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Completed

NCT Number: NCT02799355

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Ludhiana, Punjab, 141001, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon

Primary outcomes

  1. 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)

Secondary outcomes

  1. Side effect

    Time frame: 3 month

    Assess the treatment side effect

Sponsors and collaborators

Lead sponsor

Dayanand Medical College and Hospital

Other

Registry information

Acronym: GCNI-CHC

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 14, 2016
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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