Setting the record straight on use of controversial ARV

Last year in June, the Ministry of Health launched Dolutegravir, one of the newer anti-retroviral drugs, for use in the public health sector in Kenya.

The aim was to provide people living with HIV a better treatment option, seeing as Dolutegravir (DTG) has very few side effects and is easier to take (one small tablet, containing three drugs, taken once daily).

DTG is also known for its ability to decrease viral load (the amount of HIV in the blood) faster, and patients are less likely to develop resistance to the drug.

The World Health Organisation recommends DTG as an alternative first-line treatment regimen for adults and adolescents.

In recent weeks, there has been controversy on the use of DTG, with fears that the drug causes neural tube defects.

ADVISORIES

For this reason, the World Health Organisation; the US Food and Drug Administration; the US President’s Emergency Plan for Aids Relief (PEPFAR); and Kenya’s Pharmacy and Poisons Board have issued advisories to provide caution on the use of DTG by women of reproductive age (15 to 49 years).

The neural tube, which develops into the brain and spinal cord, forms within the first 28 days after conception. When it fails to form properly, neural tube defects occur.

The exact cause of neural tube defects is not known, but different factors such as genetics, nutrition, some drugs and environmental factors are likely to play a role.

Preliminary findings from a study in Botswana, which has been using DTG since 2016, identified four babies born with neural tube defects among 426 women who became pregnant while taking DTG.

This means that potentially nine babies out of every 1,000 births, would have neural tube defects, compared to one baby out of every 1,000 births, among women taking alternative HIV treatment such as Efavirenz.

Although preliminary results have caused concern, the overall risk for birth defects in babies born by women taking DTG during pregnancy remains low.

Nevertheless, the Ministry of Health is conducting an assessment to identify any birth defects in babies whose mothers were taking DTG during the first month of pregnancy.

ON-GOING CONSULTATIONS

The public will be advised once this information becomes available. The Ministry is also conducting consultations with various stakeholders including networks of people living with HIV, to get their input on HIV treatment options.

In the interim, Efivarenz, which is a safe and effective first-line treatment regimen, should be offered to women and adolescent girls of childbearing potential. Women and adolescent girls on effective contraception may choose to use DTG and should be supported to make appropriate family planning decisions.

Women who are already pregnant or breastfeeding while on DTG should continue on the treatment until they have stopped breastfeeding. This is because changing the HIV treatment regimen during pregnancy may increase a woman’s viral load and pose a risk of HIV transmission to the baby.

Moreover, DTG has not been known to affect a baby’s development after the first month of pregnancy and has not been known to affect breastfeeding infants.

Once a woman has stopped breastfeeding after the recommended period, she should speak to her healthcare provider for guidance on her treatment options, to help inform her choice to either continue on DTG or switch to an alternative HIV treatment regimen.

The Ministry of Health remains committed to providing the highest standard of attainable health for all people living with HIV and will continue to monitor dolutegravir use by women of reproductive age, and issue additional guidance as new information becomes available.

Dr Kigen is the head of the National Aids and STI Control Programme (NASCOP)