Navigation Links
FDA Approves New Once-a-Day HIV Pill
Date:8/27/2012

MONDAY, Aug. 27 (HealthDay News) -- A new pill to treat HIV infection that combines four medicines and only has to be taken once a day was approved by the U.S. Food and Drug Administration on Monday.

Stribild, which will be marketed by maker Gilead Sciences, contains the HIV drugs elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. It will be prescribed to people who have never been treated for HIV infection, the agency said in a statement.

Two of the drugs, elvitegravir and cobicistat, are new, the FDA noted. Elvitegravir interferes with one of the enzymes that HIV needs to multiply, while cobicistat inhibits an enzyme that metabolizes certain HIV drugs and so prolongs the effect of elvitegravir. The combination of emtricitabine and tenofovir disoproxil fumarate is already marketed as Truvada, and they work in concert to block another enzyme that HIV needs to replicate.

"Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens," Dr. Edward Cox, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, said in the agency statement. "New combination HIV drugs like Stribild help simplify treatment regimens."

Earlier this year, the agency approved the first over-the-counter rapid HIV test for home use and gave its blessing to the first drug to be used to prevent HIV infection when used together with safe sex practices.

Two clinical trials found between 88 percent and 90 percent of patients treated with Stribild had an undetectable amount of HIV in their blood after 48 weeks of treatment, the FDA said.

The drug will carry a boxed warning that says it can cause a build-up of lactic acid in the blood and severe liver problems, both of which can be fatal. In the clinical trials, common side effects included nausea and diarrhea. Serious side effects include new or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system, the FDA said.

Gilead, which is based in Foster City, Calif., must conduct more research to further determine the drug's safety in women and children, how resistance develops to Stribild and possible interactions with other drugs, the FDA said.

More information

For more on HIV drug therapies, visit the U.S. National Library of Medicine.

-- HealthDay staff

SOURCE: Aug. 27, 2012, news release, U.S. Food and Drug Administration


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. FDA Approves Generic Versions of Plavix
2. FDA Approves Combo Shot for Meningitis, Hib in Kids
3. FDA Approves SonixGPS Needle Guidance Technology for Vascular Access Procedures
4. FDA Approves First New Weight-Loss Drug in More Than a Decade
5. FDA Approves 1st Pill to Help Prevent HIV Infection
6. FDA Approves 2nd New Weight-Loss Drug
7. FDA Approves Flu Vaccine for Coming Season
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at ... of the most popular and least understood books in the Holy Scriptures, Revelation. The ... that have baffled scholars for centuries. Many have tossed it off as mere rubbish, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader ... been awarded a contract by the Center for Medicare and Medicaid Services (CMS). ... the enterprise use of Agile methodologies in a consistent and high value manner ...
(Date:10/13/2017)... ... , ... “America On The Brink”: the Christian history of the United States ... creation of published author, William Nowers. Captain Nowers and his wife, Millie, have ... thirty years in the Navy. Following his career as a naval aviator and ...
(Date:10/12/2017)... San Francisco, CA (PRWEB) , ... October 12, ... ... and Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus ... sleep apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral ...
Breaking Medicine News(10 mins):
(Date:9/28/2017)... Sept. 28, 2017 Hill-Rom Holdings, Inc. (NYSE: ... conference call and webcast on Friday, November 3, 2017, ... and ending at approximately 8:30 a.m. (CDT) / 9:30 ... company,s 2017 financial performance and guidance for 2018, Hill-Rom ... to enhance operational performance, and long-range financial outlook through ...
(Date:9/27/2017)... NEW YORK , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: ... data solutions, today announced that its MyDario product is expected to appear ... listings for when The Dr. Oz Show airs in your area: ... The nine-time Emmy award-winning, The ... ...
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, Inc. ... response letter from the U.S. Food and Drug Administration ... of sirukumab for the treatment of moderately to severely ... additional clinical data are needed to further evaluate the ... severely active RA. ...
Breaking Medicine Technology: