I am a 57-year-old white American male infected with Hepatitis C. I am involved in a controlled medical research study by Roche Pharmaceuticals of an experimental Polymerase Inhibitor (RO5024048 also known as RG7128) drug therapy for the virus. This document is the story of my illness and the experience of treatment. My lovely and pretty damn wonderful wife will be contributing her take on the experience as well.

Thursday, May 21, 2015

Harvoni - The Side Effects

It truly is a new day in Hep C treatment. The effects of using Harvoni are a far cry from the often brutal effects of the old Interferon/Ribavirin standard treatment. Fatigue, Insomnia, Brain Fog, Night Sweats, Irritation/Anger, Restless Leg Syndrome, Hair Loss, Depression, Memory Loss, etc. etc. etc. I believe there were some 60+ posts under the tag "Hep C treatment side effects" during the time I was on the old chemotherapy. This time around the side effects are much fewer and more easily managed.

I have noticed a persistent low-grade headache; some abdominal effects notably diarrhea and bouts of truly astonishing amounts of gas production; a bit of nausea occasionally and finally, quite contrary to the advertised fatigue, a bit of a speedy effect, especially if  any caffeinated beverages are consumed. The headache is manageable through over the counter meds, the gas is manageable by removing myself from the company of others and enduring the effects alone and the energy boost can be useful though it is accompanied by enough loss of focus that it is best avoided.

It will be interesting to keep track of how the side effects evolve over time. So far, the nausea has decreased a lot, the headache has slowly been increasing and the speed effects are something I am trying to keep away from. My primary hope in the long term, is that killing off the virus will help with the brain fog and other long term memory and cognitive deficits of Hep C. Until then I can just keep on wearing the wrist band with my name on it...

Friday, May 8, 2015

The High Cost of Harvoni; Luck was on My Side

When Gilead first announced that they were going to charge $84,000 for a twelve week course of treatment of Harvoni in the USA, it caused quite an uproar. It was shown to have a 90+% cure rate and relatively low side effects so, of course, huge numbers of people with Hep C were going to want to be treated. But at that price, the highest price they charged for the drug anywhere in the world, most people felt they were gouging the sick (and their insurance companies). Gilead trotted out all the usual arguments about the cost of developing the drug, the need for the drug (or any drug) to be profitable in order for them to have a reason to manufacture it and the fact that many countries capped the price they were able to charge, but people in the Hep C community in the USA mostly felt that the price was unreasonably high. After all, if you only treat 100,000 of the conservatively estimated 5,000,000 people with Hep C in the USA at $84,000 per treatment, you rack up $8,400,000,000 in gross sales. That seems be a number that, along with sales in the rest of the world, is going to be giving Gilead a fairly massive profit.

Aside from the sheer cost of the drug to health care providers, the hammer really falls on the people actually infected with Hep C. If you don't have insurance, you are basically screwed. If you have one of the bronze level plans of the Affordable Care Act with a 40% effective co-payment you would have to pay $33,600 for treatment. A silver level plan would leave you with a $25,200 cost and even a gold level plan would still run you a bit over $16,000 out of pocket to be cured of Hep C. For those of us in the fast disappearing middle class in the USA, these are fairly staggering amounts. Sure there are various subsidies and cost breaks available, but given the way they are structured, if you make an amount of money that puts you in the middle class, you are often ineligible for help. I could get into a long rant here about how the Affordable Care Act is really only an affordable insurance act and the cost of any serious health care is just as out of reach under Obama's sellout to the insurance industry as it was in the days before the law was passed, but I will spare you that diatribe. Suffice it to say that the combination of Gilead's predatory pricing and Obamacare's mostly high patient payments means that a large number of Hep C sufferer's are shut out of access to the latest and best treatments available.

Earlier this year, Gilead announced that it will be cutting the cost of Harvoni by 46% sometime this year. This is because AbbVie has introduced their own interferon-free treatment Viekira Pak (which is priced similarly to Harvoni). While this competition is a good thing, the fact that the AbbVie product requires 4-6 pills a day and has more side effects than the single pill Harvoni might mean that it does not provide an effective competitor. If the competition is effective and does induce a lower cost for Harvoni, it means that treatment under a bronze plan would cost about $18,000; a silver would be $13,000 and a gold plan would drop to just over $8,000. While much better for patients, these are still large numbers. Numbers that would have put the treatment out of reach for someone like me.

I got lucky. I have health insurance through my employer and the roll-out for Obamacare has been complex enough that many employers have been granted waivers the past few years allowing them to keep their former plans in place until the regulations for employer-paid Obamacare plans have been worked out. My employer was granted that kind of waiver. I am insured by Kaiser Permanente in San Francisco and my plan is one that has a $30 co-pay for prescription drugs. I have been closely watching the Kaiser drug formulary (the list of which drugs Kaiser provides through their plan) to see when and if Harvoni was added. As soon as it was, I contacted my gastroenterologist to try to initiate treatment. Luckily for me, Kaiser has an extremely proactive view toward Hep C treatment. They believe that everyone who wants to receive treatment should have access. They seem to understand that, regardless of the high cost of the medication, it is cheaper to treat than to deny treatment and then have to pay the higher costs of late stage Hep C and/or cirrhosis treatment. Many insurers are not as forward thinking. Kaiser did initially prioritize the Harvoni treatment to the sickest patients but as that cohort moved through treatment, they rapidly expanded care to their other Hep C patients.

When I saw my gastro guy, I explained that I currently had a health plan that made treatment affordable, but that our current plan would be most likely transitioning to the less affordable Obamacare varieties by the end of the year and thus I would like to be treated as soon as possible. He told me stories of a number of his patients on the lesser insurance plans who indeed were currently shut out of treatment. This factor meant that while my liver is not in a particularly bad state, he agreed that the issue of affordability was one that qualified me for moving up the queue for treatment. He set up the necessary tests and within a month, I began treatment.

I feel extremely lucky that the new drugs came out when they did, that Kaiser moved relatively quickly to include them in their formulary and that they have a very proactive institutional policy toward treatment.  If any of these factors had taken another 6 months to work out, most likely I would be like many other Hep C sufferers on the outside of treatment looking in.

Thursday, May 7, 2015

New Drugs, New Hope; I start treatment with Harvoni

I just started treatment with the new Gilead drug Harvoni. It is the first of the new set of "wonder drugs" for Hep C that do not require either interferon or Ribavirin to be taken along with the primary treatment drug. The drug itself is a combination of Sofosbuvir, a polymerase inhibitor (much like the one I took in the drug trial described in the early posts of this blog) and Ledipasvir, which is an NS5A inhibitor. NS5A is a protein is an essential component for the replication of the Hep C virus. The two compounds act together to inhibit the Hep C virus from replicating itself and thus keep the infection from spreading and allow the immune system to gradually kill off the virus present in the body (my interpretation and if wrong the blame is on me).

The cure rates for genotype 1 Hep C (most common and vicious form) are in the 94%-99% range for treatment naive patients (those who have never undergone any sort of treatment) and in the 90% range for those of us who underwent treatment in the past and failed (thus leaving behind tougher versions of the virus). The side effects are also MUCH less difficult than those of the old standard of care of interferon and Ribavirin. The most common are headache, fatigue, diarrhea, nausea and insomnia. While these sound bad, and they are no fun, most reports have them present at levels significantly lower than the same side effects on the old standard treatment.

All of this sounds pretty good. High cure rates and moderate side effects are a strong combination. This is no doubt why you are seeing numbers of soft-sell, perhaps it's time to do something about your Hepatitis C, sorts of ads on television and in print media. Now that there is a treatment without injections, taking only one pill per day, with moderate side effects and with a treatment length of only 12 weeks (and in some instances 8 weeks) it is time for the drug companies to pile on the advertising. That and the fact that Gilead is charging $84,000 ($1000 per pill) for a 12 week course of treatment. (AbbVie has a 4 pill treatment on the market as well: Viekira Pak). The fact that the price is $1000 per pill for the Harvoni may account for the fact that the pill is in the shape of a diamond.

It's a bit too early to have much to say about the side effects, but taking a pill that cost $1,000 is definitely a new experience for me. I'll have more news about how it feels in the next few days.


Tuesday, September 11, 2012

Liver Walks and Liver Disease PR

I've always wondered why folks with liver disease didn't organize events focused on Hepatitis, Liver Cancer and the other diseases that can devastate the liver. Was it the broad diversity of the afflicted group? Embarrassment about admitting to the disease? Shame about the possible, or definite, way the disease was acquired? Indifference due to the long time-span the disease takes to get really serious? A combination of all these? Who knows?

I arrived in San Francisco during the mid-1980s. It was ground zero for the raging AIDS epidemic. The AIDS afflicted community, mostly gay, began to mobilize early on to militate for research, awareness campaigns within the community, demand for drug research, medications and for companies to supply medications affordably. Perhaps because so many shared a common sexual orientation and a definite us vs. them mindset, the community was more predisposed to organize. Whatever the reasons, the AIDS community jumped in with both feet and as a result, AIDS awareness, research, drug availability and prevention education garner a great deal of attention throughout the country.

It looks like the liver disease community is starting to mobilize as well. The Fair Pricing Coalition  has been active in protesting the costs of treatment drugs, celebrities with liver disease have begun to come forward, and finally, The Liver Foundation is sponsoring a series of  Liver Life Walks in cities across the USA.

The Walk for a cause model is one of the oldest and most effective tools for raising awareness of a cause. It spreads far wider than the walkers themselves as family members, friends and sponsors of the walkers all become more aware and more likely to be talking about the theme of the Walk. It is also great therapy for the participants as they can band together to say that the status quo is no longer acceptable.

I urge anyone who has Hep C, knows someone who has it or, sadly, has lost someone who had Hep C, to join a walk, support a walker, or just talk about Hep C if the subject comes up. The more people know about it, the more likely they are to get tested, seek treatment and live better lives.

As my lovely wife put mentioned in the previous post, we formed team Heprat for the SF walk and will be walking the, extremely civilized 1.5 mile, course this Saturday, Sept. 15th. The week after there is one in Mpls/St. Paul, MN. and so on and so on. As the street hawker might say, Check It Out!

Saturday, September 8, 2012

Support Team HepRat For the September 15, 2012 Liver Life Walk in San Francisco

I've joined the Liver Life Walk in San Francisco as part of Team HepRat, in honor of my husband, the author of this HepRat blog, who has recently struggled with liver issues and the side effects of current treatments. Visit this link to read more or support our cause: GO TEAM HEPRAT!

Tuesday, August 21, 2012

Long Term Side Effects: Everything is a little bit hotter.

My core temperature has changed.

I was out at the Beach Chalet restaurant this past Sunday with my wife and a few friends listening to one of our favorite bands, the Aqua Velvets. The restaurant itself is just across the Great Highway from the beach and a perfect setting for the Surf Jazz the band features. It was a typical San Francisco summer afternoon with a bit of fog and a very slight breeze that, thankfully was shielded by the of the restaurant building. The temperature was in the mid-60s. I was wearing a T-shirt and a long sleeve dress shirt that was unbuttoned over a pair of jeans and I was perfectly comfortable. I was thinking about it while sitting there and it reinforced the fact that one of the long-term side effects of the of the hepatitis C chemotherapy treatment process is that my temperature comfort level has moved a bit lower on the spectrum. In the old days on an afternoon like that I would've been wearing a sweatshirt at least and perhaps even a light jacket over a sweatshirt. The breeze would've chilled me, my hands would have been cold and while I would have stayed and listened to the band, I would not exactly have been comfortable.

Now however it seems I am much better suited to the San Francisco climate. Many days I wear an undershirt with a long sleeve shirt over it,  either a T-shirt or golf style shirt or a button-front dress shirt and that's all I wear (except for pants, I still wear pants even after chemo...).  I generally don't need to wear a jacket or I can carry a light fleece jacket with me to can put on only in the evening when the temperature drops into the very low 60s or the wind kicks up. In the old days, pre-treatment, I would always follow the San Francisco prescription of dressing in layers with a shirt, sweatshirt and jacket always with me and most often all worn at the same time. That is no longer the case.

 Many of the long-term side effects that have stayed with me since the hepatitis C chemo are not ones that I have enjoyed or have not been ones that have benefited me in the long term. This one however is definitely an advantage. While I am no longer is able to tolerate warm temperatures as well as I was in the past and truly hot weather really leaves me exhausted, that's not the sort of weather that we have very often in San Francisco. Now I appear to be better adapted to my environment and I can tolerate the city that before I always used to find much too cold for my taste.

If global warming really intensifies in the long run, this and may not be an advantage. But for right now and for the next few years it may very well end up being the best side effect of being treated for hepatitis C.

Monday, June 25, 2012

The Day My Energy Returned

For the first several months after completing the ribavirin and interferon standard therapy I still had a  very low energy level. It wasn't exactly exhaustion but it was a situation wherein if I did anything more than normal exertion it would wear me out and I would need to take a nap or at least sit down and rest. On a normal workday, I would work seven or eight hours go home and not be able to do anything in the evening unless I took a nap after work. If it were a particularly hard day at work I wouldn't really have the energy to do anything whether or not I rested after I got home. This gradually improved as the months went by but there was no breakthrough, there was no point when I felt that my energy level had returned to normal. It was just a holding pattern with very gradual improvement.

This continued until about mid-March of this year. At that point, almost 9 months to the day when I had finished treatment, it felt as though a switch was thrown and suddenly I had my energy back. I could move faster, I had a bit more strength, but more importantly I was not exhausted by doing basic physical activities. I'm not sure why this occurred when it did. Other people who have been through treatment have told me that you have to completely ignore the time frames that the medical professionals give you for recovering from treatment. Most of the literature indicates one to 3 months, some say 3 to 6 months. People who have gone through treatment that I have talked to state almost unanimously that you will not get back to normal until the same number of months have passed from the end of treatment that you spent in treatment itself. I was in treatment for 18 months and the amount of time passing before I began to feel a genuine return of energy or and w approximation of the way I felt before treatment began was nine months, so perhaps there is a correlation where one month of recovery for every two months of treatment will eventually return you to at least a semblance of your previous state. Whatever the case, I don't have a specific reason related to the treatment that would indicate to me why suddenly I began to feel better.

I still have a long way to go. I feel tired after levels of exertion that would not have tired me nearly as much before the treatment began. I also still feel some cognitive and memory deficits that I truly hope will go away as more time passes from the end of treatment. I still hold out the faint hope that my thyroid gland may eventually recover some of its function. At this point, being able to do what I can now is a wonderful thing.

I suspect the change may have had something to do with the time of year if nothing else. I began to feel better around the beginning of spring and two things happen around that time. Daylight savings time starts, and the weather begins to dry out and get warmer. The combination of the sun not setting a 5:30 p.m. and better weather no doubt did a great deal to energize my body and my mind. I don't think it's a complete explanation, but it must have had an effect. Another thing that happens at that time of year is that spring training for the baseball season is coming to a climax and the start of the  regular season is just a few weeks away. I have loved baseball since I was a boy and I'm sure that the excitement of the upcoming season must have given me some energy as well. My fantasy baseball draft was only a few weeks away and that always sharpens the concentration and brings on the energy.

So who knows. perhaps it was not some set period of months after the end of treatment that triggered the renewal of my energy but instead was simply a combination of longer days warmer days and the start of baseball season. Whatever reason or combination of reasons it was I'll take it. I was so tired of being tired, so tired of being somewhat depressed and so tired of having my muscles feel sore and weak that whatever the reason it's good enough for me.