It has been confirmed that an HIV wonder-drug, that was partially banned in Kenya in July, causes holes in the spines and skulls of some babies.
Kenya was the first African country to provide a generic version of the Dolutegravir ARV drug mid last year.
But the Ministry of Health restricted its use in women three weeks ago after studies in Botswana linked it to birth defects in babies.
A major new study presented on Wednesday at the ongoing International AIDS Conference in Amsterdam confirmed the drug is seven times more likely to produce defects in babies whose mothers were taking it at the time of conception.
Dr Rebecca Zash of Harvard University’s medical school, who led the Botswana study, presented new data from 170 more babies born to mothers who took Dolutegravir from preconception.
“We found this possible association of neural tube defects among infants of women who were taking dolutegravir before pregnancy,” she said.
This neural defect can cause large holes in the spine or prevent the top of the skull from forming.
Zash said, however, that the risk of babies developing the birth defect is extremely minimal, standing at only 0.67 percent.
Scientists now plan to examine hundreds of babies before making a final decision on whether the drug should be completely withdrawn or kept.
Researchers indicated they could also examine Kenyan babies whose mothers were taking the drug during conception.
“This is still a preliminary signal. We need more data to confirm or refute it. It would also be nice to have data from other parts of the world,” Zash said.
Dr Linda-Gail Bekker, chair of the International Aids Society, added: “We are scanning the world to try and gather more data.”
If the risk that dolutegravir presents is not different from that of other antiretroviral drugs, the researchers could recommend its continued use in child-bearing women. The decision will be made any time from March next year.
The drug, manufactured by GSK, is still a preferred treatment because it powerfully suppresses HIV, people cope well with it and drug resistance rarely surfaces.
Early this month, director of medical services Jackson Kioko said the drug was not recommended for pregnant and breastfeeding women “due to limited safety data”.
He directed that women of childbearing age – between 15 and 49 years – be given the first-line treatment of Efavirenz.
Several modeling studies suggest that despite its flaws, Dolutegravir might be returned because it is better in suppressing the virus. It therefore has more benefits than harms.
A modeling study presented by Caitlin Dugdale of Massachusetts General Hospital shows that avoiding the use of dolutegravir in women of childbearing age carries risks for women, children and their partners, that might outweigh the risk of neural tube defects.
Martha Akello of the Nairobi-based International Community of Women Living with HIV, supported this view.
“We want to exercise choice. This is not a ‘one dress fits all’ situation,” she said.