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Drug combination shows more efficacy against hepatitis C

Drug combination shows more efficacy against hepatitis C

By Gene Emery

NEW YORK (Reuters Health) - Researchers say they have come up with a better treatment for hepatitis C, one that doesn't involve the side effects associated with interferon therapy.

The short-term results from the therapy, reported in two studies released online April 10 and 11 in the New England Journal of Medicine, show a sustained virologic response in 96% of volunteers, including those for whom previous treatments had failed to keep the virus at bay.

That's far better than the rate of 78% or lower that is typically seen with interferon treatment, they said.

The experimental treatment involves a multi-drug regimen that inhibits the ability of the virus to replicate.

"This is showing that if you attack the virus at a sufficient number of targets and so profoundly suppress it that it can't replicate anymore, it will disappear. It just decays eventually," said Dr. Ira Jacobson, coauthor of one of the studies, known as SAPPHIRE-II.

"I think if this were approved tomorrow," doctors would seize upon it, and regimens like it immediately," Dr. Jacobson, a liver disease expert at Weill Cornell Medical College in New York told Reuters Health by phone.

The studies, financed by AbbVie, included control groups that received placebo therapy. However, the researchers did not assess their viral burden after fake treatment.

"The main power of the placebo group is to do a safety analysis," Jacobson explained. "There's no expectation that they would clear the infection because there is virtually no such thing as a spontaneous cure with hepatitis C."

About 184 million people have HCV worldwide and it causes more than 350,000 liver disease deaths annually. Current therapy carries a high risk of significant side effects, such as flu-like symptoms, neuropsychiatric problems and cytopenias.

The first study, SAPPHIRE-I, led by Dr. Jordan Feld of the University of Toronto, involved people from North America, Europe and Australia who had never been treated for their HCV infection and had no cirrhosis. They had genotype 1.

Once a day, 473 received 150 mg of ABT-450, 100 mg of ritonavir and 25 mg of ombitasvir, all combined into one pill, plus 250 mg of dasabuvir twice a day and a dose of ribavirin based on body weight. Treatment lasted 12 weeks.

Instead of comparing them to the 158 who received placebos, the researchers compared them to a historical control group that had received telaprevir, peginterferon and ribavirin and who had a response rate of 78%.

Twelve weeks after treatment ended, the rate of sustained virologic response (HCV RNA levels of <25 IU/mL) was 96.2%, which was superior to the historical control rate. Only patients with a body-mass index of 30 or higher showed a slightly lower response rate. Age, gender, ethnicity, race, fibrosis score and baseline viral load did not influence the outcome. The response rates were similar for genotypes 1a and 1b.

Only 0.2% had a relapse or virologic failure during treatment. In the historical control group, the rate had been 1.5%.

Patients who received the treatment were more likely to experience nausea, pruritus, insomnia, diarrhea, and asthenia (all P<0.05). Serious adverse events were seen in 2.1% of the treated patients and none in the placebo group.

They are still being followed for a total of 48 weeks after active therapy.

SAPPHIRE-II was similar, except it involved 394 patients who had been treated previously with peginterferon and ribavirin and had shown no response, a partial response or had experienced a relapse.

Of 297 drug recipients, the overall 12-week response rate was 96.3%. It was 95.3% among the 86 patients who had had a prior relapse, 100% among the 65 who had previously had a previously had a partial response, and 95.2% for the 146 who had not had a response.

The researchers said the historical response rate is 65%.

Adverse event rates were 82.5% among patients getting placebo therapy and 91.2% for those who were receiving the active drugs. The most common issues with combined therapy -- versus side effects seen in the control group -- were pruritus, anemia, lower hemoglobin and vomiting.

"There were no moderate or severe adverse events that occurred more frequently with the active regimen than with placebo," said the team, led by Dr. Stefan Zeuzem of Johann Wolfgang Goethe University Hospital in Frankfurt, Germany.

SOURCES: http://bit.ly/1gJIplP and http://bit.ly/1nzpezU

N Engl J Med 2014

 
 
 
 
                               
 
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