SA's saviour ARV drug can give babies defects
Hailed as wonder pill, Dolutegravir found to increase chances of moms giving birth to infants with neurological damage
A wonder ARV drug, to which South Africa was planning to switch in a bid to save billions of rand, has been found to increase the risk of mothers giving birth to babies with neurological defects.
The drug, Dolutegravir, has been found to increase the chance of neural tube defects – which are defects that affect the brain, spine, or spinal cord of the foetus, usually within the first month of pregnancy.It was to be paired with two other drugs in a three-in-one pill for South Africans. Current ARVs consist of three different drugs.
The study in Botswana is preliminary but showed four women on the drug had babies with defects versus one who did not.
The study is continuing, with World Health Organisation last week calling it an “early signal”, meaning it could be confirmed by further research or refuted. WHO convened an emergency meeting last week and South African HIV scientists are pouring over the data.Dolutegravir was described as a “wonder drug” used as part of HIV treatment in the US among mostly gay men. It was favoured by South Africa because it was cheaper, had far fewer side effects and people couldn’t build resistance to it.The drug it was meant to replace gives thousands of South Africans psychiatric symptoms, nightmares and depression and can cause fatal liver damage in rare cases.
Last year the Bill Gates Foundation gave funding to ensure pharmaceutical companies in developing countries could start to manufacture the new drug, making it more available to poorer countries more quickly.
Following the Gates announcement, Health Minister Aaron Motsoaledi gushed about the cost savings it would make, saying it could save enough money to help to put two million more people on ARV treatment.
Motsoaledi said: “This is a major breakthrough for South Africa, as it means we’re going to reach six million people (with HIV) over the next six years and save R6-billion.”Stavros Nicolaou, part of strategic management in Aspen Pharmacare group, said the setback was “could have been a lot worse” as the new tender was to be rolled out next year and the drug was not yet registered locally and not yet manufactured. Aspen was expected to manufacture it.
“We have an existing ARV drug and if I was a betting man, which I am not, I would say we will continue using that. It would have been quite different if there was nothing else.”
It was estimated last year that 145,000 South Africans were accessing second line treatment, which costs thousands more a year than ordinary treatment, which costs R1,000 a year. Dolutegravir was supposed to stop people needing second line treatment.