An observational study in Hepatitis, Chronic, sponsored by Dayanand Medical College and Hospital. Completed at 1 site in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-09-27.
Sponsored by Dayanand Medical College and Hospital · Observational
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.
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.
83 studies on the registry are indexed under Hepatitis, Chronic; 10 are open to participants now.
This study's enrollment of 1,203 is above the median of 600 across 19 observational studies indexed under Hepatitis, Chronic.
Browse Hepatitis, Chronic studies →Dayanand Medical College and Hospital is the lead sponsor of 9 studies on the registry; none are open to participants now.
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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
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Drug pages: Sofosbuvir · Ribavirin · Interferons
Retrospective will carried out to find percentage of patients with sustained virologic response at 12 weeks after the end of treatment
Also known as: Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon
Proportion of patients with sustained virologic response at 12 weeks after the end of treatment.
Sustained virologic response was defined as a level of HCV RNA below the lower limit of quantification (25 IU per milliliter)
Time frame: 3 month
Side effect
Assess the treatment side effect
Time frame: 3 month
Plan to share: Undecided
The record gives a start of May 2016, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Dayanand Medical College and Hospital