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Viracept Recall Information

Lusaka
June 18, 2007
 

LUSAKA - Antiretroviral drugs, also known as ARVs, are medicines that can bring a person with AIDS back to good health and keep an HIV positive person healthy.  When you take these medicines, you are said to be on Anti-Retroviral Therapy (ART).  Currently in Zambia there are about 129,000 people on ART.

There are different combinations of ARV drugs for patients. When you first start treatment, you are said to be on a first line regimen.  Nearly 125,000 of the people currently on treatment are on first line regimens.

When first line treatment stops working, people are put on a second line regimen. This happens when there are signs that the first line ARVs are not working (also known as resistance to the first line ARVs).  As with first line therapy, there are various combinations of ARVs in the second line regimens. There are about 3,900 people on second line regimens in Zambia. 

One of the second line drugs is VIRACEPT® (NELFINAVIR).  About 500 people (in both public and private sector clinics) in Zambia are currently taking VIRACEPT® (NELFINAVIR).  VIRACEPT® (NELFINAVIR) IS NOT the same as NEVIRAPINE—this is a different drug.

Recently, Roche Pharmaceuticals, the manufacturer of VIRACEPT® (NELFINAVIR), issued a global statement recalling VIRACEPT® (NELFINAVIR) due to contamination during the manufacturing process.  The drug is being recalled as a precautionary measure. It is therefore strongly recommended that all people taking VIRACEPT® (NELFINAVIR) (NOT NEVIRAPINE) report to their health care providers so that the VIRACEPT® (NELFINAVIR) is replaced with another appropriate drug.  Please do not stop taking your ARV drugs until you receive professional medical advice.

There is no evidence that any ARV drugs cause cancer.  However, the contaminant discovered in VIRACEPT® (NELFINAVIR) has been shown to cause cancer in laboratory animals, when taken in very large quantities over a long period of time.

In Zambia, only the 500 people currently taking VIRACEPT® (NELFINAVIR) will be affected by the recall.  Hence, all patients taking VIRACEPT® (NELFINAVIR) are strongly advised to report to their health care providers for further consultation.  There is no need for panic as there are other alternative drugs available in Zambia to replace the VIRACEPT® (NELFINAVIR).  All people taking any other combination of ARV drugs NOT containing VIRACEPT® (NELFINAVIR) should continue taking their ARVs as directed; there is no danger in taking these ARV drugs.

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