Monarch study now includes hdv

[partimefriend]

Study now includes Hepatitis D 


Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic HBV(Monarch)

clinicaltrials.gov/ct2/show/NCT02577029?term=Arrowhead+pharmaceuticals&rank=2


infection of various genotypes, or patients with Hepatitis D Virus (HDV).

[qbeing1010]

From CDC:

Hepatitis D, also known as "delta hepatitis," is a liver infection caused by the Hepatitis D virus (HDV). Hepatitis D is uncommon in the United States. Hepatitis D only occurs among people who are infected with the Hepatitis B virus because HDV is an incomplete virus that requires the helper function of HBV to replicate. HDV can be an acute, short-term, infection or a long-term, chronic infection. Hepatitis D is transmitted through percutaneous or mucosal contact with infectious blood and can be acquired either as a coinfection with HBV or as superinfection in people with HBV infection. There is no vaccine for Hepatitis D, but it can be prevented in persons who are not already HBV-infected by Hepatitis B vaccination.

[dig]

They are expanding Monarch to several other locations around the world as well.

They expanded the dosing to include 4mg/kg

Here is a link to the changes.

clinicaltrials.gov/archive/NCT02577029/2016_06_01/changes

[dig]

Any time Arrowhead updates the clinical trials website it creates more questions for me.



Any thought on the new Arm added to the study that does not include NUCS.


“ ARC-520 with Peginterferon: ARC-520 (2 mg/kg every 4 weeks - 48 weeks) + Peginterferon alpha 2a (180 mcg weekly) - 48 weeks.”


Could it be that they are thinking that NUCs effect on the cccDNA is inhibiting ARC-520

                                                        Or


IT seems more likely to me they think that they might not need the NUCs in a combination.


Any thought as to why they would dose at 4mg in Monarch when they are/will be dosing ARC-520 at 5MG and 6MG in the 2001 extension.

“ARC-520 administered alone ARC-520 (2 mg/kg or 4 mg/kg every 4 weeks) for 48 weeks (13 doses).”


I realize they are using NUCs in the 2001 extension and in Monarch they are not using NUCs. It could be that is all there is to it but I would like to hear other opinions.


I am not sure when they added China to Monarch but, this is the same hospital they are using in the 2001 study. It is my guess anyone that does not get to FC in the 2001 study will enroll in Monarch so they can receive interferon as well as ARC-520.


“China: Queen Mary Hospital, Department of Medicine Not yet recruiting

Hong Kong, China Principal Investigator: Man-Fung Yuen, MD”