! #HOMECOMING
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18. Had a great time this morning with my familia Erica, Griff & Truth!!
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19. Check out my interview on @essence facebook live. #inmyownwords #nycpromo #day2
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20. #She💋 #tbt #TheCoveAtTheAtlantis #DawgPawsAndAll
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21. Bae #retailtherapy
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22. Why me and @coryhardrict got the same pose... and notee... new mouth #naked
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23. When my husband is my personal 'hype-man'! it kills me every time! 💜😂 #WHATNOW #lostfiles📷
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24. Diggy Simmons
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25. Hand full of @jacquieaiche 💙💎💍 @esnail_la 💅🏾
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26. SuperSoulers! You can watch my interview with Carl Lentz live from my Facebook page, tomorrow at 11a ET| 8a PT. #SuperSoulSunday
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27. 💋 .. When the friendship is easy like Sunday morning. ☀️
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28. Sunday mornings are the best........... hugs and cuddles with my angel
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29. #huggar16 #hellohuggars
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30. My gym is everywhere!.. #RnBMoney #TheGeneral 📸: @twelvepastseven
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31. Nothing I would rather be doing... Rocko setting up our movie, Romelō working on a puzzle & Laiyah singing and sharing all she's learning at school... I'm so grateful for the joy they've brought into my life ... Praying for peace , joy & love in the home of EVERY family ♥️ #HeadScarfPJSunday LOL 😂
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