Sofosbuvir/daclatasvir

Sofosbuvir/daclatasvir
Sovodak 60/400
Combination of
Daclatasvir NS5A inhibitor
Sofosbuvir NS5B (RNA polymerase) inhibitor
Clinical data
Trade names Darvoni, Sovodak
Pregnancy
category
  • US: B (No risk in non-human studies)
    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

    1. ↑ 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.
    2. ↑ "Highlights of prescribing information" (PDF). Retrieved 22 August 2016.
    3. ↑ http://www.sovodak.com/
    4. ↑ https://clinicaltrials.gov/ct2/show/NCT02596880?term=sovodak&rank=1
    5. ↑ http://fda.gov.ir/uploads/05d8977da309fd47b21defea18d027ed.xls
    6. ↑ http://hepatmon.com/?page=article&article_id=40959


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