FDA approves new drug for the treatment for Hepatitis C

0
286

fda_buildingU.S. Food and Drug Administration (FDA) approved a new drug simeprevir (brand name Olysio) to treat chronic hepatitis C virus infection. It belongs to class of drugs known as protease inhibitors which work by blocking the synthesis of new viral coat. This prevents replication of virus and provides long term remission of disease in most of the cases. This is the third drug of this class which is approved for hepatitis-C treatment. The other two drugs approved for hepatitis-C treatment are boceprevir and telaprevir.

Simeprevir is not intended to be used alone for treatment of Hepatitis-C. It should only be used as a combination regimen along with peginterferon-alfa and ribavirin. It can be used both for treatment of newly diagnosed cases and for those who had previous treatment failure.

This drug was tested in five different trials with total of 2,026 participants. Results showed that 80 percent of treatment-naive participants given semiprevir plus peginterferon-alfa and ribavirin achieved sustained virologic response, compared to 50 percent of participants receiving peginterferon-alfa and ribavirin alone. In one of the studies with participants had previous treatment failure, 79 percent receiving simeprevir plus peginterferon-alfa and ribavirin achieved sustained virologic response compared to 37 percent of participants receiving peginterferon-alfa and ribavirin alone.

The most common side effects reported in clinical study participants treated with semiprevirwere rash, mild photosensitivity reaction, itching and nausea. Serious photosensitivity reactions resulting in hospitalization were also reported. Therefore patients should be advised to avoid sun exposure or use sun protection if they are exposed to sunlight. Besides this no other serious drug toxicity or drug reaction was noted.