The benefits of a landmark treatment for HIV outweigh the risks, despite the fact it has been linked to birth defects in babies born to mothers taking the drug, researchers have said.
The antiretroviral drug dolutegravir, taken in conjunction with other drugs to suppress an HIV patient’s viral load and to stop them passing the virus to others, is considered one of the best HIV drugs available and has become the cornerstone of treatment in many richer countries since it was first introduced in the United States in 2013.
A cheaper generic version of the drug is also available, paving the way for its widespread adoption in poorer countries.
However, a study last year in Botswana found that the new drug was linked to an increase in neural tube defects – problems with the spine and skull that can happen in early pregnancy. The study found that babies born to women taking the drug at the time of conception were seven times more likely to have the defect than mothers who did not take the drug.
This prompted the World Health Organization to issue an alert on the safety of the dolutegravir, advising women of childbearing age to use other treatments.
But now a study, published in the Annals of Internal Medicine, has found that the risks of the treatment are outweighed by the benefits, in terms of the drug’s ability to decrease deaths among women and prevent HIV transmission to their children and sexual partners.
Researchers used a mathematical model of HIV alongside epidemiological data to look at the effects of different HIV treatments for 3.1 million women of child-bearing age with HIV in South Africa.
They found that dolutegravir would lead to more than 13,000 fewer deaths among women, nearly 60,000 fewer HIV transmissions to male partners and 7,000 fewer HIV infections in children. Overall, the study found that there were fewer deaths with dolutegravir-based treatment than with efavirenz-based treatment.
But they also found that the use of efavirenz would lead to 4,400 fewer deaths among children compared with dolutegravir-based treatment, largely due to the reduced risk of birth defects.
Caitlin Dugdale, an infectious disease specialist at Massachusetts General Hospital, who led the study, described dolutegravir as a “game-changer” for sub-Saharan African countries.
“However, as countries consider replacing current first-line treatment with now less expensive dolutegravir-based treatment, it is important to evaluate the risks and benefits of using it globally for millions of women who could become pregnant,” she said.
Anton Pozniak, former president of the International Aids Society who was not involved in this latest study, said the research could not be looked at in isolation. The researchers behind the Botswana study are due to publish more data within the next few months which, alongside this and other studies, will help policymakers decide on a definitive course of action.
“The background rate of neural tube defects is about one in 1000 and there’s been a cluster of cases in one country in one study. We don’t know if that’s happened by chance – for example, they don’t put folic acid in food in Botswana. Could it be due to that or other issues? The world is waiting to find out,” said Dr Pozniak, an HIV specialist at Chelsea and Westminster Hospital.
He added that it was important that women were given all the information about risks and benefits so they could make an informed decision. And women taking dolutegravir should be offered contraception.
Linda-Gail Bekker, professor of medicine at the University of Cape Town and co-author of the study, said: “The results of this modeling study show us that the issue is not so simple as saying we should take dolutegravir off the table because a woman might become pregnant.
“Instead these results highlight the importance of making sure that women are given all of the information about the benefits as well as the risks of dolutegravir so that they can make an informed decision about the best choice of treatment.”
Published by The Telegraph