Recently, because of clinical needs have been following up on the treatment of hepatitis C star drug “Sofosbuvir” (Sovaldi) movement, not long ago found the “Tianya community website” a name “happiness is knocking on the door 99 The owner of “Tianya Community”, 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 global marketing strategy of this star drug, price setting and possible ways to purchase the drug, suggesting that hepatitis C Patients and their families and friends are advised to follow this website. Sofosbuvir is a new drug developed by Gilead for the treatment of chronic hepatitis C. It was approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States on December 6, 2013, and by the European Medicines Agency (EMEA) on January 16, 2014. in each country of the European Union. It is the first drug to safely and effectively treat certain types of hepatitis C without the need for a combination of interferons. Clinical trials have demonstrated overall sustained virologic response (SVR) rates of up to 90% with pegylated interferon and ribavirin for hepatitis 1 and 4, 89%-95% with ribavirin for hepatitis 2, and 61%-63% with ribavirin for hepatitis 3. It is worth mentioning that clinical trials of sofibuvir 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, on an empty stomach or with meals. 1. It can be combined with ribavirin or combined 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 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 treatment with sofosbuvir combined with ribavirin for 24 weeks. 3. Patients with hepatocellular carcinoma awaiting liver transplantation should be treated with sofosbuvir combined with ribavirin for chronic hepatitis C for 48 weeks or until receiving a liver transplant, whichever occurs first. 4. Dosing 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) associated with sofosbuvir in combination with ribavirin were headache and malaise; the most common known adverse reactions associated with 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 the drug plasma concentration of sofosbuvir. For drug-drug interactions, please refer to the full drug insert before use. Use in special populations: (1) Patients with HCV/HIV-1 co-infection, where the safety and efficacy of the drug has been confirmed by studies; (2) Patients with hepatocellular carcinoma awaiting liver transplantation: where the safety and efficacy of the drug has been confirmed by studies. II. Price Differences Gilead has proposed a system of tiered pricing on a global basis, where pricing is based on a country’s gross national income per capita. The company said that 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 for about $900 for a course of treatment (12 weeks) using the drug, a price that is about 1% of the U.S. market price. Egypt has the highest incidence of hepatitis C virus in the world. Previously, the media reported that in August this year Gilead announced that it would sell sofosbuvir tablets in India at 1% of the U.S. selling price, or $900 per course of treatment. Gilead has now expanded the license for its new hepatitis C drug to include the NS5A inhibitor GS-5816, which means that Gilead’s partners in India are authorized to manufacture GS-5816 and the combination sofosbuvir (sofosbuvir)/GS-5816 and sell it to 91 developing countries worldwide, which together account for 54% of the world’s hepatitis C patients . Once the sofosbuvir/GS-5816 combination is approved, it will be the first pure oral hepatitis C drug for patients of all genotypes. To date, a total of eight Indian pharmaceutical companies have received authorization from Gilead. Third, China’s listing prospects According to the public information on the website of the Food and Drug Administration, at least three DAA drugs have applied for listing in China and entered the review stage, but still need to redo the phase III clinical trials in China and complete a series of qualification review, import customs clearance, drug company offers, bidding and procurement procedures. Experts predict that the earliest domestic market launch will be in 2017. An anonymous official at the CDC complained to the media that the reason for the slow drug review is a severe lack of manpower. The FDA’s Drug Review Center has not increased its staffing since it was fixed at 120 in 1998, and there are only less than 80 technical staff engaged in front-line audits. According to public information, the 80 people need to complete nearly 6,000 reviews each year, each responsible for an average of 75; the corresponding U.S. Food and Drug Administration Drug Review Center has more than 4,000 reviewers, only to review less than 3,000 applications. 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 hope for an alternative route, and in their joint letter they refer to Article 4 of the Measures for the Administration of 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,” and hope that this green channel will be opened in China. The FDA did not respond to the feasibility of this route, while Zhang Lan, an official from the WHO representative office in China, was not optimistic: “The number of drugs introduced in the past few years by successfully invoking this provision is zero. We’ve done a lot of research, tried on AIDS drugs, oncology drugs, but none of them have been successful.” And the aforementioned anonymous CDC official also said that Article IV is limited to difficult and critical diseases: “SARS, for example, is fine.” There is no data to support that hepatitis C is a “difficult and critical illness”. The Economic Observer’s Sun Qizi reported that Lu Yong, known to netizens as “the first person to buy anti-cancer drugs in India,” was released on the afternoon of Jan. 29, and told reporters on Jan. 31 that Chinese hepatitis C patients could consider going to India for medical treatment. “The company’s main business is to provide a wide range of products and services to the public. According to Lu Yong, Gilead authorized the Indian pharmaceutical company to produce a generic drug, which is expected to be available in March this year. But can this drug be sold directly to Chinese patients in pharmacies, unlike the treatment of anti-cancer drug Gleevec in India is mandatory to authorize generic, but the treatment of hepatitis C oral drug is different, is authorized by the restrictions. Lu Yong said, “Many hepatitis C patients have approached me before and asked if I could help them 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 was not yet available in India, and on the other hand after it was listed it could not be exported to China like the anti-cancer drug because of the restrictions of the patent license.” Hepatitis C patients themselves go abroad for treatment, a choice patients can make for themselves. It is understood that a medical visa is required to go to India for medical treatment. “First, you have to provide a medical report from the hospital, translated into English and sent to a hospital in India that is willing to accept the patient’s treatment, and there is a prescribing authority doctor there to see if it meets the medical conditions there. Only then will you be sent an invitation to participate in their clinical trials, or medical tourism. With this invitation letter to get a visa.” Lu Yong said, “I’m also contacting hospitals in India that are qualified to accept overseas patients to see if they can help facilitate this. This needs to be a long-term planned program.”