| Pharmaceutical Information |
| Drug Name |
Dasabuvir |
| Drug ID |
BADD_D00588 |
| Description |
Dasabuvir is a direct acting antiviral medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patients [L852]. Treatment options for chronic Hepatitis C have advanced significantly since 2011, with the development of Direct Acting Antivirals (DAAs) such as Dasabuvir. Dasabuvir is a non-nucleoside NS5B inhibitor which binds to the palm domain of NS5B and induces a conformational change which renders the polymerase unable to elongate viral RNA [FDA Label]. The binding sites for non-nucleoside NS5B inhibitors are poorly conserved across HCV genotypes leading to the restriction of Dasabuvir's use to genotype 1 only.
In a joint recommendation published in 2016, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recommend Dasabuvir as first line therapy in combination with [DB09296], [DB09297], and [DB00503] for genotype 1b and with [DB00811] for genotype 1a of Hepatitis C [L852]. Dasabuvir, [DB09296], [DB09297], [DB00503], and [DB00811] are used with the intent to cure, or achieve a sustained virologic response (SVR), after 12 weeks of therapy. SVR and eradication of HCV infection is associated with significant long-term health benefits including reduced liver-related damage, improved quality of life, reduced incidence of Hepatocellular Carcinoma, and reduced all-cause mortality [A19626].
Dasabuvir is available as a fixed dose combination product with [DB09296], [DB09297], and [DB00503] (tradename Viekira Pak) used for the treatment of chronic Hepatitis C. Approved in December 2014 by the FDA, Viekira Pak is indicated for the treatment of HCV genotype 1a with [DB00811] or genotype 1b without [DB00811] [FDA Label]. When combined together, Dasabuvir [DB09296], [DB09297], and [DB00503] as the combination product Viekira Pak have been shown to achieve a SVR of 100% for genotype 1b and 89% or 95% for genotype 1a after 12 weeks or 24 weeks of treatment including [DB00811]. |
| Indications and Usage |
Dasabuvir, in combination with [DB09296], [DB09297], and [DB00503] (as Viekira Pak) is indicated for the treatment of patients with HCV genotype 1a with [DB00811] or genotype 1b without [DB00811] including those with compensated cirrhosis [FDA Label]. |
| Marketing Status |
approved |
| ATC Code |
J05AP09 |
| DrugBank ID |
DB09183
|
| KEGG ID |
D10553
|
| MeSH ID |
C588260
|
| PubChem ID |
56640146
|
| TTD Drug ID |
D04KJT
|
| NDC Product Code |
68513-3075 |
| UNII |
DE54EQW8T1
|
| Synonyms |
dasabuvir | N-(6-(3-tert-butyl-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-2-methoxyphenyl)naphthalen-2-yl)methanesulfonamide | ABT-333 |
|
| Chemical Information |
| Molecular Formula |
C26H27N3O5S |
| CAS Registry Number |
1132935-63-7 |
| SMILES |
CC(C)(C)C1=CC(=CC(=C1OC)C2=CC3=C(C=C2)C=C(C=C3)NS(=O)(=O)C)N4C=CC(=O)NC4=O |
| Chemical Structure |
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| ADRs Induced by Drug |
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