I was unable to find any PI drug studies recruiting subjects, other than some for tx naive patients and many for HIV coinfected patients. However, I did run across some interesting studies. One in particular is SCV-07, a STAT3 inhibitor. They have a phase II trial currently enrolling HCV patients who have previously relapsed on SOC.
"SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which stimulates the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells. SCV-07 has been shown to be efficacious in animal models of immune-sensitive diseases, including viral infections and cancers, and in the enhancement of response to vaccines. The compound has demonstrated an ability, for example, to reduce progression of renal and lung carcinoma as well as melanoma in mouse models."
.........
"SciClone is also currently running a multicenter, multidose, open label phase 2 clinical trial of SCV-07 as a monotherapy and in combination with ribavirin to treat hepatitis C virus. SCV-07 has shown a good safety profile in several early stage clinical trials in healthy volunteers and subjects with HCV infection at various doses. SciClone expects to complete enrollment in this study in the first half of 2010 and provide initial results in the second half of 2010."
Information on the clinical trial is found on
http://www.clinicaltrials.gov/ct2/show/NCT00968357?term=HCV&recr=Open&intr=SCV+07&rank=1
Hector: Gotta say "pardon me" for my earlier question. Applied to treatment for a relapser it your statement makes perfect sense. "Peg Interferon will not cure HCV ...." I was taking it literally.
Robinandmarion: I have not heard of anyone being treated with interferon without Ribavirin either, hence that was the only reason I could see for Hector's statment that "Peg Interferon will not cure HCV ..." Peg Interferon CAN cure genotype 1 HCV, but only WITH Ribavirin. Happens all the time on SOC for first time patients.
That out of the way, I agree with GoffyDad about the ADs. My team told me the same. I elected to use the second option because the first was known to aggravate migraine headache sufferers. I took Cymbalta and I believe it helped significantly getting me through the TX. They have lots of AD options.
I would also ask about the 32 week SVR. I am not sure what you mean by that. I kind of assume you mean he was UND (undetectable for 32 of the 48 weeks)? In that case, perhaps he did not clear at 16 weeks, but he still had the SOC requisite 2 Log drop at week 12, in which case they could have kept treating, no?
good questions....when he began hw was End Stage III - not yet into cirrhosis, considered Stage IV....when he first started treatment and itwas aborted due to the rash/infection and he was put on steroids in Nov of 08, he was referred to a different doc (the first one was a very well-known GU doc but also the same doc whom his sister died under his care....does it make him not a good doc? no, but just an emotional compotent here...for him...)....so a few of his friends are in the medical friends an refererred him to the Chief of Infectious Diseaseases at a local hospital, and he then took over. He had my hnusband continue treatment past the 12-week mark doe to the steroids he was on and the abort of the first-time; neither of them (doc and hubby) wanted to give and doc has said the some people are just late responders; hence, my hubby then cleared at 16 weeks. - As for the Ads....hubby was very against them...tried Lexapro, then Zoloft, then Prozac...so he did try...nothing helped, nor was he honest w/his doc about how bad his depression was - was too afraid the doc would take him off treatment and all would be lost......so I sat silent. Just told the nurse at towards the end of his treatment...doc called hubby, not sure what happened. - thanks so much for your comments.....
Lot's of good advice here.
What exactly do you mean by "he is still end Stage III...."? The third stage of cirrhosis, or Stage 3 fibrosis?
I suggest your husband hook up with a good team, one very experienced in treating HCV. When I treated I did not need ADs, but I was told, "We have an AD we like. If we put you on that and it doesn't work we have another one we like. If that doesn't work we have yet another one." They were very experienced and proactive at managing treatment. I could email my doc anytime, or call his nurse directly. IMO, this is vitally important for a difficult tx. Ask questions and choose wisely.
I also wonder about your statement that he was SVR for 32 of 48 weeks. If he did not clear until week 16, most protocols would have done something other than plod along at status quo until week 48.
Does anyone know of current PI trials for relapsers?
I didn't know that anyone treated anymore w/out Ribaviron, so therefore I left that out of his treatment...his did treat w/that and would have to treat w/that again...I've forward a few of your comments to my husband to help aid him with his choice of when to treat and with that....it's a big decision....I do think that he should have his depression lifted and enjoy life for a bit before deciding to treat again...it was such hell for both of us....I feel so sad for him...what a let-down that just after two weeks off treatment he relapsed...he just got latest labs in....al counts are a bit high, but not bad, however his viral has climbed quite a bit....I told him not to worry about that....thank you all for posting! blessing to all....marion
Hector,
""Interferon for 1-2 years." That is not going to solve anything! Peg Interferon will not cure HCV nor will it stop the progression of his liver disease. Any good doctor will know this. Who ever is telling you this is misinformed and not qualified to treat your husband or anyone else for that matter."
I do not understand this unless you mean Peg Interferon without Ribavirin, in which case I would totally agree. Are you telling us SOC does not cure HCV or are you implying that the doctor used interferon without ribavirin? I find either alarming but in totally different ways.
Respectfully,
Brent
Thanks for the clarification.
"yes, my husband has depression....he was put on prozac while on treatment but we both think it did nothing...last week he finally went to see a psychiatrist who dx'd him w/severe depression and added wellbutrin....he has been a LOT better since off the interferon though!.....I think the depression is also from all the many stressors and losses we've faced and are dealing with....including our marriage....and the unknown of our future...."
Right. Makes perfect sense. We all handle things in life differently.
Everybody chemistry is different. Treatment (peg-interferon particularly) is known to cause depression. It usually takes try a number of anti-depressants before finding one that works. So again no reason to feel overwhelmed. This is a common occurrence and the psychiatrist should explain this when starting treatment. The good news is that there probably is a drug the will work in reliving the depression. Remember also that it could take a good 4-6 weeks for the meds to have their full affect.
From Hepatitis Central:
HCV Treatment
"Some studies indicate that chemically-induced depression occurs in approximately 20 to 40 percent of treated patients. Administering physicians have observed that depression associated with HCV therapy reduces the likelihood of eliminating the virus with peginterferon-alfa and ribavirin, due to patient non-compliance or even premature discontinuation."
Defining Depression
Depressed mood or anhedonia (inability to experience pleasure from normally pleasurable life events such as eating, exercise, social or sexual interaction) must also be accompanied by at least four of the following:
· Overwhelming sadness or emptiness
· Lack of interest or pleasure in daily activities
· Appetite or weight changes
· Disturbed sleep patterns
· Changes in psychomotor activity
· Fatigue or loss of energy
· Feelings of guilt or worthlessness
· Difficulty focusing, concentrating or making decisions
· Recurrent thoughts of death or suicidal ideation
I hope your husband can improve his mental health, then dealing with his HCV and liver disease should be manageable. He has very good odds that the new anti-viral meds will eliminate the HCV virus from his system.
Meanwhile take good care of yourself. Know that most people that are suffering from an illness would love to have someone as supportative as yourself in their corner. You did everything humanly possible to help him unfortunately your husband's mental health has been compromised so he can not comprehend the difference between his fears of illness and someone who is trying to help him with his illness. Remember he is having problems managing his own thoughts and feelings never mind anyone elses. This is a common symptom of depression. No matter what he and anyone else does seems hopeless and pointless.
When he over comes his depression he will see that he made some big mistakes. Hopefully he will be strong enough to admit his shortcomings, be humble and admit he was wrong. Hopefully then you both will be able to communicate as adults and work things out in the best interests of the both of you.
Oh by the way...my family and I used to go to the beach in Madison during our summers in Connecticut. Pretty place.
Best of luck to you both.
Cheers!
HectorSF
thanks to all that wrote back....the support helps me quite a bit as I've been alone dealing with this....I've been on this web site constantly and it has been a source of support for me....yes, my husband has depression....he was put on prozac while on treatment but we both think it did nothing...last week he finalloy went to see a psychiatrist who dx'd him w/severe depression and added wellbutrin....he has been a LOT better since off the interferon though!.....I think the depression is also from all the many stressors and losses we've faced and are dealing with....including our marriage....and the unknown of our future....yes, it is infergen, you're right....we will be discussing to wait for the boceprevir and telaprivir too when we meet w/the next specialist in June....blessings to you all!! and thank you!!!.....
i read your post over again. perhaps when the doctor was speaking of daily interferon he was referring to infergen, which might be your husbands next best hope for a drug that is currently approved. assuming he is unwilling to wait for the new drugs (i.e. protease inhibitors) which likely will be approved within a year. at first i was thinking the doctor may be talking about maintenance interferon, which has been shown in the Halt-c study to not reduce mortality.
thank you for posting. Hector has some great advice. sounds to me like it's time to go see a liver doctor at a university or at least a good gastroenterologist that is aware of the latest research.
i believe it is irresponsible not to inform a potential partner of our health status and that prior to marriage your husband should of had a medical work-up, especially considering his ongoing infections. Life is a mystery, but at least we can be a little prepared for what a potential marriage partner may be going through.
Hello. Thanks for posting. I think you will find many supportive caring people here that will help you navigate through the ups and downs. The good news is that your husband still has time to retreat and cure himself of Hep C permanently.
I'm an sorry for all the problems you and you husband are having. You have done all you know how to do to help him. At this point he needs a good doctor to work with. This is something you can't do. It is a medical problem that requires medical expertise. What you can do is to help him find a good doctor.
"Interferon for 1-2 years." That is not going to solve anything! Peg Interferon will not cure HCV nor will it stop the progression of his liver disease. Any good doctor will know this. Who ever is telling you this is misinformed and not qualified to treat your husband or anyone else for that matter. Your husband should be seeing at least a Gastroenterologist if not a Hepatologist who is experienced treating and curing Hep C patients.
"while he was on tx he was a monster.....extremely volatile, verbally abusive, major mood disorders and major depression (wanted to die).
Maybe your husband suffered from and still is suffering from depression. Was he treated for depression while on treatment? Is he still being treated? Depression during treatment depression is not that uncommon. His main problem now is his state of mind which has caused you to have a breakdown and separate. His liver disease is not that advanced that it is live threatening. But physiologically the way he is handling it is ruining both your lives. If it is due to depression he has no control over it. So he needs treatment.
You say he is Stage 3? There are many people on this forum that are Stage 3 and are leading happy and productive lives. Stage 3 means he has years before his liver will start failing to function.
This means he can still has time to retreat and cure himself of HCV once and for all. This is extremely important to understand. He can be cured and go on to live a normal life.(!)
The new meds which are much more effective in ridding the body of the virus will be out next year and they work particularly well for "relapsers" which from what I can understand, is how your husband responded to his past treatments. He has a excellent chance of beating the virus!
Best of luck to you.
Let us know what happens.
I wish I could offer something more than prayers, but that is all I have. You are in my thoughts and prayers...Kathy