Sofosbuvir/daclatasvir

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]

Sofosbuvir/daclatasvir
Sovodak 60/400
Combination of
DaclatasvirNS5A inhibitor
SofosbuvirNS5B (RNA polymerase) inhibitor
Clinical data
Trade namesDarvoni, Sovodak
Pregnancy
category
  • US: B (No risk in non-human studies)
    Routes of
    administration    		Oral
    Legal status
    Legal status

    Society and culture

    This 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][5][6] Sovodak was approved by the Iranian Food and Drug Administration in October 2015[7] 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.[8]

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    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". Hepatic Medicine: Evidence and Research. 8: 21–6. doi:10.2147/HMER.S62014. PMC 4786064. PMID 27019602.
    2. "Highlights of prescribing information" (PDF). Retrieved 22 August 2016.
    3. Codrops. "Sovodak دارو". Retrieved 2019-07-17.
    4. https://clinicaltrials.gov/ct2/show/NCT02596880?term=sovodak&rank=1
    5. Merat, Shahin; Merat, Shahin; Sharifi, Amir-Houshang; et al. (2020). "SD1000: High Sustained Viral Response Rate in 1361 Patients with Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial". Clinical Infectious Diseases. 70 (10): 2206–2212. doi:10.1093/cid/ciz628. PMID 31504303.
    6. Poustchi, Hossein; Majd Jabbari, Sara; Merat, Shahin; et al. (2020). "The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment". Journal of Gastroenterology and Hepatology. doi:10.1111/jgh.14994. PMID 31994788.
    7. http://fda.gov.ir/uploads/05d8977da309fd47b21defea18d027ed.xls
    8. "Hepatitis Monthly | International Monthly Journal in the Field of Hepatology". Hepatitis Monthly. Retrieved 2019-07-17.


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