I got a call yesterday from member Randy saying he’d been kicked out of the “program” at the Denver VAMC for non-compliance. Apparently he missed taking four doses of his Sovaldi over a month or so and had a relapse. Before you say “Well, duh. What did he expect?” let’s parse this more thoroughly. Member Mark also augered in last month due to the insidious side effects of Stage 4, depression and our favorite nutritious supplement Ribavirin.
We are in the early stages of being able to slay the dragon and it is expected that some are going to win and some lose. We just didn’t expect to have several of our members bite the dust. Sovaldi has had miraculous reviews both with Ribavirin on the 24 week regimen as well as the dreaded rerun of doing Interferon/Riba/ Sovaldi on a 12 week basis. I pity the few who went down that road as I consider Interferon useful for killing or maiming people and little else. Ribavirin is right down there in the same category or worse- a useless adjunct thrown in to the mix as a way to get rid of it before the bottom falls out of the market for it.
Randy’s predicament is not unique. Everyone of us stationed at Camp HCV knows the insidious effects of the disease on our brains-either directly from the Interferon poison they fed us to the actual debility that eventually ensues from cirrhosis. Quite simply, ammonia builds up in our systems and causes brain fog. Doctors call this cognitive disfunction. Call it what you will but it sneaks up on you. Randy just had a brain fart and suddenly discovered he had too many pills and not enough days left. Shit happens.
I had the misfortune several weeks ago to discover I had inadvertently eaten two one morning when I couldn’t remember whether I had eaten the first one. This left me in a) a panic and b) one pill short of a load. Fortunately for me, I was able to run over to Mark’s house and grab his leftover Sovaldi to get back on track. In construction, it is a tried and true axiom that nothing is a f___up until you can’t fix it. Thank you, Mark for saving my bacon.
Sovaldi in combination with some of the old crap may have been the early panacea to our disease but the newest one in the pipeline is going to be less of a problem. Sovaldi is an NS5A protease inhibitor. Please note the “A” after the 5. The new Gilead product adds a similar but subtly different protease inhibitor called NS5B. Added together, the combination approaches a 99% cure rate as the early testing of Sovaldi and Daclatasvir did. Unfortunately, Gilead refused to collaborate with Bristol-Myers Squibb, who owned the Daclatasvir patent. Instead, they went out on their own and spent a year creating Ledipasvir-the NS5B inhibitor I mentioned above. This is a win-win for us because Daclatasvir was a NS5A inhibitor rather than the newer B class.
Randy and Mark should take heart that they are not up shit creek. The combo with Ledipasvir is coming out later this fall and from all the literature I’ve read, it’s damn near bulletproof where the Sovaldi was not.
Any new product will have some flaws and we expect it in the medical field. Who could have foreseen the birth defects of Thalidomide in the sixties? Well, if they’d been more careful and done more testing, I’m sure they could have related the lack of arms or legs in the test mice to it sooner or later but the Germans are renowned for being optimists and far thinkers. So too Sovaldi. In it’s early testing, the scientists were still stuck on stupid and had trainloads of Interferon and Ribavirin they were desperate to be rid of. It probably seemed natural to blend them all in together. That’s a problem with scientists. If even one guy survived the Interferon treatment and was cured, they were hell-bent on using it on all of us. It didn’t seem to matter if we came down with raging cases of thyroid cancer or went blind. We were cured and that was the desired result. Unfortunately, they still think like this. Sometime in the near future I can see the chuckleheads trying to trot out Interferon as the new miracle cure for Ebola. Don’t laugh. They tried it on cancer, HIV and HCV in that order for over half a century and succeeded in killing and maiming untold thousands of us in a desperate bid to prove it was the magic drug.
As we move into the twenty first century and out of the dark ages, Hepatitis C will become a curio. On the rare occasion when it pops up in the future, it will be viewed like rabies. Instead of a simple series of shots over twenty eight days, HCV-infected souls will undergo a painless 12 week (or less) course of improved Sovaldi II with Ledipasvir and that will be the end of it. I suppose there may be a handful of non-responders but I am also willing to bet that, too, will become an anomaly within a decade or less.
Randy and Mark should be glad they survived the dragon all these years and will have not one but two shots at the new, improved products coming on line. As for me? I’m keeping my fingers crossed that I am still cured. VA apparently was doing viral load tests on Randy every two weeks while he was in treatment. Medicare is not so generous. I’ve had two tests to measure it to date and am now in a virtual viral panic hoping I can induce my minder to give me another when I meet with her next week. I’m on Day 96 of 168 this morning.
For those of you who have heart problems, I have some really good news. As I descended into cirrhosis, I noticed a gradual decline in the amount of Warfarin (or Coumadin) needed to sustain an INR of 2.0 to 2.3- the preferred range of blood viscosity. I was down to 1 mg. per day when I began Sovaldi in June. It wasn’t long before my INR results began to plummet. Each two-week visit for a blood test revealed a sinking number that couldn’t be explained by spinach or too many greens (Vitamin K). Each time, the pharmacist increased my dosage to no avail. I have crept up to 1.5 mg every other day and still have not plateaued back above 2.0. The reason is now glaringly obvious. Clotting factor is manufactured in-guess where- the liver. As our livers heal from decades of disease, they regenerate. The liver is the only organ with this chameleon-like capability that does so. As the Hepatitis C subsides and the liver regenerates, the ability to produce clotting factor climbs dramatically.
The bottom line here is to relax if you’ve bellied up on any of the old or new treatment programs. There are a wide mix of them out there right now and all are having spotty results. Sovladi and Olysio seems to be big back east whereas the Sovaldi/Riba is more common on the left coast. One problem with Olysio (Simeprevir) is that it was the early incarnation of the protease inhibitors (NS3A and NS4A)) and is not nearly as effective as Ledipasvir.
For any of you who own stock in Genentech, it may be time to unload it. I don’t see any future in Interferon. The same may be true for Ribavirin (Schering Plough) and Incivek (Vertex Pharmaceuticals). I’d like to see who VA unloads all theirs on. Remember they bought trainloads in 2012 of the triple drug combo called Victrelis which was a compendium of Interferon, Ribavirin and Incivek. All three are now considered as being in the same league as Thalidomide and you probably need an EPA permit to burn it. I vote we use it to pay bonuses to all the VISN Poohbahs who got big bonuses by screwing Vets out of medical appointments.
good luck to all…trying to rid yourselves of this dreaded disease is very difficult..I have had a liver transplant 07 and this liver now is in stage 3 of 4 and 10/ 31/ 14 will be a good day for moi. I hope we all get healed .I’m almost ready to throw in the towel. Couldn’t do another transplant to hard. I have geno 1 and a friend has geno 1 took the treatment and the dragon came back. I hope they give him another chance. Peace
THIS ONE is the Ticket it has a 99% cure rate Geno 1A, I hope to start soon, Hang in Brother, you have been thru Hell On Earth, We all Have, I will be praying for you.
NOD: Although I like your answer better, I think the answer is simpler. Sovaldi has many drug to drug interactions. Concentrations of Coumadin, a CYP3A4 substrate, may be increased or decreased when coadministered with Sovaldi. What worries me is that Coumadin may also be affecting the levels of Sovaldi. Better mention it to your doctor.
Not for one minute did I think this new treatment was going to be a walk in the park. I really wish you guys had had more time to wait so you could watch to see what happened to others before you took it.
If you are going to start Sovaldi treatment you have got to, somehow, make sure you don’t miss any doses. Since taking Ribavirin causes anemia and that may affect your memory, do other things so you’ll remember to take it. Use pill boxes, check lists, an alarm clock, have people call you to remind you, etc. Do anything you have to do so you won’t forget to take it.
you are very correct….get a pill box that way you can look at it and know if you forgot or not. I’ve been doing this for 8 years and even with a pill box i have forgotten more than I would like to admit.
Hang tuff Randy, Mark, NOD, and all that are on treatment or about to srart treatment. I pray you will be SVR lifer’s soon.
Prayers for all of you Brothers.
Other than the realization that I had dropped the ball and the impending wait for the new drug I feel OK. After about 15 minutes of lecturing from the Dr. I had had enough and told her, “look, MY brain does not function as a normal persons does.” They knew about the encephalopathy have done nothing short of popping some pills, Rifaximen, for the brain fog. Hell, some days I cannot get to sleep until 5-6:00 am due to the side effects of the Sol and Riba which is insomnia. I may be not sleeping which would account for the short temper which I never had before. Alas it is a wait and see until the new mix comes out in Nov. but I will beat this virus. If you miss dosages then the virus comes back and you are admonished and sent to the new line and thus I have VA card in hand and wait as patiently as my number will be called soon and I start anew. Thanks to all for the encouragement.
With such an expensive drug, one would think the VA’s Telehealth prograpm would be offered so that these self-dosing mistakes are less likely to happen.
One of the self-assessment questions is–I need help with….
Make decisions and remember things I need to do.
I would appeal. Perhaps to get on this program?
I completed the treatment for geno 2. Undetectable so far and liver enzymes went back to normal. My RA was in remission for quite a few years so I thought I would go for it. The riba night rashes and the nausea was unbearable. I felt like I got hit with the full cone of a willy peter round as my skin was on fire. My shrink was seeing me every two weeks and upped the sedative doses. Just into month 3, I was hit with a severe infection. Felt like I was knocked over with a baseball bat. The doc said that if the IVs didn’t give some improvement in a day or two then we would have some serious issues to talk about.
All went well and I survived it but I was in bed most of the time for a month. Now I am starting to get around some and my energy level is increasing and I feel better with every passing day. However my RA is back with a rage and I now need to cope with that again. I know some folks had worse problems than I did, so for that I feel fortunate. Hopefully, the dragon is gone for good and it will have been worth it all.
Ribavirin is some nasty A– shit. It was developed for Congo hemorrhagic fever: http://www.ncbi.nlm.nih.gov/pubmed/7637481
The military got tons of it.
My Doctor says, 10-31-14 for the New Stuff, Sorry Randy hang in there Bro,For US geno 1As, I think they knew that it would be very hard and few would stay clear, mine came right back after 2 clean VL tests, The New stuff is the ticket.
Good article, hope you are faring well in your battle with the dragon, sir
We will have more news next week, I pray.