Product Details
Sofosbuvir (also translated as English name br, trade name) 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 () to be marketed in the United States on March 28, 2020. The European Medicines Agency (European Medicines Agency) has approved marketing in EU countries. The drug is not yet available in China and can only be obtained from overseas hospitals.
_b> This drug is the first drug that can safely and effectively treat certain < .b types of hepatitis C without the need for interferon. 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.
The price of sofosbuvir tablets produced by Gilead Sciences in the United States is US dollars (approximately RMB) per tablet. This is the highest price ever paid for an oral drug. Gilead Sciences achieved revenue of US$100 million in the first half of this year from sofosbuvir tablets. Reporters interviewed found that more than 90% of hepatitis C patients said they could not accept such a high price.
The new drug Sofosbuvir 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.
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'r ',,, boldface, '',, 'r ' , usage and dosage
'r ',,, boldface, '',, each tablet, one day One tablet, taken on an empty stomach or with food
'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 ',,, bold, '',, 'r ' , single infection
'r ',,, bold, '',, or/-combined infection Treatment plan Treatment duration
'r ',,, boldface, '',, genotype or type sofosbuvir+peginterferon-&+ribavirin weeks
'r ' ,,, boldface, '',, genotype sofosbuvir + ribavirin weekly
'r ',,, boldface, '',, genotype sofosbuvir + ribavirin weekly< br/> 'r ',,, Bold body, '',, Patients with chronic hepatitis C who are unable to use interferon may consider using sofosbuvir combined with ribavirin for weekly treatment.
'r ',,, boldface, '',, Hepatocellular carcinoma patients awaiting liver transplantation should be treated with sofosbuvir combined with ribavirin for chronic hepatitis C for weeks or until liver transplantation, whichever occurs first shall prevail.
'r ',,, boldface, '',, Dosing recommendations cannot be made for patients with severe renal impairment or end-stage renal disease.
'r ',,, boldface, '',, 'r ' , dosage form
'r ',,, boldface, '',, each tablet: .
'r ',,, boldface, '',, 'r ' , contraindications
'r ',,, boldface, '',, & sofosbuvir combined with pegylated interferon All contraindications for peginterferon-& and/or ribavirin when used alone or in combination with ribavirin also apply to combination therapy with sofosbuvir.
'r ',,, boldface, '',, & Since ribavirin may cause fetal congenital malformation or stillbirth, [] sofosbuvir combined with pegylated interferon&+ribavir Lin, or sofosbuvir alone in combination with ribavirin should be contraindicated in pregnant women and men whose partners are pregnant.
'r ',,, boldface, '',, 'r ' , indications and uses
'r ',,, boldface, '',, Sofosbuvir is a hepatitis C Virus () nucleotide analog B polymerase inhibitor is suitable for use as a combination component in a combined antiviral treatment regimen to treat chronic hepatitis C () infection.
'r ',,, boldface, '',, Sofosbuvir has been proven effective in the treatment of genotype, , or hepatitis C in subjects, including subjects with hepatocellular carcinoma who meet the Milan criteria and are waiting for liver transplantation. and/- coinfected subjects.
'r ',,, boldface, '',, 'r ' , Warnings and Precautions
'r ',,, boldface, '',, Pregnancy: Ribavirin may cause fetal Congenital malformations or stillbirths, 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, '',, 'r ' , Adverse reactions
'r ',,, boldface, '',, Sofosbuvir combined with ribavirin has caused The most common adverse reactions known (incidence equal to or greater than %, all grades) are headache and fatigue. The most common adverse reactions known to be caused by sofosbuvir combined with pegylated interferon-& ribavirin include fatigue, headache , nausea, insomnia and anemia.
'r ',,, boldface, '',, 'r ' , drug interactions
'r ',,, boldface, '',, potent intestinal glycoprotein(-) induction Agents (such as rifampicin) may alter the plasma concentrations of sofosbuvir. Before use, please read the complete package insert for drug-drug interactions.
'r ',,, boldface, '',, 'r ' , medication for special groups
'r ',,, boldface, '',, /-Patients with co-infections: safety of this drug and effectiveness confirmed by research.
'r ',,, boldface, '',, Hepatocellular carcinoma patients awaiting liver transplantation: The safety and effectiveness of this drug have been confirmed by research.
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