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Restarting Meds after stopping for leg pain
Apr 30, 2006

Hello Doctors, I'm in a blinded study and I'm on Sustiva and either Truvada or Epzicom. During week 2 I started having myalgia in my legs. This pain became progressively worse over the next 7 days to the point that I was only sleeping 2 hours a night and pain medication would only dull the hurting. A decision was made to stop meds for now. Sustiva was stopped 2 days ago and Epzicom/Truvada (I'm in a study and one of those is a placebo) were stopped 28 hours ago. My pain level has already decreased from extreme to little pain most of the time and moderate pain from time to time, especially after laying still or sleeping.

My fear on restarting the same regime in a blinded study is the possibility of being on the Epzicom. In my reading over the past couple of days I have found data that says myalgia is reported as a symptom in 33% of the cases of hypersensitivity reactions to abacavir. It also said that two or more symptoms were reported in 95% of the cases, leaving only one symptom reported in 5% of the cases. The leg pain started in week 2 and the intensity and severity of the pain increased daily. It is my understanding that hypersensitivity reactions usually start at some level and continue to get worse until the meds are stopped. The document that I read said that if abacavir is stopped that it should never be restarted unless a hypersensitivity reaction can be definately ruled out. If there is any possibility that a hypersensitivity reaction occurred then the medication should not be restarted. Since I'm in a blinded study I don't know if I"m on Epzicom or Truvada. I know that what I experienced didn't follow the normal hypersensitivity reaction, but with what I had, can there be a certainty that it was not a hypersensitivity reaction? Would I be totally out of line in asking that the study be unblinded to insure my safety on this issue? Or am I just being a worry wart? Thanks! David in St. Louis

Response from Dr. Henry

Your concern is very reasonable. You need to discuss with the study nurse/physician. Prudence and common sense would generally lead to a recommendation to request unblinding-if you were on Epzicom then it should not be restarted. If you were not on it then you could restart the same meds possibly and know that you have not experienced the abacavir hypersensitivity reaction. KH

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