Sofosbuvir/daclatasvir

Daclatasvir/sofosbuvir (trade names Darvoni, Sovodak) is a two-drug combination for the treatment of hepatitis C.[2] It is given as a single daily pill containing daclatasvir, a viral NS5A inhibitor,[3] and sofosbuvir, a nucleotide inhibitor of the viral RNA polymerase NS5B.[4]

Sofosbuvir/daclatasvir
Sovodak 60/400
Combination of
DaclatasvirNS5A inhibitor
SofosbuvirNS5B (RNA polymerase) inhibitor
Clinical data
Trade namesDarvoni,[1] Sovodak
Routes of
administration		Oral
Identifiers
CAS Number

It is on the World Health Organization's List of Essential Medicines.[5]

Society and culture

This combination is produced by an Iranian company under the trade name of Sovodak.[6] The combination includes 400 mg sofosbuvir and 60 mg daclatasvir and has been used in clinical trials since 2015.[7][8][9] Sovodak was approved by the Iranian Food and Drug Administration in October 2015[10] 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.[11]

Research

The similarities between the hepatitis C and SARS-CoV-2 virus has led some researches to investigate the effectiveness of sofosbuvir/daclatasvir against COVID-19. Three recently published studies have found this combination to be beneficial against COVID-19 although the findings require confirmation by larger studies.[12][13][14]

In October 2020, a meta-analysis found a significantly lower risk of all-cause mortality with the drug combination when given to hospitalized patients with COVID-19.[15]

References
  1. "Home". Darvoni - Beacon Medicare Limited.
  2. 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: 21–26. doi:10.2147/HMER.S62014. PMC 4786064. PMID 27019602.
  3. "Daklinza film-coated tablets – Summary of Product Characteristics (SPC) - (eMC)". Electronic Medicines Compendium. September 2016. Archived from the original on 2016-11-09.
  4. "Sovaldi 400 mg film coated tablets - Summary of Product Characteristics". UK Electronic Medicines Compendium. September 2016. Archived from the original on 10 November 2016. Retrieved 10 November 2016.
  5. World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
  6. Codrops. "Sovodak دارو". Archived from the original on 2019-07-03. Retrieved 2019-07-17.
  7. Clinical trial number NCT02596880 for "Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics (SD100)" at ClinicalTrials.gov
  8. Merat S (May 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.
  9. Poustchi H, Majd Jabbari S, Merat S, Sharifi AH, Shayesteh AA, Shayesteh E, et al. (September 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. 35 (9): 1590–1594. doi:10.1111/jgh.14994. PMID 31994788. S2CID 210948579.
  10. "Sofosbuvir". Iranian Food and Drug Administration. Archived from the original on 23 October 2017.
  11. "Hepatitis Monthly | International Monthly Journal in the Field of Hepatology". Hepatitis Monthly. Retrieved 2019-07-17.
  12. Eslami G, Mousaviasl S, Radmanesh E, Jelvay S, Bitaraf S, Simmons B, et al. (November 2020). "The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19". The Journal of Antimicrobial Chemotherapy. 75 (11): 3366–3372. doi:10.1093/jac/dkaa331. PMC 7529105. PMID 32812051. S2CID 221182215.
  13. Sadeghi A, Ali Asgari A, Norouzi A, Kheiri Z, Anushirvani A, Montazeri M, et al. (November 2020). "Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial". The Journal of Antimicrobial Chemotherapy. 75 (11): 3379–3385. doi:10.1093/jac/dkaa334. PMC 7454592. PMID 32812039. S2CID 221181054.
  14. Abbaspour Kasgari H, Moradi S, Shabani AM, Babamahmoodi F, Davoudi Badabi AR, Davoudi L, et al. (November 2020). "Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial". The Journal of Antimicrobial Chemotherapy. 75 (11): 3373–3378. doi:10.1093/jac/dkaa332. PMC 7454669. PMID 32812025. S2CID 221180153.
  15. Simmons B, Wentzel H, Mobarak S, Eslami G, Sadeghi A, Ali Asgari A, et al. (January 2021). "Sofosbuvir/daclatasvir regimens for the treatment of COVID-19: an individual patient data meta-analysis". The Journal of Antimicrobial Chemotherapy. 76 (2): 286–291. doi:10.1093/jac/dkaa418. PMC 7665526. PMID 33063117.
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