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sofosbuvir : ウィキペディア英語版
sofosbuvir

Sofosbuvir (brand name Sovaldi) is a nucleotide analog used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection. It has been marketed since 2013. Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and a two- to four-fold reduced duration of therapy. Sofosbuvir allows most patients to be treated successfully without the use of peginterferon, an injectable drug with severe side effects that is a key component of older drug combinations for the treatment of HCV.
Sofosbuvir inhibits the RNA polymerase that the hepatitis C virus uses to replicate its RNA. It was discovered at Pharmasset and developed by Gilead Sciences.〔(【引用サイトリンク】 PSI-7977 )
In 2013, the FDA approved sofosbuvir in combination with ribavirin (RBV) for oral dual therapy of HCV genotypes 2 and 3, and for triple therapy with injected pegylated interferon (pegIFN) and RBV for treatment-naive patients with HCV genotypes 1 and 4. In 2014 a combination of sofosbuvir with the viral NS5A inhibitor ledipasvir was approved.〔(【引用サイトリンク】title=FDA approves first combination pill to treat hepatitis C )〕 This latter combination provides high cure rates in people infected with genotype 1 (the most common subtype in the U.S., Japan, and much of Europe) without the use of interferon, irrespective of prior treatment failure or the presence of cirrhosis.
The price of sofosbuvir, quoted in various media sources as $84,000 to $168,000 for a course of treatment in the U.S., £35,000 in the UK for 12 weeks has engendered considerable controversy. In September 2014, Gilead announced that it would permit generic manufacturers to sell sofosbuvir in 91 developing countries and that it would sell a name brand version of the product in India for approximately $300 per course of treatment.
It is on the World Health Organization's List of Essential Medicines, a list of the most important medications needed in a basic ].
== Medical uses ==
Sofosbuvir is used for the treatment of chronic hepatitis C, genotypes 1, 2, 3, and 4, in combination with pegylated interferon and ribavirin, or with ribavirin alone. It is also used in combination with the viral NS5a inhibitor ledipasvir in an interferon-free combination for the treatment of genotype 1 hepatitis C infection.〔 Sofosbuvir is also used in HCV patients with an HIV coinfection.〔 The treatment is based on a number of clinical trials, for example the ELECTRON trial which showed that a dual interferon-free regimen of sofosbuvir plus ribavirin produced a 24-week post-treatment sustained virological response (SVR24) rate of 100% for previously untreated patients with HCV genotypes 2 or 3.〔(AASLD: PSI-7977 plus Ribavirin Can Cure Hepatitis C in 12 Weeks without Interferon ). Highleyman, L. HIVandHepatitis.com. 8 November 2011.〕
In early 2014, the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America jointly published a recommendation for the management of hepatitis C. In this recommendation, sofosbuvir and ribavirin, with or without pegylated interferon, are part of all first-line treatments for HCV genotypes 1 to 6, and are also part of some second-line treatments.〔(【引用サイトリンク】title=Recommendations for Testing, Managing, and Treating Hepatitis C )

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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