European medicine regulators have concluded that last summer’s contamination of nelfinavir (Viracept) did not involve any risk of cancer for patients. The regulators will not, therefore, be going ahead with two proposed registries to assess the long-term risk of patients exposed to contaminated nelfinavir.
Roche conducted a number of studies to see if the accidental contamination of nelfinavir by excess levels of ethyl mesilate increased exposed individuals’ risk of cancer. These studies, which have been reviewed by independent panels of expert toxicologists, HIV doctors, and treatment advocates, found that the level of exposure to ethyl mesilate was so low that it did not involve any risk of cancer.
The European Medicines Agency (EMEA) has accepted these conclusions, and in a statement said: “Roche showed that it is possible to calculate a threshold value below which ethyl mesilate does not cause irreversible damage (mutations) in the DNA…patients or children born to mothers who had taken contaminated Viracept were exposed to levels well below this threshold, and therefore…there was no increased risk of developing cancer for these patients compared to those patients who were not exposed to the contaminant.”
Last summer Roche undertook to establish two registries to monitor the long-term cancer risk in patients treated with nelfinavir. But as the EMEA is satisfied that the level of ethyl mesilate exposure was so low that it did not involve any risk of cancer, these registries are not needed and will not go ahead.