Okay I'll Play

[Bituman]

In about 30 minutes I take pill #10.  Approved for 12 weeks, Harvoni.  So far feeling fine, no side effects whatsoever.  Naturally, I caught a cold about 2 days before starting, but considering that, I'm great.  I bike a lot (occasional racer) and there appears to be no effect of treatment on my riding.  In the 10 days since I started, I've done 3 very long mountain bike rides and 5 gym workouts.  Maybe tomorrow the headaches and fatigue will start, but for now, nothing.

My stats: 
Age=59
Genotype 1a diagnosed in 2007
VL=3.6 million in mid January, ranged from 1.48 to 11 million, avg 5.64 million since diagnosed in 2007
Grade 1, Stage 0, HAI=2/18 (one of the lucky ones!) all via biopsy in 2007
ALT avg=57, AST avg=42 since 2007
One CT scan and two ultrasound indicate no change in liver condition since diagnosed

HCV most likely as a consequence of blood transfusion during cancer surgery in 1975.  It was called rhabdomyosarcoma or RMS, a soft tissue cancer most common in children under 20.  I was 19.  It was manifested by a tumor in my abdomen the size of a grapefruit.  Through the grace of God, a skilled surgeon, and a world class oncologist at the University of Texas Medical Branch, I managed to survive that.  Treatment involved the aforementioned surgery plus two miserable years of chemotherapy during my jr and sr year of college.  Can't remember what I had for lunch yesterday, but I can sure remember the chemotherapy drug names:  adriamyacin, d-actinomyacin, vincristine, cyclophosphamide.  By mid 1976 there was no longer any evidence of tumor in my abdomen where my oncologist said it started.  Getting treated for and surviving RMS has been the seminal event in my life. 

So on the day in July 2007 when I was diagnosed with HCV, it was like the RMS had come back after 32 years to grab me again.  In my mind, I was once again that 19 year old kid trying to face down a monster.  After a few weeks of feeling sorry for myself, I did the best thing I could have possibly done and started getting health care at Mayo Clinic in Scottsdale.  My IM doctor and hepatologist ran tests and offered assurances that my HCV could be managed, and that while a very serious health issue, it wasn't anything like RMS.  Even my dentist reassured  me that many of his patients were living full lives with HCV.  Again, I got so lucky compared to many of you because my liver has remained in good condition throughout the years.  I have no idea why.  So at least I didn't yet have to endure the awful, and mostly ineffective treatment that many of you had to go through. 

The last two or three years, my hepatologist continued to suggest I wait for more effective treatments that were in clinical trials.  So when I called and spoke to his PA back in December, she said "it's time."  Once again, I was lucky and my insurance approved 12 weeks Harvoni in just a few days.  To me Harvoni is not only zapping my HCV, it's finishing RMS once and for all.  I am anxious for a time when approval for these miracle drugs for all forms of hepatitis is as easy as getting approved for routine things like high blood pressure medicine. 

Like most of you I have many, many more observations regarding living with HCV.   But I've already written too long of a post.  I'll leave this with three last observations:  (1) screw cancer, (2) to hell with liver disease, and (3) hoping for SVR for all of us afflicted with something that was not our fault and didn't deserve to get.  Almost forgot, God Bless all the skilled health care professionals and brilliant scientists that stand with us to fight these killers. 

Bob

[lporterrn]

Hi Bob,
I loved your post. Although you commented on it being "too long" - I enjoyed reading it. In fact, this is a perfect example of what Hep Stories is looking for. http://www.hepmag.com/hep_stories.shtml I hope you will consider submitting it (you can copy and past it in to the field). Some people like to finish their treatment first, either is fine. Please keep it in mind.

And keep posting!

[Bituman]

Well maybe I will take a look at Hep Stories, and thank you for the kind words.  I have been reading your blogs and really enjoy them. 

I remain one of the extremely lucky people, still, free of side effects from Harvoni.  I rode my bike this morning, 30 miles of hills.  My butt is really dragging now.  However it's normal for me to be zapped after that ride.  So I guess every thing is okay.  Tonight is Pill #11. 

Bob

[dragonslayer]

Bob, u fit the 8 wk profile, so did you have to fight for the 12 wks, or did your doctor not even consider the shorter duration?

[MEG]

To me Harvoni is not only zapping my HCV, it's finishing RMS once and for all.

Bob, I really loved reading your post. Thanks so much for sharing. I too acquired my HCV during treatment for a rare ovarian cancer at age 13 in 1974.  I vividly recall the fear of dying, whether I would make it through high school, then college. By the time I was in my late 20s/early 30s, that fear had subsided. My 30th birthday was seminal for me because I was able to feel, with certainty, that that cancer was never coming back.  Three years later, I developed the profound fatigue that would lead to the HCV diagnosis.

I couldn't agree with you more that curing the HCV means curing that ovarian cancer that influenced the trajectory of my life---in both positive and negative ways. I want that chapter closed and sealed forever. I'm so grateful that Harvoni potentially will do that.

I also love cycling but it sounds like I've had more fatigue than you.  On my best days---which is last summer---40 miles of rolling hills was my max. 

Here's to new chapters.

[Bituman]

Dragonslayer that's something I've been wondering too. When I met with the PA to discuss treatment, she told me that under 6 million viral loading meant that insurance would only approve 8 weeks Harvoni for people with my stats.  But she also told me that the Mayo hepatology staff did not agree with the 8 week conclusion of the ION trial data made by the FDA.  Therefore, when they prescribe, they ALWAYS ask for 12 weeks and then appeal if insurance only approves 8.  The other thing that she said was that the "dust was still settling" in terms of what insurance would pay versus treatment protocol.  After reading many of the posts on this forum, I think her phrase about dust still settling made a lot of sense.  In any case, I was very much surprised when I was approved so fast and for 12 instead of 8 weeks.  This is something I plan to ask about next time I see the PA. 

One other thing about my initial meeting with the PA, she mentioned that it was possible that my insurance company (BCBS-TX) would only approve Viekira Pak.  Of course the down side is that protocol uses Ribavarin.  She went on to explain that would probably cause me to be anemic and it was a much more PITA with respect to taking pills.  Turns out that just in the past few weeks, BCBS-TX's pharmacy manager Prime Theraputics approved BOTH Viekira and Harvoni.  Anyway, my doctor had prescribed Harvoni and that's what I ended up getting.  But I think this is one more example of the dust still settling and also another example that I have been really lucky by comparison.  But if I end up having to take Ribavarin, I will happily do so. 

MEG it looks like we have much in common, but it made me so sad that you had to go through that when only 13.  I can only imagine what that would have been like in the early high school years.  At least I was in college.  At that point, most of my friends remained friends and were mature enough not to shun me for fear I was catchy.  I hope your friends stuck with you.  I'm guessing your treatment involved radiation?  Chemotherapy?  Michael Jordan made it cool for men to be bald, but it's never cool for 13 year old girls to be bald I'm sure.  Maybe you didn't have to go thru that.  Actually, MJ's career came after I was sick, so it really wasn't cool for me to be bald either! 

I really liked your phrase about cancer influencing the "trajectory of my life."  I couldn't have said it better.  Even though you successfully faced down the monster, it's always with you, isn't it?  I think cancer left me with mild hypochondriac tendencies.  If I had a twinge under my arm, it was all "oh crap, cancer of the arm pit..."  Of course when I found out about my HCV, it reminded me of the quote, "just because you're paranoid, doesn't mean they aren't out to get you."  And so it goes. 

Well I'm so happy for you MEG and all those new chapters.  By the way, 40 miles of hills will give anyone fatigue!  Endurance athletes are known to use mantras to overcome physical things like fatigue.  So here's one for you that came from Steve Prefontaine and I think he stole it from the Marines, "pain is fear leaving the body."  Feel free to use that one as it has worked for me for a long time.  I think that would work for fatigue, needles in the arm, side effects from treatment, etc. 

Bob

[MEG]

MEG it looks like we have much in common, but it made me so sad that you had to go through that when only 13.  I can only imagine what that would have been like in the early high school years.

Indeed, Bitumen. It's rare for me to meet someone who had a childhood/young adult cancer.

High-fives for beating that monster--that's how I visualized the cancer at the time. 

Early on in my PICU career, we had a baby with RMS on the unit.  The poor thing(and doctor because I got to know how competent he indeed was) got an overdose of adriamycin--in 1981 the sophisticated check and balance systems that we have today did not exist.  As you know, adriamycin is cardio-toxic and she almost died. She was in our ICU for weeks. But, at the same time, the oncologist felt that she'd been cured by this excessive dose. He wasn't saying this to diminish what happened, but instead to point out the irony. 

Ya, dealing with it during high school was complicated. Much more to say....for some other time.

I think cancer left me with mild hypochondriac tendencies.  If I had a twinge under my arm, it was all "oh crap, cancer of the arm pit..." 

Chuckle....I was hyper vigilant for several years post-cancer but then during my 20s, I went in the opposite direction. Although I continued followup, I didn't fear anymore. "I got sick early in life and now it's my time to live." 

I recall that as the fatigue grew worse and worse, my thinking was: if just gave up meat, exercised harder, drank more water, ate more organic foods, left the stressful PICU/ER environment, etc., etc., that I would get better...Imagine the shock when turned out to be real.   Then the hyper vigilance would return---as if "it" had never left. ;-)

Thanks for the Steve Prefontaine quote. I'll put it in my jersey pocket. 

I'm so looking forward to this cold clearing out and hopping on the saddle again---and feeling that burn in my legs as I re-condition myself to conquer one of the hills around here that's a challenge every season.

Hoping you continue side-effect free on the H. This drug is incredible. My LFT's decreased by 1/2 within just 14 days.  Wow.

[MEG]

Bob, u fit the 8 wk profile, so did you have to fight for the 12 wks, or did your doctor not even consider the shorter duration?

Dragonslayer(and Bitumen) my doctor ordered 8 weeks for me. He was one of the  principle investigators for the trials and felt that given my profile(no liver disease, relatively low viral loads) and what he noted during the trials, that 8 weeks was  sufficient.  I hope he's right.

[Bituman]

Early on in my PICU career, we had a baby with RMS on the unit.  The poor thing(and doctor because I got to know how competent he indeed was) got an overdose of adriamycin--in 1981 the sophisticated check and balance systems that we have today did not exist.  As you know, adriamycin is cardio-toxic and she almost died. She was in our ICU for weeks. But, at the same time, the oncologist felt that she'd been cured by this excessive dose. He wasn't saying this to diminish what happened, but instead to point out the irony. 

Wow, giving adriamycin to a baby!  Adriamycin, aka Big Red, because it looked like a big IV bag of red kool aid.  Urinated red for 48 hrs after dose.  The needle slipped out of my vein one time and it caused a sore on the back of my hand that took six months to heal.  Yes they told me, cardio toxic.  Real good stuff. 

With respect to that leg burn, I have another mantra for that.  It comes from Bob Roll who is the color analyst on the Tour de France broadcasts.  It goes like this, "Shut up legs!" 

Bob

[MEG]

Wow, giving adriamycin to a baby!  Adriamycin, aka Big Red, because it looked like a big IV bag of red kool aid.  Urinated red for 48 hrs after dose.  The needle slipped out of my vein one time and it caused a sore on the back of my hand that took six months to heal.  Yes they told me, cardio toxic.  Real good stuff.

 

Yes, the Big Red! You're right. It looked like it tasted like kool aid. LOL...I was so glad when they began using central lines instead of peripheral IV's for chemo. I was petrified of an IV with chemo getting infiltrated into the surrounding tissues.

With respect to that leg burn, I have another mantra for that.  It comes from Bob Roll who is the color analyst on the Tour de France broadcasts.  It goes like this, "Shut up legs!" 

Thanks for the reminder about "Shut up legs!"  Ya, Bob Roll loves that one. He stole it from Jens Voigt. I will miss him terribly this year.  July is Tour Day France month. It's so motivating to get out there after watching those guys climbing Alp D'Huez first thing in the morning ;-)

[Bituman]

Thought it was Bobke because he had that on his road ID.  We will all really miss Jens Voigt.  He's my wife's favorite rider, well she likes Chris Froome too.  I like Nairo Quintana and hope he rides the Tour this year.  I also like  Cadel Evans because he started as a mountain biker, but think he's getting a little over the hill now.  The Tour is like one giant soap opera!  It dominates our July. 

Bob

[MEG]

Jensy is also my favorite of all time. Such an all-around great person---and he tells it like he sees it.

I was rooting for Andy Schleck but it doesn't appear that his young talent will translate into a TDF win. 

Quintana is going to be a force(!) if his collar bone injury has healed thoroughly. 

Of the previous old timers, Robby McKewen ranked up there---his skill, confidence, and humor were wonderful.

A friend sent me Armstrong news today---apparently he had to pay one of his sponsors $10million.  He breaks my heart. My old boyfriend even bought a framed pic of him on Champs at a silent auction because I loved him so much. Sigh.....

Hope you're having a great day.

[Bituman]

I read that Lance is appealing that and may have a pretty good case.  I have just about forgiven him.  Here's how I look at it: 

Lance used PED's and lied about it.
Other riders used PED's and lied about it.

Lance raised $10's of million for cancer and formed a very altruistic foundation.
Other riders???

The main thing about Lance is he evidently was (is) a gigantic jerk.  And he dumped Sheryl Crow, which I and about 99% of the male population consider downright stupid.  Probably if he were a nicer person, he would get forgiven. 

A friend of mine actually met him once.  They met on Trail 100 here in Phoenix a few years back before Lance got banned from tri's.  I think he was here training for one.  My friend was riding a mountain bike and Lance and another guy were running the other way.  They stopped and had a short chat about trail directions and that was it.  Supposedly he was very nice, unlike his reputation. 

Well, I'm sure nobody else cares about this stuff.  Now back to SVR, which by now many more have achieved!  I go Friday for my 2 week labs, expecting favorable results. 

Bob

[apache]

Hi Meg,

Dragonslayer(and Bitumen) my doctor ordered 8 weeks for me. He was one of the  principle investigators for the trials and felt that given my profile(no liver disease, relatively low viral loads) and what he noted during the trials, that 8 weeks was  sufficient.  I hope he's right.

Your doctor is correct, according to the official Harvoni product insert (http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf ), which explains the Phase 3 study parameters and results.

On that .pdf, if you look at "Table 6, Study ION-3", where they compare 8 vs 12 weeks, at first glance it looks like... the 12-week protocol is slightly better (eg, Genotype 1a has 93% success rate after 8 weeks, but 96% success after 12 weeks).

However... and here's where it gets really interesting... if you read the text below Table 6, they do a more rigorous analysis of the Table 6 data and reveal that for the category of folks with < 6 million IU/mL, they actually got better results with the 8 week protocol!   Ie,
     o  97% success (8 weeks)
     o  96% success (12 week)

===> implies a longer course of Harvoni isn't necessarily better!

Here's the key sentence:

Among subjects with a baseline HCV RNA < 6 million IU/mL, the SVR was 97% (119/123) with 8-week treatment of HARVONI and 96% (126/131) with 12-week treatment of HARVONI

In reality, this is just a mathematical oddity which is caused by the relatively low numbers of test subjects.   If the numbers of test subjects were larger, we'd probably see that 12-weeks is not actually less successful than 8-weeks.

But on the other hand, the ION-3 results also provide zero evidence that 12-weeks is actually better than 8-weeks (for those who fit the category of no cirrohosis and < 6 million IU/mL).    That should be very reassuring to those who fit that category, and "only" got approved for an 8-week course of Harvoni 

And if I worked for Gilead, I too would probably bury results like this in the text, rather than highlighting them in a table.  After all, there is a massive profit margin in each pill.  And there is no harm to the patient in taking an extra 2 weeks of Harvoni.  So if those doctors who are rushed (and who isn't?) don't read every single sentence of the Detailed Product Insert, and just prescribe 12-weeks by default, Gilead probably sees it as "no harm, no foul".   And a big ka-Ching ($$$) for the owners of Gilead stock.

[MEG]

Ah, thanks apache. I'll head over and read it now. Quite encouraging.

[kate0b1]

@apache, this is freaking me out lol now I'm working that i will be on treatment for to long  my VL has stayed fairly low since my relapse.

kate

[Bituman]

Here's the key sentence:
In reality, this is just a mathematical oddity which is caused by the relatively low numbers of test subjects.   If the numbers of test subjects were larger, we'd probably see that 12-weeks is not actually less successful than 8-weeks.

But on the other hand, the ION-3 results also provide zero evidence that 12-weeks is actually better than 8-weeks (for those who fit the category of no cirrohosis and < 6 million IU/mL).    That should be very reassuring to those who fit that category, and "only" got approved for an 8-week course of Harvoni 

I agree with you.  I looked at the summary tables from the ION trials and my first thought was there is no statistically significant or practical difference between the 8 and 12 week success rate.  I would have been, and still would be, pleased with either protocol.  On the other hand, my hepatologist's PA said the 8 instead of 12 decision was based on FDA analysis of the ION data, and their staff was not yet in complete agreement.  So I assumed there must be some data not in the tables that we can't see. 

I think the key point, and you made it, is that there is a high probability of success with 8 week as well as 12 week protocol.  When you compare the 95-ish percent success rate of these new DAA's with the success rates of the older treatments, the 8 vs 12 week debate is like "how many angels can you fit on the head of a pin?" 

Bob

[MEG]

Hi Bitumen and Apache,

I also read through and it is surprising that they both did *essentially* as well.

I'm trusting my hepatologist on this one. He's known me since diagnosis and I know he went to bat for me to get approved since the insurance companies were initially only approving those with cirrhosis and high viral loads.

He has been part of every clinical trial for HCV since the days when it was called nonA/nonB.

Fingers crossed. As hopeful as I am, I'm leaving the space in my heart and mind that I may relapse---knowing that Gilead has other even more effective agents in the pipeline.

But...Aiming. For. The. Cure. Now.!

[dragonslayer]

Hi Meg,

Your doctor is correct, according to the official Harvoni product insert (http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf ), which explains the Phase 3 study parameters and results.

On that .pdf, if you look at "Table 6, Study ION-3", where they compare 8 vs 12 weeks, at first glance it looks like... the 12-week protocol is slightly better (eg, Genotype 1a has 93% success rate after 8 weeks, but 96% success after 12 weeks).

However... and here's where it gets really interesting... if you read the text below Table 6, they do a more rigorous analysis of the Table 6 data and reveal that for the category of folks with < 6 million IU/mL, they actually got better results with the 8 week protocol!   Ie,
     o  97% success (8 weeks)
     o  96% success (12 week)

===> implies a longer course of Harvoni isn't necessarily better!

Here's the key sentence:
In reality, this is just a mathematical oddity which is caused by the relatively low numbers of test subjects.   If the numbers of test subjects were larger, we'd probably see that 12-weeks is not actually less successful than 8-weeks.

But on the other hand, the ION-3 results also provide zero evidence that 12-weeks is actually better than 8-weeks (for those who fit the category of no cirrohosis and < 6 million IU/mL).    That should be very reassuring to those who fit that category, and "only" got approved for an 8-week course of Harvoni 

And if I worked for Gilead, I too would probably bury results like this in the text, rather than highlighting them in a table.  After all, there is a massive profit margin in each pill.  And there is no harm to the patient in taking an extra 2 weeks of Harvoni.  So if those doctors who are rushed (and who isn't?) don't read every single sentence of the Detailed Product Insert, and just prescribe 12-weeks by default, Gilead probably sees it as "no harm, no foul".   And a big ka-Ching ($$$) for the owners of Gilead stock.

I agree with all of this.  From the trial data, there is absolutely no disadvantage for the  folks in the appropriate group, doing 8 wks of Harvoni vs. 12.  Two things come to mind, however, that need to be said. 

First, coming from one who at EOT tested with a low detectable reading, I think there is undoubtedly a measure of safety in going for 12wks vs 8.. What if, in the ensuing time between the issuance of the prescription and the first pill (often this can take over a month what with denials, runarounds, and communication delays), viral load  slipped from < 6mil to > 6 mil?  Or what if the liver condition diagnosis was not completely accurate (Fibroscan is being increasingly used as a biopsy alternative, yet, we know that while diagnosis at the extreme ends of the scale is fairly accurate, readings in the middle ranges, ie intermediary fibrosis, tend to not be reliable ...  http://www.ncbi.nlm.nih.gov/pubmed/20850886.  To wit:  "The diagnostic accuracy of non-invasive tests was high for cirrhosis, but poor for significant fibrosis. A clinically relevant gain in the likelihood of diagnosis was achieved in a low proportion of patients. Although the diagnosis of cirrhosis may rely on non-invasive tests, liver biopsy is warranted to diagnose intermediate stages of fibrosis."  However, this study was done in 2010 and perhaps results have been improving )?   These situations would likely not arise during trial, but in the real world, they need to be respected.

Secondly are the recommendations from the AASLD :
 (http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection).  As has been pointed out elsewhere, this excerpt comes to mind:

" Post hoc analyses of the 2 RBV-free arms assessed baseline predictors of relapse and identified lower relapse rates in patients receiving 8 weeks of ledipasvir/sofosbuvir who had baseline HCV RNA levels below 6 million IU/mL (2%; 2 of 123), and was the same for patients with similar baseline HCV RNA levels who received 12 weeks (2%; 2 of 131). This analysis was not controlled and thus substantially limits the generalizability of this approach to clinical practice. Shortening treatment to less than 12 weeks should be done with caution and performed at the discretion of the practitioner."

So, while I agree that the Ion-3 results show no reason for <6mil, treatment naive, and non-cirrhotic patients  not to do the 8wk course, I think real world results remain to be seen, and for safety, Im not sure that 12 wks isnt the safer way to go.  Had I tested UND at end of my 8 wk treatment, Id likely not be taking this position, however my eyes have been opened. 

[MEG]

Thanks Paul for those links...now I certainly do wish and would feel more confident if I'd gotten the 12 week treatment. 

How is your hepatologist dealing with your EOT 29? What is the next step for you?

My doc is on vacation right now and don't want to bother him---he's fabulous in all ways. I love him. He'll answer emails within a couple of hours. I'm going to wait until he comes back to ask him about this.

Paul at what point were you initially undetectable.?

[dragonslayer]

Thanks Paul for those links...I certainly do wish, would feel more confident if I'd gotten the 12 week treatment. 

How is your hepatologist dealing with your EOT 29? What is the next step for you?

Meg, I was never tested UND.  I was  told to retest at 12 wks post treatment and to see him then, which is mid April, which is what Im going to do.  He only wanted to do a 12 wk test anyway, so this is in keeping with his original plan. Also, if I need to retreat, he'll need those new numbers anyway... Also, why order a test earlier, when the 12 wk test is the only one that matters in the end... This is why Im going along with this; it just makes sense to me.

I just wanted to add yet another factor in support of why real world 8wk results may not be as strong as Ion-3:  supplements and coincident meds taken.   These would likely  have been way more highly controlled and logged in the trials than in the real world.. Theyve tested so few meds and supplements' interaction with Harvoni, that its really a crapshoot until more is known... So this just redounds, again, to the argument of safety in 12 wks vs 8.

[MEG]

Not sure I understand. Are you saying that you never reached undetectable during your treatment or that you did not have viral loads done during treatment?

I agree with you re: meds and esp supplements. I will not take anything beyond Vitamin C and my baseline of meds(diuretic and antidepressant---these latter meds are so common that they were surely being taken by many of the folk in all the trials.

I do take my Harvoni at dinner time and my other meds in the morning and won't take Vit C 4 hours prior or after the H. It's the best schedule that I could think of to minimize the risk of reactions.

[dragonslayer]

Not sure I understand. Are you saying that you never reached undetectable during your treatment or that you did not have viral loads done during treatment?

I agree with you re: meds and esp supplements. I will not take anything beyond Vitamin C and my baseline of meds(diuretic and antidepressant---these latter meds are so common that they were surely being taken by many of the folk in all the trials.

I do take my Harvoni at dinner time and my other meds in the morning and won't take Vit C 4 hours prior or after the H. It's the best schedule that I could think of to minimize the risk of reactions.

Meg, let me explain.. Response guided therapy was used during earlier treatment protocols.. Then, and during trials where they need to check results for their analysis, it was customary to take many on treatment bloodtests.   With the new treatment regimens, this has largely been dropped. .Some doctors still do it, either out of habit, or patients wishes, but its definitely not in the treatment recommendations from the manufacturers.  So, consequently, I had no on treatment tests... It is very rare for Harvoni prescribers to change the prescriptions mid stream, or to  order more as a result of on treatment testing.  It's done, but its rare.  The only test which matters with these new drugs is what you achieve 12 wks post treatment. .Even an EOT test is meaningless, and can be counter productive in giving false hope, or false agita.. Its all noise in the system until 12 wks post treatment.

[MEG]

Thanks Paul. I was not aware that blood levels(of any kind) during treatment were not part of the manufacturers recommendations. I assume your doctor is a hepatologist?

I had 2 week lft/creatinine and next week I'm having 4 week on treatment viral load/lft's and then the latter batch every 4 weeks until 12week post EOT.

I didn't question it since I figure that this is a major medical institution who has shepherded all these meds over the years---that I'm part of a quasi clinical trial. Since the drug is so new that they want to follow the real world results carefully and evaluate them for signals to guide future treatments..

Best luck. I did read in another thread that some people like yourself who test for slight amt of virus eventually clear it...I pray for that for you.

[Bituman]

Here' a progress report. 

Just finished day 19 of 12 weeks Harvoni.  I did labs last Friday at two week mark.  ALT=24, down from an average of about 57 last 8 years.  AST=29, down from average of about 41. 

Oddly, Bilirubin=1.3, almost normal and down from an average of about 1.81 over the last 8 years and it has been elevated since at least 1976 during my battle with RMS.  In fact, my first liver biopsy was back then trying to figure out why bili was so high.  My oncologist back then said nothing to worry about, my liver looked fine, some people just live with slightly elevated bili.  My hepatologist now says it's called Gilbert's syndrome.  Again, nothing to worry about and he says not related to HCV.  Just seems odd it improved. 

Oh yeah, almost forgot, HCV RNA = 59 IU/mL, down from 3.59 million on January 26 and an average of 5.64 million over the last 8 years.  As the PA said, "...that stuff is evidently working..." 

Still no treatment side effects, no fatigue, no headaches, no anxiety, nothing.  Worked out 3 times last week and yesterday rode mountain bike 41 miles, 2600 ft climbing, 4 and a half hours.  It's spectacular in the Arizona desert now and it's so fun to be out in it.  (If I could figure out how to post attachments, I'd show you a picture.)  Between my job, riding, yard work, and "honey do's" I don't have time for SE's.  Again, that could all change tomorrow, but for now A-okay. 

Best of luck to all.  I'm sure all of you are achieving same or better results.  Healing vibes to all of you.

Bob

[MEG]

Wow Bob---those are incredible numbers....congratulations.

And power to you bro' for being able to do all that you do---all while also on treatment..

Keep it going!

[Bituman]

I consider myself lucky in all this.  It helps that I am in an area with primo weather, at least for now.  I feel bad for those that suffer some from SE.  On the other hand, I think if there were a poll of those on Harvoni, I bet we would find there are way more people like me.  On this forum there are several very active posters, gym rats, cardio freaks, etc.

More healing vibes to all!

Bob

[Bituman]

Update via 4 week labs:

AST and ALT unchanged from 2 week tests, 29 and 25, respectilvely. 

Bili back up to 2.1.  This confirms what my IM doctor and hepatologist independently  told me, it's Gilbert's, unrelated to HCV infection.  Oh well...

Platelets at 149, just below the lower recommended limit of 150.  For the last 7 years they have averaged 159 (n=14).  Doctors got modestly concerned when 3 years ago it dropped to its lowest value of 116.  They thought it might be an indicator of liver issues, but CT scan indicated not.  One of them told me it might just be caused by my platelets clumping together and not getting counted accurately.  I suspect he just made that up to make me feel better.  Don't know why this one bugs me so much. 

Lastly, HCV RNA < 15 IU/mL.  So the downward trend continues, and while there is still virus present, it's below the detection limit of the test.  I guess I'm in that netherworld of 1 to 14.  See below, looks like the Harvoni is hunting down he virus and beating it into submission.  I guess technically it's preventing the virus from reproducing.  Would that mean it's "condoming" the virus into submission?  As of today, I have 54 more orange pills to finish the job. 

Next labs due at 8 weeks at the end of March. Then I'll qualify to post in MEG's 8-week thread. 

Traveling today, in Portland, OR.  Weather is spectacular just like back in Phoenix.  Room overlooks Willamette River right by this really neat looking drawbridge.  I envy those that live in this part of the US.  It's a nice setting to receive good lab results. 

Best of luck to all.  Sending more healing vibes. 

Bob

[MEG]

Congratulations on such great news! Ya, it seems sometimes there are few hcv critters hanging on for dear life---but, 8 more weeks of constant assault should do the trick ;-)

About your platelets---one thought that comes to mind--because you're drinking more water than usual since you began Harvoni, your blood is literally a bit more dilute-- might also be contributing to the small down-tick? We saw this often in the PICU. Dehydration giving false highs of platelets(and other blood components). Rehydrating the child would see a commensurate decrease in platelets.  In addition to the Gilbert's...I wouldn't worry about them. Your lft's are proof positive that your liver is getting a break and is on its way to healing.

Your trip in Oregon sounds wonderful.........on the Williamette River. Sigh. It's on my list of places to visit.

I'm sure you know that it's a cyclist's city.  ;-)

PS: Jens Voigt will be leading fans on one of the stages at the Amgen Tour in May. I wish it wasn't so hard. I'd do it in a NY minute..

L’ETAPE CALIFORNIA 2015 SET FOR MAY 16

As part of the 2015 Amgen Tour of California, race presenter AEG will once again bring cycling fans the ultimate road race experience – the opportunity to ride a stage just hours before the world-renowned professional cyclists competing in the eight-day stage race May 10-17. Leading the peloton of amateur cyclists expected to be in the thousands on the L’Etape California course Saturday, May 16 will be acclaimed fan favorite Jens Voigt, who retired from a celebrated 17-year career after last season and joins the race in a new capacity as the 2015 Amgen Tour of California ambassador in celebration of the race’s 10th anniversary.

The 2015 L’Etape California will feature the same Mt. Baldy climb and many of the same roads the professional riders will race during the Amgen Tour of California’s Queen Stage (Stage 7, Presented by Lexus). Two distances are offered, both showcasing beautiful roads and significant climbing. The 80-mile long ride will begin at 7 a.m., with the 40-mile short ride following at 9 a.m. Once they cross the finish line, L’Etape California riders will have front-row seats to the conclusion of the professional race stage inside the final mile of the climb.

http://tahoesouth.com/press-release/jens-voigt-named-amgen-tour-california-ambassador/

[Bituman]

MEG with respect to platelets, perhaps you're right, dilution.  Sounds plausible.  Overall, very happy with the labs. 

I actually looked into the L'etape ride at TOC.  That Mt. Baldy climb would be sweet plus it's my best opportunity to check out high level pros.  But I developed a conflict with the date.  Signed up for the middle distance at the Whiskey Off Road in Prescott, AZ.  It's more fun than serious for me. 

More healing vibes sent to all! 

Bob