More all-oral research .including genotypes 1,2 and 3.

[willbb]

Pharmasett anounces three new Inf. free Phase III trials for all geno types:

http://investor.pharmasset.com/releasedetail.cfm?ReleaseID=619564

[UKgirl55]

The trial for 1's is only for those that cannot take inteferon. No tx naive. The other trials are for 2's and 3's...right?

[R Glass]

It wouldn’t take “The Sharpest Knife in the Drawer” to figure out they’re getting Placebos. If you’re taking “placebo PSI-7977 and placebo ribavirin” you’re not going to have any sx.

[can-do-man]

"you’re not going to have any sx"

Maybe a surgar high.:)

[can-do-man]

"sugar"

[nygirl7]

LOL yes people who feel absolutely fine should wonder why after a while but they wont come online because they wont have any problems. Vicious circle!

[gonnabhepcfree]

I am in the PSI 7977 and BMS 790052 and although i had some minor fatigue  initially for a short time -I had no other and still not side effects..I was also undetected after 7 days..

[R Glass]

That’s Great News that you are having no sx and in order to be undetected, you can’t be taking a Placebo. However, it is uncommon not to have any sx from Riba. Congratulations.

[curiouslady1]

Gonnabhepcfree is not alone in not having side effects.  I also had minor fatique and, from what I have been told by five other study participants in the same trial, they have had little or not side effects.  None of us were taking Ribaviron however and I would be very appreciative if you could let us know what sort of side effects do people have when they are taking Ribaviron without interferon but with drugs which are known to have few or no substantial side effects.  Many people have asked me this question and I have not been able to provide an answer.  By the way, our trial was open so we knew exactly what we were taking.  

[curiouslady1]

I see UK girls has answered my question on another thread.  Would others agree with this?  I don't think we have much experience with Ribaviron when it is not paired with ifn, do we?  If so, please post here.  Thanks.

[gonnabhepcfree]

that's so true..my study has a ribavirin arm and when I seemed disappointed to not be in that arm my study coordinator said "Why you want to feel all the side effects that come with the ribaviri?" She then named them and now I am grateful beyond words to so far be having the result I am with no sides..The Quantum study is at my Dr's office and the arms that get the placebo will eventually get the study meds.

[R Glass]

“I don't think we have much experience with Ribaviron when it is not paired with ifn, do we?” Good Point.  

“None of us were taking Ribaviron” Was this a Typo? If not, I’m confused about how  anyone could have sx from a drug your not taking.
Nevertheless, here are the listed sx from Ribavirin

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000301/#
Ribavirin may cause anemia (condition in which there is a decrease in the number of red blood cells)
Ribavirin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
· cough
· upset stomach
· vomiting
· diarrhea
· constipation
· heartburn
· loss of appetite
· weight loss
· changes in ability to taste food
· dry mouth
· difficulty concentrating
· difficulty falling asleep or staying asleep
· memory loss
· rash
· dry, irritated, or itchy skin
· sweating
· painful or irregular menstruation (period)
· muscle or bone pain
· hair loss
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, or those listed in the IMPORTANT WARNING section, call your doctor immediately:
· hives
· swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
· hoarseness
· difficulty swallowing or breathing
· pain in the stomach or lower back
· bloody diarrhea
· bright red blood in stools
· black, tarry stools
· stomach bloating
· confusion
· dark-colored urine
· yellowing of the skin or eyes
· unusual bleeding or bruising
· vision changes
· fever, chills, and other signs of infection
· depression
· thinking about hurting or killing yourself
· mood changes
· excessive worry
· irritability
· starting to use street drugs or alcohol again if you used these substances in the past
· intolerance to cold
Ribavirin may slow growth and weight gain in children. Talk to your child's doctor about the risks of giving this medication to your child.
Ribavirin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

[Susan_1a_CC]

They mention in the study outline that there will be legs for "those who can not take ifn."  Are these people w/ autoimmune disorders?  What else would keep a person from being able to take ifn?  Just wondering...

[UKgirl55]

Those that have been on INF and had a bad reaction from it.

[UKgirl55]

The next phase of this trial can't come soon enough for me to jump in!!

Glad to hear you are doing well.

[Juttutin]

As the one in my PSI7977 Cohort who was on RBV and 7977 only (no IFN), and talking with my equivalents in a couple of other cohorts, RBV can make you 'ragey'  -  one of the other participants nicknames it 'roid-rage'.

Can make life a bit unpleasant for people around you, somewhat mitigated by not wanting to be around them anyhow.

On a side note, I have my SVR36 test on Friday.  Cleared my HCV with just RBV and 7977, to SVR24, and they decide they want to extend rechecking out to 48 weeks.  Kinda spoiled the party somewhat!  Lol!.

(I suspect this is because success rates at 24 weeks were so close to 100%, they wanted to go for gold and see if they'd knocked off the relapsers as well)

Am delighted to see they are moving into Stage III, and also that they are starting trials without even RBV - which will probably truly be virtually side-effect free treatment.  I presume(?) that there will be no placebo trial, since they can't offer SOC (incl IFN) as a placebo, and that the entire intake will get treatment.  (Which was the case in my Stg-II 7977 trial)

[joy5116]

I'm hoping to get in the Quantum study which unfortunately does have a placebo arm since there is no intf arm.  
Gee, I sometimes already don't want to be around people, you mean that will be intensified?  You are the only person I've seen post who had riba withiout intf.  Ragey, huh?  

[curiouslady1]

"Can make life a bit unpleasant for people around you, somewhat mitigated by not wanting to be around them anyhow." ~~~

Hellarious!!! LOL!

"On a side note, I have my SVR36 test on Friday.  Cleared my HCV with just RBV and 7977, to SVR24, and they decide they want to extend rechecking out to 48 weeks.  Kinda spoiled the party somewhat!  Lol!.

(I suspect this is because success rates at 24 weeks were so close to 100%, they wanted to go for gold and see if they'd knocked off the relapsers as well)"

This is wonderful news.  Where have you been?  There have been a number of questions and concerns expressed at this site regarding SVR with all oral drugs.  There are a number of people who are thinking seriously of getting into trials but are hesitant because they are not aware of this info.  Can you give any further info. on the SVR rate?  I for one would appreciate it immensely.  Thanks!

[curiouslady1]

BTW the placebo arm in Quantum is converted to an experimental arm after 6 months.  In essence, the entire trial will get treatment but some have to wait.  

[UKgirl55]

I second that...Where have you been? Can you tell us what genotype you are?

[joy5116]

Good point on the placebo arm in Quantum, they are re-randomized.

[journey91]

Where are these trials being held that you are referring to?

[Puppyluvur]

I am hoping to get into the pharmacett trials myself. Still waiting for something close to my area. I contacted a Sandra Kirvin( Clinic co-ordinator) she said right now the closest place is San Antonio, Tx. And to keep checking the Pharm website because they are adding new places every day and also contact liver Dr.  I'm going to call my Dr tomorrow and hopefully there will be something getting ready to start close by soon. Got to stay on top of Dr.'s around here. Keep your fingers crossed friends. Sandi

[curiouslady1]

Susan, people who have psychological or psychiatric problems are often recommended not to take interferon.  Of course, I assume that there are many who have psychological issues with taking interferon so they might qualify too.  I don't know if it matters but I wouldn't/couldn't take it because of my job.  I can't imagine they would be that exclusive as to reject someone because they couldn't come up with a good enough reason not to take ifn.  

[Puppyluvur]

Oh and tx naive? Does this mean someone whose never been through any kind of tx? Don't mean to sound dumb, just still learning alot of the lingo.