18 June 2018

Zimbabwe: Government Defers Arv Drug Roll-Out

Government has deferred the national roll-out of Dolutegravir -- an anti-retroviral drug for adolescent girls and women of child-bearing age --following reports from Botswana that the drug is associated with birth deformities in infants born to HIV-positive mothers taking the drug.

Zimbabwe intended to scale up dolutegravir- (DTG) as a first choice ARV to all people living with HIV in the country next year.

The drug is being used in Zimbabwe as a third line -- meaning it is only used by people who would have failed to respond to first and second options of ARVs.

In a statement, the Ministry of Health and Child Care said adolescents and women of child-bearing age who were taking DTG should immediately report to their nearest health facilities for further advice and counselling.

According to the ministry, a total of 200 people living with HIV were taking DTG as a third line drug, from which 108 of them were women -- some of whom could have been of child bearing age.

The ministry further said since the current complications were reported in adolescents and women of child-bearing age only, Government will continue switching to DTG at a national level in 2019 as a first option (first line) as initially planned for the rest of the population.

"The ministry would want to inform our partners and the public that the potential safety issues raised in the WHO statement affect only women living with HIV of child bearing age using DTG, and not the rest of the population," said the ministry.

"Therefore, Ministry still plans a transition to DTG later in 2019 for the rest of the population.

"It will defer the transition to DTG for women living with HIV of child bearing age, who intend to fall pregnant, until these safety issues have been addressed.

"These women (of child bearing age) will continue to take efavorenz-based regimens as a safe and effective first line regimen until further data is available."

The ministry said a series of meetings will be convened to consult on all stakeholders on which position Government should take with regards to use of DTG in Zimbabwe.

These developments were necessitated by a World Health Organisation (WHO) statement released in May this year on potential risk of DTG to foetuses of pregnant women taking the drug.

The statement was related to data from a preliminary study on DTG in Botswana, which identified four cases of neural tube defects out of 426 women who became pregnant while taking the drug.

The neural tube comprises of the tissues that form the spinal cord and brain of a child before birth and is formed very early during pregnancy up to 28 days after conception.

The study is still ongoing and it is projected that there will be more births from pregnant women who were using DTG at the time of conception.

According to WHO, the pregnancies will be closely monitored over the next nine months and results from the group are anticipated to provide more useful information about the safety of DTG for adolescents and women of child bearing age living with HIV during conception.

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