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1961140 tn?1450738712

RE: Trouble in Sovaldi Land?

Hey Guys, I thought this was worth bringing attention to:
http://www.healio.com/hepatology/hepatitis-c/news/online/%7Ba024e17c-a849-4cdd-86d2-3efab75cf434%7D/study-shows-low-svr-among-veterans-on-sovaldi-based-regimens?utm_source=maestro&utm_medium=email&utm_campaign=hepatology%20news

I hope this is just an anomaly, in particular for those who shelled out big $$ to get it. The data keeps rolling in, on all of these "*.svir" meds.  Finally enough time has passed post treatment to see what the reality is.       mac
29 Responses
2059648 tn?1439766665
"I hope this is just an anomaly, in particular for those who shelled out big $$ to get it."

___________________________________

Which in this case…..us.  The tax payers.
Avatar universal
I am willing to bet that the patients in their cohort were/are sicker than the general population, both the Hep C and other medical problems.  

One thing, even under those conditions, it shows that the meds do work, just not as well in the sickest people, or perhaps those with 'comorbidities' (am I using that eord correctly?  Mean to say, other serious medical conditions).

Also, there is probably a larger segment of that population than of the 'normal' population who are not as complaint with meds for one reason or another.

Please remember, this is only an opinion.

Pat
Avatar universal
Thank you for the info.

link to full article
Article first published online: 26 JUN 2015

DOI: 10.1111/apt.13300

Published 2015. This article is a U.S. Government work and is in the public domain in the USA (this means free view no registration or membership etc)
Title
Effectiveness of sofosbuvir-based regimens in genotype 1 and 2 hepatitis C virus infection in 4026 U.S. Veterans

http://onlinelibrary.wiley.com/doi/10.1111/apt.13300/full

I'm not a medical professional and it will take some time so if I get a chance to review the details I will give you my personal opinion.

Opinion so far
SA Vets have a higher rate of PTSD and mental health issues than the general public.

SVR rates only include those who achieve SVR

Statistics can be interpreted in many way depending on which details are available, used and compared.

Important Questions besides GT, medical condition, age, cirrhosis, bmi  etc that I would want to know but haven't analyzed the data yet.


Does SVR percentage include for those not achieving SVR
1. Those who were not compliant with treatment but no severe adverse medical condition requiring discontinuing treatment.
2. Those who had to stop  treatment foe medical reasons.
3. Those lost to follow up before 12 week SVR  viral load test.

If I was considering treatment I would not include 1 and 3 in the SVR percentage.

I would then go through as many specific conditions to best match to my conditions. For some the narrowing of the patient sample numbers to better match your situation may reduce the sample size too much to be an accurate predictor.  

That's a good reason for some requirement to release not only trial data but real use results in a timely fashion for new fast tract approved drugs at least for the first year or two.  

see
http://www.medhelp.org/posts/Hepatitis-C/Public-Health-Groups-Sue-FDA-for-access-to-HCV-clinical-trial-data/show/2649488
2059648 tn?1439766665
My opinion is the VA would give a good representation on how these drugs respond in realtime.   There isn't a selection process to create the best outcome.   I applied for a few clinical trials and by doing so found they can't be producing accurate results.  One of the most interesting was a clinical trial nurse in the selection process told me I wouldn't qualify because I had had breast cancer and chemotherapy 15 years ago.  I really couldn't see how this would have changed the outcome of this trial except I didn't have a perfect cancer free past.  Good thing we hadn't talked about the Hepatitis C treatment yet.  For sure that would have ended my chance at a clinical trial.    

In realtime people don't have perfect health.   Or never had an serious illness. I find it offense that it was brought up that Vets couldn't be good candidates for determining this factor because of a higher rate of PTSD and mental health issues than the general public.   The general public does experience PTSD for numerous reasons and mental health is a huge issue in the general population.  

Avatar universal
This comes to no surprise as trial results and real life results are never the same in these Hep C trials as they cherry pick people. As for patras statement about vets? I find that very offensive and just flat out silly. Now that's just my opinion.
Avatar universal
I am a Vet and have no problem with patra's opinion. "sicker than the general population" "not as complaint with meds" and my opinion on PTSD & mental health.

First it does not diminish nor imply that non-vets who have similar problems have it any easier.

The opinion that veterans have a higher percentage could mean 5% 10% etc.   Just google and the percentages and or situations are quite debatable.

"trial results and real life results are never the same in these Hep C trials" this is pretty well known to many of us and wasn't used to differentiate Vets from general HCV treatment population. .

The veteran discontinuation rates were comparable although somewhat higher than discontinuation rates reported by CVS Health.

from the report
"Another notable finding of the present analysis relating to differences between real-world experience and clinical trials is the rate of early treatment discontinuation. The discontinuation rates we observed (13.7% for SOF + PEG + RBV, 11.8% for SOF + SIM, 9.9% for SOF + SIM + RBV, 14.3% for SOF + RBV) were comparable although somewhat higher than discontinuation rates reported by CVS Health (10% for SOF + PEG + RBV, 4% for SOF + SIM, 9% for SOF + RBV).[19] These discontinuation rates, however, are markedly higher than those observed in clinical trials (0–3.6%).[5, 14, 16, 17] The early treatment discontinuation rates likely contributed to the lower SVR rates observed in our cohort compared to the clinical trials, highlighting that the observed effectiveness may be substantially undermined by issues such as patient tolerability, social or behavioural factors, adverse events and baseline characteristics pre-disposing patients to failure.

What we need is more complete disclosure from real life treatment results in the USA combined in a sort-able aggregate accumulative total from a high percentage of everyone that gets treatment within the first year or two.
within a timely period post 12 week SVR like 3 -4 months afterwards.
Avatar universal
last paragraph was my opinion also.

BTW I was one of those VA patients
GT2 Cirrhosis Class A well compensated, 35 BMI  who thankfully achieved SVR last year  SOV/RBV 12  weeks  Was lucky should have got 16 weeks.
The ESAL recommends 16-20 weeks

If interested in my details see my pre, during and post TX Journals
click my name link to profile page then lower left for my Journals. (Full site) not sure about mobile
2059648 tn?1439766665
The VA is the largest single provider of Hepatitis C treatment.   All the records in one spot.   CVS Health is not and doesn't have all the health records to see who has what.   I'm not a vet and totally agree with what candoman
said.   If you go to the doctor your seem sicker than most.   The VA tests
everyone for Hepatitis C.   All you have to say to your doctor is NO.  I think (In my opinion) it's an excellent place to find out real results.   All the real true actual records are available in one place. Which might be why results are higher in the vet population.  

Government Retiree
Avatar universal
Actually this side discussion isn't my primary forward looking opinion.

There have now been over 100,000 people treated with Sovaldi and Harvoni is catching up and will surpass Sovaldi sometime within a year.

We need the real time results of at least 50,000 to 100,000 by the end of the year.  With special focus on those that don't achieve SVR and serious side effects. Either the providers, insurance companies or other would collect and pass data (non personal identifying)to the agency assigned to do this.  The drug manufactures would bear the cost.   They have plenty of money to advertise and mail me high gloss expensive brochures a year after treatment with Sovaldi for Harvoni

The VA was limited to Sovaldi Oyliso PegINF RBV 12 weeks and took 1 1/2 years for results.  some subcategories didn't have enough data.

My suggestion is results would be submitted by some form electronically within 6 months post treatment 3 months after 12 week Post tx VL.  The Assigned agency would update database at least within 30 days of receiving the data. This would be available on line for the public
Avatar universal
Sorry if I got off on a tangent

Lets look at the data and see if there any interesting info maybe not anticipated or because the sample is too small.

Since I was GT2 naïve here are a few for GT2 only  JM =my notation
Table 3. SVR rates for treatment naïve by regimen for genotype 1 and genotype 2 patients
Genotype 2 SOF + RBV (N = 468)
Overall SVR 81.6 (382/468)
Age (years)
<55  77.6 (45/58)
55–64 82.1 (238/290)
≥65 82.5 (99/120)
JM older has slightly better SVR %

HCV RNA
<800 000 IU/mL 77.1 (108/140)
800 000–1 999 999 IU/mL 81.8 (72/88)
2 000 000–5 999 999 IU/mL 83.2 (119/143)
≥6 000 000 IU/mL  85.6 (83/97)
JM who would expect highest VL to be over 8% higher SVR than lowest

IL28B Polymorphism
CC 68.8 (11/16)
CT 92.9 (13/14)
TT 80.0 (4/5)
JM sample too small but CC lowest SVR opposite GT1

4 week treatment HCV RNA
Undetectable 91.0 (263/289)
Detectable <43 IU/mL 69.4 (34/49)
Detectable ≥43 IU/mL 74.1 (20/27)
JM ?

BMI, MALE, Higher APRI FIB-4, compensated had lower SVR as expected

Lucky for me had .BMI, MALE, Higher APRI FIB-4 just over 800k vl maybe lowering my odds for SVR    66-67 age during tx  not sure if + or -
2059648 tn?1439766665
Doctors are required to report to the public health department those with Hepatitis C.  Only that you "have" Hepatitis C. So "NO" the public health doesn't know you were cured of hepatitis C.

So, why doesn't the government require public health to track those with Hepatitis C.  Otherwise,  require doctors to report the treatment/outcome and current status of Hepatitis C infections.   Currently, all my public health agency knows is I have hepatitis C.  That's all they know.  

The Public Health Depatment does have a reporting system in place.   Doctors could simply be required to provide the additional information
to the health department.  It's not complicated.  




Avatar universal
I am sorry you found my statement offensice and silly.  I based that statement on having soent 30+years of fighting to get Veterans into medical treatment, get them benefits, both comp and pension, etc.  The reason i said a sicker population, is because there are so many who had no insurance, and whose comp % was not high enough for them to have been eligible for medical treatment all along, so had not been getting any health care except maybe emergency.  The Health Care Act was not available, so Insurance was not available to all, across the board.

I was not saying that to be derogative, but only to state that a consideration would be the health and treatment availability, as well as the over all health of many Vets who were getting treatment.  Of course, in the last few years, they are supposed to be opening medical care to way more, but as I have been retired for 5 years, I don't know, currently if everyone who needs tretment is getting it.  All I was speaking from and can speak from is the expierences I had then.

I was not saying that there was a difference in a comparison to a similar cohort, just that I didn't think test trials reflected that, and that I think that, generally those in the Vet cohort, were sicker than the 'average  general population now seeking treatment.

If that offends you, again, I am sorry, but that is my opinion.
Avatar universal
"Also, there is probably a larger segment of that population than of the 'normal' population who are not as complaint with meds for one reason or another."

That was the part I found offensive. I've read here many times where people skip doses, seem to forget, or just don't take it serious and they were not Vets. These new meds are not like the old SOC so I don't think being a vet has anything to do with not taking a pill or two a day. BTW what is "normal"?

My opinion, have a great day.
Avatar universal
I know that the reporting of ACUTE hep c is required in 49 states. I don't know if it is required in chronic cases. Surveillance of hep C is sorely lacking and a big problem in the USA, making policy on transmission and preventative issues a big problem. It is almost impossible to diagnose acute HCV as we all know. Do any of you know if chronic case are a requirement for reporting and can you cite a reference? Many thanks.
2059648 tn?1439766665
Public Health is notified if you have chronic or acute Hepatitis C.  All who work in the medical and those with association to the field of Hepatitis C
know this.  

http://www.cdph.ca.gov/pubsforms/forms/CtrldForms/cdph110a.pdf

Avatar universal
Your form tells me that it is reportable in California. And, apparently not all people who work in the hepatitis community know this. I haven't worked in that area since the early 90's so wasn't quite sure what the federal laws are now.
Avatar universal
So, here is the "real" scoop. Each State has its own rules and regs on reporting chronic hepatitis C on a state level. There is NO federal law that requires a State to report chronic hepatitis C on a national basis. This comes from the Division of Viral Hepatitis at the CDC. So , DW, I guess everyone who works in the field and reads here at Medhelp knows now. Hepatitis C is not listed as a reportable disease according to the CDC. Now we know one of the reasons surveillance is so poor.
2059648 tn?1439766665
Public Health reports to the CDC.  I do believe the states don't having any issue with reporting that information.   There is no benefit to not providing the information.  Statistical information comes from the states/county health departments.

http://www.cdc.gov/hepatitis/statistics/index.htm

There are forms to provide much more detailed information and I'm sure the CDC "should ask" and would love to but the ADA law won't let them.  Yes we do have laws concerning this matter that protect us from disclosure.

http://www.cdc.gov/hepatitis/statistics/index.htm
    
Avatar universal
Not my point DW. My only point was in asking if there were federal laws requiring the States to report chronic hep C to the CDC. The answer is a definite no. Hepatitis C is still not listed by our government as a reportable disease on a federal level. I realize I did not make my question clear in the beginning. I also don't see it as an issue re hippa and disclosure as it could be done anonymously. If the States would report all cases,We would have a better handle on surveillance. But, 20 years later, we still do not.
2059648 tn?1439766665
These forms about information CDC (federal) are on the referenced page.
Regardless, this thread is about reporting information that came from the VA.
The general publics information comes under different set of rules than the VA.   Bet the information is a lot more accurate from the VA than the public which doesn't disclose all the other factors like who took the medication as directed and who didn't.  
1961140 tn?1450738712
C-D-M,   I've known Pat for a long time, and she has no malice in her heart. She obviously has experience in this field that I do not. My personal experience with a combat Vet was with my Father, who after enduring Kamakazie strikes on the carrier Essex came out of the service a changed man. He did everything possible to neglect his health, and am sure he was suffering from what we now recognize as PTSD. Perhaps "survivor's guilt" as well, who knows? He would never talk about it. He became a totally different individual. Between the metal stress, the unsanitary living conditions sometimes necessary, exposure to all sorts of toxins, the heavy reliance on tobacco products to ease the stress, exposure to foreign illnesses, and a medical care system that fails them miserably in a lot of cases, it would be no great surprise if the Vets were not as healthy as their civilian counterparts. I am sorry you took offense to what Pat said, but I feel it was done with the best of intentions. It is odd, I have been posting here for 2+ years, and this one topic has generated the most dialog. Dialog is good, and "ignorance in action is fearful".Someone a lot smarter than me said that once, and I  heartily agree. The poltiticians are an endless supply of hot air about the problems of the VA, but offer us no concrete overhaul plans for a system that still generates horror stories about lousy care on a regular basis. That is the real shame of it. As far as "cherry picking" who gets to participate in a clinical trial, the inclusion/exclusion criteria varies between drug maker, but tend to be very tedious and exhaustive.The exclusion criteria were extensive, the blood panels were the most thorough I have ever seen.I had to get an endoscopy for varices, and a core liver biopsy. They checked me for HIV on every visit. They were also doing tox screens, although they never told us that, the whole time.  I missed out on the trial before mine because my RBC count was a few tenths below the normal range. So, I don't think it is so much "cherry picking", but selecting candidates that were healthy enough other than their HCV to make sure these new meds were not going to have adverse effects. The long term sfx/SVR data are still the big mysteries though... Except for chiming in on the forum though, I have put it behind me. My liver will never get measurably better most probably, but at least I shouldn't progress to Stage 6. As with all in life, there are no guarantees, so I choose to relegate my HCV to my subconscious.  mac
Avatar universal
Just like we all have "bottoms" we all have our opinions. I "agree to disagree"
https://en.wikipedia.org/wiki/Agree_to_disagree
"After all, those who will live in peace must agree to disagree in many things with their fellow-labourers, and not let little things part or disunite them."
Whitefield had used it in a letter as early as June 29, 1750.

Time for me to take an electronic communication stress break.  Will be traveling to two music festivals Grassroots in Trumansburg, NY and another one in Scranton, Pa Camping in a tent with 15' high inflatable bed.

Wish everyone the best. Back next week.
Avatar universal
Here is the email regarding reporting hepatitis C:

49 state and D.C. have laws that require reporting of hepatitis C.  The specificity of the laws vary from state to state.  Most states have a general law that requires reporting of hepatitis C.  Some states have more specific laws.   In California, Connecticut, Indiana Kentucky, Louisiana, North Carolina, and Texas, the law only requires reporting of acute cases.  The laws in Georgia and Montana explicitly require reports of past or present infections.   And, as I’m sure you’re aware, reporting practices in a state don’t necessarily match the legal requirements.   Also, since the below request mentions federal laws, just a note that the states are not obligated to report to CDC/federal government.  

Cecilly Campbell JD, LLM
Division of Viral Hepatitis
National Center for HIV, Viral Hepatitis, STD and TB Prevention
CDC
Avatar universal
gilead page friday july 17

10:40 am Gilead Sciences: A Cigna (CI) analysis has found that 98.4% of Cigna Pharmacy Management customers treated with Harvoni for hepatitis C genotype 1 achieved a sustained virologic response (GILD) :  

====================
Regarding the other discussion.
We all have our own particular response rates.

It could be due to age, sex, race, genetics, co-morbidities, treatment history, as well as past or current drug exposures and interactions.
It could very well be true for veterans.(for a variety of reasons)

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