Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium
Condition: Hepatitis, Chronic
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Chronic
Study type: Observational

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.
    

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.
    

Intervention name(s): Sofosbuvir, Ribavirin, With or Without Pegylated Interferon
Intervention type(s): Drug
Intervention description(s): Retrospective will carried out to find percentage of patients with sustained virologic response at 12 weeks after the end of treatment
Other intervention name(s): Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon
Intervention MeSH terms: Interferons; Ribavirin; Sofosbuvir
Time perspective: Retrospective
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