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EASL Telaprevir Report (coinfection too)
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From Jules: In this report is information on responses to treatment by treatment-naives & prior treated, IL28B, early responses predict outcome for all including African-Americans & Latinos, anemia & SVR, and drug resistance. The FDA hearings for telaprevir & boceprevir are in 10 days on April 27 & 28, and so I expect these drugs to be available shortly after that.
Coinfection HCV/HIV
CROI: Telaprevir + Peginterferon and Ribavirin: phase 2a study in coinfected patients on HAART Reported at CROI March 2 2011 - (03/2/11)
CROI: Positive Phase 2 Interim Data from First Study of Telaprevir in People Co-Infected with Hepatitis C and HIV Presented at CROI Conference - (03/2/11)
Vertex press release
CROI: Pharmacokinetic Interactions Between Antiretroviral Agents and the Investigational HCV Protease Inhibitor Telaprevir in Healthy Volunteers - (03/2/11)
CROI: Clinical Pharmacology of Boceprevir: Metabolism, Excretion, and Drug-Drug Interactions - (03/2/11)
CROI: Summary from CROI for Hepatitis Coinfection - New drugs for treatment of hepatitis C are becoming available: what does that mean for the HIV coinfected patient? - Jurgen K. Rockstroh M.D., Professor of Medicine University of Bonn, Germany - (03/19/11)
EASL
EASL: Telaprevir Week 4 Response Predicts Outcome (SVR) - (04/13/11)
The very early responses of being undetectable by week 1 as well as week 2 and week 4 appears to be predictive in these studies in HCV monoinfected patients. read this, its very interesting. Treatment-naive patients with a good response at both weeks 4 and 12, undetectable viral load, can shorten duration of therapy to 24 weeks.
EASL: Telaprevir Substantially Improved SVR Rates Across All IL28B Genotypes in the ADVANCE Study - (04/03/11)
In treatment-naive patients, those never treated before: those with CC did better (90% SVR), CT 71% SVR, TT 73%, so although IL28B can predict if you will do better, its not very relevant at all because you won't not treat if a patient is CT or TT but it means if a patient is CC the chance for SVR is very high. The big key in my opinion is adherence, although Vertex did not present an adherence analysis my guess is if a patient is 100% adherent that will make increase the chance for achieving SVR a lot.
EASL: Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin Increased Sustained Virologic Response Rates in Treatment-naïve Patients Regardless of Race or Ethnicity - (04/01/11)
- SVR 61% for African-Americans, 70% for Latinos, 74% for others.
- At week 4 (RVR), 61% of AAs, 64% of Latinos, 72% of caucasians had undetectable viral load.
- At weeks 4 & 12: 46% of AAs, 58% of Latinos, 64% of caucasians had undetectable viral load & could stop therapy after total of 24 weeks.
EASL: Anemia had No Effect on Efficacy Outcomes in Treatment-naïve Patients Who Received Telaprevir-based Regimen in the ADVANCE and ILLUMINATE Phase 3 Studies - (04/04/11) - patients developing anemia on the 3 drugs in this study, low discontinuation rate, SVR rates were the same as for patients who developed anemia, EPO not used. Ribavirin dose interruptions/modifications were used.
EASL: Similar SVR Rates in IL28B CC, CT or TT Prior Relapser, Partial- or Null-responder Patients Treated with Telaprevir/Peginterferon/Ribavirin: Retrospective Analysis of the REALIZE Study - (04/01/11) Amongst these prior relapsers, partial responders & null responders, responses were similar regardless of whether a patient was IL28B CC, CT or TT, so there was little value in trying to predict outcome by IL28B genotype based on this study in prior treated patients.
(Lead-In, 1a vs 1b, cirrhotics)
EASL: REALIZE Trial Final Results: Telaprevir-based Regimen for Genotype 1 Hepatitis C Virus Infection in Patients with Prior Null Response, Partial Response or Relapse to Peginterferon/Ribavirin - (04/01/11)
- 85% SVR for prior relapsers; 56% for prior partial responders; 31% for prior null responders with 48 weeks treatment (12 weeks telaprevir, 48 weeks peg/rbv)
- Lead-In - in this study a 4 week lead-in with peg/rbv alone then adding telaprevir showed no benefit compared to starting all 3 drugs together in terms of SVR.
- 1a vs 1b genotype: for prior null responders - 27% SVR for 1a vs 37% for 1b; for partial prior responders - 47% for 1a vs 68% for 1b; for relapsers no real difference - 84% for 1a vs 88% for 1b.
- cirrhotics did not do as well if they were prior partial responders or null responders but did the same if they were prior relapsers. Partial prior responders: 72% SVR if no or minimal fibrosis; 56% SVR with bridging cirrhosis; 34% if cirrhotic. For prior null responders 41% with no or minimal fibrosis & 39% with bridging fibrosis had SVR compared with 14% SVR for those with cirrhosis.
EASL: Evolution of Treatment-Emergent Variants in Telaprevir Phase 3 Clinical Trials - (04/03/11)
EASL: HCV Drug Resistance - (04/06/11)
Vertex Press Release:
EASL: Results From Phase 3 REALIZE Study Showed Telaprevir-Based Therapy Significantly Improved SVR (Viral Cure) Rates in People Whose Prior Treatment For Hepatitis C Was Unsuccessful - (03/31/11)
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