The Health ministry recently banned the prescription of dolutegravir (DTG) as a front-line drug for women of child bearing age and recommended Efavirenz as a replacement.
The ban followed an advisory by the US Food and Drugs Administration and the European Medicines Agency that new studies indicate that women with HIV taking DTG at the time of conception or during the first trimester of pregnancy appear to be at higher risk of giving birth to babies with neural tube defects.
A ban on an HIV drug linked to birth defects should be limited to pregnant women or those planning to conceive to avoid a resurgence of the endemic, a group of medics urged.
The Health ministry recently banned the prescription of dolutegravir (DTG) as a front-line drug for women of child bearing age and recommended Efavirenz as a replacement.
The ban followed an advisory by the US Food and Drugs Administration and the European Medicines Agency that new studies indicate that women with HIV taking DTG at the time of conception or during the first trimester of pregnancy appear to be at higher risk of giving birth to babies with neural tube defects.
Neural tube defects occur early in pregnancy when the spinal cord, brain, and related structures do not form properly.
“Since the defects occur early in pregnancy, they should just use the drug and when they feel they want to have a baby, they consult their service provider to switch to another drug and after giving birth and breastfeeding they continue with the drug,” Maureen Kimani, the programme manager HIV care and treatment, at the National AIDS and STI Control Programme (NASCOP) said.
“I am happy that health providers have warned women of the risks of the drug to the unborn babies. They should use family planning to avoid such risks,” she added.
Dismas Oketch, head of HIV clinical trials at the Kenya Medical Research Institute’s Centre for Global Health Research, said HIV positive women of reproductive age should be given folic acid three months before their pregnancies rather than stopping prescription of the drug.
He said the introduction of folate early prevents neural tube defects.
“Some degree of caution has to be exercised to prevent such defects. women should plan their pregnancies and ensure that they are on folic acid earlier enough before pregnancy,” Dr Oketch warned.
“DTG is safe and has a high genetic barrier, it is difficult for HIV to develop resistance to DTG as compared to other drugs,” adding that when patients are placed on DTG, viral suppression is achieved very fast, which is one of the treatment goals,” Dr Oketch said.
Current 2016 WHO Guidelines caution that there is insufficient data for using DTG during pregnancy or breastfeeding and recommended efavirenz (EFV) in combination with tenofovir (TDF) + lamivudine (3TC) or emtricitabine (FTC) as the preferred option in pregnancy.
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