Dont want to give my hopes up but is this effectively a cure? Second question, i remember asking my doctor what would happen if a cure was found. He said it depends on my insurance and whether or not they could be willing to cover the drug. Meaning, if i am not at risk of developing cancer, then back of the line i go.
Wouldn’t a person with chronic HepB considered a high risk of liver cancer HCC? In that sense, insurance companies would benefit by preventing cancer than treating someone with cancer which in the long run is more costly.
I’d be curious to see what the cure rate was that they found in these phase III trials, but unfortunately the press release doesn’t say. There was a previous phase II study on Bepirovirsen, and they found that approximately 10% of people achieved a cure. It should be noted that the rate of functional cure depended heavily on the baseline level of HBsAg, so people with HBsAg < 1000 were seeing cure rates around 25%. The phase III trial only included patients with a baseline HBsAg below 3000.
If I were to guess, I’d say that insurance will likely require extra documentation before they agree to cover this drug, because I expect the price to be very high. Extra documentation may include proof of baseline surface antigen levels, since no one from the phase II study with HBsAg > 10000 achieved functional cure. Kind of a tough sell to convince insurance to pay for it in that case.
I’ve spent a ton of time looking at all of the available data, because I’m participating in another clinical trial that includes Bepirovirsen. I wanted to know what I’m getting myself into!
Saw it on some blogs about GSKs new treatment, is this legit and functional cure for Hep b carrier?
Or this only works on people who got infected not through birth?
Please share your thoughts
Hi! Fellow patient here. I’m actually currently participating in a study involving treatment with Bepirovirsen. I have some thoughts on your questions based on discussions I’ve had with my investigator, and through doing my own homework.
Is it legit? Yes, but it does have some limitations. What we see from the clinical trial data that has been published so far is that baseline surface antigen levels seem to be the strongest predictor of success. The phase 3 study that just wrapped up only recruited patients with surface antigen < 3000. If it’s approved, we do not expect a 90-95% cure like we got with the hepatitis C drugs (I wish)! Phase 2 trials showed a 10% cure rate overall, but around 25% for people with HBsAg < 1000. We are all eagerly awaiting the phase 3 trial results to be published. My investigator thinks that the details will be withheld until conference season, and then they will be presented at a live session (likely at EASL in Barcelona at the end of May).
Does it work for people who were infected at birth? Yes, there’s a possibility that it could work. My investigator hypothesizes that it would work best for people who are infected as adults, because the immune system is more mature at that point. However, that doesn’t mean that it won’t work for people who were infected at birth. I was most likely infected at birth, and have been able to get to undetectable on Bepirovirsen. I’m still in the treatment phase now, so we don’t know yet if I will have a sustained response, but it’s certainly possible. He also thinks that it may work better for people who are younger, vs people who are older, perhaps because younger people likely haven’t been infected for as long, and because our immune systems get weaker as we age. But again, all of these things are hypotheses, and we don’t know for sure yet. I’m hoping that the phase 3 study results will shed more light on this, as it was a much larger sample size (over 1800 patients).
THANK YOU SO MUCH FOR THE REPLY,
SO what ive read from your reply to summarize them
it is legit, and they will soon publish statements and statics about the trial result, and the treatment only work best for people whose surface antigen is under certain amount, and carrier since birth might benefit from it too, but most likely to be people who got infected young.
i was born with hep b also, my mom never had it, my dad had i was one out of five siblings who got infected with it ;/, im now living in uk, and ive been on tenofovir for 3 years now, still my virus is 107 , but my liver function and everything else is normal, i forgot to ask bout my surface antigen amount, ill check with doctor about this soon,
this GSK news is such an amazing thing to hear, im hoping soon in future they can give us more hope!
Yes, I think there’s definitely reason to be hopeful. While this treatment won’t work for everyone, I think we can still consider it a success if it works as well, or better than existing treatments (peginterferon) with fewer side effects. I’ve had some side effects from it, but it’s been less bad than some of the stuff I’ve heard about interferon.
I wonder though how you would have gotten HBV at birth if your mother didn’t have it. Do you know if she is core antibody positive? If she has core antibody, that would indicate that she was infected with hepatitis B in the past, and has cleared the infection. If she contracted hep B while she was pregnant with you, then it’s absolutely possible that she could have passed it to you at birth, even if she recovered from it shortly thereafter. That could also potentially explain why none of your other siblings have it.
If she has no evidence of past infection at all, then it’s not possible that you could have gotten it at birth, but since you said that your dad has it, it’s possible that you could have gotten it through household transmission as a young child. This can happen through sharing personal care items, or if you’re not careful about covering/bandaging open wounds if you cut yourself.
If your surface antigen is really high, don’t lose hope. The study that I’m in is evaluating whether or not sequential therapy with an siRNA, followed by bepirovirsen will deliver higher functional cure rates than bepirovirsen alone. The purpose of the siRNA is to reduce surface antigen levels prior to starting treatment with bepirovirsen. Unfortunately for me, I think I got a placebo siRNA, because my surface antigen levels essentially didn’t change at all during that phase.
I followed hep b new drugs for a long time and finally got the great news about bepi. Since it is more effective to people qHbsAg < 1000, I asked my doctor ordered qHbsAg labcorp test for me and I got the test result Negative. Thanks God. I feel so happy and peaceful now.
I started taking Viread back in year 2012 and switched Vimlidy when it was available. I got HbsAg tested back in 2022 and was still Positive then.
I was diagnosed when I was 22 years (now I am almost 60 years old). Actually my HbsAg turned to Negative after a couple months and continued to be Negative for at least half a year. But I got sick again with HbsAg Positve a few years later and never cleared HbsAg to negative until this time. From my experience, I can see even HbsAg Negative can relapse back to Positve because I could never get HbsAb (antibody) so far. My qHbsAb is < 3.5 this time.
Here is my detail info INTRODUCTION THREAD: People affected by Hep B - #494 by Dan
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Hi @Dan ,
Wow what a journey. That’s pretty crazy that your HBsAg flipped back and forth from positive to negative so many times. That’s awesome that you’re negative now — hopefully it sticks this time! Fingers crossed for you 
Thank you. I will do a few more follow-up tests this year and post them here.