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New tender for medicines to save costs due in December


According to Pillay, six companies had registered generic three-in-one pills containing dolutegravir, tenofovir disoproxil fumarate and lamivudine with the Sanitary Products Regulatory Agency of SA. The last company to announce the registration of its product is the local pharmaceutical manufacturer Aspen Pharmacare, which launched its version on Monday, under the Emdolten brand.

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

Dolutegravir offered considerable advantages for public health, since the likelihood of patients developing resistance is extremely low, said Francois Venter, deputy director of the Wits Institute for sexual and reproductive health, HIV and related diseases. A little less than a million patients were taking dolutegravir-based regimens worldwide, and none had developed resistance so far, he said.

"That's pretty remarkable," he added.


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