New ARV comes with curb

● The health department is pushing forward with its plans to roll out a combination antiretroviral (ARV) drug despite concerns that it may cause birth defects.

This month pharmaceutical companies were awarded a three-year tender to provide the state with triple combination ARVs, the bulk of which are tenofovir/emtricitabane/efavirenz and dolutegravir/lamivudine/tenofovir (DLT).”

Department spokesperson Popo Maja said the department decided to provide DLT while it waited for the results of an ongoing study.

“This drug does present a number of advantages over the current treatment regimen in other patient groups, except women of child-bearing age. The risks relating to mothers and their infants have not been confirmed through a proper study, he said.

Women of child-bearing age will be excluded until the results are finalised.

A study conducted in Botswana found four cases of neural tube defects in the babies of 426 women who conceived while taking the drug.

Neural tube defects affect the spinal cord, spine or the brain.

The two common neural tube defects are spina bifida, a condition in which the backbone and the membranes around the spinal cord do not close properly, and anencephaly, in which babies are born without parts of the brain and skull.

Based on the findings of the study, the World Health Organisation recommended that women of child-bearing age be on reliable and consistent contraception if they decided to use the drug. Last year, SA put the rollout of drugs containing dolutegravir on hold, following the study.