Simeprevir marketing approval

The hepatitis C protease inhibitor simeprevir received marketing approval in the European Union in May 2014. Simeprevir will be marketed under the brand name Olysio. Simeprevir is a second-generation protease inhibitor that is approved for use in combination with other agents for treatment of hepatitis C genotype 1 or 4.

Simeprevir is licensed for use in combination with sofosbuvir (with or without ribavirin) in a 12-week treatment course for genotypes 1 or 4, for people who urgently need treatment and are either ineligible for interferon or intolerant.

Simeprevir is also licensed for use in combination with pegylated interferon and ribavirin (12 weeks of triple therapy followed by 12 weeks of pegylated interferon and ribavirin, or 36 weeks in previous non-responders) for genotypes 1 or 4.

Hepatitis B screening recommendations

The United States Preventive Services Task Force has issued final guidelines on screening for hepatitis B virus (HBV). The Task Force recommends screening for people in the following categories:

  • People born in countries and regions with a high prevalence of HBV infection, such as Africa, southeast Asia, Pacific Islands, China, Middle East, eastern Europe, and the northern countries in south America;
  • US-born persons not vaccinated as infants whose parents were born in countries or regions with a high prevalence of HBV infection;
  • People living with HIV, people who inject drugs, men who have sex with men, and those living with or having sex with someone with HBV infection; or
  • People with weakened immune systems or undergoing treatment for kidney failure (haemodialysis).

Sofosbuvir for treatment of genotype 4 hepatitis C

A 24-week regimen of sofosbuvir (Sovaldi) plus ribavirin cured 93% of people with hard-to-treat hepatitis C virus genotype 4, though treatment for only 12 weeks was not as effective, according to a poster presented at the International Liver Congress in London in April.

Genotype 4 infection predominates in Egypt and accounts for approximately 20% of infections worldwide. The Egyptian government has negotiated a price of US$300 per month for sofosbuvir and hopes to begin providing the drug later in 2014. 

Sofosbuvir for treatment of post-transplant hepatitis C recurrence

An interferon-free combination of sofosbuvir (Sovaldi) plus ribavirin taken for up to 24 weeks led to sustained virological response in 70% of liver transplant recipients with hepatitis C virus recurrence, according to a poster presented at the International Liver Congress in London in April. Forty per cent of these patients had already developed cirrhosis in their new livers.

Hepatitis C recurrence is universal after liver transplantation; liver disease after recurrence is often aggressive. It has been estimated that around 25 to 30% of transplant patients with hepatitis C will develop cirrhosis again within five years of transplantation.

Another small study presented at the International Liver Congress showed that a combination of three direct-acting antivirals developed by AbbVie cured 96% of patients with hepatitis C recurrence after liver transplant. Patients in this trial had early stage disease with a fibrosis grade of F0-F2.

US health insurers question the price of sofosbuvir

America’s Health Insurance Plans, which represents health insurance providers in the United States, has warned that the cost of sofosbuvir (Sovaldi) will be unsustainable for insurers, patients and governments. A course of sofosbuvir costs US$84,000 in the United States and manufacturer Gilead Sciences reported that sales of the drug in the first quarter of 2014 amounted to US$2.27 billion. Gilead Sciences says that the cost of the drug will be outweighed by long-term savings to the healthcare system, but insurers say that the cost of treating everyone in need is unaffordable, whatever the long-term savings might be.

New! Hepatitis C treatment factsheets

At the International Liver Congress, we launched three new hepatitis C treatment factsheets.

Each factsheet focuses on one direct-acting antiviral drug and gives an overview of how it works, who can use it, how it is taken, what trial results tell us about how effective it is, known side-effects and drug interactions.

The factsheets are available to read online, and are also designed to be printed and shared. Find out more in the blog.

New! Customise your hepatitis information

We have also recently developed a simple tool to customise the hepatitis treatment information on

For example, you can choose to search for information according to the genotype it is relevant to, or information relevant for people who have taken treatment before.

Answer a few simple questions, and the information presented will be our news reporting on the studies relevant to your search.

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