New Hep C Drug Shows Promise in Phase 2 Testing

An experimental therapy, which was developed to treat hepatitis C, has been showing some real promise in a small hepatitis C clinical study. While this therapy is still in the earliest stages of development, it really seems like it has significant potential. Of course, leading healthcare experts still advise that it will be some time before we know if this injectable form of hepatitis C treatment will become established with other medications which can be taken orally for this infectious disease.

The latest research has suggested that this drug, known as miravirsen, could be added to drug concoction which would be used to manage the hepatitis C virus (HCV). These drug “cocktails” have been used successfully in the past, making what once was a death sentence into a chronic but manageable disease.

How Does This New Hep C Drug Therapy Work?

This new drug therapy works by suppressing the molecules which HCV needs in order to reproduce. Miravirsen proved to reduce viral loads by nearly 500-fold when taking in larger doses during this phase 2 clinical study conducted by a group of international investigators. In addition, these patients did develop any drug resistance, something that is an issue with other hep C medications, while taking this experimental drug therapy.

“This is the first real clinical study of this approach and the results are encouraging,” stated Dr. Judy Lieberman, the acting chairwoman of molecular and cellular medicine the Children’s Hospital in Boston. “What’s exciting to me is that there doesn’t seem to be any drug resistance developing. If there’s a way to develop a drug cocktail that doesn’t require a half a year of treatment … that would be really exciting, but it’s too early to tell.”

HCV is Asymptomatic

Hepatitis C is an infectious form of liver disease and it currently infects almost 200 million people around the world. Hepatitis C can be transmitted in a number of different ways, but many people have been infected from sharing needles to inject illicit drugs. Unfortunately, this disease is often asymptomatic (it produces no noticeable symptoms), and many people could have HCV without realizing it.

Phase 2 Clinical Study Shows Promise

This phase 2 clinical study was headed by Dr. Harry Janssen, a professor of medicine at the University of Toronto and Erasmus University Rotterdam in the Netherlands. The participants that enrolled for this hepatitis C clinical trial were split into four groups. Nine people were chosen from the first three groups to be given a dose of either 3 mg, 5 mg, 7 mg of this drug therapy per kg of body weight for a full 29 days. The last nine participants were given a placebo, and all were observed for 18 weeks.

Researchers reported a reduced viral-load of nearly 500-fold in the patients when they were given the highest dosage. In the meantime, the virus had fallen below detectable levels for four of these patients. Incredibly, this experimental treatment produced no significant toxic effects in any of the participants. The only effects that researchers identified were a minor reaction around the injection site and brief increase in liver enzyme levels.

One Drawback to this Injectable Drug

Dr. David Bernstein, the head of the division of hepatology at North Shore University Hospital in Manhasset, N.Y., claims that this hepatitis C study was quite intriguing. He says that this injectable drug would probably have less appeal to patients compared to other new medications which can be taken orally.

“It’s a novel concept, but it’s only 36 patients and a phase 2 study,” states Dr. Bernstein. “It’s impressive that their viral loads came down, but most suffered a recurrence of the virus.”



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