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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.

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. 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. However, sofosbuvir is significantly more affordable in Japan and South Korea at approximately $300 and $5900 respectively for a 12-week treatment, with each government covering 99% and 70% of the cost respectively.

In September 2014, Gilead announced that it was proposing generic licensing agreements with manufacturers in 91 developing countries to produce and sell sofosbuvir, and that it would sell a name brand version of the product in India for approximately $300 per course of treatment.

In August 2015, Beacon Pharmaceuticals of Bangladesh got approval from Directorate General of Drugs Administration, Ministry of Health & Family Welfare, Government of Bangladesh as generic version of Sovaldi named Soforal. The company kept its price very affordable.

It is on the World Health Organization's List of Essential Medicines, a list of the most important medications needed in a basic health system.