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.

Wednesday, July 14, 2010

RO5024048 Side Effects Reconsidered

Now that I am out of the study and on the Standard of Care of Interferon and Ribavirin, I have been looking back at the first 8 to 12 weeks of treatment to try to determine whether the RO5024048 polymerase inhibitor had side effects of its own, whether it intensified the side effects of the interferon and Ribavirin or did both.

As I have mentioned before in this post, I believe I received the study drug at the beginning of treatment. My viral load dropped log 3.6 or so during the first week of the drug trial, which is almost unheard of on the standard of care. I have yet to drop a full log number from the peak viral load after my viral breakthrough 5 weeks ago now that I am on Standard of Care treatment. This just reinforces my belief that I was given RO5024048. That said, I do not know either how long I received the study drug, nor the size of the dose I received. I could have received 500 mg for 12 weeks, 1000 mg for 12 weeks, or 1000 mg for 8 weeks. In any case, I believe I received the polymerase inhibitor for either the first 8 weeks or the first 12 weeks of the study.

Looking at the list of side effects from the drugs involved I can draw some conclusions about the variation in them as the study went on.

Nausea: seems about the same throughout the study, mild but occasionally intrusive
Vomiting: only happened once
Diarrhea: definitely more serious at the beginning of the study and gradually disappeared as the study went on
Abdominal Pain: is more noticeable in the past 8 weeks
Anorexia: I don’t believe I had it
Dysgeusia: Didn’t notice it until about 8 weeks into treatment
Dry Mouth & Dyspepsia: consistently present throughout treatment
Anemia: seems worse now that I am on standard of care
Neutropenia: set in about 8 weeks into the study and has been consistently present since
Fatigue: seems a bit better since I have been on only interferon and Ribavirin
Chills: present the first several weeks of the trial has disappeared since
Fever: cyclic with the interferon injection schedule throughout the trial
Muscle Pain: intermittently present throughout treatment up to the present, also a general feeling of muscle weakness and fatigue after exertion
Joint Pain: present during the first few months of the trial not present now
Headache: present throughout the trial, more intense early in the trial and during the past 5 weeks
Rash: Never a big problem, but more noticeable during the first few months
Dizziness: only when taking some of the ancillary drugs
Anxiety: peaked during weeks 12-18
Depression: peaked during weeks 10-18
Insomnia: consistently present throughout treatment
Irritability: very irritable early in the trial, became a problem again in weeks 12-18, not a problem since introduction of antidepressants
Throat Pain: have not had any
Injection Site Redness: has not appeared at any time
Sinus Congestion: tends to occur during the first 4 or 5 days after each interferon injection
Alopecia: Hair loss consistent through first 20 weeks of treatment, has moderated since
Blurred Vision: not specifically noticed, but my close focusing ability deteriorated immediately at the start of the trial and the deterioration has remained
Eye Pain: have consistently had eye pain. It tends to happen when attempting to focus on something relatively close to my eyes. Generally moderates when I relax my eyes and my focus
Blood Sugar Problems: none
Back Pain: tightness occurs within a few days of every interferon injection
Laryngitis: none
Sore Throat: has occurred intermittently since the start treatment
Loss of Concentration: As the treatment progressed, my ability to concentrate noticeably declined at about 2:30 every day
Confusion: my short term memory has declined noticeably since the start of treatment
Liver Problems: I developed a hypothyroid condition starting at about week 10


As I look over the list of side effects I notice only a few that seem like they could be directly related to the RO5024048. Diarrhea is something that was only a problem during the time I was on the test drug. Chills have not really happened since the first 8 weeks either. Fatigue seems to have been amplified a bit by the polymerase inhibitor. Joint pain also seemed to disappear after the first 8-10 weeks of the trial. The rash problem was never more than an annoyance and was more extensive during the first 8 weeks. Irritability was definitely high at the beginning of the trial and has moderated since them, particularly since taking the antidepressants. The vision change happened right away, but I also noticed that there was a bit of change to it when I went back on full interferon doses 5 weeks ago.

Most of these are also side effects of the interferon and Ribavirin so the fact that they have moderated over time might just be that my body acclimated to the drugs. If I had to make the call, I would say that diarrhea, joint pain fatigue and rash were all either caused by or intensified by the RO5024048. It seems that the polymerase inhibitor is an easier to tolerate drug that the protease inhibitors such as Telaprevir and Boceprevir. The research coordinators I talked to all said that the Telaprevir study they had run had been much harder on the patients in terms of side effects (especially rash) than the RO5024048.

Given that it seems to hit the virus like the blitzkrieg hit Poland and that it appears to have a more moderate level of side effects than some of the other new drugs, RO5024048 seems to have a bright future fighting Hepatitis C.

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