Saturday , June 12 2021

New cost-saving Aids drug tender due in December



Six companies have registered generic three-in-one tablets 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 the 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 to end in March, but was extended by a year to allow enough companies to register products to ensure competitive tendering. There were also delays due to safety concerns, as 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 defects of neural tube. These findings still need to be confirmed when the final results of the study are published in 2019.

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

"That's pretty remarkable," he added.

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