The U.S Food and Drug Administration has approved the use of Olysio (simeprevir) as treatment to hepatitis C.
Hepatitis C is an infectious disease cause by the hepatitis C virus primarily affecting the liver. It is often asymptomatic or displays no symptoms, but chronic infection can lead to liver scarring, then to cirrhosis, and eventually to loss of liver function.
According to the Centers for Disease Control and Prevention (CDC), roughly 3.2 million Americans have the hepatitis C infection, and hopefully, with the approval of Olysio, some cases can be reversed and cured.
Olysio “is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. It is to be used as a component of a combination antiviral treatment regimen. In clinical studies, Olysio was evaluated in combination with peginterferon-alfa and ribavirin, two drugs also used to treat hepatitis C virus infection.”
It is a drug intended to treat adults with compensated cirrhosis (a scarred liver that is still functioning) and those who have not received treatment and those who have received treatment but was proven not effective.
Dr. Edward Cox, director of the Office of the Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the news release, “Olysio is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease.”
To prove the safety and efficiency of Olysio, researchers assigned 2,026 participants, who have either received no treatment or received ineffective treatment, to take in Olysio along with peginterferon-alfa and ribavirin or placebo plus peginterferon-alfa and ribavirin.
The studies conducted were intended to measure whether a participant’s hepatitis C virus was no longer spotted in the bloodstream at least 12 weeks after the treatment has ended and if so, it suggests that the participant’s infection had been cured.
Results showed that 80 percent of the participants who have not received any treatment before and was given Olysio plus peginterferon-alfa and ribavirin achieved a positive response, meaning, the virus was no longer detected in their bloodstream.
The common side effects noted during the study were rash, itching, and nausea. Serious photosensitivity has also been noted. During treatment, researchers strongly suggest that limiting sun exposure and using sun protective gears while taking Olysio in combination with peginterferon alfa and ribavirin is a must.
Another caution is that Olysio alone should not be used to treat hepatitis C infection.
