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

NCT02799355 | Completed DMC

• 1 other identifier: GCNI-CHC
• Study Type: observational
• Target: 1,203
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis, Chronic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Side effect

  3 month

Interventions

Sofosbuvir, Ribavirin, With or Without Pegylated Interferon DRUG

Retrospective will carried out to find percentage of patients with sustained virologic response at 12 weeks after the end of treatment

Also known as: Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study is a retrospective study conducted on 1500 to 2000 patients who have recieved treatment of Sofosbuvir and Ribavirin or Sofosbuvir, Ribavirin and peg interferon alpha 2a

You may qualify if:

• Age more then 18 years.
• Patient who on treatment of either Sofosbuvir and Ribavirin (24 weeks) or Sofosbuvir, Ribavirin and peginterferon (12 weeks).

You may not qualify if:

• Patient who are lost to follow up.

Sponsors & Collaborators

• Dayanand Medical College and Hospital: lead

Study Sites (1)

Department of Gastroenterology, D.M.C. and Hospital

Ludhiana, Punjab, 141001, India

Location

Related Publications (13)

• 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.

  PMID: 24010641 RESULT

• 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. No abstract available.

  PMID: 19330875 RESULT

• 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. No abstract available.

  PMID: 21371579 RESULT

• 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.

  PMID: 24155107 RESULT

• Wartelle-Bladou C, Le Folgoc G, Bourliere 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.

  PMID: 22762136 RESULT

• 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 patients in the large real-world PROPHESYS cohort confirm results from randomized clinical trials. Hepatology. 2012 Dec;56(6):2039-50. doi: 10.1002/hep.25892. Epub 2012 Aug 8.

  PMID: 22706730 RESULT

• 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. doi: 10.1016/j.jhep.2004.04.008. No abstract available.

  PMID: 15158348 RESULT

• 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.

  PMID: 23807378 RESULT

• 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 AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.

  PMID: 23607594 RESULT

• 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, Hezode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4.

  PMID: 24795201 RESULT

• 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.

  PMID: 23281974 RESULT

• 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(3):326-31.

  PMID: 21441689 RESULT

• 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.

  PMID: 15147119 RESULT

MeSH Terms

Conditions

Hepatitis, Chronic

Interventions

Sofosbuvir; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 14, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

IN (1)