Hi Colleague my doctor told me today to explore hap D treatment in Europe because the European Union has approved a drug (Hepcludex). The drug has not been approved in the US. Any one with experience with this drug?
I’ve included a journal article which looks at the experience of 114 patients being treated with Hepcludex (bulevirtide) in Hepatitis D patients.
It seems that people have responded well to the treatment in clinical trials but hopefully someone on the forum will be able to tell you their personal experiences with the drug.
Thank you. Hopefully we hear from someone. Do know anything about cost for non-EU resident? Or anyone know anything about cost?
I know @Pietro_Lampertico has been involved with a lot of the studies with Hepcludex/Bulevertide (Safety and effectiveness of up to 3 years' bulevirtide monotherapy in patients with HDV-related cirrhosis - PubMed) and could give some comment. Having seen his presentations at the recent Singapore cure meeting, it looks like it is well tolerated and helps slow down or stop liver damage in HDV infection. I’m not sure if he can share some comments on cost though.
I was heard that this drug could be the closest one to us for the functional cure, as it already shown effectiveness for HBV infection. I read the news that FDA rejected it but did not demand new trail. Is this drug now investigated particularly for hep B and is there any trails on this?
Dear @DZ6 ,
Unfortunately, bulevirtide has little impact on HBV infection so there is not really any role for this drug in functional cure for HBV.
In patients with HBV / HDV co-infection, this drug works by preventing the entry of HDV into cells by the NTCP receptor. The latest trial data show that ~55% of patients do not experience clinically significant (> 2 log decline from baseline) HDV RNA response to this drug, with only ~12% of patients achieving clearance of HDV RNA with continued therapy. There now a growing problem with the development of resistance (and rebound of HDV infection) during bulevirtide therapy in patients after ~1 year of therapy. This is likely driven by selection of HDV which can entry hepatocytes via an NTCP-independent mechanism.
One month of bulevirtide costs 13,500 Euro.