Journal of Ecophysiology and Occupational Health

Open Access Open Access  Restricted Access Subscription Access

Sofosbuvir and Daclatasvir Bypassing Genotypic Investigation of Chronic Hepatitis C Infection: A Real-Life Experience at Tertiary care center in North Indian Population Sofosbuvir and Daclatasvir Bypassing Genotypic Investigation


Affiliations
1 Experimental and Public Health Laboratory, Department of Zoology, University of Lucknow, Lucknow – 226007, Uttar Pradesh, India
2 Department of Medicine, King George’s Medical University, Lucknow – 226003, Uttar Pradesh, India
3 Department of Medical Gastroenterology, King George’s Medical University, Lucknow – 226003, Uttar Pradesh, India
 

Background and Aims: The goal of Hepatitis C Virus infection treatment is to remove the virus, to avoid advancement of Hepatitis C Virus (HCV) infection and progression of related disease such as liver cirrhosis and hepatocellular carcinoma and to achieve End of Treatment Response (ETR) with 12-week therapy and Sustained Virological Response (SVR) at post-treatment week 12 (SVR-12), which is defined as undetectable HCV RNA at 12 weeks post ETR. In the Compassionate Use Program (CUP) in Europe, Sofosbuvir (SOF) and Daclatasvir (DCV) were used in all genotypes and achieved SVR-12. Aims: Our aim is to compare the efficacy and effectiveness of Sofosbuvir and Daclatasvir in the treatment of HCV infection in the patients who could not afford for the investigating of HCVGenotype and to those in whom genotyping was done. Methods: Group 1 includes ten patients, given Sofosbuvir and Daclatasvir without genotype and group 2 includes nine patients, given Sofosbuvir and Daclatasvir with genotype. The patient group selection was done using a randomized table generated by using excel. All the patients in the groups completed the twelve weeks treatment with twelve weeks and twenty-four weeks of follow up. All the nineteen patients were given Sofosbuvir and Daclatasvir for twelve weeks and the endpoint of therapy was marked by undetectable HCV-RNA in blood by ETR-12 (end of treatment response), Sustained Virological Response at post-treatment week 12 (SVR-12) and Sustained Virological Response at post-treatment week 24 (SVR- 24). Results: Quantitative HCV-RNA (IU/ml) by RT-PCR was undetectable in all the patients in both groups at the end of treatment (ETR-12) and SVR-12- and SVR-24-weeks follow-up after completion of treatment i.e. Sofosbuvir and Daclatasvir has 100% ETR-12, SVR-12 and SVR-24 in both the groups. Conclusion: If patients do not investigate for genotype and use the Sofosbuvir and Daclatasvir in HCV infected patients, there is no effect on outcome ETR. This will reduce the risk of late stage complications such as liver cirrhosis and hepatocellular carcinoma and will also leads to the economic benefits such as no extra burden on patients.

Keywords

Cirrhosis, End of Treatment Response (ETR), Hepatocellular Carcinoma (HCC), Sofosbuvir and Daclatasvir (SOF+DCV), Steatosis, Sustained Virological Response (SVR).
User
Notifications
Font Size


  • Nazish B, Tariq M. An overview about Hepatitis C: A devastating virus. Crit Rev Microbiol. 2010; 36(2):91–133. PMid: 20345213.https://doi.org/10.3109/10408410903357455

  • Alter MJ, Margolis HS, Krawczynski K, Judson FN, Mares A, Alexander WJ, et al. The natural history of communityacquired Hepatitis C in the United States. The Sentinel Counties Chronic non-A, non-B Hepatitis Study Team. N Engl J Med.1992; 327:1899–905. PMid: 1280771. https://doi.org/10.1056/ NEJM199212313272702

  • Kim WR. The burden of Hepatitis C in the United States. Hepatology.2002; 36:S30–4. https://doi.org/10.1002/hep.1840360705

  • Singh S, Malhotra V, Sarin SK. Distribution of Hepatitis C Virus genotypes in patients with chronic Hepatitis C infection in India.Indian J Med Res. 2004 Apr; 119:145–8.

  • Prakash S, Jain A, Jain B. Development of novel triplex singlestep real-time PCR assay for detection of Hepatitis Virus B and C simultaneously. Virol. 2016 May; 492:101–7. PMid: 26914508.https://doi.org/10.1016/j.virol.2016.01.029

  • Sievert W, Altraif I, Razavi HA, Abdo A, Ahmed EA, Alomair A, et al. A systematic review of Hepatitis C Virus epidemiology in Asia, Australia and Egypt. Liver Int. 2011; 31(sup 2):61–80. PMid: 21651703. https://doi.org/10.1111/j.1478-3231.2011.02540.x

  • http://www.millenniumpost.in/india-lacks-accurate-data-totackle-hepatitis-155867

  • American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for testing, managing and treating hepatitis C. 2015. http://www.Hcvguidelines.org/full-Report-View

  • European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015; 63:199–236.PMid: 25911336. https://doi.org/10.1016/j.jhep.2015.03.025

  • Majumdar A, Kitson MT, Roberts SK. Systematic review: Current concepts and challenges for the direct-acting antiviral era in Hepatitis C Cirrhosis. Aliment Pharmacol Ther. 2016; 43:1276– 92. PMid: 27087015. https://doi.org/10.1111/apt.13633

  • Holmes JA, Thompson AJ. Interferon-free combination therapies for the treatment of Hepatitis C: Current insights. Hepat Med.2015; 7:51–70. PMid: 26586968 PMCid: PMC4636173. https:// doi.org/10.2147/HMER.S55864

  • Gao M. Antiviral activity and resistance of HCV NS5A replication complex inhibitors. Curr Opin Virol. 2013; 3:514–20. PMid: 23896281. https://doi.org/10.1016/j.coviro.2013.06.014

  • Sofia MJ, Bao D, Chang W, Du J, Nagarathnam D, Rachakonda S, et al. Discovery of a β-d-20-deoxy-20-α-fluoro-20-βCmethyluridine nucleotide prodrug (PSI-7977) for the treatment of Hepatitis C Virus. J Med Chem. 2010; 53:7202–18. PMid: 20845908. https://doi.org/10.1021/jm100863x

  • Wyles DL, Ruane PJ, Sulkowski MS, et al. Daclatasvir plus Sofosbuvir for HCV inpatients coinfected with HIV-1. N Engl J Med. 2015; 373:714–25.

  • Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, et al. All-oral 12-week treatment with Daclatasvir plus Sofosbuvir in patients with Hepatitis C Virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015; 61:1127–35. PMid: 25614962 PMCid: PMC4409820. https://doi.org/10.1002/hep.27726

  • Poordad F, Schiff ER, Vierling JM, Landis C, Fontana RJ, Yang R, et al. Daclatasvir with Sofosbuvir and ribavirin for Hepatitis C Virus infection with advanced cirrhosis or post-liver transplant recurrence. Hepatology. 2016; 63:1493–505. PMid: 26754432 PMCid: PMC5069651. https://doi.org/10.1002/hep.28446

  • Prakash S, Shukla S, Ramakrishna V, Jain A. Distribution of Hepatitis C genotypes in Uttar Pradesh, India; Rare genotype 4 detected. Journal of Medical Virology. 2018; 90:1875–81. PMid: 30085356. https://doi.org/10.1002/jmv.25277

  • Lole KS, Jha JA, Shrotri1 SP, Tandon BN, Mohan Prasad VG, Vidya A. Arankalle VA. Comparison of Hepatitis C Virus genotyping by 5′ Noncoding Region- and Core-based reverse transcriptase PCR assay with sequencing and use of the assay for determining subtype distribution in India. J Clin Microbiol.2003 Nov; 41(11):5240–4. PMid: 14605173 PMCid: PMC262521.https://doi.org/10.1128/JCM.41.11.5240-5244.2003

  • Deep A, Kumar A, Swaroop S. There is no need of investigating for genotype if we use Sofosbuvir and Daclatasvir for chronic Hepatitis C infection. Journal of Clinical and Experimental Hepatology. 2017; 7(2):S19. https://doi.org/10.1016/j.jceh.2017.05.043

  • Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, et al. Daclatasvir plus Sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a realworld cohort. Gut. 2016; 65:1861–70. PMid: 27605539 PMCid: PMC5099229. https://doi.org/10.1136/gutjnl-2016-312444


Abstract Views: 322

PDF Views: 98




  • Sofosbuvir and Daclatasvir Bypassing Genotypic Investigation of Chronic Hepatitis C Infection: A Real-Life Experience at Tertiary care center in North Indian Population Sofosbuvir and Daclatasvir Bypassing Genotypic Investigation

Abstract Views: 322  |  PDF Views: 98

Authors

Amar Deep
Experimental and Public Health Laboratory, Department of Zoology, University of Lucknow, Lucknow – 226007, Uttar Pradesh, India
Ajay Kumar
Department of Medicine, King George’s Medical University, Lucknow – 226003, Uttar Pradesh, India
Sumit Rungta
Department of Medical Gastroenterology, King George’s Medical University, Lucknow – 226003, Uttar Pradesh, India
Suchit Swaroop
Experimental and Public Health Laboratory, Department of Zoology, University of Lucknow, Lucknow – 226007, Uttar Pradesh, India

Abstract


Background and Aims: The goal of Hepatitis C Virus infection treatment is to remove the virus, to avoid advancement of Hepatitis C Virus (HCV) infection and progression of related disease such as liver cirrhosis and hepatocellular carcinoma and to achieve End of Treatment Response (ETR) with 12-week therapy and Sustained Virological Response (SVR) at post-treatment week 12 (SVR-12), which is defined as undetectable HCV RNA at 12 weeks post ETR. In the Compassionate Use Program (CUP) in Europe, Sofosbuvir (SOF) and Daclatasvir (DCV) were used in all genotypes and achieved SVR-12. Aims: Our aim is to compare the efficacy and effectiveness of Sofosbuvir and Daclatasvir in the treatment of HCV infection in the patients who could not afford for the investigating of HCVGenotype and to those in whom genotyping was done. Methods: Group 1 includes ten patients, given Sofosbuvir and Daclatasvir without genotype and group 2 includes nine patients, given Sofosbuvir and Daclatasvir with genotype. The patient group selection was done using a randomized table generated by using excel. All the patients in the groups completed the twelve weeks treatment with twelve weeks and twenty-four weeks of follow up. All the nineteen patients were given Sofosbuvir and Daclatasvir for twelve weeks and the endpoint of therapy was marked by undetectable HCV-RNA in blood by ETR-12 (end of treatment response), Sustained Virological Response at post-treatment week 12 (SVR-12) and Sustained Virological Response at post-treatment week 24 (SVR- 24). Results: Quantitative HCV-RNA (IU/ml) by RT-PCR was undetectable in all the patients in both groups at the end of treatment (ETR-12) and SVR-12- and SVR-24-weeks follow-up after completion of treatment i.e. Sofosbuvir and Daclatasvir has 100% ETR-12, SVR-12 and SVR-24 in both the groups. Conclusion: If patients do not investigate for genotype and use the Sofosbuvir and Daclatasvir in HCV infected patients, there is no effect on outcome ETR. This will reduce the risk of late stage complications such as liver cirrhosis and hepatocellular carcinoma and will also leads to the economic benefits such as no extra burden on patients.

Keywords


Cirrhosis, End of Treatment Response (ETR), Hepatocellular Carcinoma (HCC), Sofosbuvir and Daclatasvir (SOF+DCV), Steatosis, Sustained Virological Response (SVR).

References





DOI: https://doi.org/10.18311/jeoh%2F2020%2F24450