Sofosbuvir/daclatasvir
 Sovodak 60/400 | |
| Combination of | |
|---|---|
| Daclatasvir | NS5A inhibitor |
| Sofosbuvir | NS5B (RNA polymerase) inhibitor |
| Clinical data | |
| Trade names | Darvoni, Sovodak |
| Pregnancy category |
|
| Routes of administration | Oral |
| Legal status | |
| Legal status |
|
Daclatasvir/sofosbuvir is a two-drug combination for the treatment of hepatitis C.[1] It is given as a single daily pill containing daclatasvir, the viral NS5A inhibitor and sofosbuvir, a nucleotide inhibitor of the viral RNA polymerase.[2]
Society and culture
Daclatasvir/sofosbuvir was developed by a Bangladeshi pharmaceutical company Beacon Pharmaceuticals Limited and approved by Directorate General of Drug Administration, Ministry of Health and Family Welfare, People's Republic of Bangladesh.
The same combination is produced by an Iranian company under the trade name of Sovodak.[3] The combination includes 400 mg sofosbuvir and 60 mg daclatasvir and has been used in clinical trials since 2015.[4] Sovodak was approved by the Iranian Food and Drug Administration on October 2015[5] and is currently marketed in Iran as the treatment of choice for all genotypes of hepatitis C as recommended by the national Iranian guideline for treating hepatitis C.[6]
References
- ↑ Pol S, Corouge M, Vallet-Pichard A (2016). "Daclatasvir-sofosbuvir combination therapy with or without ribavirin for hepatitis C virus infection: from the clinical trials to real life.". Hepat Med. 8: 21–6. doi:10.2147/HMER.S62014. PMC 4786064
. PMID 27019602. - ↑ "Highlights of prescribing information" (PDF). Retrieved 22 August 2016.
- ↑ http://www.sovodak.com/
- ↑ https://clinicaltrials.gov/ct2/show/NCT02596880?term=sovodak&rank=1
- ↑ http://fda.gov.ir/uploads/05d8977da309fd47b21defea18d027ed.xls
- ↑ http://hepatmon.com/?page=article&article_id=40959