An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens



Status:Terminated
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2010
End Date:April 2015

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A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections (CHC)

This observational long-term follow-up study will assess the persistence of direct acting
antiviral (DAA) resistant mutations and the durability of sustained virological response in
patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol.
Up to 5 scheduled monitoring visits for blood sampling during an observational period of up
to 36 months.


Inclusion Criteria:

- adult patients, >/=18 years of age

- chronic hepatitis C

- participation in Roche DAA treatment protocol for CHC infection

- DAA-associated resistant mutations persisting through to last evaluation in donor
protocol , or partial viral response or viral load rebound while on RO5024048
treatment, or sustained virological response >/= 20 weeks after last dose of study
medication in donor study

Exclusion Criteria:

- For patients participating in DAA resistance monitoring: Initiation of treatment
after participation in the donor protocol for which there is evidence of
cross-resistance to donor protocol DAA

- For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy
since establishing SVR in the donor study
We found this trial at
35
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