Will naps be available in Indonesia one day, sir?
Dear mr @availlant
Thank you for your answer. I have started to take TAF and have received the first injection of PegIF (its side effects, fever, body ache and headache make me too uncomfortable). After a month, I will go back to review and hope that everything will develop in a good direction.
Thank you again for your answer.
2 Likes
Hi @Helmy ,
Our intention is that REP 2139-Mg will be available to every person on the planet who needs treatment. This includes Southeast Asian countries like Indonensia where HBV infection is a significant problem.
Best regards,
2 Likes
Hi @Tamron ,
For many patients, side effects from pegIFN are stronger at the beginning of therapy and ease as your body gets used to the constant increased levels of interferon in your blood stream.
Given your self a month or two if you feel able before you decide to stop pegIFN. TAF + pegIFN is your best chance for functional cure with currently approved medications.
Best regards,
God bless you and your family sirā¦
I hope the REP 2139 develops quickly and without obstacles so that many lives are savedā¦
3 Likes
Dear mr @availlant
Thank you for your answer. I will try it for a few months. I hope I can share good news with you then. At the same time, I wish you all the best in drug research and development.
Best regards,
1 Like
Dear @Tamron ,
Functional cure of HBV during TDF + pegIFN is always predicted by a strong elevation in ALT / AST (without any changes in bilirubin, albumin or INR) and rapid decline in HBsAg and HBsAg loss within 12-24 weeks of therapy.
Good luck!
2 Likes
Hello, Doctor, can anyone infected with the B virus use pegif+tdf and how much can a functional cure be achieved when using it?
1 Like
Dear @HASANAIN_GALIL_KDHIM ,
TDF (and ETV and TAF) are safe to use for all patients with HBV infection. The addition of pegIFN is only considered safe in patients who do not have very advanced liver disease (decompensated cirrhosis).
If baseline HBsAg (before starting therapy) is very low (< 500 IU/mL), HBsAg loss and functional cure can be achieved in up to 30% of patients - the lower the baseline HBsAg the better. With HBsAg > 1000 IU/mL, functional cure is much more difficult to achieve and only occurs in about 6% of patients and never in patients with genotype D; this is the most difficult strain of HBV in which to achieve functional cure.
Best regards,
4 Likes
When will your Naps be available?
1 Like
Hi @Godsown ,
I really cannot be as specific as you (and the community) would like.
What I can say is to continue to follow updates on the development of NAPs as we post on the website. You can ask to be on our newsletter for press releases at info@replicor.com.
Best regards,
5 Likes
I remember when i was diagnosed around 2012 replicor was the hype back then, here we are 11 years later and still nothing. Very disappointing.
Hi @Jb007 , welcome to the forum!
Certainly in 2012 NAPs were greeted with curiosity but there was definitely a lot of skepticism regarding our early trials in Bangladesh. At that time, we were unknown in the field and the rapid HBsAg losses we were reported were something that had been impossible to achieve previously. Also, in 2012 there was a very poor understanding of oligonucleotide and subviral particle biochemistry in the HBV field. This not only created problems for people to understand NAPs (which are oligonucleotides) and their mechanism of action but also led to a great deal of energy being funneled into a large variety of other antiviral approaches, all of which have failed to date and many have been abandoned in the last year.
No one feels this frustration of developmental delay more than the development team at Replicor and you are of course not the first to comment on the delay with NAPs in the forum. See here for some previous detail I have given on this.
We cannot control how lack of a understanding of the disease, or how politics within the industry have created a funding vacuum for Replicor despite it still being the ONLY technology able to achieve high rates of HBsAg loss and functional cure.
Our currently ongoing compassionate access program (see here) is not only reproducing the tremendous safety and efficacy of NAPs in patients with very advanced liver disease but also giving numerous well known and independent investigators the chance to see for themselves this drug working in their own patients (see here)
We continue to press on!
3 Likes
Hi Andrew, thank you for your reply. I totally understand you had to change from iv to sc delivery method, and that took a while, but in the years i have been following hbv drug development there has not been anything else as promising as naps, i just donāt understand how it has not gained much traction. Lots have ideas and companies have come and gone with no fruition, I remember when hcv was cured the rate of drug development was very quick, even covid has more approved treatments. Hopefully the next few years and we will see some good developments. Thank you again.
Hi @Jb007 ,
This is a very common but very incorrect comparison: HCV is so easy - lets take the same direct acting antiviral approach for HBV. This is one of the reasons for an explosion in companies (and investment capitol) targeting HBV viral replication after the breakout of sofosbuvir in HCV in 2012 (this drug essentially does the same thing in HCV) and the persistence in the belief in these approaches could work for so long.
This intense focus on various direct acting antiviral approaches (now fairly well established as futile by the end of 2022) has prevented for many years highlighting the critical differences in HBV which tell us that these approaches would never work. The most important of these being:
- The genomic reservoir of HBV infection in the nucleus of liver cells (cccDNA minichromosomes) can persist for a very long time in the absence of viral replication.
- HBsAg is a key viral protein which blocks restoration of immune function.
- Almost all HBsAg is produced as non-infectious subviral particles which are produced by a distinct mechanism from the production of infectious virus.
- HBV genomes can integrate into host chromosomes and provide an additional reservoir of HBsAg. As a result, HBsAg loss and functional cure require the removal of these cells.
So while NAPs have been accomplishing all of these things, industry and investor attention has until only very recently been focused in the wrong direction.
Best regards,
1 Like
Almost every day I read all about NAPS in this forum, and I really hope that NAPS can one day cure my wife from hbv.
NAPS has gone through a long process, I am very optimistic that NAPS can be approved in many countries as a cure in the next 3-4 years.
Thank you @availlant God bless you 
And best wishes to all hbv scientists on this forum @ThomasTu
am from Indonesia
Thank Helmy,
We are working diligently to make this happen as quickly as possible.
Best regards,
4 Likes
@availlant do you already have secured funds for future few years of NAPs research and clinical trials or still investors scepticism/lack of knowledge delays the process ? Iām worrying because every month or even more often some new hbv drug appears in preclinical or phase 1, which may dry investors money on useless trials.
1 Like
Dear @sorte ,
While some companies may attempt to develop variants of technologies which have already been shown to fail, a lot of money has been lost in the venture capitol space from investments made on ASO, siRNA, CAMs and even inactive versions of NAPs we discarded years ago (see Aligos) for functional cure of HBV. The sting of these losses has made the investor community take the time to understand the reasons for the futility of these approaches and they are not likely to take the risk on these or related approaches in the future.
Best regards,
1 Like
@availlant so you may be short on cash for future development ? Do you plan eg. stock market public offer to gain some funds ? Or there are some investors on the horizon ?
1 Like