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Hepatitis | New Drug Combination Highly Effective For Hepatitis C

Hepatitis C, a bloodborne liver disease, primarily acquired via unscreened blood products or blood transfusions, IV drug use, or inadequate sterilization of medical equipment in the healthcare setting, can potentially result in a condition known as cirrhosis or scarring of the liver and lead to liver cancer.

Hepatitis C represents the most common chronic viral infection in the US, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong ailment. It is estimated that 130″150 million people globally have chronic hepatitis C infection, with about 3.5-4 million in the US alone, and nearly 350,000 to 500,000 people globally die each year from hepatitis C-related liver diseases.

With an estimated 4 million people in the US with chronic hepatitis C, the disease is now the nation’s leading cause of liver cancer and liver transplantation, and is more common than HIV/AIDS as a cause of death. While research is progressing, there is currently no available vaccine for hepatitis C.

On May 4, at the 45th annual Digestive Disease Week (DDW) meeting in Chicago, Dr. David Bernstein, chief of the division of hepatology at North Shore University Hospital, presented research involving a novel drug regimen for chronic hepatitis C. The study involved more than 400 subjects with a subgroup of the disease, known as genotype 1A, who did not have cirrhosis.

The study was published May 4 in the online edition of the New England Journal of Medicine (NEJM).


In the study, subjects were given the experimental medications ABT-450/Ombitasvir and Dasabuvir with and without the antiviral drug ribavirin for 12 weeks. At the conclusion of the study period, investigators reported that the experimental drugs cured 97 percent of the subjects.

“The majority of patients with hepatitis C in the United States are genotype 1A,” said Dr. Bernstein. “Historically, this has been one of the most difficult patient population’s to treat and cure.”

“This is an exciting advance in the treatment of chronic hepatitis C,” added Bernstein.

With the advent of a new and powerful group of oral drugs called directly acting antiviral agents (DAAs) evaluated in this study, patients now have the opportunity for a high cure rate for a disease that used to involve lengthy treatments with injectable drugs with potentially serious side effects.

Pegylated interferon (peg-IFN) and ribavirin (RBV), combination antiviral therapy, had been the standard treatment for hepatitis C prior to arrival of DAAs with FDA approval in December, 2013. This combination, involving up to 48 weeks of therapy, is effective against all the genotypes of hepatitis viruses (pan-genotypic). Unfortunately, interferon is poorly tolerated in some patients and not widely available globally to help all patients. As a result, the majority of patients will not complete their treatment.

As a class, the DAAs are much safer, more effective and better tolerated than currently available options. Oral directly acting antiviral agents (DAAs) have significantly changed hepatitis C management by greatly decreasing requirements for monitoring and evaluation, while drastically improving cure rates.

“You have to take a step back and look at all of these steps as positive,” explained Bernstein, describing the multiple new drug regimens (DAAs) being evaluated for hepatitis C. “There are going to be multiple types of regimens with various combinations for hepatitis C treatment,” according to Bernstein.

“This trial examined the efficacy of these new drugs on their own merit”not comparing these drugs to sofosbuvir ( Sovaldi ),” explained Bernstein. “These are three new DAAs with or without ribavirin for the treatment of patients who are non-cirrhotic genotype 1A.”

“What you are getting is a 12-week response rate in the ribavirin group of 97% and in the non-ribavirin group, 90 %. “It a high number and it’s very impressive”.

The current standard of care is interferon, ribavirin


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Posted on May 20, 2014, 8:52 pm By
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