Sofosbuvir
Sofosbuvir is an antiviral medication that has direct acting-properties. It is prescribed as a part of
combination therapy to treat chronic Hepatitis C. Hepatitis C is an infectious liver disease caused by
infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus with nine distinct
genotypes. Its genotype 1 affects 72% of all chronic HCV patients in the USA. Treating chronic
Hepatitis C have advanced significantly since 2011, with the introduction of Direct Acting Antivirals
(DAAs) like Sofosbuvir.
In a joint recommendation by the American Association for the Study of Liver Diseases (AASLD) and
the Infectious Diseases Society of America (IDSA) in 2016 recommends Sofosbuvir as the first line
therapy in combination with other antivirals for all six genotypes of Hepatitis C 14.
Sofosbuvir is sold under the brand names Brands Hepcinat, Hepcvir, Resof, SoviHep amongst others.
Michael Sofia at Pharmasset, sold to Gilead Sciences, discovered it in 2007 and was approved for use
in the USA by the FDA in 2013 for the combination of sofosbuvir and ribavirin antiviral. Sofosbuvir’s
Gilead products are Sovaldi and Harvoni.
Dosage and Administration
Sofosbuvir is sold as a 400mg tablet. In the treatment of Hepatitis C Virus (HCV) Infection, in
combination antiviral regimen for HCV mono-infection and HCV/HIV-1 coinfection, the regime and
duration are decided on genotype and patient population. In treating infection related to Genotype
1 or 4, the dose is 400 mg a day given with Ribavirin and peginterferon alfa for 3 months or 12
weeks. Sofosbuvir with ribavirin is prescribed for 24 weeks in genotype 1 patients who are ineligible
to receive a peg-interferon-based regimen. Hepatocellular carcinoma patients who are awaiting liver
transplantation, are given these medicines for prevention and reinfection post-transplant. The dose is
set at 400 mg with ribavirin until the time of liver transplantation or for up to 48 weeks or,
whichever comes first.
There are several other combinations with other medicines targeted at specific genotypes, so
consult with the doctor to choose the specific combination and dosage.
The price of Sofosbuvir
In the USA, the consumers pay a wholesale acquisition cost of USD 1000 for each 400 mg pill,
totaling a total of USD 84,000 for 12- week treatment. The same medicine is made by generic drug
makers in countries like India, where the same 400 mg pill costs only USD4, USD350-400.
How does it work?
Sofosbuvir is a nucleotide analog inhibitor. It targets HCV NS5B RNA-dependent RNA polymerase
specifically for inhibition. After intracellular metabolism, it converts to active uridine analog
triphosphate. Sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain
terminator Synthesis resulting in the prevention of HCV viral replication by binding to the two Mg2+ ions
present in HCV NS5B polymerase's GDD active site motif. This prevents further replication of HCV
genetic material. Sofosbuvir actions inhibit the reproduction of genetic material of the hepatitis C virus,
through inhibition of an RNA-dependent polymerase needed by the virus to replicate itself.
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