HIV-Positive People In Zambia React To Recall Of Roche Antiretroviral Viracept

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Roche Antiretroviral Viracept Recall

The recent recall of Roche's antiretroviral drug Viracept has "created panic" among HIV-positive people taking antiretrovirals in Zambia, some of whom believe that other drugs might not be safe, IRIN News reports (IRIN News, 6/19).


The European Medicines Agency earlier this month recalled Viracept because of contamination. Roche in a statement said that it is recalling all batches of the drug in cooperation with EMA and Swissmedic, Switzerland's drug regulator, in Europe and other undisclosed countries. According to Roche, the drug was recalled after tests indicated that certain batches were contaminated with higher-than-normal levels of methane sulfonic acid ethyl ester -- a chemical normally used in the drug in small quantities.

William Burns, CEO of Roche's pharmaceutical division, said the impurity had been caused by the interaction of two chemicals in a vessel where the drug is produced. Investigators still are trying to determine what occurred in the Swiss plant where the drug is manufactured. It is believed that the contamination might have occurred in March and has affected supplies of the drug for three months (Kaiser Daily HIV/AIDS Report, 6/8).

Zambia's Health Minister Brian Chituwo last week announced that the country immediately will discontinue Viracept, which primarily is used in second-line treatments in Zambia. He also ordered health care workers to explain the situation to people affected by the recall. The Zambian government estimates that fewer than 1,000 of the 100,000 HIV-positive people in the country receiving antiretroviral treatment are taking Viracept. Some independent analysts said the number of HIV-positive people taking the drug could be much higher, IRIN reports. Nkandu Luo, an HIV/AIDS consultant and former health minister, said, "There could be more people affected by this because some of them take Viracept as part of a combination therapy." He added that the government should be "speaking to Roche because the damage has been done. Roche should take responsibility for distributing contaminated drugs."

Chituwo said that all HIV-positive people taking Viracept will be examined by health care providers before being switched to other antiretrovirals. He added that HIV-positive people "should not unilaterally decide to change drugs on their own" (IRIN News, 6/19).

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