Sofosbuvir Sofosbuvir, a new drug developed by Gilead for the treatment of chronic hepatitis C, was approved by the U.S. Food and Drug Administration for marketing in the United States on December 6, 2013, and by the European Medicines Agency for marketing in European Union countries on January 16, 2014. The drug is not yet available in China and can only be obtained in foreign hospitals.
The drug 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 an overall sustained virologic response rate of 90% for the drug combined with pegylated interferon and ribavirin for hepatitis 1 and 4; 89%-95% SVR for the drug combined with ribavirin for hepatitis 2; and 61%-63% SVR for the drug combined with ribavirin for type 3 hepatitis C. It is worth noting that clinical trials of sofibuvir also included some patients with hepatitis C combined with cirrhosis, and the efficacy was also significant.
Sofosbuvir, a new drug for hepatitis C, has caused another dilemma for the controversial U.S. health care reform. Some states, including Oregon, are looking for ways to limit the availability of the drug due to their inability to address health care spending challenges, and the expansion of Medicaid proposed by President Barack Obama’s health care reform package has been significantly reduced.
Dosage
Take one tablet of 400mg a day on an empty stomach or with a meal. (May be combined with ribavirin or combined ribavirin + pegylated interferon for the treatment of chronic hepatitis C)
Dosage form
Each tablet: 400mg.
Contraindications
When Sofosbuvir is used in combination with pegylated interferon-alpha + ribavirin, or in combination with ribavirin alone, all contraindications to pegylated interferon-alpha and/or ribavirin also apply to Sofosbuvir combination therapy.
Sofosbuvir in combination with pegylated interferon-alpha + ribavirin, or Sofosbuvir alone in combination with ribavirin, should be contraindicated in pregnant women and men whose partners are pregnant due to the potential for congenital malformations or stillbirths with ribavirin.
Indications and Uses
Sofosbuvir is a hepatitis C virus nucleotide analogue NS5B polymerase inhibitor indicated as a combination component in combination antiviral regimens for the treatment of chronic hepatitis C infection.
Sofosbuvir has been shown to be effective in the treatment of subjects with genotype 1, 2, 3 or 4 hepatitis C, including subjects with hepatocellular carcinoma who meet Milan criteria and are awaiting liver transplantation, and subjects with HCV/HIV-1 co-infection.
Warnings and Precautions
Pregnancy: Ribavirin has the potential to cause congenital malformations or stillbirths in the fetus, and animal studies have shown that interferon can trigger miscarriage. Therefore, female patients taking this drug and the spouses of male patients should avoid pregnancy. Before starting treatment, patients must have a negative pregnancy test, have used at least two non-hormonal methods of contraception, and need to have a monthly pregnancy test.
Adverse Reactions
The most common known adverse reactions to sofosbuvir in combination with ribavirin are headache and malaise; the most common known adverse reactions to sofosbuvir in combination with pegylated interferon-alpha and ribavirin include malaise, headache, nausea, insomnia, and anemia.
Drug Interactions
Potent intestinal glycoprotein inducers may alter drug plasma concentrations of sofosbuvir. For drug-drug interactions, please refer to the full drug insert before use.
Use in Special Populations
Patients with HCV/HIV-1 co-infection: The safety and efficacy of this drug have been confirmed in studies. Patients with hepatocellular carcinoma awaiting liver transplantation: The safety and efficacy of this drug have been confirmed in studies. The drug is available in the United Kingdom and the United States, but is not yet available in China. Domestic customers who wish to purchase this drug may seek assistance from a major pharmacy chain in the United States.