The Potential Role of Simeprevir for the Treatment of Hepatitis C

Cristina del Barrio Gascón; Maria Buti


Future Virology. 2015;10(2):67-75. 

In This Article

SMV in European Commission: Summary of the Product Characteristics

In Europe, SMV has been approved for use in two ways. In IFN-based therapy, SMV is indicated in combination with PEG-IFN/RBV for the treatment of adult chronic hepatitis C patients infected by genotype 1 or 4. The recommended combination and treatment duration with SMV plus PEG-IFN/RBV in genotype 1 or 4 treatment-naive patients and relapsers is 12 weeks of triple therapy followed by an additional 12 weeks of PEG-IFN/RBV. If HCV RNA level is greater than or equal to 25 IU/ml at week 4 of therapy, SMV-based therapy should be discontinued. In prior partial responders and null responders, the duration of therapy should be 48 weeks, 12 weeks of SMV triple therapy and 36 additional weeks of PEG-IFN/RBV. The stopping rule is the same as for naive patients at week 4. Genotype 1a patients should be tested for the NS3A Q80K viral polymorphism before starting treatment.

In IFN-free therapy, SMV use in combination with sofosbuvir remains is approved for HCV patients with genotype 1 or 4, regardless of the previous treatment history (including naive patients, relapsers and partial or null responders). This combination should only be used in patients who are intolerant to, or ineligible to receive, IFN therapy and are in urgent need of treatment.

The recommended treatment duration is 12 weeks. A longer treatment duration (up to 24 weeks) of SMV with sofosbuvir (with or without RBV) could be considered based on an individual basis.