A long-term monitoring study to evaluate the persistence of direct acting antiviral (DAA) treatment-resistant mutations or the durability of sustained virological response in patients treated with DAA-containing regimens for chronic hepatitis C infection

Study Status

Open to Enrollment

Study Description

Despite the reduction of development of drug resistance when direct acting antivirals (DAAs) are used in combination with standard of care to treat hepatitis c, recent reports have shown that protease-resistant mutations may persist for 7 months after treatment. Also, resistant variants in a gene in the hepatitis c virus have been demonstrated in patients treated with boceprevir up to 4 years after the completion of direct acting antivirals.

The purpose of this study is to monitor for resistance mutations once the antivirals have been withdrawn. The speed at which DAA(s) resistant mutation(s) are replaced by virus unchanged by having developed drug resistance may have important implications for subsequent treatment of hepatitis c.

The purpose of this study is to also investigate the long-term response of the hepatitis c virus to antiviral medication.

Disease Status and/or Stage

Chronic Hepatitis C

Sponsor

Roche

Key Eligibility

  • Patients who have participated in Roche DAA treatment protocol or protocols for the treatment of chronic hepatitis c infection and who have:
    • Developed direct antiviral-associated resistant mutations which persisted through the last evaluation of drug resistance in the donor protocols; or achieved only a partial viral response; or experienced a viral load rebound while on RO5024048 treatment not associated with selection of S282T resistance mutations
    • Achieved sustained virological response (SVR), or undetectable hepatitis c virus ≥ 20 weeks after the last dose of study medication
  • More detailed eligibility requirements will be discussed with you when you contact the study team

Principal Investigator

Ira Jacobson, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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