Gilead harvoni was approved, and the new gold standard of anti hepatitis C was released

Source: American and Chinese drug sources in the afternoon of October 11, 2014, the FDA approved the listing of all oral and once-a-day anti HCV compound harvoni (compound sofosbuvir and ledipasvir) of Gilead science for the treatment of gene 1 hepatitis C infection without any suspense Harvoni charges $94500 and $63000 for a 12 - or 8-week course in the United States, respectively Because the FDA's decision was within investors' expectations, Geely's shares rose only slightly to $106.88 a share today, an increase of 1% Hepatitis C, or hepatitis C for short, is a viral hepatitis caused by the infection of hepatitis C virus (HCV) According to the World Health Organization statistics, the global HCV infection rate is about 3%, a total of about 180 million people There are about 3.2 million hepatitis C patients in the United States HCV infection mainly includes immune-mediated and direct HCV damage After infection, it leads to liver inflammation and liver function decline or even failure The main pathological manifestations are liver cell necrosis and lymphocyte infiltration The majority of hepatitis C patients did not find the symptoms of liver injury until a long time after infection From 20 to 30 years after infection, 10% to 20% of the patients developed cirrhosis, and 1% to 5% of the patients died of HCC Moreover, once decompensation occurs in cirrhosis, such as jaundice, ascites, variceal bleeding, hepatic encephalopathy and so on, the survival rate will drop sharply Harvoni is a combination of the heavy weight anti hepatitis C product sovaldi (general name: sofosbuvir) of Gilead and ledipasvir, a fixed dose protease NS5A inhibitor Harvoni is the first all oral anti HCV protocol approved for the treatment of hepatitis C virus type 1 infection and does not require the combination of interferon or ribavirin Harvoni can be used either alone or in combination with other oral preparations such as ribavirin The key data supporting FDA approval of harvoni are mainly from three phase 3 clinical trials involving 1518 patients These patients have not been treated before (treatment na? VE), including patients who have been treated before but have poor efficacy and have cirrhosis Subjects were randomly divided into harvoni single drug group or ribavirin combined group The primary endpoint was sustained virologic response rate (svr12) after 12 weeks of treatment The results showed that 94% of the patients who had not been treated before in the first phase 3 trial got sustained virological response after 8 weeks of treatment, and the sustained virological response rate increased to 96% after 12 weeks of treatment The second phase 3 clinical trial with partial cirrhosis achieved 99% sustained virological response rate after 12 weeks of treatment The third clinical trial evaluated patients who had previously been treated but did not respond, and included some patients with cirrhosis After 12 and 24 weeks of harvoni treatment, 94% and 99% of patients received sustained virological response, respectively The most common side effects in these experiments were fatigue and headache Harvoni has obtained the FDA's "priority review" qualification and is the seventh drug to obtain the "breakthrough drug" qualification Although sovaldi is the number one star of anti hepatitis C drugs, with sales of US $2.3 billion and US $3.5 billion in the first two quarters after its launch, harvoni believes that once sales start, it will soon replace sovaldi's dominant position and become a new standard therapy for anti hepatitis C Some doctors even suggested that some early patients wait for harvoni to enter the pharmacy Of course, Gilead won't always be at ease Ibuprofen's all oral anti hepatitis C triple is expected to be approved by the US FDA in December this year, and the average sustained virological response rate in several disclosed clinical trials is higher The second phase clinical results of Merck's mk-5172 / mk-8742 combination are also eye-catching, and even some analysts think it can directly catch up with Gilead In any case, in the short term, harvoni will surely become a hit, with an annual sales peak expected to exceed $10 billion.