Recently, because the clinical needs have been following up the treatment of hepatitis C star drug “Sofosbuvir” (Sovaldi) movement, not long ago found “Tianya community website” a name “happiness is knocking on the door 99 “The owner of the Tianya community website”, on July 9, 2014, “called on our government to introduce a new life-saving oral drug for hepatitis C”, followed by nearly 500 posts, until February this year, basically reflecting the marketing strategy of this star drug in the world, the price of the development of the possible ways to buy drugs, suggesting that patients and their relatives and friends of hepatitis C to pay attention to this website. patients and their friends and family to follow this site. Below, I have organized the information about Sofosbuvir as follows: Sofosbuvir (Sofosbuvir in English, trade name Sovaldi) is a new drug developed by the U.S.-based Gilead for the treatment of chronic hepatitis C. It was approved by the U.S. Food and Drug Administration (FDA) on December 6, 2013 for marketing in the United States, and was approved by the European Medicines Agency (EMEA) on January 16, 2014 for marketing in the European Union countries (EU). EMEA) approval for marketing across the European Union. The drug is the first to safely and effectively treat certain types of hepatitis C without the need for combination interferon. Clinical trials have confirmed an overall sustained virologic response rate (SVR) of up to 90% for hepatitis 1 and 4 in combination with pegylated interferon and ribavirin, 89%-95% for hepatitis 2, and 61%-63% for hepatitis 3 in combination with ribavirin. It is worth mentioning that the clinical trials of sofosbuvir also included some patients with hepatitis C combined with cirrhosis, and the efficacy was also more significant. I. Clinical application Dosage: 400mg per tablet, one tablet a day, taken on an empty stomach or with meals. (1) It can be combined with ribavirin or combined with ribavirin + pegylated interferon for the treatment of chronic hepatitis C (CHC). The recommended regimen is as follows: HCV infection alone or HCV/HIV-1 co-infection treatment regimen treatment duration: genotype 1 or 4 sofosbuvir + pegylated interferon-alpha + ribavirin for 12 weeks; genotype 2 sofosbuvir + ribavirin for 12 weeks; genotype 3 sofosbuvir + ribavirin for 24 weeks. (2) Patients with type 1 chronic hepatitis C who are unable to use interferon may be considered for 24 weeks of treatment with sofosbuvir in combination with ribavirin. (3) Patients with hepatocellular carcinoma awaiting liver transplantation should be treated with sofosbuvir in combination with ribavirin for chronic hepatitis C for 48 weeks or until receiving a liver transplant, whichever occurs first. (4) Dosage recommendations cannot be given to patients with severe renal impairment or in end-stage renal disease. ADVERSE REACTIONS: The most common known adverse reactions (incidence equal to or greater than 20%, all grades) caused by sofosbuvir in combination with ribavirin were headache and malaise; the most common known adverse reactions caused by sofosbuvir in combination with pegylated interferon-alpha and ribavirin included malaise, headache, nausea, insomnia, and anemia. DRUG INTERACTIONS: Potent intestinal glycoprotein (P-gp) inducers (e.g., rifampin) may alter drug plasma concentrations of sofosbuvir. See full drug insert for drug interactions before use. Special Population Use: (1) HCV/HIV-1 co-infected patients, the safety and efficacy of the drug has been confirmed by research; (2) patients with hepatocellular carcinoma awaiting liver transplantation: the safety and efficacy of the drug has been confirmed by research. Second, price differences Gilead has proposed a system of tiered pricing on a global scale, whereby pricing is based on a country’s per capita gross national income. The company said Sovaldi costs$84,000 per course of treatment in the U.S., about$57,000 in the U.K., and about$66,000 in Germany. On March 21, 2014, Gilead agreed to supply the new drug in the Egyptian market, where a course of treatment (12 weeks) with the drug costs about$900, a price that is about 1% of the U.S. market price. Egypt has the highest prevalence of the hepatitis C virus in the world. This comes after media reports that in August this year Gilead claimed that it would sell sofosbuvir tablets in India at 1% of the US selling price, i.e.$900 per course of treatment. Gilead has now expanded its license for new hepatitis C drugs to include the NS5A inhibitor GS-5816, which means that Gilead’s partners in India are authorized to manufacture GS-5816 and the combination of sofosbuvir/GS-5816 and sell it to 91 developing countries around the world, which collectively account for 54% of the world’s hepatitis C patients . Once the combination of sofosbuvir/GS-5816 is approved, it will be the first purely oral hepatitis C drug for patients of all genotypes. As of now, a total of eight Indian pharmaceutical companies have received authorization from Gilead. Third, the prospect of listing in China According to the public information on the website of the Food and Drug Administration, at least three DAA drugs have been applied for listing in China and entered the audit stage, but still need to redo the Phase III clinical trials in China and complete a series of qualification audits, import customs clearance, pharmacy quotes, bidding and procurement procedures. Experts predict that the earliest domestic listing will have to wait until 2017. An anonymous official at the CDC complained to the media that the reason for the slow pace of drug review is a severe shortage of manpower. Since the Food and Drug Administration’s Drug Review Center was established in 1998 with a staff of 120, there has been no increase in its establishment so far, and there are only less than 80 technicians engaged in front-line audits. And according to public information, each year these 80 people need to complete nearly 6,000 reviews, an average of 75 per person responsible for; corresponding to the U.S. Food and Drug Administration’s Drug Evaluation Center, but there are more than 4,000 auditors, only less than 3,000 applications need to be reviewed. The European Union, the United States, Japan, Taiwan and most other developed regions of the world have joined a drug registration coordination meeting (ICH), which aims to reduce the duplication of clinical trials of new drugs in different countries. The mainland has not signed this agreement. Some Hepatitis C patients want an alternative route, referring to Article 4 of the Administrative Measures for Drug Registration, which states that “special approval shall be given to new drugs created and new drugs for the treatment of difficult and critical diseases,” in a joint letter, and hope that this green channel can be opened in China. The FDA has not responded to the feasibility of this pathway, while Zhang Lan, an official with the WHO representative office in China, is not optimistic: “The number of drugs that have been successfully introduced in the past few years by invoking this provision is zero. We’ve done a lot of research, tried it on AIDS drugs, oncology drugs, but it didn’t work.” And the aforementioned anonymous CDC official also said that Article IV is limited to difficult and critical diseases: “SARS, for example.” There is no data to support that hepatitis C is a “difficult and critical disease”. Fourth, other ways to buy drugs to explore the “Economic Observer” reporter Sun Qizi reported that netizens called “India’s anti-cancer drugs on behalf of the purchase of the first person,” Lu Yong has been released on the afternoon of January 29, he said to reporters on January 31, China’s patients with hepatitis C can consider going to India for medical treatment. “Hepatitis C patients can go to India to stay for three months for treatment, this is the best way I can think of at present, legal and reasonable, operability is also relatively strong.” According to Lu Yong, Gilead authorized Indian pharmaceutical companies to produce generic drugs, is expected to be available in March this year. But the pharmacy this drug can not be sold directly to Chinese patients, unlike the treatment of anti-cancer drugs Gleevec in India is mandatory to authorize the generic, but the treatment of hepatitis C oral medication is different, there are authorized restrictions. Lu Yong said: “Before a lot of patients with hepatitis C found me and asked me if I could help buy hepatitis C drugs. I contacted the drug company in India before I was arrested, and the drug company said no, on the one hand, Gilead’s drug is not yet available in India, and on the other hand, after it is available, it can’t be exported to China like anti-cancer drugs because of the restrictions on patent authorization.” Hepatitis C patients go abroad for treatment by themselves, which is a choice that patients can make by themselves. It is understood that a medical visa is required to go to India for medical treatment. “First of all, you have to provide the hospital’s medical report, translated into English and sent to the hospital in India willing to accept the patient’s treatment, there is a prescriptive right doctor over there to see if it is in line with the medical conditions over there. Only then will they send you an invitation to participate in their clinical trials, or medical tourism. Only with this invitation can you go and get a visa.” Lu Yong introduced, “Currently I am also contacting hospitals in India that are qualified to accept overseas patients to see if I can help facilitate this. This needs to be a long-term planned program.”