People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents

Summary

Participation Requirements

Description

We intend to observe up to 350 patients with chronic HCV infection who have successfully eradiated HCV following therapy with direct acting antiviral agents and describe the clinical, virological, laboratory, histological and immunological outcomes following eradication of HCV. Subjects will be recr...

We intend to observe up to 350 patients with chronic HCV infection who have successfully eradiated HCV following therapy with direct acting antiviral agents and describe the clinical, virological, laboratory, histological and immunological outcomes following eradication of HCV. Subjects will be recruited from two sources: 1) subjects who have already achieved SVR with a DAA only regimen and who have undergone a liver biopsy within five years prior to therapy and no history of hepatic decompensation or hepatocellular carcinoma and 2) treatment na(SqrRoot) ve or experienced who have failed a prior treatment (including DAA-experienced) who are willing to undergo a pre-treatment liver biopsy. Subjects yet to achieve SVR with evidence of clinical cirrhosis will undergo a transjugular liver biopsy with measurement of portal pressures in lieu of the percutaneous liver biopsy. Subjects yet to achieve an SVR will receive 12 weeks of therapy with sofosbuvir/velapatasvir fixed dose combination. Subjects who have attained a SVR (or upon achieving an SVR) will undergo a thorough medical evaluation, laboratory testing, transient elastography and hepatic ultrasound. Thereafter, subjects will be followed prospectively every 24 weeks for liver decompensation (ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, variceal hemorrhage), hepatocellular carcinoma, liver-related mortality and all-cause mortality. During each study visit, subjects will be questioned on the development of these adverse outcomes. In addition, blood will be drawn for the assessment of routine blood tests, quantitative viral biomarker levels, serological response markers and immune cell functional status. Blood, urine and stool will be collected and stored for exploratory biomarker development. Transient elastography will be performed annually in all subjects. For subjects with cirrhosis, esophagogastroduodenoscopy will be performed annually and imaging every 24 weeks. At the end of 240 weeks, all subjects will be admitted to undergo a liver biopsy to assess the stage of liver fibrosis. In subjects with cirrhosis at study entry, the liver biopsy will be performed by the transjugular route with hepatic venous pressure measurements. The primary goal of the study will be to describe the natural history of viral eradication following treatment with direct acting antiviral agents, to identify predictors of adverse outcomes after sustained viral eradication and regression of fibrosis/cirrhosis.

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