3-Year Observational Virology Follow-up Study in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
All subjects in this study have previously been in an Idenix HCV study and received study drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study will not be enrolled in this study.
In this study, researchers will try to find answers to these questions:
- How much (if any) hepatitis C virus is in your blood after stopping your Idenix study drug?
- Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or similar drugs?
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals|
- Durability of Sustained viral response [SVR] [ Time Frame: every 3 months ] [ Designated as safety issue: No ]To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time.
- Kinetics of resistant variants [ Time Frame: every 3 months ] [ Designated as safety issue: No ]To describe the kinetics of resistant variants to Idenix direct acting antivirals (DAAs) by HCV RNA sequencing. The presence of each identified resistant variant in the viral population will be descriptively evaluated until the viral population consists entirely of wild-type virus or over a period of 3 years, whichever comes first.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
The data obtained from this study will be used to further understand the long-term efficacy of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to Idenix DAAs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721265
|Contact: John Z Sullivan-Bolyai, MD, MPH||1877-433-6491||Sullivan-Bolyai.John@idenix.com|
|United States, Kansas|
|Overland Park, Kansas, United States, 66212|