"Drug Combo Disappoints in Hepatitis B" on www.medpagetoday.com

[melcul]

here is the link : http://www.medpagetoday.com/MeetingCoverage/AASLD/48571

"Just 9% of patients getting 48 weeks of interferon and tenofovir cleared the virus, compared with 2.8% of those getting either 48 weeks of interferon alone or the shorter interferon/tenofovir combination."

"About 10% of patients in each arm reported serious adverse events, Petersen said."

1 year of treatment - 9% cleared . interesting .

Also makes me worried that 10% of each arm reported serious adverse effects

[stef2011]

i didnt notice it was an old study from 2011 i thought it was earlier study, it is then justified because few sequential trials were already known and well defined at that time

the fact easl is adding ongoing trials section will help very much so studies in this section will be the most updated

i stress also we are not attacking anyone here but just discussing, our way of posting is very different from some old monster

[melcul]

Let's not argue now, we are all here for the same reason. I wasnt attacking anyone. Although i think my frustration is real and common between hbv carriers. It was just my point of view, i dont really know what is happening in there, but the process is just very slow, and i am not asking for a magical cure, but when you hear that there are meds like replicors but the trials are going so slow and they just treat us with same old nucs,  dont you agree that this is frustrating ?

[StephenCastlecrag]

I will give you an answer. Melcul attacked the study as "poor" because of "lack of interest" by the scientists. Basically, he is the repeating the same old illogic that if the scientists are more interested or caring for Hepatitis B patients, they would have discovered a cure by now. This I totally disagree and repudiate. On the other hand, Stef2011 also attacked the study as poor, but he cited his scientific reasons based on his understanding and known facts. Sure, he used colorful language, but at least it is reasoned. I don't totally agree with him about the quality of the study, so I provided more details about the study, the large number of patients and the international co-operation of some very well known researchers. But more importantly, the trial began in January 2011 when not all of the facts argued by stef2011 are known.

[HK_1966]

Someone's back.

[monster_in_my_dna]

why are you quick to attack melcul? i agree with what he says, why did you not say anything to stef with his comments towards the study as toilet paper?with who i also agree with.

[StephenCastlecrag]

Thanks, that is good news. It should be useful to learn of all the on-going trials.

[stef2011]

that they made a special section to report on clinical trials ongoing.....this is perfect for the add on studies, rep9ac and cuban vaccines, all of these are giving extremely good results so they may report results at 24weeks, 48weeks and follow up even if the study is not finished

[melcul]

what this mean ?that they will include this on they're agenda ?

[stef2011]

good news from easl which is scheduled in april 2015 in vienna, hopefully they will cover both the italian study of pegintf add on and rep9ac

easl 2015 is happy to announce the opening of a new category for abstract submissions: CLINICAL TRIALS IN PROGRESS

[StephenCastlecrag]

Some more information about this very large(740 enrolled) international study(166 locations):

"Joerg Petersen from the University of Hamburg, on behalf of an international team of collaborators, presented findings from a study of tenofovir plus pegylated interferon alfa-2a (Pegasys or PegIntron) for chronic hepatitis B, with the primary endpoint being HBsAg loss with a finite course of treatment. Unlike most previous research, this large trial was adequately powered to compare outcomes that occur in only a small proportion of patients."

The team consisted of members from France, Germany, Italy, Romania, Taiwan, Korea, Singapore, Hong Kong etc.

The list of authors:
Patrick Marcellin1, Sang Hoon Ahn2, Xiaoli Ma3, Florin A. Caruntu4,
Won Young Tak5, Magdy Elkashab6, Wan-Long Chuang7, Fehmi
Tabak8, Rajiv Mehta9, Joerg Petersen10, Eduardo B. Martins11,
Phillip Dinh11, Amoreena C. Corsa11, Prista Charuworn11, Mani
Subramanian11, John G. McHutchison11, Maria Buti12, Giovanni
B. Gaeta13, George V. Papatheodoridis14, Robert Flisiak15, Henry
Lik-Yuen Chan16; 1Hopital Beaujon, University Paris-Diderot, Clichy,
France; 2Division of Gastroenterology, Yonsei University College
of Medicine, Seoul, Republic of Korea; 3Drexel University
College of Medicine, Philadelphia, PA; 4National Institute for Infectious
Diseases “ Matei Bals”, Bucharest, Romania; 5Kyungpook
National University Hospital, Daegu, Republic of Korea; 6Toronto
Liver Center, Toronto, ON, Canada; 7Kaohsiung Medical University
Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan; 8University
of Istanbul, Istanbul, Turkey; 9Liver Clinic, Surat, India; 10IFI
Institute for Interdisciplinary Medicine at the Asklepios Klinik St.
George, University of Hamburg, Hamburg, Germany; 11Gilead
Sciences, Foster City, CA; 12Hepatology Unit, Hospital Universitari
Vall d’Hebron, Barcelona, Spain; 13Viral Hepatitis Unit, Department
of Infectious Diseases, Second University of Naples, Naples,
Italy; 14Athens University Medical School, “Hippokration” General
Hospital of Athens, Athens, Greece; 15Medical University of Bialystok,
Bialystok, Poland; 16Department of Medicine and Therapeutics
and Institute of Digestive Disease, The Chinese University of Hong
Kong, Hong Kong SAR, Hong Kong

A very good report by Liz Highleyman can be read at:
http://www.aidsmap.com/Adding-pegylated-interferon-to-tenofovir-improves-odds-of-HBsAg-loss-in-hepatitis-B-patients/page/2922867/

The clinical trial:
"A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a (Pegasys) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)"
was sponsored by Gilead and first registered on January 2011. The trial had concluded but still in the follow-up period.
http://clinicaltrials.gov/ct2/show/study/NCT01277601?term=tdf+%2B+peg&rank=1&show_locs=Y#locn

I expect a lot more papers will be published when the follow-up concluded, and hopefully will shed light on this type of treatment.

[melcul]

100% agree with you

[stef2011]

this said you are right the study you posted is useless, poor data and as i said toilet paper because:
- we know 1 year of antiviral makes nothing to immune system and nothing to intrahepatic hbv dna for almost all treated.hbsag quantitative is not reported, cccdna not reported, genotypes and so on not reported

- so after all studies of combo failed since 2000 era, why are you wasting time and money on it?

- after we know cd8 rescue comes only by years and years of antivirals why waste money on soemthing we already know doesn t work?

if i was at that conference i d have put so much shame on this researcher

[stef2011]

i ve been told this from a scientist (a good one for sure):
great discoveries (we were talking of hbv cure) are not from big scientists, big money, big pharma, most come out by chance and sometimes not even from scientists but from normal men studying the subject with a great intuition again by chance

[melcul]

This conversation is going nowhere, all i wanted to say is that the study has no t revealed to much informations and only a few key notes .and if you say that this study has revealed so much information, then please, enlighten me, because everything they found out is something we already knew

[StephenCastlecrag]

You must have the answers as you can judge the studies as poor. Many years ago, an American president declared war on cancer and poured money into it. Well, that much interest did not bring us a cure. I don't buy this argument that more interest will bring us a cure quicker, or that more money will definitely get us a cure. Einstein worked for years without finding the Theory for Everything, and all the rich people still died from the same disease as the poor despite their wealth. Money and motivation help but cannot solve every problem.

[melcul]

Just wanted to say that if there was much more interest on hbv we wouldnt just have this poor studies.. what answers?? I only have questions. Breakthrough does not mean cure for me, mean that they are advancing

[StephenCastlecrag]

Thanks for reminding me. I just had a quick read, bit heavy going for me, but MiR-B-Index looks very useful. Being host related(?), it may be different for different ethnicity. Do keep us informed.

[stef2011]

http://www.medhelp.org/posts/Hepatitis-B/full-study-immune-system-marker-of-activation-M-rna/show/2377314

did you see the full study on M-rna i linked?

this is the best marker of immune activation to signal when pegintf add on works or even discontinuation of nucs.i wil talk to pisa researchers next month so i will be able to hear directly from them where to have this test and how reliable it is to know when pegintf add on will work

[StephenCastlecrag]

Actually I don't get your point - what "caring" has to do with scientific studies?You seem to imply that you have all the answers and you want them confirmed by the doctors and scientists. A cure for MS?

[melcul]

it also could be that those 9% could be the ones who had the Lowest hbsag quant. there is just not enough data on this trials, this are totally unprofessionally trials. and also, when the treatment was administred, maybe in which phase, vit d lvl's , stile of life, ETC . There is just not enough interest for us, the patients. Someone should stand up for this, like for the MS ince challange bucket. i know that MS is much more dangerous than hepatitis,i am glad they've done that, i've seen that already they had a breakthrough in treatment with MS, but you got my point, they have to care much so they be able further to help.

[StephenCastlecrag]

"Drug Combo Disappoints in Hepatitis B" or "Tenofovir Plus Interferon Improves Antigen Clearance in Chronic Hepatitis B"
So, is the cup half full or half empty?
Obviously, the combination therapy(sequential, or add-on) of PegIFN and NA can benefit some but not all. So to optimize, we need clinical studies that:
1. Identify patients who are most likely to respond;
2. for patients selected, during therapy identify those who are unlikely to benefit and therefore should stop.
This should improve the odds of success for those who will complete the course.

But ultimately, we want to identify all the ingredients of a "cocktail" therapy that will cure everybody.

[mer971]

You making a poor judgement. Ebola is deadly disease,and there is really an emergency plan, while with hep b you can live decades. Second it is worth of money to come out with a cure for 400 million people. there are billions of dollars profit. think only last years how fast they are advancing,compare 2 or 1 decade ago.

[flyinsky]

Hope so

[melcul]

This cannot be true. Let's hope there is sone of the humanity left in the world