Dasabuvir
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| Clinical data | |
|---|---|
| Trade names | Viekira Pak (with ombitasvir/paritaprevir/ritonavir tablets), Exviera |
| AHFS/Drugs.com | viekira-pak |
| Pregnancy category |
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| ATC code | J05AX16 (WHO) |
| Legal status | |
| Legal status |
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| Identifiers | |
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| Synonyms | ABT-333 |
| CAS Number | 1132935-63-7 |
| ChemSpider | 29776744 |
| ChEBI |
CHEBI:85182  |
| ChEMBL | CHEMBL3137312 |
| Chemical and physical data | |
| Formula | C26H27N3O5S |
| Molar mass | 493.58 g/mol |
| 3D model (Jmol) | Interactive image |
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Dasabuvir (trade name Exviera in Europe) is an antiviral drug for the treatment of hepatitis C virus (HCV) infection. In the United States, it is approved by the Food and Drug Administration for use in combination with ombitasvir, paritaprevir, and ritonavir in the product Viekira Pak.[1] Dasabuvir is a separate tablet from the Viekira Pak; the remaining three medications are put together in a fixed-dose tablet.[1]
Medical uses
Dasabuvir is used in the treatment of chronic Hepatitis C infection. It is used in the following HCV subtypes: genotype 1a, genotype 1b, genotype 1 of unknown subtype, and genotype 1 mixed infection without cirrhosis or with compensated cirrhosis.[2]
Contraindications
People should not be taking dasabuvir if they meet any of the following criteria:
- They have a hypersensitivity to it or any of the substances in the tablet.[3]
- They are taking any hormonal contraception that contain ethinylestradiol (often found in combined oral contraceptives or vaginal rings).[3]
- They are also taking medications that are strong or moderate enzyme inducers such as carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine, etravirine, mitotane, rifampicin, enzalutamide, and St. John's Wort (Hypercium perforatum).[3]
- They are also taking medications that are strong CYP2C8 inhibitors (gemfibrozil).[3]
- They meet contraindication criteria for ombitasivir, paritaprevir, and ritonavir since dasabuvir is used in combination with those three medications.[3]
Adverse effects
The FDA approved combination of dasabuvir used with ombitasvir, paritaprevir, and ritonavir in the product Viekira Pak can cause a number of adverse effects. When Viekira Pak was used without Ribavirin, nausea, severe itching, and insomnia occurred in more than 5% of the subjects.[4] Less commonly, patients experienced increases in liver enzymes, such as AST and ALT, to greater than five times the upper limit of normal (occurred in 1% of patients).[4] Usually this was asymptomatic. However, this is notable because females who are taking ethinyl estradiol are at an increased risk for this side effect (25%).[4]
Mechanism of action
Dasabuvir works by inhibiting the action of NS5B palm polymerase, effectively terminating RNA polymerization and stopping the replication of the HCV's genome.[5] By blocking NS5B polymerase, the virus can no longer multiply and infect new cells.[3]
History
The U.S. FDA approved regimen of ombitasvir-paritaprevir-ritonavir and dasabuvir on December 19, 2014 to be used in the treatment of genotype 1 chronic hepatitis C infection in adult patients, which includes those with compensated cirrhosis.[1]
Administration and storage
The two tablets of ombitasvir, paritaprevir, ritonavir will be taken in the morning and the one dasabuvir tablet taken twice a day in the morning and in the evening with a meal.[4]
The combination pack is packaged in a monthly package for 28 days of treatment.[4] Be sure to store the package and drugs included at or below 30°C to maintain the integrity of the drugs.[4]
References
- 1 2 3 "Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir (Viekira Pak) - Treatment - Hepatitis C Online". www.hepatitisc.uw.edu. Retrieved 2016-11-09.
- ↑ Commissioner, Office of the. "Safety Information - Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Copackaged for Oral Use". www.fda.gov. Retrieved 2016-11-17.
- 1 2 3 4 5 6 "European Medicines Agency - Find medicine - Exviera". www.ema.europa.eu. Retrieved 2016-11-09.
- 1 2 3 4 5 6 AbbVie Inc. (December 2014). "Prescribing Information: Veikira Pak" (PDF). FDA. Retrieved October 28, 2016.
- ↑ "The DrugBank database". www.drugbank.ca/drugs/DB09183. Retrieved 2016-10-28.