New Hepatits C Therapy Approved by the FDA


FDA APPROVES FIRST NUCLEOTIDE INHIBITOR TO TREAT HCV –  The US Food and Drug Administration (FDA) approved the first- nucleotide analog inhibitor sofosbuvir, brand named – Sovaldi – to treat adults with chronic Hepatitis C infection, genotypes (GT) 1-4.   

For patients with chronic HCV 2 and 3 the great news is that treatment with sofosbuvir in combination with Ribavirin is just 12 weeks, compared to 26 or more for previous HCV therapies: and best of all treatment is interferon free. The drug’s maker, Gilead Sciences reported cure rates of 89% to 95% for GT 2 and 61% to 63% for GT 3. 

For patients with chronic HCV 1 and 4, sofosbuvir still requires Interferon and Ribavirin, but the treatment time is just 12 weeks, a dramatic shortening of earlier therapies which required up to six months of interferon.  In clinical trials, Sofosbuvir demonstrated a sustained viral response (SVR) in 89% of patients.  

Companies with HCV therapies in the pipeline include:  Abbvie, Janssen, Boehringer-Ingelheim, Bristol Myers Squibb, Merck, Achillion, and Medivir AB.  Stay-Tuned as HCS reports on the real world clinical outcomes of these new life-saving compounds as they come to market.