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 , ... ... that offers insurance and financial preparation services, is providing an update on a ... organization. , Rock City Rescue is a locally recognized nonprofit that provides shelter ...
(Date:10/13/2017)... Vegas, Nevada (PRWEB) , ... October 13, 2017 , ... ... 7® Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD ... dose required and providing a CBD form that can be easily incorporated into liquid ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) ... a collection of specialty vendors and unique items from across the nation, this holiday-themed ... and wellness services offered by the VNA. The boutique will be open Saturday, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in ... 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 across ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of ... announced today its plans to open a flagship location in Covington, LA at 401 ... Rooms To Go store next to Office Depot in the Holiday Square shopping center. ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... to the Centers for Disease Control and Prevention (CDC), influenza vaccination ... is helping communities across Massachusetts , Connecticut ... flu shots through the end of the month. *Some exclusions ... ... shot is by the end of October, according to the Centers for ...
(Date:10/2/2017)... INDIANAPOLIS , Oct. 2, 2017  Eli Lilly ... its financial results for the third quarter of 2017 ... a conference call on that day with the investment ... performance. The conference call will begin at ... public can access a live webcast of the conference ...
(Date:10/2/2017)... 2, 2017 The Rebound mobile app is poised ... reverse the tide of prescription drug addiction. The app empowers ... intake and stepping down their dosage in a safe, controlled ... December 2017; the first 100,000 people to sign up will ... http://www.rebound-solution.com/ ...
Breaking Medicine Technology: