Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium

Hepatitis, Chronic Clinical Trial

— GCNI-CHC  

Official title:

Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799355
• Other study ID #: GCNI-CHC
• Status: Completed
• Phase: N/A
• First received: May 18, 2016
• Last updated: September 24, 2016
• Start date: May 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Dayanand Medical College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Of the six main genotypes of the hepatitis C virus (HCV), genotypes 2 and 3 account for approximately 30% of chronic infections worldwide. In North India, Genotypes 3 and 1 account for 95% of chronic hepatitis C patients The first three direct-acting antiviral agents to receive FDA approval—boceprevir, telaprevir, and simeprevir—do not currently have a role in the treatment of genotype 3 infection. In contrast, the direct-acting antiviral agents, daclatasvir and sofosbuvir, have good activity against all genotypes. The SVR rates of 90 - 100% in genotype 3 were achieved with oral sofosbuvir plus ribavirin regimen to 24 weeks. Similar SVR rates were achieved in Genotype 1 with oral sofosbuvir plus weight based ribavirin and Pegylated Interferon alpha 2 a. However, the ongoing discovery and development of agents that directly target various stages of HCV replication are likely to provide HCV-infected patients with effective interferon-free therapy. HCV genotype 3 infection is associated with a higher incidence of hepatic steatosis, more rapid progression of fibrosis, and possibly a greater risk of hepatocellular carcinoma than is HCV genotype 2 infection.Moreover, patients with HCV genotype 3 infection are less responsive to peginterferon based treatment than are patients with HCV genotype 2 infection.

Description:

Sofosbuvir is an oral nucleotide analogue inhibitor of the HCV NS5B polymerase that is effective against HCV genotypes 2 and 3 when it is administered in combination with weight based ribavirin for 24 weeks. In Genotype 1, a combination of Pegylated Interferon alpha 2 a with oral Sofosbuvir and weight based Ribavirin for 12 weeks resulted in 90 -100 % sustained virological response rates (SVR). These SVR rates for chronic hepatitis C genotypes 1,2 and 3 are all based on Western studies. The investigators plan to conduct a retrospective study in Northern India region on patients treated with Sofosbuvir and Ribavirin or Sofosbuvir, Ribavirin and Peginterferon alpha 2a. The purpose of the investigators study is to assess the percentage of patients with sustained virologic response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1203
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age more then 18 years.

• Patient who on treatment of either Sofosbuvir and Ribavirin (24 weeks) or Sofosbuvir, Ribavirin and peginterferon (12 weeks).

Exclusion Criteria:

• Patient who are lost to follow up.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Chronic

Intervention

Drug:
• Sofosbuvir, Ribavirin, With or Without Pegylated Interferon
Retrospective will carried out to find percentage of patients with sustained virologic response at 12 weeks after the end of treatment

Locations

Country	Name	City	State
India	Department of Gastroenterology, D.M.C. and Hospital	Ludhiana	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Dayanand Medical College and Hospital

Country where clinical trial is conducted

India, 

References & Publications (13)

Alberti A. Optimizing PEG-interferon and ribavirin combination therapy for patients infected with HCV-2 or HCV-3: is the puzzle completed? J Hepatol. 2004 Jun;40(6):1032-5. Review. — View Citation

Chakravarti A, Dogra G, Verma V, Srivastava AP. Distribution pattern of HCV genotypes & its association with viral load. Indian J Med Res. 2011 Mar;133:326-31. — View Citation

European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2011 Aug;55(2):245-64. doi: 10.1016/j.jhep.2011.02.023. Epub 2011 Mar 1. — View Citation

Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, Hindes RG, Berrey MM. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):34-44. doi: 10.1056/NEJMoa1208953. — View Citation

Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. doi: 10.1002/hep.22759. — View Citation

Goossens N, Negro F. Is genotype 3 of the hepatitis C virus the new villain? Hepatology. 2014 Jun;59(6):2403-12. doi: 10.1002/hep.26905. Epub 2014 Apr 14. Review. — View Citation

Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh — View Citation

Manns MP, von Hahn T. Novel therapies for hepatitis C - one pill fits all? Nat Rev Drug Discov. 2013 Aug;12(8):595-610. doi: 10.1038/nrd4050. Epub 2013 Jun 28. Review. — View Citation

Marcellin P, Cheinquer H, Curescu M, Dusheiko GM, Ferenci P, Horban A, Jensen D, Lengyel G, Mangia A, Ouzan D, Puoti M, Rodriguez-Torres M, Shiffman ML, Schmitz M, Tatsch F, Rizzetto M. High sustained virologic response rates in rapid virologic response p — View Citation

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(4):145-8. — View Citation

Tapper EB, Afdhal NH. Is 3 the new 1: perspectives on virology, natural history and treatment for hepatitis C genotype 3. J Viral Hepat. 2013 Oct;20(10):669-77. doi: 10.1111/jvh.12168. Review. — View Citation

Wartelle-Bladou C, Le Folgoc G, Bourlière M, Lecomte L. Hepatitis C therapy in non-genotype 1 patients: the near future. J Viral Hepat. 2012 Aug;19(8):525-36. doi: 10.1111/j.1365-2893.2012.01634.x. Review. — View Citation

Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hézode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with sustained virologic response at 12 weeks after the end of treatment.	Sustained virologic response was defined as a level of HCV RNA below the lower limit of quantification (25 IU per milliliter)	3 month	Yes
Secondary	Side effect	Assess the treatment side effect	3 month	Yes