New treatments for hepatitis C

Current treatment for hepatitis C is based on pegylated interferon and ribavirin. People with genotype 1 infection also receive a direct-acting antiviral (DAA). Several pharmaceutical companies are working to develop interferon-free combinations of DAAs and new DAAs that can be used with interferon.

Two new drugs manufactured by different companies have already been submitted for licensing approval in the United States and the European Union. One drug is called sofosbuvir. It is a drug of the nucleotide polymerase inhibitor class and is being developed by Gilead Sciences. The other is called simeprevir and is being developed by Janssen. It is an HCV protease inhibitor.

Both agents could be approved in the United States by the end of 2013, and shortly afterwards in the European Union, it was announced in the past month. Reimbursement approval will vary from one country to another.

Janssen is seeking approval for the use of simeprevir in combination with pegylated interferon and ribavirin in people with genotype 1 infection.

Sofosbuvir’s manufacturer is seeking approval for use of the drug in combination with ribavirin in the treatment of people with hepatitis C genotypes 2 and 3. This will be the first interferon-free combination available for the treatment of hepatitis C. For people with genotypes 1, 4, 5 and 6 sofosbuvir will be used with pegylated interferon and ribavirin.

There is particular interest among physicians in learning more about how sofosbuvir and simeprevir could be used together, without interferon, in people with genotype 1 infection. A small study was presented at the Digestive Disease Week conference in late May. This study showed that in previous null responders to pegylated interferon and ribavirin, 12 weeks of treatment with simeprevir and sofosbuvir was safe and produced a sustained virologic response eight weeks after stopping treatment in almost all patients. Final cure rates 24 weeks after stopping treatment have yet to be reported. Further research is underway in patients with advanced fibrosis and cirrhosis.

AbbVie announced last month that its interferon-free drug combination has been granted 'Breakthrough Therapy' status by the US Food and Drug Administration. This means that the drug licensing application will receive rapid review.

HCV treatment after liver transplantation

While many hepatitis C patients await interferon-free direct-acting antiviral regimens, others have advanced liver disease and need treatment now. This group includes liver transplant recipients, as HCV almost always recurs and infects the new liver.

There has been little research to show whether or not triple therapy for hepatitis C using the protease inhibitors boceprevir or telaprevir is safe and effective for this group of patients.

A study of American liver transplant patients presented at the 48th International Liver Congress (EASL 2013) in April found that around two-thirds of patients achieved an early virologic response to treatment. Of those who had completed a course of treatment, 65% had a sustained virologic response (SVR) four weeks after completing treatment. Final cure rates 24 weeks after stopping treatment have yet to be reported.

Eleven per cent had to stop treatment due to adverse events and one in five patients had to be hospitalised due to adverse events during their course of treatment. More research to help determine which patients are most likely to respond to treatment is needed, say the investigators, together with more tolerable HCV treatments for liver transplant patients.

European prevalence of viral hepatitis

New epidemiological data released in May indicate that one in fifty adults in the European region – including the Russian Federation and central Asia – has hepatitis B or C. Approximately 13 million people have hepatitis B and 15 million have hepatitis C. Around two-thirds of these people live in eastern Europe and central Asia.

At the World Health Assembly meeting in May national governments renewed their commitment to give greater priority to viral hepatitis in national policy responses. An international summit on viral hepatitis policy will take place in November 2013.

HCV treatment as prevention and access to treatment

An increase in the proportion of people with hepatitis C who are cured would have a substantial impact on new infections, according to a mathematical model developed by researchers in the United Kingdom and Australia. There are big variations between European countries in the proportion of people with hepatitis C who receive treatment, however.

A study that set out to estimate the proportion of people in Europe who received treatment in 2010 was presented at the 48th International Liver Congress (EASL 2013) in April. This study estimated that 6.7% of French patients with hepatitis C underwent a course of treatment in 2010, compared to less than 1% of Italian or Russian patients. 2010 was chosen because it was the last year in which all patients in Europe received the same regimen of interferon and ribavirin.

These findings suggest that the gap between European countries in access to treatment might also have an impact on prevention of hepatitis C transmission in the future. But prevention of new infections through the wider use of treatment requires that all groups of people with hepatitis C have equal access to treatment.

A number of important barriers to treatment must be overcome to ensure that people who inject drugs receive hepatitis C treatment. A systematic review of the scientific literature, published in May, found multiple problems affecting access to treatment. Social stigma, unstable housing, criminalisation of drug use, lack of co-ordination in healthcare systems, and female gender were identified as key issues. The findings of the review are likely to be useful for policy advocacy at national and regional level.

The Global Commission on Drug Policy reported in May that aggressive policing approaches to injecting drug use are making the hepatitis C epidemic worse in many countries, and are a major obstacle to harm reduction and prevention of hepatitis C transmission.

World Hepatitis Alliance plans for World Hepatitis Day

The three wise monkeys getting to know infohep.org

For many of us in Europe who work in hepatitis, or are patient advocates, World Hepatitis Day on 28 July offers an opportunity to get people talking about hepatitis. This year’s theme is: This is hepatitis. Know it. Confront it.

The World Hepatitis Alliance is co-ordinating a campaign known as ‘three wise monkeys’ or ‘See no evil. Hear no evil. Speak no evil’. The idea behind the campaign is that hepatitis is often ignored, and it’s important for people to open their eyes and ears to it.

Find out more about the campaign on the infohep.org noticeboard.

Is your organisation listed in the infohep services database?

We aim to provide a comprehensive online database of organisations offering services to people with hepatitis or working in the field of viral hepatitis. We already list nearly 200 services in the European and Eastern Mediterranean region. You can also search for services by country.

Check the infohep database of services and organisations working in viral hepatitis to find out whether your organisation is already listed.

If we don’t have a listing yet, please add your details for review and inclusion in the database.