Daclatasvir

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Information about Daclatasvir

HCV NS5A Inhibitors Daclatasvir is an orally available antiviral agent that inhibits the NS5A region of the hepatitis C virus (HCV) and is used in combination with other oral antiviral agents to treat chronic hepatitis C.

Liver safety of Daclatasvir

Elevations in serum enzyme levels during daclatasvir therapy are uncommon, and it has yet to be convincingly implicated in cases of clinically apparent liver injury with jaundice. Nevertheless, and for unknown reasons, successful all-oral regimens of antiviral therapy in patients with chronic hepatitis C and cirrhosis is occasionally complicated by hepatic decompensation and may cause reactivation of hepatitis B in susceptible patients coinfected with the hepatitis B virus (HBV).

History of Daclatasvir

The hepatitis C virus is a small RNA virus that is a major cause of chronic hepatitis, cirrhosis and hepatocellular carcinoma in the United States as well as worldwide. Various approaches to antiviral therapy of chronic hepatitis C have been developed, starting in the 1980s with interferon alfa, which was replaced in the 1990s by long acting forms of interferon (peginterferon) to which was added the oral nucleoside analogue, ribavirin. Between 2010 and 2015, several potent oral, direct acting anti-HCV agents were developed and combinations of these found to have marked activity against the virus, allowing for highly effective therapy without use of interferon, with excellent tolerance and safety and treatment courses of 8, 12 or 24 weeks only. These direct acting agents included HCV protease (NS3/4) inhibitors, structural replication complex (NS5A) inhibitors and the HCV RNA polymerase (NS5B) inhibitors.

Mechanism of action of Daclatasvir

Daclatasvir (dak lat' as vir) is an oral antiviral agent with specific activity against the NS5A region of the hepatitis C virus. The role of the NS5A region and how daclatasvir inhibits its function are not well defined, but NS5A is necessary for formation of the replicative complex of HCV and the various NS5A inhibitors, such as daclatasvir, appear to bind to this polypeptide and prevent its participation in forming the intracellular complex that is necessary for HCV replication. In cell culture and in animal models, daclatasvir caused a rapid and marked decrease in viral replication and HCV RNA levels. In several prospective, placebo controlled trials, daclatasvir in combination with other antiviral agents (such as sofosbuvir, asunaprevir, peginterferon and ribavirin) was found to decrease HCV RNA levels and lead to sustained loss of HCV RNA in a high proportion of patients with chronic hepatitis C.

FDA approval information for Daclatasvir

Daclatasvir was approved for use in combination with other antiviral agents as therapy of chronic hepatitis C in the United States in 2015. It is available as tablets of 30 and 60 mg under the brand name Daklinza.

Dosage and administration for Daclatasvir

The recommended dose in adults is one capsule (60 mg) orally once daily in combination with sofosbuvir (400 mg daily) for 12 weeks.

Clinical use of Daclatasvir

Current indications are limited to patients with HCV genotype 3, although several studies have shown that it is also active against other HCV genotypes. Side effects are uncommon, but are generally mild and can include headache, fatigue and nausea.

The following are drugs for Hepatitis C:

Interferon Based Therapies

HCV NS5A Inhibitors

HCV NS5B (Polymerase) Inhibitors

HCV Protease Inhibitors

Combination Therapies

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