Two New Drugs: Sofosbuvir and Simeprevir

Two New Drugs: Sofosbuvir and Simeprevir

The U.S. Food and Drug Administration or FDA has given its stamp of approval on the nucleotide analog inhibitor sofosbuvir to treat adults with chronic hepatitis C virus or HCV infection.   In addition simeprevir, a once-daily protease inhibitor is approved for a combination antiviral treatment for liver disease.  


Sofosbuvir can be used in combination with ribavirin or RBV for oral therapy of liver infections specifically HCV genotypes 2 and 3. It can also be used in triple therapy with injected pegylated interferon and RBV for treatment in those patients that have HCV genotypes 1 and 4. This is a huge advance in the fight to cure liver diseases. With the usage of this new drug, cure rates are high and with only 12-week regimens. Sofosbuvir has many advantages over the current hepatitis C therapies and has been proven to be safe, maintain a high efficacy profile, and is tolerated well by many patient populations. Sofosbuvir is a simple drug to use; it is the first all-oral option for patients with HCV. Researchers have proven you can cure HCV without interferon being a part of the treatment.

(Interferons are naturally occurring proteins that are secreted and manufactured by the immune system. They are the white blood cells, natural killer cells, fibroblasts and epithelial cells. Commercially, interferons used in injectable therapies are human interferons manufactured using DNA (recombinant or cloning) technology. Basically interferons modulate the response of the immune system to defeat viruses, bacteria, and cancer. They do not kill viral or cancerous cells, but boost the immune system and regulate the ratios of genes that control the secretion of cellular proteins.)


Simeprevir is approved for use in the treatment of chronic hepatitis C or HCV plus those with cirrhosis or stable liver diseases. When used in conjunction with sofosbuvir it inhibits the HCV NS3/4A protease and is the preferred treatment of infections caused by HCV genotype 1. Clinical trials proved participants with genotype 1 infections who used simeprevir were free of HCV infection after they completed their treatments.

The recommended dosage of simeprevir is one 150 mg capsule taken once a day with food. Simeprevir should also be used in combination with peginterferon alpha and ribavirin. Scientists recommend that simeprevir be used 12 week with a triple therapy of medications, followed by another 12 additions week of dual therapy.

When using simeprevir and sofosbuvir for HCV note that you may experience serious skin rashes and photosensitivity reactions. You may also have symptoms of itching, and nausea. Do avoid becoming pregnant during treatment.


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