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

NCT02799355 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1203

Last updated 2016-09-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Dayanand Medical College and Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02799355 on ClinicalTrials.gov