I have HDV and HBV

General Discussion
1

Hi

I am new to the forum, I have HDV and HBV.
The HBV has the antivirals but for the HDV, there is Bulevirtide but its not available in my country.

Anyone here has the experience or knowledge about HDV.
Please share.

Thanks.

Regards,

Suresh

2

Dear @Suresh786,

Welcome to the Community! I hope you can find the answers and support you need in this community. It is very supportive.

Bulevirtide is a very new drug (known in scientific circles by its original name, Myrcludex B). It is a very good drug for HDV that efficiently blocks entry of the virus into new cells. It also works quite well against HBV in cell culture and animal models, and it is in clinical trials against HBV. As an HBV virologists, I’m personally sure it will be approved for HBV too. I suspect the drug will be fairly rapidly approved in other countries too given that the safety and clinical data for it are quite impressive. I hope that happens in your country!

I wish you the best

John Tavis

1 Like
3

Dear @Suresh786,

Welcome to the community and I’m sorry to hear that it is difficult to get the treatment that you need. If you need more information about HDV, there are of course scientific and medical experts here to answer any questions you might have.

There are also some resources available. The Hepatitis B foundation has a whole site for HDV: https://www.hepb.org/research-and-programs/hepdeltaconnect/.

Hope this helps,
Thomas

4

When my viral load of HBV drops, will it drop the viral load of HDV also.

5

Not necessarily. Even if your HBV DNA load drops, the HDV load can stay high because the HBV drugs don’t affect HDV at all.

6

What is other option except to the PEGylated interferon, any other drug?

7

I don’t think there are any other drugs clinically approved for HDV infection. However, there are many HDV treatments that are in pre-clinical and clinical trials (see Hepatitis B Foundation: Drug Watch for a list of them).

Thomas

8

Thanks John.
Any idea when it will be approved by FDA for HDV.
Also what is expected cost

9

Dear @Suresh786,

As I understand it, Gilead (who own the rights to Bulevirtide/Hepcludex) submitted a biologics licence application in November last year (https://www.drugs.com/nda/bulevirtide_211119.html). The general timeline that I could see is that the approval should come within a year of that filing.

@john.tavis likely knows more about this process than me though, so I’ll defer to his opinion.

Hope this helps,
Thomas

10

Hi @Suresh786,

Thomas is probably right about the timing for approval in the USA, but the functioning of the US Food and Drug Administration (FDA, the government agency that regulates drugs) is quite opaque. Much of their staff has been shifted to emergency analysis of COVID therapeutics and vaccines, so a fast review is not assured. As to pricing—that is up to Gilead, and the drug is unlikely to be cheap. It is hard to make (it is a modified peptide that needs to be lipidated) and must be packaged into single-use syringes. That is much more expensive than making a pill.

On the plus side, I had a long conversation with the drug’s inventor, Dr. Stephan Urban, yesterday. He is a really great scientist and person. He’s set up a foundation to take some of the funds he received when Gilead purchased his company. He’s using this money to promote HBV and HDV cure and control efforts in the developing world. I am very impressed with his kindness and generosity.

John.

2 Likes
11

Thanks john. Some questions:

  1. Do you know the optimal dose of bulvertide, 2mg, 5mg or 10mg.
  2. How much is the success rate of bulvertide for HDV
  3. Will bulvertide help to clear HBV also
12

Dear @Suresh786,

The phase 3 trial of Bulevirtide is still ongoing, but the interim results (presented at a major international meeting last year - Bulevirtide Monotherapy at Low and High Doses in Patients With Chronic Hepatitis Delta: 24-Week Interim Data of the Phase 3 MYR301 Study) show that 2mg looks sufficient to get results (10mg doesn’t look much different).

After 24 weeks, about half of the patients on Bulevirtide end up having reduced liver inflammation or reduction in HDV viral load, ~40% with both.

HBV DNA markers and HBsAg don’t change that much, so it doesn’t directly help with HBV more than the current antiviral therapies.

Hope this helps,
Thomas

13

Thanks Thomas for the reply and the results.
How much percentage had negative HDV after the treatment?

14

They are only half way through the trial, but 6% go negative after being treated with 2mg, another 52% have at least a 100-fold drop.

1 Like
15

Hi all,

Just to add to Thomas’ comments. It is true that Bulvertide does not have stronger direct effects against HBV than the current drugs. However, it works by a totally different mechanism than current drugs, and that may well be quite useful as drugs are combined to seek a functional cure. We won’t be able to assess that possibility until it starts being tested in combinations, but I’m personally optimistic that blocking infection of new cells will help accelerate a cure.

John.

1 Like
16

Thanks Thomas.
Thanks John.
6% is not very good as that can be achieved with Interferon

17

These numbers are very preliminary as larger scale trials have not been completed, so the efficacy rate of Bulvertide is not yet known. Also, remember that the drug will not likely be used by itself. Its real potential will be revealed once it starts being combined with other drugs. That will take time because the investigators must be exceptionally careful not to place research participants in danger.

John.

1 Like
18

In addition to John’s great points, the trial is only gone through half way, there’s a good chance many more people will become HDV RNA negative. If you look at the graphs in that past graph, the hdv rna of the treated cohorts are continuing to go down. So people with initially higher levels may need a longer-term treatment to fully clear.

Bulevertide has also been used with interferon in previous trials, so it’s not just one or the other.

Thomas

19

Thanks a lot for the detailed replies. I pray that the treatment become available soon.

I had 3 Fibro Scan from 3 different laboratories. It came 12.9 from first lab in December 2021 then 9.1 from second lab in February 2022 and then 8 from third lab in March 2022.
What could be the reason?

20

This is a good sign that your liver damage is reducing over time. I’m not sure if you are on HBV antivirals but it could be an indication that they are working. Otherwise it may be your immune system, reducing the virus and also the liver inflammation.