The European Association for the Study of the Liver (EASL) has issued revised guidelines for the treatment of hepatitis C virus (HCV). The guidelines were released in advance of the 50th International Liver Congress in Vienna, Austria.
Europe has the same approved hep C therapies as the United States, with the addition of Bristol-Myers Squibb’s (BMS) Daklinza (daclatasvir), which is under review by the U.S. Food and Drug Administration (FDA) to treat genotype 3 of the virus in combination with Sovaldi (sofosbuvir).
Like the guidelines of the American Association for the Study of Liver Diseases (AASLD), the EASL recommendations outline which people with hep C should be prioritized for treatment. The criteria are similar: Those with more advanced liver disease, or who have other health problems such as HIV or hepatitis B virus (HBV), are prioritized.
The treatment recommendations are broken down by genotype, treatment history and liver disease stage. They provide detailed information about the safety of combining the various hep C therapies with specific HIV antiretrovirals as well as with a roster of illicit drugs.
For genotype 3, EASL recommends 12 weeks of Daklinza and Sovaldi for those without cirrhosis and 24 weeks of the two drugs plus ribavirin for those with compensated cirrhosis. Both of these categories include treatment-naive people and those who have failed an interferon and ribavirin regimen.
If someone with genotype 3 has already failed treatment with a direct-acting antiviral (DAA) regimen (meaning treatment with any of the new hep C therapies approved since 2011, not a regimen limited to interferon and ribavirin), 12 weeks of Daklinza and Sovaldi plus ribavirin are recommended for those with stage 2 fibrosis or below, and 24 weeks of that regimen for those with stage 3 fibrosis or cirrhosis. Daklinza-based treatment is the only regimen recommended for people who have failed a previous DAA regimen.
To read the guidelines, click here.
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