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

Trial ID:
IRB-10-5500
Paul Pockros
This observational long-term follow-up study will assess the persistence of dire ct acting antiviral (DAA) resistant mutations and the durability of sustained vi rological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood s ampling 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

Contact Info:

  • Reference Study ID Number: NV22688 www.roche.com/about_roche/roche_worldwide.htm
  • global.rochegenentechtrials@roche.com
  • 888-662-6728