FDA Advisory Committee Supports Approval of Gilead’s Truvada® for Reducing the Risk of Acquiring HIV
On Thursday, May 10, 2012 Gilead Sciences, Inc. (Nasdaq:GILD) announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada® (emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP. If the FDA decides to approve Truvada for PrEP, it would be the first agent indicated for uninfected individuals to reduce their risk of acquiring HIV.
In response to questions posed to the committee, members voted 19 to 3 in favor of approval for Truvada for PrEP in men who have sex with men; 19 to 2 (with 1 abstaining) in support of use in HIV-uninfected partners in serodiscordant couples; and 12 to 8 (with 2 abstaining) in other individuals at risk for acquiring HIV through sexual activity.
The recommendations of the Advisory Committee are not binding, but will be considered by the FDA as the agency completes its six-month priority review of Gilead’s supplemental New Drug Application (sNDA) of Truvada for PrEP. Gilead submitted the sNDA on December 15, 2011 and the FDA has established a target review date under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012.
The committee’s positive recommendation followed presentations today of efficacy and safety data from several clinical studies of Truvada for PrEP, including two large placebo-controlled Phase 3 trials sponsored by the U.S. National Institutes of Health and the University of Washington, respectively. Several other clinical studies support the use of Truvada for HIV risk reduction.
Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States. Truvada is not indicated for HIV prevention.
Important Safety Information about Truvada:
WARNINGS: Lactic Acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including Viread®, a component of Truvada, in combination with other antiretrovirals.
Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
New onset or worsening of renal impairment may also occur, including acute renal failure and Fanconi Syndrome. Creatinine clearance should be calculated prior to administering Truvada. Truvada should not be used in patients with severe renal disease (CrCl < 30 mL/min), and routine monitoring of CrCl and serum phosphorous in patients at risk for renal impairment is recommended. Avoid administering concurrently with or with recent use of nephrotoxic drugs.
Truvada should not be co-administered with any other antiretroviral agents for HIV that contain emtricitabine or tenofovir disoproxil fumarate, nor should it be co-administered with products containing lamivudine. Do not administer with Hepsera. Decreases in bone mineral density, fat redistribution and immune reconstitution syndrome may also occur. Common side effects reported during clinical studies with Truvada (in combination with efavirenz) include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams and rash. Caution should be exercised when co-administering Truvada with didanosine, atazanavir and lopinavir/ritonavir due the potential for toxicity. U.S. full prescribing information for Truvada is available at www.Truvada.com.
About Gilead Sciences:
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 worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
Photo credit to: AP Photo/Gilead Sciences.
Sources: BUSINESS WIRE & Gilead Sciences.
Editor’s Note: This is a great news for those people who are taken multiples pills, now they only need to take one. The only bad thing is the each pill cost about $36 and if you need for 30 days = $1080.00×12 months = $12,960.00. Talk to your insurance and your doctor to get generic and we hope in the coming months the cost will be lowered because the Government will expend less money on ill people who can not afford it and to reduce the risk of infection.
On Thursday, December 22, 2011 AIDS Healthcare Foundation (AHF) announced that its parade float entry, ‘Elizabeth Taylor: Our Champion,’ which AHF entered for consideration for the 123rd Tournament of Roses Parade was approved by Tournament officials and will be sailing down Colorado Boulevard in Pasadena, California for all the world to see in the iconic parade Monday, January 2, 2012 starting at 8:00am Pacific Time (11am ET).
AHF’s parade float entry—the first in the 123-year history of the Tournament parade to focus on HIV/AIDS and the first-ever sponsored by the 25-year-old global AIDS organization—honors two-time Academy Award-winning actress Elizabeth Taylor for her tireless, nearly three decade-long advocacy and compassion on behalf of people with HIV/AIDS. Taylor, who died March 23rd at age 79, championed HIV and AIDS programs starting in the 1980s, she co-founded the American Foundation for AIDS Research (amFAR) in 1985 and the eponymous Elizabeth Taylor AIDS Foundation (ETAF) in 1993.
“Our Tournament of Roses Parade float is a tribute to someone who was more than a film star—Elizabeth Taylor was a real hero and one who truly deserves all the accolades she has received,” said Michael Weinstein, President of AIDS Healthcare Foundation, which provides medical care and services to more than 124,000 people in 26 countries around the globe. “Long before it was fashionable, she was there by our side—a singular and fearless champion for AIDS activism. She spoke truth to power on a variety of issues, and her organization, which had no overhead, helped fund AHF and other AIDS organizations in Los Angeles at a time when funding was hard to come by. For her to speak out and show her compassion really changed the game.”
Over the years AIDS Healthcare Foundation received several grants from the Elizabeth Taylor AIDS Foundation (ETAF). These funds were specifically designated for AHF’s ‘Ithembalabantu’ Clinic (Zulu for ‘people’s hope’) in Durban, South Africa, which provides free lifesaving antiretroviral treatment to people with AIDS. The first of these grants came long before President George W. Bush created the US’ global AIDS program known as PEPFAR (President’s Emergency Plan for AIDS Relief) and at a time when treatment was not widely available in poor countries around the world. Just has she had in the earliest days of the epidemic, Ms. Taylor once again demonstrated real leadership in the fight against AIDS—this time, in helping to prove that treatment could and should be brought to those in need around the world.
“AHF’s ‘Our Champion’ float also serves as a reminder that, though Ms. Taylor bravely stood up for people living with HIV/AIDS at an important moment in history, the AIDS epidemic is still not over and there remains much work to be done,” added Weinstein.
Sale of ‘AHF Memory Flowers’ will help build AHF’s ‘Our Champion’ Float
In another potential first for the Tournament of Roses Parade, the public at large across the country and around the world will have a chance to contribute to the construction of AHF’s float honoring Elizabeth Taylor while also honoring memories of their own loved ones who have died. This week, AHF is kicking off a novel ‘Text to Donate’ fundraising campaign offering the sale of ‘AHF Memory Flowers.’ For a modest $5 dollar donation contributed via a cell phone text donation, a donor will have the name of a loved one who has died hand-written on a water vial holding one of the over 150,000 roses that will make up the Elizabeth Taylor float. The significance of the roses is that they will serve as “memory flowers”, honoring any “rose” in your life that you miss. To participate in the AHF Memory Flower living tribute honoring Elizabeth Taylor’s AIDS advocacy and your own loved one, simply text the word FLOWER and the NAME OF THE PERSON you are honoring to the text number 20222.
AHF’s ‘Elizabeth Taylor: Our Champion’ Parade Float
AHF’s ‘Elizabeth Taylor: Our Champion’ Parade Float has been designed by award winning float designer Raul Rodriquez and is being built by the respected and award-winning Fiesta Parade floats. The float will be made of 150,000 flowers and will take the form of an oversized red ribbon, the international symbol of AIDS, with a circling world globe. There will be photographs of Taylor from various stages in her life and career: from ‘National Velvet,’ her breakthrough film as a child; from the film, ‘Cleopatra;’ and an iconic photo from her later years when she was devoting much of her life to advocacy on AIDS. The photos will be largely be rendered in black and white, using seeds and grains to capture the effects of a black and white photo. At least one of the photos will have spot color, also rendered in seeds, grains and flowers: for her world famous eyes, and to color a small red AIDS ribbon pinned to her blouse.
“We are honored that the Executive Board of the Tournament of Roses approved our float this year and who better to honor than the late Dame Elizabeth Taylor for her leadership on AIDS,” added AHF’s Weinstein. “This year, the theme of the Tournament of Roses Parade is ‘Just Imagine.’ In honor and remembrance of Elizabeth, let’s imagine and work toward a world without AIDS.”
About AIDS Healthcare Foundation: AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 124,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific region and Eastern Europe. For more information visit www.aidshealth.org
Photo/graphic credit to: Business Wire