Showing posts with label HCV. Show all posts
Showing posts with label HCV. Show all posts

Friday, May 8, 2015

INCREASED HEPATITIS C INFECTIONS RELATED TO INJECTION DRUG USE OF PERSONS OVER 30

FROM:  U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION
Increases in Hepatitis C Virus Infection Related to Injection Drug Use Among Persons Aged <30 Years — Kentucky, Tennessee, Virginia, and West Virginia, 2006–2012

Evidence suggests drug injection and prescription opioid abuse are fueling hepatitis C increases in four states east of the Mississippi River. Surveillance data show a national increase in acute hepatitis C virus (HCV) infections from 2006-12, with the largest increases occurring east of the Mississippi River. To better understand the increase in HCV and its correlation to injection drug use, researchers reviewed surveillance data from four states showing a 364 percent increase in cases — Kentucky, Tennessee, West Virginia, and Virginia — along with drug treatment admissions data. Nearly half (44.8 percent) of HCV cases occurred among people under 30, with a median age of 25. Significant increases in both urban and non-urban areas were found, with more than double the rate of cases occurring in non-urban areas. The majority of those diagnosed were white, and equally as likely to be male as female. Of the cases for which risk data were identified, 73.1 percent reported injecting drugs. Data showed increases in the proportion of persons under 30 admitted for abuse of any opioid (21.1 percent), abuse of prescription opioids (16.8 percent), and injection of any opioid (12.6 percent). While HIV prevalence in this population is currently low in these four states, the regional increase in HCV infections raises concerns about the potential for an increase in HIV infections, as injection drug use is a risk factor for both HIV and HCV. Combined, these findings highlight the need for increased HCV testing, care, and treatment services within substance abuse treatment programs.

Saturday, December 20, 2014

FDA APPROVES VIEKIRA PAK FOR TREATMENT OF HEPATITIS C

FROM: U.S. FOOD AND DRUG ADMINISTRATION 
FDA approves Viekira Pak to treat hepatitis C

The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

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

Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).

“The new generation of therapeutics for hepatitis C virus is 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. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.”

Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014.

Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis. In different trials, participants were randomly assigned to receive Viekira Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.

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. Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of participants who received Viekira Pak at the recommended dosing achieved SVR. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily.

The most common side effects reported in clinical trial participants were feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping.

Viekira Pak is the eleventh new drug product 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. Viekira Pak 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.

Viekira Pak is marketed by AbbVie Inc., based in North Chicago, Illinois. Olysio is marketed by Raritan, New Jersey-based Janssen Pharmaceuticals. Sovaldi and Harvoni are marketed by Gilead Sciences, based in Foster City, California.

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.

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