CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,203 enrolled
Drug / intervention
Sofosbuvir, Ribavirin, With or Without Pegylated Interferondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT02799355
NCT02799355N/ACompleted

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

Dayanand Medical College and Hospital·observational·Posted Jun 14, 2016·Updated Sep 27, 2016

In Brief

An observational study evaluating Sofosbuvir, Ribavirin, With or Without Pegylated Interferon for Hepatitis, Chronic. Completed, enrolled 1,203 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 14, 2016
Enrollment StartMay 1, 2016
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.0 years ago

Interventions

Sofosbuvir, Ribavirin, With or Without Pegylated Interferondrug

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