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.

Monday, January 4, 2010

Treatment: Lord Knows the Shape I’m In.

Started treatment this weekend.

There was a two hour appointment where they took the standard 14 vials of blood, 2 EKGs, Height, Weight, Temp, Blood Pressure and we got the skinny on what the procedures are for the trial. We are doing the Standard of Care (SOC) which is pegylated interferon and Ribivarin as well as the experimental drug or placebo. Of course we are all telling ourselves we are getting the new drug.

We were shown how to fill a syringe with the interferon and how to inject it, given 4 weeks worth of the various drugs and a set of syringes, alcohol wipes and band-aids – all in an attractive mini insulated fanny pack with a prominent Roche logo. Now if we could only get T-shirts and hoodies we could really be stylin’.

The interferon injection is pretty much the same as injecting insulin. It uses the same syringes and needles and the same technique of pinching up a bump of skin, sticking the needle and injecting the drug. It’s only 1 ml, so it’s not a lot and is quite painless at the time of the injection. We will be doing it once a week for the next 24 weeks at the minimum.

The Ribavirin and the RO5024048 are pills. 2 RO5024048 and 3 Ribavirin each morning and evening. With food or they say the nausea will be pretty intense.
We have to keep a diary noting the exact time each dose of the oral meds is taken and the day we inject the interferon. We have to keep all the bottles, vials, labels and syringes and show them to the researchers at every appointment. They count all the pills to make sure we have taken them and check the vial labels to see that we have injected. If we do not keep an accurate diary, we get one chance to make a mistake and at the second mistake or missing data or missed dose of the meds, we are bounced from the trial. (Now I’m not one to encourage the wrong sort of behavior, but if you knew that you were in a trial for a promising drug that ups the cure rate for your disease and you missed a dose, would you report missing a second dose? Or would you just throw the pills out, write something in the diary and never say a word? Human nature is a strange and wonderful thing…).

We were also given information on the common side effects and some techniques to mitigate them. The interferon can be pretty nasty to many people with flu-like symptoms, muscle aches, fever and nausea. It also suppresses the white blood cell production in your bone marrow making you more susceptible to infection during treatment. The Ribavirin will make you anemic over time and also has fatigue and (delightful combination this) insomnia as common side effects – and let’s not forget hair loss, also common. The RO5024048 has some similar side effects but the ones they are really worried about are kidney damage and problems with the eyes.

Did the first injection at the appointment and took the first 5 pills. We were told on a two separate occasions to make sure to bring 2 Tylenol to take before the injection, some food to eat (some sort of snack) to settle the stomach and a urine sample. The other guy who was in the training session with me forgot both Tylenol and food – I hope he remembered the urine but…

Went home and hung around waiting for the side effects shoe to drop. And waited and waited. Eventually I noticed that my neck and shoulders hurt and I was a bit chilled but only a touch of nausea as long as I was stretched out. As soon as I went to bed and slept in my usual side-sleeping fetal position, the nausea hit and I had to straighten out my body. It was a strange feeling to start to go into my normal position, feel really crappy, straighten my legs out and feel it subside. If you were really perverse, you could give yourself waves of nausea at will.

Over the next two days, I had some mild nausea, heartburn whenever I ate anything with any heft to it, and mild muscle aches. Not bad at all compared to the horror stories I had been hearing from people who had done the treatment and from what I read on treatment websites and bulletin boards.

On Sunday night (the third day) the insomnia set in. I was up till 2:00 a.m. before I could sleep. It wasn’t the sort of insomnia I have had before, thoughts racing through my head, anxiety, or nervous energy from late-in-the-day caffeine; it was just lying there with my eyes closed, comfortable and tired without be able to sleep at all.

Needless to say, Monday was a long slow slog through my first day back at work.

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