Ab-729 Trial, should I join?

Has anyone heard of a new drug Ab-729 trial? I was offered to participate in the trial. It seems the medicine can reduce the surface antigen level significantly. I have been using entecavir for a few years now, and the current HBV DNA is not detectable, and Hbsag is 400iu/ml. I am interested in joining this trial, hoping to reduce surface antigen level further, so I can stop taking medicine. The trial involves interferon injections as well, which can induce some bad side effects. One hand I really want to give it a go, the other hand I am worried about the side effects from interferon. Also,it seems my virus level is quite low and stable for many years, I am worried introducing new medicine to my body might lead to activate virus in my body and if the trail fails, It might take a long time to get virus under control again. Appreciate your opinions here to help me to analyze pros and cons so I can make a sound decision. Thanks in advance.

Hi @Civilke,

I’m not sure we can make the decision for you or for this specific trial, but I would like to encourage everyone to participate in clinical trials if you can (as long as you feel comfortable and it’s an appropriately-run trial).

Clinical trials are incredibly important and are the only way we’ll get closer to a Hep B cure. Not only might you have a chance of clearing your infection with the newest drugs, but also you are helping the entire affected community by participating.

With any trial, there is always the option of discontinuing the study if side-effects interrupt your life too much.

You have valid concerns, and you should bring them up with your doctor before considering your participation. As mentioned in a recent thread (Tips on making the most of your consults) it can really help to write down all of your questions beforehand and bring them into your consult.

Thomas

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Yes I strongly upport Thomas’s comments.
Trials can be a great way to get early access to new treatments, but of course there are no guarantees the treatment will work (which is why we need trials to prove they are effective!). There is also the potential risk for side effects as you say, but by the time larger Phase 2/Phase 3 trials are under way most potential common side effects are known about and you will be advised of those.

I can’t comment on this particular trial, although can say that we have been involved in a couple of similar trials and our experience has been good to date.

You need to talk to the trial staff at your site, who should be able to provide all the information you need.

Best wishes
Mark Douglas (Infectious Diseases specialist)

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If it was me, unless the medication is no longer working, I wouldn’t get on it

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Hi,
I was reading this post and found myself asking the same question about joining Ab-729 Trial or not. Trying to find some answers in order to help me to decide if I should join it or not, searching for results from previous phases I decided to accept and join this trial. I was and I’m still worried about the side effects of Pegasys, but I am praying that God will give me strength and courage to continue the trial and to not experience bad side effects.
Four days ago I was given the first dose of Ab-729, and I feel great, no side effects so far. I’m on Tenofovir for nearly 8 months already.

I encourage you to try new medicines as you may benefit from it and other people too.
I should mention that the Ab-729 Trial is the third trial I have joined.

God bless!

Dear Civilke,

Here are some additional pieces of information which may be helpful:

PegIFN side effects
Tolerability of pegIFN is generally much better in HBV than in HCV. Most people with chronic HBV infection who take pegIFN experience mild to moderate fatigue and mild to moderate joint pain and or flu like symptoms. You should be able to continue with your daily routine. Since this is a triple combination trial with NUC +RNAi (AB-729)+ pegIFN, you would not be allowed into the trial unless your liver disease was mild so your chance of experiencing another more serious side effects is quite unlikely. In any case your liver function will be monitored closely by the trial investigators.

RNAi side effects
RNAi is quite well tolerated. The only side effects you may experience are injection site reactions or upper respiratory tract infections.

Your potential for HBsAg loss and achieving functional cure
Of course the reason you are considering this trial is the chance that you could achieve functional cure and be free of antiviral therapy. Your HBsAg is quite low (400IU/mL). At this level of HBsAg, we already know that pegIFN therapy has a much better chance of achieving HBsAg loss and functional cure. It is important to know that pegIFN is still the immunotherapy with the best impact on HBV infection that we have available. We also know that RNAi is more effective with lower HBsAg. Given that RNAi has been shown to reduce HBsAg by at least 90% in all patients, there is a reasonable chance that you could achieve functional cure.

On the other hand, we know that the addition of pegIFN to RNAi compounds like AB-729 only results in a small increase in HBsAg reduction compared to RNAi alone and still insufficient to achieve functional cure.

Hope this helps.