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, January 6, 2010

Side Effects: Whose Idea Was This Exactly?

I am fascinated with the side effects of medications. I read the data sheets that come with any prescription med I get – provided I can unfold them successfully without destroying them. I listen to all the side effects they are now required to recite in the TV and Radio ads for the meds they claim you should be begging your doctor for. The intensity and extent of some of the side effects that drugs treating relatively benign conditions can induce is quite astonishing. So, in that spirit I offer you the official list of side effects for the drugs in this study:

For RO5024048 and Interferon (Pegasys) and Ribavirin (Copegus) the side effects can be:

Nausea
Vomiting*
Diarrhea
Abdominal pain
Anorexia
Dysgeusia (change in the sense of taste) *
Dry mouth and dyspepsia (feeling of fullness or abdominal pain when eating)
Anemia (low red blood cell count)
Neutropenia (low white blood cell count)
Fatigue*
Chills*
Fever
Muscle pain
Joint pain*
Headache*
Rash
Dizziness
Anxiety
Depression
Insomnia
Irritability
Throat pain
Interferon injection site redness
Sinus congestion
Alopecia (Hair Loss)
Blurred vision*
Eye pain*

The side effects with the star (*) after them occurred more often in people who received higher doses of RO5024048.


For just the Interferon (Pegasys) and Ribavirin (Copegus) the side effects can be:

Flu-like symptoms such as fever, chills, muscle aches, body weakness, joint pain and headaches;
Extreme Fatigue
Skin reactions such as a rash, dry skin or itchy skin
Upset stomach (including related events such as nausea, vomiting, taste changes and diarrhea);
Blood sugar problems which may lead to diabetes,
Redness and swelling at the site of the injection;

Other possible side effects of the Pegasys and Copegus are:
Pain,
Back pain
Laryngitis,
Sore throat,
Increased liver enzymes
Loss of concentration
Confusion

Infrequently reported side effect include:
Fainting,
Palpitations (rapid or irregular heart beat)
Heart or kidney disorders

Additional Serious side effects possible (apparently all the side effects described up till now how been the normal, commonplace sort of side effects) of the Pegasys and Copegus treatment can be:

Risks to pregnancies and unborn children
Mental health problems including irritability, depression, anxiety, aggressive
behavior, suicidal behavior (including thoughts about suicide and suicide
attempts), homicidal thoughts and trouble with drug addiction or overdose,
Blood problems including a drop in various blood cells (white, red and platelets)
that can lead to an increased risk for infections, bleeding and/or heart or
circulatory problems that can result in Death. (Rapid decreases in red blood
cell counts may infrequently be associated with shortness of breath and heart
symptoms).
Autoimmune problems, where the body’s own immune system attacks itself including
psoriasis and thyroid problems,
Heart problems including chest pain and rarely, a heart attack
Macular degeneration (a disorder that affects the macula –the center of the retina –
and causes decreased visual detail and possible loss of central vision
Infections that have sometimes caused death
Lung problems including trouble breathing and pneumonia
Eye problems including blurred vision or loss of vision
Development of an unusual rash (also known as Stevens-Johnson syndrome) which could become severe or life threatening

There are a few more general side effects that were described in yet another pamphlet about the study but only one stood out: Listed under “Rare, but Serious” was the statement, “Patient may collapse and die for no apparent reason.”

Most side effects (with the possible exception of altered thyroid function which may require life long medical treatment and the Definite Exception of Macular Degeneration) will generally reverse upon stopping treatment with the study medication.

I don’t imagine you come back to life if you have died either. If I die, however, I am trusting that the folks who will receive the envelope of unmarked bills will do the right thing by me.

1 comment:

  1. OK I am being treated with the two above drugs for hep C after 9 weeks of treatment my Hep C Viral load went from Six million five hundred thousand to 90:) Here is whats scary I get my next blood test on Wed. 2'3'11 It should be undetectable! I weigh ...now 136 pounds from 145 just 9 weeks ago. My RBC's dropped to 8.3 (wanna feel like something is not right try that!) They said I need to do this for 9 more months..LOL I will surely be dead if I continue and I am talking DEAD IN THE NEXT 9 MONTHS!!! So what I am going to do is say FUCK the DRUG companies Stay on for 6 more months then ween myself off and Keep my mouth shut and watch my Blood test closely. I am going to request blood test every two weeks...This is AMERICA a country built on MONEY I don't trust these drug companies! I know how I feel....They don't!

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