Another Med for Liver Infection

Miravirsen safe and effective for hepatitis C infection

/ Author:  / Reviewed by: Robert Carlson, M.D

(RxWiki News) Hepatitis C infection is often treated with antiviral medications. One such medication is currently being tested.

Miravirsen safely and effectively suppressed the reproduction of hepatitis C, according to a recently published study.

The medicine inhibits certain cells in the liver that are key to the spread of hepatitis C. These findings suggest that miravirsen could be a potential treatment for the infection, researchers said.

"Talk to a doctor about your medications."

For their small phase 2A study, researchers led by Harry Janssen, MD, PhD, professor of hepatology at Erasmus MC University Hospital in the Netherlands, looked at how well miravirsen worked against the hepatitis C virus.

The medicine has not yet been approved by the FDA. Hepatitis C infection attacks the liver and causes inflammation, though most cases have no symptoms. 

The study included 36 adult patients with chronic hepatitis C genotype 1 infection between September 2010 and November 2011 at seven international sites.

Participants had no other chronic liver diseases nor cirrhosis and had not previously been treated for the infection.

Half the patients were randomly assigned to receive five weekly injections of the medicine for 29 days at different doses depending on body weight. The rest received placebo, or fake medication.

Researchers followed participants for 18 weeks total and found that miravirsen reduced hepatitis C and maintained the reductions after the injections were complete.

The virus decreased by 1.2 IU per milliliter in patients who received 3 milligrams per kilogram of miravirsen. Patients who received 5 and 7 milligram dosages saw a 2.9 and 3.0 IU per milliliter reduction.

At the same time, the virus decreased by 0.4 IU in participants who received the placebo.

"It is possible that miravirsen could be used as a host-targeting agent to increase the antiviral efficacy of such combination regimens by providing a continuous barrier to viral breakthrough, an approach that would seem worth testing...," researchers wrote in their report.

One of the 5-milligram recipients and four of the 7-milligram recipients did not have any new hepatitis C viruses spring up during the follow-up period. 

Over the course of the study, five patients in the miravirsen group and two in the fake pill group had moderate adverse side effects, including headaches, ear inflammation and flu-like symptoms.

Treatment of hepatitis C has seen several significant advances in the past few years, according to Jason Poquette, BPharm, RPh, a registered pharmacist and dailyRx Contributing Expert.

"These drugs have increased the resources available to physicians to treat HCV, adding to the effectiveness of the standard interferon and ribavirin therapies," he said.

"However, due to potential side effects, treatment failures, complexity and contraindications, there is need for further treatment options to address this condition affecting upwards of 170 million patients worldwide."

The study, supported by Santaris Pharma, was published online March 27 in the New England Journal of Medicine.

Reviewed by: 
Review Date: 
April 9, 2013
Last Updated:
January 20, 2014