Product Details
'r ',,, boldface, '',, Sofosbuvir tablets
'r ',,, boldface, '',,(
< 'r ',,, boldface, '', ,Sofosbuvir tablets'r ',,, boldface, '',,)
'r ',,, boldface, '',,
'r ',,, boldface, '', ,(1) Sofosbuvir drug name
'r ',,, boldface, '',, Trade name: < .b
'r ',,, boldface, '',, refer to general Name: sofosbuvir, sofosbuvir
'r ',,, boldface, '',, code name: -
'r ',,, boldface, '',, English name: br
'r ',,, boldface, '',,Chemical name: (){[(R,R,R,R)(,-dioxo-,-dihydropyrimidinyl)fluorohydroxymethyl -Tetrahydro-furylmethoxy]-phosphorylamino}-isopropylpropionate
'r ',,, boldface, '',, registration number:
'r ',,, boldface, '',,Registration category: +
'r ',,, boldface, '',,Function classification: Antiviral-Hepatitis C
'r ',,, boldface, '', , Original research: Gilead (r)
- - 'r ',,, Blackbody, '',,
'r ',,, Blackbody, '',, (2) Chemistry of Sofosbuvir Structure
'r ',,, boldface, '',,Chemical structural formula:
'r ',,, boldface, '',,Molecular formula:
'r ',,, boldface, '',, Molecular weight:.
'r ',,, Black body, '',, (3) Physical and chemical properties of sofosbuvir
'r ',,, Black body, '',, (4 )Pharmacological effects of sofosbuvir
'r ',,, boldface, '',,br is metabolized in cells to form the drug's active uridine triphosphate form (-), which can be embedded by hepatitis C virus polymerase Interrupt copying.
'r ',,, boldface, '',,(5) Dosage forms and specifications of sofosbuvir preparations
'r ',,, boldface, '',,yellow, capsule shape, film Coated tablets
'r ',,, boldface, '',,(6) Indications, usage and dosage of sofosbuvir
'r ',,, boldface, '',,genotypic medication Medication cycle of the regimen
'r ',,, boldface, '',, sofosbuvir+peginterferon&+ribavirin
'r ',,, boldface, '' ,, Sofosbuvir + Ribavirin
'r ',,, Bold type, '',, Sofosbuvir + Ribavirin
'r ',,, Bold type, '' ,,(7) Sofosbuvir registration classification and basis
'r ',,, boldface, '',,This product has obtained marketing authorization and has not yet been marketed in China. According to the "Drug Registration Management Measures", domestic The registration classification is chemical drugs.
'r ',,, boldface, '',, 1. Introduction to Sofosbuvir tablets
'r ',,, boldface, '',, Sofosbuvir (also translated as Sofosbuvir) Buvir, English name br, trade name) is a new drug developed by Gilead for the treatment of chronic hepatitis C. It was approved for marketing in the United States by the U.S. Food and Drug Administration () on March 21, 2020, and was approved by the European Medicines Agency ( ) approved for marketing in EU countries. The drug is not yet available in China and can only be obtained from overseas hospitals.
'r ',,, boldface, '',, Sofosbuvir: Sales of Gilead's () hepatitis C star drug reached an astonishing US$100 million in the first half of the year. The drug was launched in the United States in March 2018 and has become the focus of industry attention since its birth. Its pricing in US dollars per course of treatment (US dollars per tablet) has also been controversial from all parties.
'r ',,, boldface, '',, Sofosbuvir is the first drug that can safely and effectively treat certain types of hepatitis C without the need for combined interferons. Clinical trials have confirmed that against hepatitis C, the overall sustained virological response rate (R) of this drug combined with pegylated interferon and ribavirin is as high as %. Against hepatitis C, the R of this drug combined with ribavirin is %- % Against hepatitis C, the R of this drug combined with ribavirin is %-%. It is worth mentioning that the clinical trials of sofosbuvir also included some patients with hepatitis C and cirrhosis, and the efficacy was also significant.
'r ',,, boldface, '',, Sofosbuvir tablets, a new drug for the treatment of hepatitis C, has put the controversial US health care reform into another dilemma. Unable to solve the health insurance cost problem, some states, represented by Oregon, are seeking ways to limit the supply of the drug. As a result, the expanded Medicaid program proposed in President Obama's health care reform plan has been greatly reduced.
'r ',,, boldface, '',, 2. Synthetic route of sofosbuvir
'r ',,, boldface, '',, synthetic route of sofosbuvir (br):
'r ',,, bold body, '',, starting from compound -, through the process, the diol compound - is obtained, and - is reacted with to obtain the sulfoxide intermediate, after oxidation, the sulfone compound - is obtained, and then reacted with & reaction, introduce atoms, pass through the intermediate salt -, remove the sulfonyl group under acidic conditions, and obtain the cyclic intermediate -, and then protect it with Bz to obtain -. After - is reduced to obtain hemiacetal, it reacts with sulfonyl chloride. Chlorine belt later gets -.
'r ',,, bold body, '',, - in the presence of Lewis acid, after the carbocation is formed, it is attacked by - to obtain -. Under acidic conditions, water attacks and hydrolyzes the cytosine fragment to obtain -, and then Remove the Bz protecting group under the / condition to obtain -, use B as a base, remove the proton and attack the prepared - to obtain the final (br).
'r ',,, boldface, '',,This drug can be called the most blockbuster drug approved in the year. According to analysts' predictions, its hepatitis C business, with BR as the main force, has annual sales of up to 100 million U.S. dollars, of which BR alone can account for 100 million U.S. dollars. It is optimistically estimated that once br is launched, its sales are expected to eventually exceed 100 million US dollars.
'r ',,, boldface, '',, 3. Usage and dosage of sofosbuvir
'r ',,, boldface, '',, one tablet per day, on an empty stomach or at any time Take with meals (.)
'r ',,, bold, '',, can be combined with ribavirin or combined with ribavirin + pegylated interferon to treat chronic hepatitis C (). The recommended combination treatment plan is as follows:
'r ',,, black body, '',, single infection
'r ',,, black body, '',, or/- combined infection treatment plan treatment duration Time
'r ',,, boldface, '',, genotype or type sofosbuvir+peginterferon-&+ribavirin week
'r ',,, boldface , '',,Genotype Sofosbuvir + Ribavirin Weekly
'r ',,, Boldface, '',,Genotype Sofosbuvir + Ribavirin Weekly
' r ',,, bold, '',, patients with chronic hepatitis C who are unable to use interferon may consider using sofosbuvir combined with ribavirin for weekly treatment.
'r ',,, Bold body, '',,B Hepatocellular carcinoma patients awaiting liver transplantation should be treated with sofosbuvir combined with ribavirin for chronic hepatitis C for weeks or until liver transplantation, as the first occurs.
'r ',,, boldface, '',,Dosing recommendations cannot be made for patients with severe renal impairment or end-stage renal disease.
'r ',,, boldface, '',,4. Sofosbuvir dosage forms
'r ',,, boldface, '',,Sofosbuvir is in the form of tablets, each tablet: .
'r ',,, boldface, '',,5. Contraindications of sofosbuvir
'r ',,, boldface, '',,interference of sofosbuvir combined with polyethylene glycol When used with sofosbuvir plus ribavirin, or in combination with ribavirin alone, all contraindications for peginterferon-&/or ribavirin also apply to combination therapy with sofosbuvir.
'r ',,, boldface, '',, Since ribavirin may cause fetal congenital malformation or stillbirth, [] sofosbuvir combined with pegylated interferon & + ribavirin , or sofosbuvir alone in combination with ribavirin should be contraindicated in pregnant women and men whose partners are pregnant.
'r ',,, boldface, '',, 6. Indications and uses of sofosbuvir
'r ',,, boldface, '',, Sofosbuvir is a C Hepatitis C virus (HCV) nucleotide analog B polymerase inhibitor is suitable for use as a combined component in a combined antiviral treatment regimen to treat chronic hepatitis C (HCV) infection. []
'r ',,, boldface, '',, Sofosbuvir has been proven effective in the treatment of genotype, , or type hepatitis C subjects, including hepatocellular carcinoma who meet the Milan criteria and are waiting for liver transplantation subjects and/- coinfected subjects.
'r ',,, boldface, '',,7. Sofosbuvir Warnings and Precautions
'r ',,, boldface, '',,Pregnancy: Ribavirin is possible It can lead to fetal congenital malformation or stillbirth, and animal experiments show that interferon can cause miscarriage. Therefore, female patients taking this drug and the spouses of male patients should avoid becoming pregnant. Before starting treatment, patients must have a negative pregnancy test, use at least two non-hormonal methods of contraception, and undergo monthly pregnancy tests.
'r ',,, boldface, '',,8. Adverse reactions of sofosbuvir
'r ',,, boldface, '',, caused by sofosbuvir combined with ribavirin The most common known adverse reactions (incidence % or greater, all grades) are headache and fatigue , headache, nausea, insomnia and anemia.
'r ',,, boldface, '',,,Drug Interactions
'r ',,, boldface, '',,potent intestinal glycoprotein(-) inducers (e.g. Rifampin) may alter sofosbuvir drug plasma concentrations. Before use, please read the complete package insert for drug-drug interactions.
'r ',,, boldface, '',,, medication for special groups
'r ',,, boldface, '',,()/-Patients with co-infections: the safety and safety of this drug Effectiveness confirmed by research.
'r ',,, bold, '',,() Hepatocellular carcinoma patients waiting for liver transplantation: The safety and effectiveness of this drug have been confirmed by research.
'r ',,, boldface, '',, this drug has been launched in the UK and the US, but has not yet been launched in China. Domestic customers who want to purchase this drug can seek help from large US chain pharmacies such as [r] , or you can consider purchasing Sofosbuvir through the official Chinese website of India.
'r ',,, boldface, '',, Sofosbuvir (br) is a B-polymerase inhibitor, which was developed by r company and later acquired by Gilead for US$100 million. For genotype () and genotype () infections, (br) only needs to be used in combination with ribavirin (r).br Therefore, it has become the world's first hepatitis C treatment without the need to use interferon at the same time. Fully oral combination therapy. It is also approved (br combined with pegylated interferon (-) and ribavirin (r) for infections with genotypes and (,).
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