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:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Comfort Keepers® of ... Cancer Society and the Road To Recovery® program to drive cancer patients to and ... other adults to ensure the highest quality of life and ongoing independence. Getting ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty Network, affiliated ... Weintraub as a prominent plastic surgeon and the network’s newest partner. , ... most handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) sponsors Luke’s ... June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. ... helping service members that have been wounded in battle and their families. Venture Construction ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
(Date:6/23/2016)...  In a startling report released today, National Safety Council ... a comprehensive, proven plan to eliminate prescription opioid overdoses. ... states are tackling the worst drug crisis in recorded U.S. history, ... Kentucky , New Mexico , ... the 28 failing states, three – Michigan , ...
Breaking Medicine Technology: