Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Mail & Guardian (Johannesburg) - August 13, 2004
This week the Treatment Action Campaign (TAC) and MSF expressed concern about the council's decision to recall all stocks of this medicine currently on the market.
The MCC said Duovir has been withdrawn because it has serious concerns about the quality of the bioequivalence studies that formed the basis of the medicine's registration. It has given manufacturer Cipla-Medpro 30 days to submit documentation explaining discrepancies in the studies that formed the basis for Duovir's registration by the council. The purpose of a bioequivalence test is to demonstrate that a generic medicine has the same therapeutic benefits as the original product. "It is critical that Cipla provides the council with this information before the deadline," said the MCC statement.
The effect is that people currently being treated with Duovir will have to switch to another anti-retroviral combination while the council makes its decision, said Jonathan Berger of the Aids Law Project, the legal arm of the TAC.
Nic De Jongh, medical director of Cipla in South Africa, said that the company has been in discussions with the council and that Cipla would be submitting new bioequivalence studies.
In addition, the Department of Health, the MCC and researchers met on Thursday to discuss the future of nevirapine as monotherapy for prevention of mother-to-child transmission.
At the 15th International Aids conference in Bangkok last month the MCC caused an uproar by recommending that nevirapine not be used as a single-dose option for mother-to-child transmission because of high levels of resistance.Activists and researchers agree that nevirapine as part of combination therapy is a better option than monotherapy.
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