New ARV not for women wanting to fall pregnant

Although the brand name version of dolutegravir is registered for use in South Africa, generic registrations may take up to three years.

South Africa stopped its planned switch to dolutegravir in June after a study in Botswana found that four women out of 596 pregnant women on the drug had given birth to babies with neural tube defects.

But Dr Rebecca Zash, from the Botswana-Harvard AIDS Institute Partnership, told the International AIDS Conference that it seemed that only babies born to women who had been taking dolutegravir at conception were at risk.

“Dolutegravir was just as safe as efavirenz [the ARV it replaced] for women who started on dolutegravir during pregnancy,” said Zash, but said that more information about the drug was needed.

“The study was small. We have since had another 170 births with no defects, but we need more data,” said Zash.

Neural tube defects happen in the first 28 days after conception.

Benefits of dolutegravir

Dolutegravir is easily tolerated, suppresses the virus faster than many other ARVs and the virus does not develop resistance to it fast.

Botwana switched to dolutegravir in June 2016, and South Africa was due to follow suit this June. A modeling study of a dolutegravir-based treatment regimen predicted that it could prevent over 25,000 deaths among women and 5,000 child infections compared to efavirenz-based ART over five years in South Africa.

Civil society delegates staged a protest at the conference demanding that women be given the right to choose between dolutegravir and efavirenz.

However, scientists said that women on dolutegravir must be on contraception until safety concerns are addressed.


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