Hi everyone! I recently signed up for the B-United study to research a potential cure for hepatitis B. It is a sequential study with daplusiran/tomligisiran, followed by bepirovirsen. I know that there have been multiple other trials with bepirovirsen only, so I feel hopeful that this can help. It looks like it might still be recruiting. Curious if anyone else here is participating in this one?
https://www.bunitedstudy.com/
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Update:
I just got my 3rd injection last week. I’m currently 2 months in since starting treatment with the study drug. Feeling slightly frustrated/discouraged because my surface antigen levels are more or less the same as when I started. That being said, this first phase of the study with daplusiran/tomligisiran might be a placebo, and neither I, nor the study doctor knows which treatment arm I’m assigned to. The good news is that even if I’m getting placebo now, the second phase of the study includes treatment with bepirovirsen, and there is no placebo for that phase.
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Hi @et5656,
Your frustration is understandable, but these things take some time to see their effect, hence the multiple injections. Could it be that you are receiving a placebo? Which can be difficult to tell because no one knows who is getting what. A unique feature of a randomized clinical trial. Hopefully, things begin to look promising down the road for you. Keep us posted. Bansah1
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I pray for your recovery. Thanks for keeping us posted.
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I just got my last injection of DAP/TOM, and I start treatment with Bepirovirsen next month. My HBsAg has started to go down, but not as much as I hoped. It usually takes a few weeks for me to get the blood test results, so the latest ones I have are based on the results after 4 injections. My HBsAg has gone down by 38% so far. I started at 458, and now I’m down to 288. I think I expected that it would have gone down by at least 60% at this point in time, but it’s not over yet.
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How did you all learn about these trials? Is there something to subscribe to?
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Hi @bornwithhepb,
You can check on clinicaltrials.gov and visit the hepatitis B Foundation’s website to sign up for their monthly newsletter, which sometimes shares information. Please speak to your doctor, as they may be aware of additional options. For example, my doctor conducts some of this research, so he will bring it up during a visit, or I will ask him about the latest happenings in the clinical trials world. I hope this is helpful. Bansah1
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Just to expand a bit more on @Bansah1’s comment, the appropriate HBF site is here: Clinical Trials for Hepatitis B » Hepatitis B Foundation
TT
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Thanks for sharing! I am really interested to hear how this treatment goes for you. Hoping you’ll keep us updated!
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do you have any update, please
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Update: I’ve been on Bepirovirsen for a little over a month now. I was at the doctor today, and I got my latest blood test results (I think they’re from week 4 of Bepi). HBsAg is down to 100! This is the first time since starting the study that I’ve seen a really statistically significant drop. Hoping the trend continues. I’ve been tolerating the medication well.
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Dear @et5656,
How many doses you took and what was your initial HBsag?
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My regular hepatologist ordered qHBsAg before I got involved with the clinical trial, and that result was 458. My official baseline at screening for the trial was 354. The doctor said that my levels of HBsAg fluctuate a bit more than what’s typical. I’m not sure exactly what the clinical significance of that is, but I’ve never been as low as 100 before! I believe that result is from my 4th week of Bepi, so I still have a while to go (treatment phase is 24 weeks in total). I understand that the rate of decline will slow down as I get closer to undetectable, sort of how exponential decay works, but I still think it’s a positive step.
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Update: I have the results from my 6th week of Bepirovirsen, and I got my first undetectable result! I really didn’t expect it to drop so quickly.
The downside is that I had a spike in ALT and AST accompanied with the drop, so now I need to pause treatment until it goes back down. I think that the drop is most likely caused by my immune system waking up and fighting the virus. I’m hoping that now that I’m undetectable, the liver enzymes will stabilize.
Also, I know that reaching undetectable while on treatment is not a guarantee that it will be sustained when treatment ends, but I choose to be hopeful that my liver enzymes will go back down, and that I will be able to resume treatment soon. We will see if this ultimately works for me, but there’s a real possibility that it could.
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Dear @et5656,
It is a great news. Would you tell me what is the current level of your Alt?
@et5656
Thank you for the update and sharing us !!! I plan to be one of the first after FDA approval .. hope this year!!!
Definitely ALT/AST spike is also a good sign according to several literature I read….
Loooking forward to 2026 to be a year of hope and better treatment!!
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@Nass yes, I just saw the press release that GSK will start the regulatory approval process with their phase III trial results. From what I’ve seen, baseline HBsAg is the strongest predictor of success, with ~25% of patients with HBsAg < 1000 reaching functional cure. My clinical trial doctor also thinks that age and duration of chronic infection will influence functional cure rates. I also wonder how these parameters will affect insurance coverage. It kind of seems like a tough sell for insurance companies to cover it for people with high surface antigen (greater than 10 000), but hopefully you’re in the low/intermediate range.
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@et5656
Yes.. last time I checked my baseline was 870… fingers crossed!!
Thanks!!
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Update: I’ll be honest, I’ve been struggling a lot this past month. I had to pause treatment 3 weeks ago because my ALT got too high. The study protocol says that if my ALT is elevated for > 4 weeks, I have to discontinue treatment permanently. I had my last injection a month ago, on December 30th, and this morning I got the news that it still hasn’t come back to a level where I’m allowed to resume treatment, so now I’m done with Bepi for good. My ALT has come down significantly in the past week, but it’s still not enough to restart treatment.
I obviously feel sad and disappointed, because this is not the outcome I was hoping for. Additionally, there was a big winter storm in the US recently, which delayed a lot of the blood samples being shipped out, so I actually don’t know if my surface antigen is still undetectable. The last result I have is from over 2 weeks ago, on January 13th. That being said, it’s not necessarily over, because it is still possible that I could remain undetectable for an extended period of time, though I think it’s significantly less likely than it would have been if I’d been able to complete the recommended 24 weeks of treatment.
I’m not getting kicked out of the study. They still need to monitor me, because we all want to know if this treatment will work. If I somehow end up cured from the 6 weeks of Bepirovirsen that I had, the research team will certainly want to study me and my immune system.
I know that I signed up for this study voluntarily, and I knew that there were risks, but even looking at the data from the phase II study, where 3-4% of patients had to stop treatment early due to side effects, I didn’t really expect that would happen to me. I still think it’s fair to be frustrated/disappointed when treatment is not going according to plan.
I have to remind myself that this is not necessarily the end. If my surface antigen comes back, it’s possible that I could try Bepirovirsen again if it gets approved by the FDA and becomes available on the open market. We know that my body responds to it. If I don’t end up being cured from this round of treatment, I at least hope that I’ll have a partial response, where my surface antigen stays below 100, and then it would hopefully be easier to get rid of with new treatments coming out. I still choose to remain hopeful that a cure is on the horizon.
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Dear @et5656,
I’m sorry to hear about your frustrations with this, but getting to HBsAg-negative is a great result! There is no telling what may happen down the road, so please keep your head up and hope for the best.
TT
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