Targeted therapy for uncontrolled erythrocytosis in PV with rusfertide

*rusfertide, a novel hepcidin mimetic

To view this content we will need your consent to set third party cookies.
For more detailed information, see our cookies page.

Accept third party cookies

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.

 

 

 

 

* 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)

ClinicalTrials.gov

clinicaltrials.gov

To view this content we will need your consent to set third party cookies.
For more detailed information, see our cookies page.

Accept third party cookies

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;"

• Does a high hematocrit change your blood's clotting profile? High altitude vs TRT?
• Are coagulation profiles in Andean highlanders with excessive erythrocytosis favoring hypercoagulability?

 

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;"

• Does a high hematocrit change your blood's clotting profile? High altitude vs TRT?
• Are coagulation profiles in Andean highlanders with excessive erythrocytosis favoring hypercoagulability?

Where have you been we are well aware here!

Testosterone Therapy and Erythrocytosis - the most common dose-limiting effect of testosterone therapy

https://www.thebloodproject.com/cases-archive/testosterone-therapy-and-erythrocytosis-2/ Introduction Androgens play a crucial role in the development and maintenance of: Male reproductive and sexual functions Body composition Erythropoiesis Muscle and bone health Cognitive function...

www.excelmale.com

Secondary Polycythemia

https://emedicine.medscape.com/article/205039-overview?form=fpf Practice Essentials In secondary polycythemia, the number of red blood cells (RBCs) is increased as a result of an underlying condition. Secondary polycythemia would more accurately be called secondary erythrocytosis or...

www.excelmale.com

High Testosterone on only 80mg/week

Also please enlighten us on where you attended medical school and where you got your degree in endocrinology? Your argument is small-minded and weak. If I told you, the moon revolves around the earth and the earth revolves around the sun, so by your logic, I don’t know what I’m talking about...

www.excelmale.com

 

This headline drew my attention: Targeted therapy for uncontrolled erythrocytosis in PV with rusfertide.​

The article/post may be out-of-date.

 

This headline drew my attention: Targeted therapy for uncontrolled erythrocytosis in PV with rusfertide.​

The article/post may be out-of-date.

The thread was meant for men who have PV and had nothing to do with men on testosterone therapy which is why it was posted under the Health and Wellness section of the forum.

 

To view this content we will need your consent to set third party cookies.
For more detailed information, see our cookies page.

Accept third party cookies

Arturo Molina, MD, Protagonist Therapeutics, discusses results from the phase 2 REVIVE clinical trial testing rusfertide in patients with polycythemia vera (PV).

PV is a myeloproliferative disorder characterized by an elevated absolute red blood cell mass caused by uncontrolled red blood cell production, frequently associated with uncontrolled white blood cell and platelet production.

The REVIVE clinical trial is a phase 2 study evaluating rusfertide in patients with PV. Rusfertide is a subcutaneous peptide hepcidin-mimetic compound. The trial consisted of three parts: part one, initial dose of 20 mg rusfertide; part two, patients were randomized to receive rusfertide or placebo; and part three, open-label extension where all patients receive rusfertide.

Of the 70 patients enrolled in part one, 59 were randomized in part two, and 58 continued to part three. The estimated average phlebotomy rate (EAPR) in patients prior to the study was 8.5/year. In part one, this was reduced to less than 1/year. In part two, the EAPR remained at less than 1/year in the rusfertide group and 6.6/year in the placebo group. An EAPR of less than 1/year remained in part three.

Rusfertide was observed to maintain hematocrit levels less than 45%, increase and stabilize platelet count, maintain stability of leukocyte counts, normalize mean serum ferritin levels, increase mean transferrin saturation, increase mean serum iron levels, and slightly increase mean corpuscular volume.The most common treatment-emergent adverse events included injection site reactions, fatigue, COVID-19, pruritus, arthralgia, dizziness, nausea, headache, and anemia.




Chapters:

Polycythemia Vera Overview 00:00
Rusfertide Overview 1:21
REVIVE Clinical Trial Results 2:10
Ongoing Phase 3 Trial 10:19