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Promising results for new hepatitis C drugs

A pill combining two new hepatitis C treatments may clear the virus that causes the infection in people in whom other treatments have failed.

BMJ Group News

What do we know already?

researcher

Hepatitis C is an infection that can harm your liver. It is caused by a virus carried in the blood. When the hepatitis C virus gets to the liver it causes inflammation ( swelling). Eventually (usually after many years), having hepatitis C may cause scarring in the liver and stop the liver working properly.

While some people can stay healthy with hepatitis C all their lives, having treatments that get rid of the hepatitis C virus can reduce the chances of getting liver problems. The most widely used treatment is a weekly injection of a medicine called pegylated interferon (also called peginterferon), plus daily tablets called ribavirin. But these treatments can cause unpleasant side effects, and they don’t work for everyone. And some people can’t take ribavirin.

Recently researchers have developed several new drugs for treating hepatitis C. Two of these are called ledipasvir and sofosbuvir. Previous small studies had suggested that these treatments could help people with hepatitis C. Now a larger study has looked at whether they could be useful for people who haven’t been helped by the existing treatments.

How was the new study done?

The new study included 440 people who had had hepatitis C for more than six months and who had not been cured by treatment with peginterferon and ribavirin, or by another type of treatment called a protease inhibitor. Some people took a pill that combined the new drugs while others took both the newer drugs together with ribavirin, to see whether that worked better than just taking the newer drugs.

After the treatment had ended the researchers looked at how many people had no measurable hepatitis C virus in their blood.

What does the new study say?

The new drugs cleared up the virus in most people in the study. About 94 in 100 people who took ledipasvir and sofosbuvir had got rid of the virus after 12 weeks. There wasn’t much difference in how many people were clear of the virus if they took ribavirin as well.

Side effects are common with treatments for hepatitis C. And many people in the study had what could be described as mild side effects, including tiredness, headaches, difficulty sleeping, and feeling sick. But as the study didn’t include a comparison group of people who didn’t take the new drugs, or who took completely different treatments, we can’t say that these side effects were definitely caused by the new treatments.

How reliable is the research?

The main drawback of this study is that it didn’t have a comparison group of people who took another treatment, or who took a dummy treatment (a placebo). But as the people in this study had already tried treatment with other drugs, the results are still promising. But this study doesn’t tell us how the side effects of the new drugs compare with those of the older treatments such as ribavirin.

Alongside this study, a second new study of ledipasvir and sofosbuvir looked at people with hepatitis C who had had no previous treatment. After up to 24 weeks, the new drugs cleared the virus in about 98 in 100 people in the study. However, again, the study contained no comparison group. So, although these results look encouraging, we can’t say how other treatments would have worked in these people.

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