I got this news, what do the experts here think?
Hi @Helmy,
Unfortunately, this is a lot of hype over the top of a fairly intriguing result. I did not dig into it in heavy detail, but according the the abstract of the scientific report Intranasal therapeutic vaccine containing HBsAg and HBcAg for patients with chronic hepatitis B; 18 months follow-up results of phase IIa clinical study - PubMed), it is a nasal HBV vaccine administered 10 times. The logic behind a nasal vaccine is not really clear as that approach is typically used when trying to generate mucosal immunity (like in your nose or mouth membranes, or your intestines). The results are intriguing because some patients developed anti-HBs antibodies despite having chronic HBV infection. Note the rate of functional cure was small (8.4%) in a small phase II study. This is interesting to me as Iām not familiar with any other vaccination strategy without more complex immune manipulation and HBV suppression that can cause HBs antibodies to develop and achieve detectable functional cure rates. However, Iām not an immunologist, so others with more understanding of this could provide better insight.
So in short, I think the press releases is a bunch of hot air around an intriguing observation.
John
John has this exactly correct.
There is some other off target immunological process going on here aside from the stimulation of immunity against HBsAg. It may have something do do with the intranasal route of administration - this induces a different kind of antibody response compared to vaccines introduced directly into the blood.
More importantly, all of the patients in the study John has cited were āunicornā patients (HBsAg range from 83 - 2187 IU/mL with average of 467 IU/mL). These patients are called unicorn patients because they represent a small fraction of the patient population as a whole (~5%) and respond much better to immunotherapy than the typical patient with chronic HBV infection. For example, pegIFN can achieve functional cure of HBV in 30% of unicorn patients.
All patients should watch carefully for this recruitment parameter in trials with new antivirals being developed for HBV. There an unfortunate shift in recruiting in new trials which is designed to enrich the trial population with unicorn patients (i.e. recent trials with VIR-2218 + pegIFN, completed phase II and ongoing phase III trials with bepirovirsen and the recent trial started with TheraVac).
With highly biased selection like this, none of the data from these trials will give us any idea how these drugs can work in the average patient. This is very unfortunate.
Thank you for your response sir
I feel really appreciated here.
and know more about hep and future progress
I hope you are healthy and successful in your endeavorsā:pray:
You are our heroes who suffer from Hep B