Sofosbuvir/daclatasvir

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Sofosbuvir/daclatasvir
Sovodak.jpg
Sovodak 60/400
Combination of
DaclatasvirNS5A inhibitor
SofosbuvirNS5B (RNA polymerase) inhibitor
Names
Trade namesDarvoni, Sovodak
Clinical data
Drug classCombination direct-acting antiviral
Main usesHepatitis C[1]
Side effectsHeadache, tiredness, nausea, abdominal pain[2]
Routes of
use
By mouth

Daclatasvir/sofosbuvir (SOF/DCV), sold under the brand name Sovodak among others, is a combination medication used to treat hepatitis C.[1] It is a first line treatment and is effective against all subtypes.[3] It is more than 90% effective.[1] It may be used in those who are at least 3 years old.[4] It is generally take by mouth once per day for 12 weeks as either a single pill or separately.[2][1]

Common side effects include headache, tiredness, nausea, and abdominal pain.[2] Serious side effects are uncommon.[2] Use of daclatasvir and sofosbuvir has not been found to be harmful in pregnancy but has not been well studied.[5][6] It contains daclatasvir, a viral NS5A inhibitor,[7] and sofosbuvir, a nucleotide inhibitor of the viral RNA polymerase NS5B.[8]

It is the most commonly used treatment for hepatitis C in low and middle income countries as of 2022.[3] The combination has never been approved in the United States and sale of daclatavir was stopped their in 2019.[9] It is on the World Health Organization's List of Essential Medicines.[10] It is the least expensive modern hepatitis C treatment, with costs from 50 to 1,400 USD.[2][3]

Medical use

Dosage

The combination includes 400 mg sofosbuvir and 60 mg daclatasvir and has been under study since 2015.[11][12][13]

Society and culture

This combination is produced by an Iranian company under the trade name of Sovodak.[14] It was approved by the Iranian Food and Drug Administration in October 2015[15] and is marketed in Iran as the treatment of choice for all genotypes of hepatitis C.[16]

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.[17][18][19]

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.[20]

References

  1. 1.0 1.1 1.2 1.3 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.
  2. 2.0 2.1 2.2 2.3 2.4 "Application for Inclusion of Sofosbuvir/Daclatasvir on the WHO Model List of Essential Medicines for Children (EMLc)" (PDF). Archived (PDF) from the original on 2 December 2022. Retrieved 2 December 2022.
  3. 3.0 3.1 3.2 "Hepatitis C". www.who.int. Archived from the original on 26 May 2020. Retrieved 2 December 2022.
  4. "WHO publishes updated guidance on hepatitis C infection – with new recommendations on treatment of adolescents and children, simplified service delivery and diagnostics". www.who.int. Archived from the original on 6 October 2022. Retrieved 2 December 2022.
  5. "Daclatasvir (Daklinza) Use During Pregnancy". Drugs.com. Archived from the original on 6 December 2021. Retrieved 2 December 2022.
  6. "Sofosbuvir (Sovaldi) Use During Pregnancy". Drugs.com. Archived from the original on 5 February 2020. Retrieved 2 December 2022.
  7. "Daklinza film-coated tablets – Summary of Product Characteristics (SPC) - (eMC)". Electronic Medicines Compendium. September 2016. Archived from the original on 2016-11-09.
  8. "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.
  9. Abraham, GM; Obley, AJ; Humphrey, LL; Qaseem, A; Scientific Medical Policy Committee of the American College of, Physicians; Centor, RM; Akl, E; Forceia, MA; Haeme, R; Hamilton, PG; Hood, GA; Jokela, JA; Kansagara, DL; Levine, MA; Mason, JR; Marcucci, M (January 2021). "World Health Organization Guidelines on Treatment of Hepatitis C Virus Infection: Best Practice Advice From the American College of Physicians". Annals of internal medicine. 174 (1): 98–100. doi:10.7326/M19-3860. PMID 33017566.
  10. 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.
  11. Clinical trial number NCT02596880 for "Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics (SD100)" at ClinicalTrials.gov
  12. 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.
  13. 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.
  14. Codrops. "Sovodak دارو". Archived from the original on 2019-07-03. Retrieved 2019-07-17.
  15. "Sofosbuvir". Iranian Food and Drug Administration. Archived from the original on 23 October 2017.
  16. "Hepatitis Monthly | International Monthly Journal in the Field of Hepatology". Hepatitis Monthly. Archived from the original on 2020-04-05. Retrieved 2019-07-17.
  17. 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.
  18. 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.
  19. 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.
  20. 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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