Hepatitis C Community
all oral trial
About This Community:

This forum is for questions about medical issues and research aspects of Hepatitis C such as, questions about being newly diagnosed, questions about current treatments, information and participation in discussions about research studies and clinical trials related to Hepatitis. If you would like to communicate with other people who have been touched by Hepatitis, please visit our new Hepatitis Social/Living with Hepatitis forum

Font Size:
A
A
A
Background:
Blank
Blank
Blank
Blank Blank

all oral trial

My Dr gave me info about an all oral trial. Is the injection the interferon? If so, then this trial is without interferon? That would be good, right? Isn't interferon the worst of all the treatment drugs? This is all new to me and I feel so lost in this hep c forum. So please be patient with me as I ask questions that may have been asked before. Thanks
Related Discussions
13 Comments Post a Comment
Blank
Avatar_m_tn
all oral is without interferon...yes interferon is injected...

interferon with ribavirin (tablets) has cured a lot of people, but interferon is nasty...

peace
Blank
163305_tn?1333672171
Curiouslady has been doing an all oral trial, as well as a few others on the forum.
Maybe she'll come along and give you some advice.

My doctor says they're the hep C treatment of the future.

Good luck.
OH
Blank
419309_tn?1326506891
Isn't interferon the worst of all the treatment drugs?
-----------------
Different strokes for different folks, as they say.  

Some folks suffer few side effects from Interferon, while others suffer terribly; many folks find treatment with Interferon tolerable but get hammered by Ribavirin's effects.

On the other hand, there are folks who treated with several different Interferons tolerably but could not take the side effects of the PIs (which also have viral-mutation issues).  

All oral treatments sound promising, but remember that clinical trials usually include drugs that have less history and questionable efficacy and/or side effects, and in some ways can be just as much a gamble (or more).  

Unfortunately, not so cut-and-dried as "good" or "bad" -- but definitely excellent that you're asking questions, though.  There are a few people on the forum currently enrolled in oral trials, so hopefully they will pop in to share their experience as well.  ~eureka
Blank
Avatar_f_tn
One of the forum members, specda, recently posted this link which has information regarding clinical trials and medical research.  It has some good insights to help with decision making about trials.  I also posted it in my journals.  I think that my husband would have gone with a trial if there were no good treatment options and if he qualified for one that looked good for him.
Here is the link:
http://www.hcvadvocate.org/community/Clinical_Trials.htm#_Clinical_Trials_for_Chronic_Hepatit
Advocate1955
Blank
Avatar_m_tn
I am currently enrolled in Gilead all oral trial, I have a severe case of psoraisis (psoriasis) and I did not qualify for any trial with interferon, I started my trial 2 weeks ago, and I started with a viral load of 1980000 and after 72 hours on these oral drugs, my viral load dropped to 418 that is a 3.6 log drop which is great!! so there are some real promising all oral drugs out there, I am geno 1A and BX 2/2, the treatment is for 24 weeks, no injections is the best part for me, I have no side effects other then some slight headaches but very much bearable, i would suggest you go to http:clinicaltrials.gov and search for a trial in your area.
Blank
1722607_tn?1335751458
One study my dr is referring me to is at a hospital near my house. The 3 investigational drugs are BMS-650032, BMS-790052, BMS-791325. Its an all oral study. Anyone ever heard of this?
Blank
1747881_tn?1358189534
http://clinicaltrials.gov/ct2/show/NCT01455090?term=BMS-650032%2C+BMS-790052%2C+BMS-791325&rank=1
Blank
Avatar_f_tn
I'll take OH up on her invitation.  I am much biased toward the PSI 7977 experimental drug because of the results I and others I have been able to track have had with it up to this point.

I am GT1.  I had a 4 log drop in Viral Load within 72 hours on PSI 7977 alone.  When BMS 790052 was added on Day 7 I was already down to double digits and went UND a few days later.  Two other GT 1s I know who were in the same arm have had similar results.  So far I have been able to track about 10 people with a variety of GT on this drug in combo with one other drug plus or minus ribaviron.  No breakthroughs.  Haven't heard of any breakthroughs in whatever research I was able to find.  

It is too early to determine SVR rates for GT 1 without interferon but with GT 2/3 it has been close to 100% in their small samples and with interferon 90-100% taking drop outs into consideration.  You can easily google relevant research about these various drugs and research articles.  If you want to restrict the search try Google Scholar.

This drug is being paired with other company's drugs with similar early successes (not yet SVR rates available).  I think there is one trial now with Tibotec.  Many or all of the other experimental drugs are too weak to be considered as monotherapy or in a small combo. However, this drug has a high barrier to resistance and is quite powerful on its own.  It is currently in trial as a monotherapy while other trials with other drugs seem to be going in the opposite direction when they go "all oral".  I wouldnt have noticed this trend if the PI for my own trial had not pointed it out.  Notice how many drugs are in the combinations of the trials you are evaluating.

The side effects reported are quite minimal with PSI 7977, even with ribaviron added as far as I have been able to determine.  In my trial, the absorption issue is with BMS 790052.  I had to give up my reflux medicine to be in the trial because such meds interfere with that drug.  I have had heartburn pretty much throughout the trial because of it.

I would recommend that you check the archives at this site because some of the members have had a variety of experiences with the different experimental drugs and it could give you a good sense of what is being done in experimental trials, what drugs are involved and whether members have had successful outcomes with them.

I have been accused of shameless promotion of this particular experimental drug PSI 7977 but, with results like these over the past year, I cannot refrain from putting the information out there so others might have the opportunity to see for themselves.  If you don't know, it can't be part of the decision making process.  Best of luck in whatever you decide.  Live long and prosper.  
Blank
Avatar_m_tn
well said curiouslady1:)
my study nurse on the Gilead trial speaks highly about PSI 7977, Gilead Science believes in this drug so much, they paid 11 billion dollars to buy out Pharmasset for this drug, it is definetly the way of the future!!
Blank
Avatar_f_tn
I hope that GS finds a way to develop a combo with a GS drug and a PSI drug to keep the potential for sides low since some people don't want ribaviron to be the second drug and it doesn't seem that PSI 938 will do as a second drug either.  BMS 790052+7977 seems to work ok so far and I hear TMC 435 + 7977 also is getting good reviews.    
Blank
1722607_tn?1335751458
I'm sorry but all of this makes no sense to me. I feel like an idiot reading this. I get so frustrated because I don't understand any of it! Trials seem so complicated. I wouldn't even know where to begin or what questions to ask. I'm glad people on this forum are so educated and I want all the advice I can get, but I'm so confused.
Blank
Avatar_f_tn
My suggestion is that you take it one step at a time.  Start reading a little bit of information at a time.  For me, it's easier if I print the information out so I can write notes or highlight it, file it, and refer to it later.  Maybe you would prefer to save it on your hard drive rather than print it.  Whatever works best for you.  When my husband was first diagnosed, I bought a big expanding folder just for his medical information, and I divided it up into sections so that I could file insurance information, bills, medical reports, appointments, etc. and find them more easily.  Initially I brought that expanding file folder with me to all of his appointments, but as I got more comfortable with the doctor and the information, I found that I didn't need to bring it with me.  Another thing I did was I bought a small spiral bound notebook where I wrote down our questions before his appointments, and I also wrote down my notes during his appointments.  Basically, that little notebook has become a log of 4 years worth of questions and notes from 3 Hep C treatments, and I can refer to it at any time.  I also created a medical history summary and a medication list in Word documents on our computer, which I can update and print at any time.  So, for example, if he is referred to a dermatologist or an ophthamologist, I can print those easily and take them with us to the appointment.  You are overwhelmed right now with both the diagnosis, treatment options, and information.  My personality style is to read, gather information, and organize the information.  This helps me to process the information as well as to manage stress and anxiety about illness.  I don't know if the things that I do will help you or not, but I do think it's a good idea to learn more about Hep C, learn more about treatment options, make sure you trust your doctor, organize your records and your information so that you can find them easily, and then make decisions with your doctor.  You don't have to remember everything.  You can store it on your hard drive, in print outs, or in your journals on medhelp and refer to it later.  Everything is changing so fast right now within clinical studies and medical research for Hep C that it would be impossible to keep up with it all and memorize it.  I have some good "cheat sheets" on my journals (information shared by other people on this forum more knowledgeable than me) that I refer back to frequently.  Summer, even medical doctors who do not specialize in liver disease often do not know the basics such as stages of fibrosis, stages of liver disease, various Hep C treatments, and what's going on with research and new drugs being developed.  In fact, that is one of my frustrations.  My husband's general internist knows very little about these topics, yet in between and during treatments, he has to go to the general internist to manage other health concerns, so we have to spend time sharing information with him.  The general internist was alarmed at things that were expected side effects of treatment that were being monitored by the hepatologist, and yet he wasn't alarmed at things that he should have been.  So, we try to avoid the general internist during Hep C treatment, unless absolutely necessary, because it confuses things.  As I said, it is a learning curve, but there are lots of folks on this forum who are farther along in the learning curve and willing to help.  
Advocate1955
Blank
1722607_tn?1335751458
Thanks Advocate. I will try your advice. I guess I am just very overwhelmed right now. Before I got my biopsy, this whole hep c thing seemed kind of surreal. Now that I know my liver is not healthy, I am freaking out a little. I feel like I need to make a decision right away. But I guess I nerd time to make an educated decision. Thanks for speaking in terms that I can understand!
Blank
Post a Comment
To
Blank
Weight Tracker
Weight Tracker
Start Tracking Now
Hepatitis C Community Resources
RSS Expert Activity
242532_tn?1269553979
Blank
The 3 Essentials to Ending Emotiona...
Sep 18 by Roger Gould, M.D.Blank
242532_tn?1269553979
Blank
Control Emotional Eating with this ...
Sep 04 by Roger Gould, M.D.Blank
242532_tn?1269553979
Blank
Emotional Eating Control: How to St...
Aug 28 by Roger Gould, M.D.Blank
Top Hepatitis Answerers
96938_tn?1189803458
Blank
FlGuy
South, FL
1747881_tn?1358189534
Blank
hrsepwrguy
Greeley, CO
446474_tn?1404424777
Blank
HectorSF
CA
766573_tn?1365170066
Blank
Idyllic
Avatar_f_tn
Blank
Livelife777
Avatar_f_tn
Blank
dontworry_behappy1