Showing posts with label TREATMENTS. Show all posts
Showing posts with label TREATMENTS. Show all posts

Monday, October 13, 2014

U.S. FDA APPROVES HEPATITIS C COMBINATION PILL

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
FDA approves first combination pill to treat hepatitis C
For Immediate Release
October 10, 2014

The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.

Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.

“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”

Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.

Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.

Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.

In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.

The most common side effects reported in clinical trial participants were fatigue and headache.

Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Sunday, September 15, 2013

FIRST INTREPID SPIRIT CENTER OPENS FOR TREATMENT OF TBI AND PTS

FROM:  U.S. DEFENSE DEPARTMENT
First of 9 'Intrepid Spirit' Centers Opens at Fort Belvoir
By J.D. Leipold
Army News Service

FORT BELVOIR, Va., Sept. 12, 2013 - Since the 9/11 terrorist attacks 12 years ago, more than 2.5 million U.S. troops have deployed to Iraq and Afghanistan, and over that same period, more than 260,000 service members have been diagnosed with the invisible wounds of traumatic brain injury and post-traumatic stress as a result of combat-related injuries and accidents
To treat and care for those service members suffering from the most severe forms of traumatic brain injury, known as TBI, and post-traumatic stress, or PTS, the first of nine Intrepid Spirit Centers planned nationwide officially opened its doors here yesterday in a dedication ceremony sponsored by the Intrepid Fallen Heroes Fund, a $100-million campaign funded entirely with donations from public and private sources.
The center has actually been operating for two months and has treated some 80 patients thus far, said Martin Edelman, a trustee with the fund, who acted as master of ceremonies.

Edelman added that the ribbon-cutting ceremony also signified the transfer of the $11 million, 25,000-square-foot center to the Defense Department. A second satellite center will open at Camp Lejeune, N.C., in October, and a third at Fort Campbell, Ky., in mid-2014, he said.

David Winters, president of the nonprofit fund, said there are plans to build and equip satellite centers at Fort Bragg, N.C.; Fort Hood, Texas; Fort Carson, Colo.; and Fort Bliss, Texas; as well as at Marine Corps Base Camp Pendleton, Calif., and Joint Base Lewis-McChord, Wash. All will be built and equipped from donations, Winters said.

All Intrepid Spirit centers will be located at military bases and medical centers around the country to provide medical care for service members meaning they will not have to leave their units and families for extended treatment. The centers are designed to enhance rehabilitation, officials said.

The design and mission of the satellite centers was based on the original National Intrepid Center of Excellence, or NICoE, which opened at Walter Reed National Military Medical Center in Bethesda, Md., in 2010. It's the most advanced facility of its kind in the country and serves as the center of the military's efforts in researching, diagnosing and treating TBI, PTS and related injuries.

Speakers at yesterday's ceremony included Arnold Fisher, honorary chairman of the Intrepid Fallen Heroes Fund; Army Col. Charles Callahan, commander of Fort Belvoir Community Hospital; Dr. Heechin Chae, director of the Fort Belvoir Intrepid Spirit Center, and Intrepid Spirit patient Army Sgt. Maj. Robert Haemmerle, who told the story of his recovery from the extreme, invisible signature wounds he received in Iraq and Afghanistan.

Capping the event and speaking on behalf of senior leadership across all the services, Army Vice Chief of Staff Gen. John F. Campbell reminded the audience that there are still 50,000-plus soldiers, sailors, airmen, Marines, Coast Guardsmen and civilians who continue to be in harm's way in Afghanistan, and many will need the type of help the Intrepid Spirit Centers offer.

"In this short month of September, the Army has already faced close to 50 wounded and in the months of June and July, it was in the hundreds for wounded and that will continue and we seem to forget that," he said. "What makes this event here extra special is to have the opportunity to honor our warriors who have sacrificed so much on Patriot Day, a day of service and a day of remembrance 12 years [after the 9/11 attacks].

"We are succeeding in recruiting America's finest to serve in all of our military, and that is a direct result of our commitment to programs like this that care for injured soldiers and their families. If we lose that commitment, if we waiver in that commitment, we lose," Campbell said. "We thank all of you for enabling the loyal and experienced warriors and their families who want to continue to serve."

First Lady Michelle Obama later toured the Intrepid Spirit Center and nearby USO and visited with wounded warriors and their families.

Search This Blog

Translate

White House.gov Press Office Feed