IN MADRID, SPAIN
Researchers have warned countries against stopping the use of a drug linked to birth defects in HIV-positive women.
They said the decision to ban the drug was arrived at without outweighing the benefits and risks of dolutegravir (DTG) in women living with the virus.
Presenting different papers on the drug at the third international HIV and Aids conference on research for prevention in Madrid, Spain, the researchers said there is need for a full picture of antiretroviral safety across the lifespan of women before an action is taken.
Dr Sharon Hiller from the University of Pittsburg, US, said there was no data to confirm that the drug was risky and banning it was patriarchal.
"With the position taken by most countries, it clearly says that women must just take what they are given and that don't have a voice to choose. We are robbing the women off choices. It is fault protection; it is patriarchal. We need to stop," she said during a presentation on striking a balance.
NEURAL TUBE DEFECTS
The Health ministry in July asked counties to stop prescribing DTG to HIV-positive women.
This was after a warning from the international regulators, US Food and Drugs Administration and the European Medicines Agency.
Studies had shown that women with HIV taking the drug at the time of conception or during the first trimester of pregnancy appear to be at higher risk of giving birth to babies with neural tube defects.
Neural tube defects in babies can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly during the first trimester.
Director of Medical Services Jackson Kioko directed county health directors to ensure that expectant and breastfeeding mothers to whom a front-line drug had been prescribed, continue their current prescription until they stop breastfeeding.
But those of childbearing age of between 15 and 49 years, who are on the drug, should be given the first-line treatment Efavirenz.
"I advocate for women to be told the risk in a clear way that can be understood to decide for themselves. If they cannot tolerate a drug, then they should be placed on another. If she goes off treatment to become pregnant because of the rare birth effects, she is risking her life and the baby," Dr Hiller said.
When asked to compare the benefits versus risks of the drug, she noted the good outweigh the bad.
She urged HIV-positive women not to be afraid of the rare effects and instead ensure they take treatment that they can tolerate and stick to.
She asked countries to strike a balance between risks and benefits of women having healthy children.
Dr Michelle Moorhouse of Wits University in South Africa, said it is a tricky situation since dolutegravir is a great drug, and for those women who are using effective contraception, then it remains a great option.
“I have to say this is an early signal, which we need to take seriously, but we have seen similar signals before with other drugs, which over time turned out not to be the problem we anticipated,” she said.
She added there are a number of other studies underway which could clear up the link and potentially clear dolutegravir’s association with this serious potential side-effect.
“The benefits of the drug, including the fact that it has shown no development of resistance in any patients should not be overshadowed by this “signal”. I really do want to caution against panic,” she said.