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.

CDC SAYS NOROVIRUS LEADING CAUSE OF GASTROENTERITIS IN CHILDREN



Credit:  CDC

FROM: CENTERS FOR DISEASE CONTROL AND PREVENTION
Norovirus is now the leading cause of severe gastroenteritis in US children

Norovirus is now the leading cause of acute gastroenteritis among children less than 5 years of age who seek medical care, according to a new study published in the New England Journal of Medicine. Norovirus was responsible for nearly 1 million pediatric medical care visits for 2009 and 2010 in the United States, amounting to hundreds of millions of dollars in treatment costs each year.

"Infants and young children are very susceptible to norovirus infections, which often result in a high risk of getting dehydrated from the sudden onset of intense vomiting and severe diarrhea," said Dr. Daniel Payne, an epidemiologist in the Division of Viral Diseases at the Centers for Disease Control and Prevention. "Our study estimates that 1 in 278 U.S. children will be hospitalized for norovirus illness by the time they turn 5 years of age. It is also estimated that about 1 in 14 children will visit an emergency room and 1 in 6 will receive outpatient care for norovirus infections."

The researchers tracked infants and young children requiring medical care for acute gastroenteritis, which causes inflammation of the stomach and intestines, from October 2008 through September 2010. The study looked at more than 141,000 children less than 5 years of age living in three U.S. counties. Lab testing was done to confirm specimens for norovirus.

Norovirus was detected in 21 percent (278) of the 1,295 cases of acute gastroenteritis, while rotavirus was identified in only 12 percent (152) of the cases. About 50 percent of the medical care visits due to norovirus infections were among children aged 6 to 18 months. Infants and 1-year-old children were more likely to be hospitalized than older children. However, overall rates of norovirus in emergency rooms and outpatient offices were 20 to 40 times higher than hospitalization rates. Nationally, the researchers estimated that in 2009 and 2010, there were 14,000 hospitalizations, 281,000 emergency room visits, and 627,000 outpatient visits due to norovirus illness in children less than 5 years of age. This amounted to an estimated $273 million in treatment costs each year.

"Our study confirmed that medical visits for rotavirus illness have decreased," said Dr. Payne. "Also, our study reinforces the success of the U.S. rotavirus vaccination program and also emphasize the value of specific interventions to protect against norovirus illness." Norovirus vaccines are currently being developed, which may be especially important for young children and elderly people who are high risk.

Norovirus is highly contagious. Each year, more than 21 million people in the United States get infected with norovirus and develop acute gastroenteritis, and approximately 800 people die. Young children and elderly people are more likely to suffer from severe norovirus infections. The virus spreads primarily through close contact with infected people, such as caring for someone who is ill. It also spreads through contaminated food, water and hard surfaces. The best ways to reduce the risk of norovirus infection are through proper hand washing, safe food handling, and good hygiene.