According to early studies, there is a potential link between the drug and neural tube defects in children born from women who were using the drug when they conceived. (Neural tube defects are congenital disabilities of the spinal cord and brain that leads to conditions like spina bifida). A 2018 Botswana study raised the possible safety concern after four cases out of 426 were reported in women who became pregnant while taking the drug.
Using those preliminary findings, countries are suggesting pregnant women and childbearing age women to use efavirenz (EFV).
Two large clinical trials revealed new information about the safety of DTF and EFV in Africa has added more to the evidence. Based on the latest information, the chances for neural tube defects is much lower than previous studies indicated.
The groups’ guidelines also looked at the mathematical models related to the benefits and dangers of the two drugs, along with HIV positive people’s preferences and values, the factors of enacting HIV programs in various countries and the cost.
It was noted that DTG was far more effective, easier to take and had fewer side effects than other drugs already in use. On top of that, DTG has a high genetic barrier that could lead to drug resistance – a noteworthy factor based on the fact that some resistance trends are occurring in nevirapine and EFV-based regiments.
Out of 18 countries the WHO looked at, 12 of them noted higher than 10 percent pre-treatment drug resistance levels. The findings were used to update the guidelines for 2019.
In 2019, middle and low-income counties were in the process of moving to the DTG-based HIV treatment regimens. The latest recommendations are geared to help other countries to better their HIV policies.
Like any medication, a person can take, knowledge is power. The more information a person has, the higher chance they have of making an informed decision. People are encouraged to talk to their doctor about the different options available and weigh the pros and cons.
WHO wanted to stress how important it was to give women information so they can make a sound decision about their medical treatments. This is why WHO put together an advisory group of females who have HIV from backgrounds of all types to help them with developing policies that relate to their health. The agency said it would continue to look at DTG and its potential link to neural tube defects.
Written by Mark Riegel, MD
Here’s what we've been up to recently.