Based on new data, the World Health Organization (WHO) recommended dolutegravir as a preferred HIV drug for all populations living with HIV, including pregnant women and those wanting to conceive.
Previously, a study in Botswana reported a preliminary signal for—a possible connection with—a serious birth defect in infants of women who had conceived while on dolutegravir.
Neural tube defects (NTDs) had been seen in four infants among 426 mothers (0.9%) who started taking dolutegravir before pregnancy and were still taking it at the time of conception.
At IAS, the Tsepamo Study team provided an update, reporting that NTDs occurred in three out of 1,000 infants whose mothers were on dolutegravir at the time of conception. The report called this “a small but [statistically] significant increase compared with all other antiretrovirals.”
Among the women who had taken dolutegravir since conception, five NTDs occurred in 1,684 births (0.30%). This compared to 15 NTDs in 14,792 births (0.10%) in women taking other HIV medications at the time of conception.
The team said the increased risk between dolutegravir and other antivirals was about two more cases of NTDs per 1,000 women.
The study will continue to conduct surveillance.
WHO said, “The risks of neural tube defects are significantly lower than what the initial studies may have suggested.”
Following the initial report, precautions were taken around the world. For example, U.S. HIV treatment guidelines recommended a pregnancy test before beginning a dolutegravir-based regimen.
WHO pointed out that “DTG [dolutegravir] is a drug that is more effective, easier to take, and has fewer side effects than alternative drugs that are currently used.”
WHO also noted the increasing rates of drug resistance being seen with efavirenz, which some countries had turned to as an alternative to dolutegravir before conception. Dolutegravir, on the other hand, has a high genetic barrier to the development of drug resistance.
While those are benefits seen with dolutegravir, WHO called “informed choice” important, saying people should weigh the pros and cons of specific anti-HIV therapy with a healthcare provider.
The organization also convened an advisory group of women living with HIV to advise it on policy issues.
Read the July 22 WHO press release at bit.ly/2XUlRQl; abstract MOAX0105LB from the Tsepamo Study at bit.ly/2STSRSN.
Folic acid reduces risk
The Baylor College of Medicine, which has long focused on pediatric HIV, reported on its study looking at folic acid (vitamin B9) deficiency in relation to NTDs seen with dolutegravir.
The report noted that studies over the decades have found that adding folic acid to the diet “has a protective effect against the vast majority of neural tube defects.”
“This work underscores the importance of considering the dietary conditions of individual populations when introducing new medications, as drug interactions with individuals and their offspring may be different depending on the nutritional status of the population,” the college reported.
The study was published June 26 in the journal AIDS.
Local considerations such as nutritional status and the availability of clean water are always a concern in the care of people living with HIV in resource-poor countries.
Read the detailed report on folic acid and dolutegravir in pregnancy at bit.ly/2YAbCjA.