Targeted therapy for uncontrolled erythrocytosis in PV with rusfertide

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madman

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*rusfertide, a novel hepcidin mimetic





Elevated hematocrit is a hallmark of polycythemia vera (PV), and it is associated with higher rates of death. Whilst it is essential to maintain hematocrit levels below 45% to decrease the risk of thrombotic and cardiovascular events, current standards of care (SOC) are not effective in the majority of patients. In this presentation, Ronald Hoffman, MD, presents results from the REVIVE study (NCT04057040), which evaluated the efficacy of rusfertide, a novel hepcidin mimetic, in patients with PV. The study met its primary endpoint of maintaining hematocrit levels below 45% and demonstrated that rusfertide was highly efficacious in controlling erythrocytosis. The data from the randomized withdrawal phase demonstrated the superior efficacy of rusfertide in eliminating the need for additional therapeutic phlebotomies as compared to placebo. Rusfertide therapy was associated with persistent hematocrit (HCT) control and improvements in PV-related symptoms. The treatment was generally well tolerated. The positive outcomes of the REVIVE study showcase the efficacy and tolerability of rusfertide as a highly effective therapy for uncontrolled erythrocytosis and associated symptoms in PV and is currently being investigated in the ongoing Phase III VERIFY study (NCT05210790). This press briefing took place at the European Hematology Association (EHA) Congress 2023, held in Frankfurt, Germany.
 

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* Long-term data demonstrate that the initial hematocrit responses and decrease in phlebotomy needs are maintained, with no new safety signals reported. The agent is now being studied further in the Phase III VERIFY study (NCT05210790)






Kristen Pettit, MD, University of Michigan, Ann Arbor, MI, presents the updated
long-term results of the Phase II REVIVE study (NCT04057040), which evaluated rusfertide in patients with polycythemia vera (PV) who are phlebotomy dependent
. Long-term data demonstrate that the initial hematocrit responses and decrease in phlebotomy needs are maintained, with no new safety signals reported. The agent is now being studied further in the Phase III VERIFY study (NCT05210790). This interview took place at the 29th Congress of the European Hematology Association (EHA) in Madrid, Spain.
 
Polycythemia vera (PV) is a cancer; secondary erythrocytosis, whether caused by TRT, OSA, or altitude, is not.

*** TLDNR regarding HCT and donation: If you are asymptomatic (e.g., have NO SYMPTOMS), then do nothing about erythrocytosis secondary to TRT.***

Evidence-based Source About Elevated Hematocrit (Due to TRT or Gear) & Donation:
Up To Date (paywall): Polycythemia vera and secondary polycythemia: Treatment and prognosis (SECONDARY POLYCYTHEMIA section)
"There is no persuasive evidence that prophylactic phlebotomy or cytoreduction reduces the risk of thrombosis in patients with secondary [erythrocytosis]."
Note: polycythemia vera (a cancer) is often wrongly confused with secondary erythrocytosis.!
For those WITH SYMPTOMS: "There is no specific target Hct for patients with secondary [erythrocytosis]. Rather, cautious phlebotomy (e.g., removal of 250 mL blood, replaced by an equal volume of crystalloid) may be evaluated for symptom relief;"
 
Polycythemia vera (PV) is a cancer; secondary erythrocytosis, whether caused by TRT, OSA, or altitude, is not.

*** TLDNR regarding HCT and donation: If you are asymptomatic (e.g., have NO SYMPTOMS), then do nothing about erythrocytosis secondary to TRT.***

Evidence-based Source About Elevated Hematocrit (Due to TRT or Gear) & Donation:
Up To Date (paywall): Polycythemia vera and secondary polycythemia: Treatment and prognosis (SECONDARY POLYCYTHEMIA section)
"There is no persuasive evidence that prophylactic phlebotomy or cytoreduction reduces the risk of thrombosis in patients with secondary [erythrocytosis]."
Note: polycythemia vera (a cancer) is often wrongly confused with secondary erythrocytosis.!
For those WITH SYMPTOMS: "There is no specific target Hct for patients with secondary [erythrocytosis]. Rather, cautious phlebotomy (e.g., removal of 250 mL blood, replaced by an equal volume of crystalloid) may be evaluated for symptom relief;"

Where have you been we are well aware here!






 
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