Telaprevir with Adjusted dose of Ribavirin in naive CHC-G1: Efficacy And Treatment in CHC in Hemodialysis population. TARGET C Trial- A Placebo Randomized Control Clinical Trial

P Patrick Basu, MD, MRCP, FACG, AGAF, Niraj J Shah, MD, Md Ashfique, MD, Sakina Farhat, MD, Ravi Siriki, MD. 1. Columbia University College of Physicians and Surgeons, NY 2. NSLIJHS/ Hofstra North Shore LIJ School of Medicine, NY 3. James J. Peters VA Medical Center, Mount Sinai School of Medicine, NY.

Objective: The prevalence of Chronic hepatitis C (CHC) in Hemodialysis population is 3%. Standard of care (SOC) offers reduced dose of Peg IFN Alfa (p-IFNα) and reduced Ribavirin (RBV) doses eliciting sub optimal SVR of 27%. Morbidity and mortality of CHC has impact on liver kidney transplant and graft failure. Triple therapy is SOC in CHC patients. Telaprevir is not cleared renally and hence is safe in the hemo-dialysis population. This study evaluated the efficacy of triple therapy with Telaprevir, adjusted dose of RBV and p-IFNα in naïve CHC-G1(CHC Genotype 1) individuals on hemodialysis as a Respond Guided Therapy (RGT)

Methods: Total of thirty five (n=35) naïve CHC-G1 were recruited and subdivided into two sub-groups.
Group A – (n=18): Received p-IFNα 135mcg once weekly, Telaprevir 750mg two tablets – TID for four days and three tablets BID post dialysis for three days along with RBV 400mg daily for 12 weeks followed by p-IFNα 135mcg plus RVB 400mg till 24weeks of duration
Group B- (n=17): Received p-IFNα 135 mcg once weekly with Telaprevir 750mg two tablets – TID for four days and three tablets BID post dialysis for three days (same as Group A) with RBV 200mg for 12 weeks followed by p-IFNα 135mcg with RBV 400mg till 48 weeks. The IL28B was evaluated for all individuals. Hematological, Liver and renal parameters were followed regularly during the trial. Viral load was followed to evaluate for response guided therapy (RGT) in all individuals.

Results: See table (VRVR- Very Rapid Virological Response, ETVR- End to treatment virological response)

• Triple therapy : In special hemodialysis patients with CHC has SVR of 63% in 24 weeks
• Traditional SOC: For 48 weeks- SVR was 25%
• Dual therapy with Placebo overlapped with reduced dose of RBV- yield SVR of 50%
• 24 weeks of triple therapy in ESRD on hemodialysis have substantial efficacy over 63%
• This study postulates truncated triple therapy with optimal retention, efficacy with cost show a definite benefit in treating this special population


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