Only anti-retroviral drugs with adequate safety data should be administered to HIV-positive women of childbearing age, including pregnant women, the World Health Organisation (WHO) has said. The caution comes at a time when the Health Ministry has warned counties against prescribing to women an HIV drug linked with birth defects.
Last week, Medical Services Director Jackson Kioko said pregnant and breastfeeding women who are already taking the drug should continue with their current prescription until they stop breastfeeding. But he reminded county directors of health that there was limited safety data on the drug.
“The ministry therefore advises that Efavirenz-based regimen is the preferred first-line treatment for women of childbearing age between 15 and 49 years,” a letter from his office said.
In a statement sent to newsrooms, WHO said pregnant women taking dolutegravir (DTG) should not stop the ARV therapy but should seek additional guidance from their health providers.
WHO was responding to concerns raised over the past two months about preliminary studies in Botswana showing that DTG, also called Tivicay, when used by women of childbearing age, could cause birth defects.
The study shows that the drug can affect a baby’s spinal cord, brain, neural tube, and related structures.
But WHO said that if other first-line ARVs cannot be used in women of childbearing age, DTG may be considered in cases where consistent contraception is assured. Consistent contraception is use of a contraceptive method during every act of sexual intercourse.
“Current WHO guidelines released in 2016 said there was insufficient data on DTG usage during pregnancy and breastfeeding. The guidelines said Efavirenz (EFV), in combination with Tenofovir (TDF) and Lamivudine (3TC), or Emtricitabine (FTC), were the preferred ARV treatment during pregnancy,” said WHO.
Preliminary findings of a recent, independent study identified potential risks of HIV anti-retroviral medicine Dolutegravir (DTG), and reported the issue to WHO, the statement noted.
The ongoing Botswana study found four cases out of 426 women of neural tube defects in babies born to mothers who were taking the drug.
Two international regulators, US Food and Drugs Administration and the European Medicines Agency, last month warned against use of DTG, which was first approved less than four years ago.
Following reportage of the US and European warnings, the Health Ministry last week issued an internal memo to county directors of health directing them to ensure that HIV-positive women of child bearing age who are on the alternative frontline ARV drug are given the first-line treatment, efavirenz, and not DTG.
“Preliminary data from the Botswana study suggests that the potential safety issues arise from a woman’s exposure to DTG at conception, rather than during pregnancy,” said WHO in the statement. It said there was no evidence of an infant born with neural tube defects due to use of DTG during pregnancy.
According to the latest WHO guidelines titled: Consolidated Guidelines on the use of Anti-retroviral Drugs for Treating and Preventing HIV Infection 2016, only adults and adolescents should use Dolutegravir as alternative first-line treatment.