Groundbreaking HIV drug safe to use in women of reproductive age

A groundbreaking HIV drug is safe to use by women who want to get pregnant after a review found that the risk of birth defects is lower than first thought.

The World Health Organization has updated its guidelines for the HIV drug dolutegravir (DTG), now recommending that it can be given to everyone, including women of reproductive age.

Last year WHO said that women who want to get pregnant should not take the drug after a study in Botswana - the first sub-Saharan African country to introduce the drug - found a higher than expected number of babies born with neural tube defects, which are problems with the spine and skull that occur in early pregnancy.

Researchers found that of the 426 women taking DTG, four of their babies - 0.9 per cent - were born with the defects, compared to just 0.1 per cent of babies born to HIV-positive mothers on other drugs.

But updated analysis of the original study, presented at this week’s International Aids Society conference in Mexico City, has found that the risk of birth defects is lower than originally thought.

Researchers looked at 119,000 deliveries in Botswana between August 2014 and April 2019, including nearly 1,700 women who were taking the new drug when they became pregnant.

They found that defects occurred at a rate of three out of 1,000 babies born to mothers on DTG compared to one out of 1,000 among women on other HIV drugs.

Another study in Botswana found one case of neural tube defect among 152 mothers who had taken DTG when they conceived. By comparison the study found two cases of neural tube defects in around 2,300 HIV negative mothers.

And another analysis of data from Brazil looked at at 382 who were taking DTG at the time of conception and found no cases of neural tube defects.

This is good news for HIV patients as DTG has benefits over other HIV treatments: it is more potent, reducing a patient’s viral load more quickly; it is cheaper; it has fewer side effects and is less likely to lead to drug resistance.

However, WHO said that the link with birth defects needs to be monitored.

Dr Meg Doherty from WHO's department of HIV and Aids, told a press briefing before the conference: “The guideline development group emphasised the need for ongoing monitoring of their risk of neural tube defects and the importance of supporting women’s autonomy in decision-making, including provision of information and options to help women make an informed choice when deciding to use DTG or not.”

In 2019, 82 low- and middle-income countries reported that they were moving to DTG-based HIV treatment regimes. WHO said the new updated recommendations would help more countries adopt the drug.

The updated guidelines were published on the same day as WHO’s annual report on resistance to HIV drugs.

The report found that in 12 of 18 countries reporting data more than 10 per cent of adults were resistant to the two most common HIV treatments - efavirenz and/or nevirapine.

Levels of resistance are twice as high in women as in men and the report recommends that countries urgently move to the new treatment.

In Cuba, Honduras and Nicaragua more than 30 per cent of women were resistant to one of the two treatments.

Dr Doherty said that the increasing resistance meant that countries "should be moving to a new first-line treatment and that first-line treatment should [contain] DTG".

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