Sofosbuvir/daclatasvir explained

Daclatasvir/sofosbuvir (trade names Darvoni, Sovodak) is a two-drug combination for the treatment of hepatitis C.[1] It is given as a single daily pill containing daclatasvir, a viral NS5A inhibitor,[2] and sofosbuvir, a nucleotide inhibitor of the viral RNA polymerase NS5B.[3]

It is on the World Health Organization's List of Essential Medicines.[4] __TOC__

Society and culture

This combination is produced by an Iranian company under the trade name of Sovodak.[5] The combination includes 400 mg sofosbuvir and 60 mg daclatasvir and has been used in clinical trials since 2015.[6] [7] Sovodak was approved by the Iranian Food and Drug Administration in October 2015[8] 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.[9]

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.[10] [11] [12]

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.[13]

Notes and References

  1. Pol S, Corouge M, Vallet-Pichard A . 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 . 2016 . 27019602 . 4786064 . 10.2147/HMER.S62014 . free .
  2. Web site: Daklinza film-coated tablets – Summary of Product Characteristics (SPC) - (eMC). Electronic Medicines Compendium. September 2016. live. https://web.archive.org/web/20161109153440/https://www.medicines.org.uk/emc/medicine/29129. 2016-11-09.
  3. Web site: Sovaldi 400 mg film coated tablets - Summary of Product Characteristics. UK Electronic Medicines Compendium. 10 November 2016. September 2016. live. https://web.archive.org/web/20161110235042/https://www.medicines.org.uk/emc/medicine/28539. 10 November 2016 .
  4. Book: ((World Health Organization)) . World Health Organization model list of essential medicines: 22nd list (2021) . 2021 . 10665/345533 . World Health Organization . World Health Organization . Geneva . WHO/MHP/HPS/EML/2021.02 . free .
  5. Web site: Sovodak دارو. Codrops. en. 2019-07-17. 2019-07-03. https://web.archive.org/web/20190703071820/http://sovodak.com/. dead.
  6. Merat S . 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 . May 2020 . 31504303 . 10.1093/cid/ciz628 .
  7. Poustchi H, Majd Jabbari S, Merat S, Sharifi AH, Shayesteh AA, Shayesteh E, Minakari M, Fattahi MR, Moini M, Roozbeh F, Mansour-Ghanaei F, Afshar B, Mokhtare M, Amiriani T, Sofian M, Somi MH, Agah S, Maleki I, Latifnia M, Fattahi Abdizadeh M, Hormati A, Khoshnia M, Sohrabi M, Malekzadeh Z, Merat D, Malekzadeh R . 6 . 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 . September 2020 . 31994788 . 10.1111/jgh.14994 . 210948579 .
  8. Web site: Sofosbuvir . https://web.archive.org/web/20171023231746/http://fda.gov.ir/uploads/05d8977da309fd47b21defea18d027ed.xls . 23 October 2017 . Iranian Food and Drug Administration .
  9. Web site: Hepatitis Monthly International Monthly Journal in the Field of Hepatology. Hepatitis Monthly. 2019-07-17.
  10. Eslami G, Mousaviasl S, Radmanesh E, Jelvay S, Bitaraf S, Simmons B, Wentzel H, Hill A, Sadeghi A, Freeman J, Salmanzadeh S, Esmaeilian H, Mobarak M, Tabibi R, Jafari Kashi AH, Lotfi Z, Talebzadeh SM, Wickramatillake A, Momtazan M, Hajizadeh Farsani M, Marjani S, Mobarak S . 6 . The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19 . The Journal of Antimicrobial Chemotherapy . 75 . 11 . 3366–3372 . November 2020 . 32812051 . 7529105 . 10.1093/jac/dkaa331 . 221182215 . free .
  11. Sadeghi A, Ali Asgari A, Norouzi A, Kheiri Z, Anushirvani A, Montazeri M, Hosamirudsai H, Afhami S, Akbarpour E, Aliannejad R, Radmard AR, Davarpanah AH, Levi J, Wentzel H, Qavi A, Garratt A, Simmons B, Hill A, Merat S . 6 . 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 . November 2020 . 32812039 . 7454592 . 10.1093/jac/dkaa334 . 221181054 . free .
  12. Abbaspour Kasgari H, Moradi S, Shabani AM, Babamahmoodi F, Davoudi Badabi AR, Davoudi L, Alikhani A, Hedayatizadeh Omran A, Saeedi M, Merat S, Wentzel H, Garratt A, Levi J, Simmons B, Hill A, Tirgar Fakheri H . 6 . 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 . November 2020 . 32812025 . 7454669 . 10.1093/jac/dkaa332 . 221180153 . free .
  13. Simmons B, Wentzel H, Mobarak S, Eslami G, Sadeghi A, Ali Asgari A, Abbaspour Kasgari H, Tirgar Fakheri H, Merat S, Hill A . 6 . Sofosbuvir/daclatasvir regimens for the treatment of COVID-19: an individual patient data meta-analysis . The Journal of Antimicrobial Chemotherapy . 76 . 2 . 286–291 . January 2021 . 33063117 . 7665526 . 10.1093/jac/dkaa418 .

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