Romiplostim’s Effect to Optimize SVR with Telaprevir, Ribavirin, And Peg Interferon-alfa 2a in Thrombocytopenic Cirrhotics with Chronic Hepatitis C. A Placebo Controlled Prospective Clinical Trial: RESTRAINT C Trial

Prithwijit Basu, MD, MRCP, FACG, AGAF, Niraj J Shah, MD, Ravi Siriki, MD, Md Ashfique, MD, Sakina Farhat, MD. 1Columbia 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.

Objectives: Treating CHC (Chronic hepatitis C) cirrhotic patients with thrombocytopenia is often challenging; requiring dose reduction or even discontinuation of treatment to avoid complications. Significant dose reduction affects the response guided therapy (RGT); adversely affecting outcomes. Thrombopoietin (TPO) agonists are used to avoid disruption or therapeutic failure to optimize SVR (Sustained Virological response). This study evaluated the use of TPO agonist in thrombocytopenia in cirrhotics with treatment experienced CHC-GT1 (CHC-Genotype 1) on treatment with Telaprevir, Ribavirin (RBV) and Peg Interferon-alfa 2a (p-IFNα-2a).

Methods: Total of Forty five (n=45) cirrhotic treatment experienced CHC-GT1 patients with a mean MELD of 16 and mean platelet count 95 thousand were recruited and subdivided into three groups. Group A- (n=15) Received placebo plus reduced dose of p-IFNα-2a with RBV and Telaprevir. Group B (n=15) Received Romiplostim 500 mcg lead in 1 month prior to initiation of therapy and SOC with Telaprevir. Group C (n=15) Received Elthrombopag 50mg orally daily lead in prior 15 days and SOC with Telaprevir for 12 weeks. RGT was analyzed with serial platelet counts, hemoglobin/hematocrit, absolute neutrophils count and platelet antibodies. HCV RNA quantitative count was measured at 1ST, 2ND, 4TH, 12TH 24TH, 36TH and 60th weeks for SVR.

Results: See table. ( VRVR- Very Rapid Virological Response, ETVR- End to treatment Virological Response, R- Relapser, PR- Partial Responder, BT- Break through )

Conclusion:
• TPO agonist in moderate to severe Thrombocytopenia is approved in the treatment of CHC
• This study demonstrates the efficacy of TPO agonist ( Romiplostim 250 mcg IM ) in Thrombocytopenic Cirrhotics (prior experienced) with triple therapy
• Romiplostim demonstrated higher retention rate without therapeutic disruption and higher SVR compared to placebo
• Both the TPO agonist has comparable SVR, yet the cost index and pill burden is higher in Elthrombopag group
• Cirrhotics with minimal Hepatic encephalopathy can be challenging with high pill burden that affect negatively with SVR due to compromised compliance
• Span of Platelet survival with optimal quantity remains longer in Romiplostim group. Also is required at a lesser frequency
• This pilot needs a larger controlled trial to validate
 

 

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