Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium (GCNI-CHC)

September 24, 2016 updated by: Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Department of Gastroenterology, D.M.C. and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with sustained virologic response at 12 weeks after the end of treatment.
Time Frame: 3 month
Sustained virologic response was defined as a level of HCV RNA below the lower limit of quantification (25 IU per milliliter)
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effect
Time Frame: 3 month
Assess the treatment side effect
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dayanand Medical College and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 24, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCNI-CHC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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