New cost-saving Aids drug tender due in December


Six companies had registered three-in-one pills containing dolutegravir, tenofovir disoproxil fumarate and lamivudine with the SA Health Products Regulatory Agency, according to Pillay. The latest company to announce the registration of its product is local pharmaceutical manufacturer Aspen Pharmacare, which on Monday launched its version, branded Emdolten.

The current tender, valued at R14bn when it was announced in January 2015, was originally due in March, but was extended by a year to allow enough companies to register competitive bidding products. There were also delays due to safety concerns, the interim results from a small study in Botswana found women who took dolutegravir in early pregnancy were at higher risk of having fetuses with neural tube defects. Those findings have yet to be confirmed when the final results of the study are published in 2019.

According to Francois Venter, deputy director of the Wits Institute for Sexual and Reproductive Health, HIV and Related Diseases, Dolutegravir offered considerable public health advantages as well as the likelihood of patients developing resistance to it. Just under a million patients were taking dolutegravir-based regimens around the world, and none had developed resistance so far, he said.

"That is pretty remarkable," I added.

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