I wonder what are the FDA case here… they cited manufacturing and delivery issue….this come out the same day Gilead reported 5% decrease of revenue….
But……
Wow, not sure what is going on here, but Gilead seem to be resubmitting. I’m sure there will be a point soon that it will be approved, it doesn’t look like it’s due to the safety aspect but instead the production somehow. Perhaps @john.tavis has a bit more idea around this?
By the way, the last line is particularly bad: “transmitted through broken skin via sexual contact or contact with tainted syringes” is not right for most cases…
TT
These press releases always have to be taken with a grain of salt. It is worth pointing out that production control by the EMA, BFARM (Germany) and ANSM (France) are at least as stringent and demanding as that of the FDA. Bulevirtide was granted conditional approval in the EU so its unclear how this could be an issue.
It is important to note that HDV rebound during bulevirtide therapy is now becoming increasingly prevalent in the patient populations in Europe now that we are seeing longer term exposure in these jurisdictions. This is an important concern as the large majority of patients have a significant proportion of HDV which is not affected by long term bulevirtide therapy. There is a concern amongst many physicians, some of which was voiced at the recent Deltacure meeting in Milan that viral rebound may occur in many of these patients.
Thanks @availlant ….HDV rebound is a big problem. I wonder if they are working to improve that…
Thanks for the info always!!
Unfortunately, this is a fundamental issue with how bulevirtide works which cannot be corrected, even with increased dosing.
It is important to note here that there are no safety issues with bulevirtide and as noted in the Gilead press release, normalization of liver function does occur in 48% of patients. In the short term, lives hang in the balance with this co-infection so access to any intervention , even if only temporarily effective, is critical.
This is why are are making REP 2139-Mg available on a compassionate use basis to patients with very advanced liver disease (most of these have failed to respond to or experienced HDV rebound on 2 or 10mg bulevirtide)
Thank you…agreed any intervention will help…in the meantime, we all looking forward to Rep 2139 MG…hopefully it will be ready and approved sooner than anticipated…2025!!
Doctor @availlant , is there anything new about bulevirtide treatment? How long did it remain effective in reducing HDV?
I ask these questions to verify that the agency responsible for authorizing the use of new medicines granted a visa for bulevirtide last year.
Dear @La.sciamachie ,
For the community at large: Buleviritde (BLV) is a medicine which inhibits the entry mechanism of HBV and HDV viruses into liver cells which uses a specific receptor on the surface of the cell (the NTCP receptor). This drug has little overall impact on HBV infection but has some important effects on HDV levels in the blood. BLV is taken by a daily SC injection (at the 2 mg dose) and is safe and well tolerated.
The latest phase III clinical trial data with BLV mirrors earlier clinical data showing that it is effective in reducing HDV RNA and normalizing liver function at about half the patients who receive treatment. Of these patients a small fraction (12% at the 2mg dose) achieve undetectable HDV RNA.
As you mentioned, BLV has been conditionally approved for the treatment of HDV co-infection in Europe based on earlier phase IIB data and BLV was also used under compassionate use prior to that. From this significant exposure data we now understand the following:
To date only one patient case has been published where BLV could be removed with persistent HDV RNA loss. This means that BLVwill be a life long therapy in almost all patients.
With longer exposure to BLV therapy (> 1 year) there is a significant (and growing) proportion of patients which develop HDV rebound while still on therapy. This is likely due to the presence of additional (but lower efficiency) NTCP-independent entry pathways utilized by a subset of HDV virus produced by the liver which is not targeted by BLV.
If you have HDV co-infection, starting BLV therapy is something you should consider as it can have a real chance to provide control of your HDV infection and stop the progression of liver disease. This is important for this subset of patients with HBV infection since liver disease progresses much faster in the presence of HDV co-infection.
Thank you for your continued attention to us, @availlant . I still don’t know my real condition, but I’m already waiting for new data and the entry of promising medicines onto the market, especially those from Replicore.