The Ministry of Health and Child Care has warned the public of potential safety issues affecting adolescents and women of child bearing age who are on Antiretroviral medication, Dolutegravir (DTG).
In a statement released last week, MoHCC noted that the potential safety issue is related to data from a preliminary ongoing study on DTG in Botswana which has identified four cases of neural tube defects out of 426 women who became pregnant while taking the medicine.
“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 safety concern is therefore related to the neural tube defects in infants born to women who were taking DTG at the time of conception,
“This 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. Their pregnancies will be closely monitored over the next 9 months and results from this group will help provide more useful information about the safety of DTG for adolescents and women of child bearing age living with HIV during conception,” the Ministry said.
The World Health Organization statement on DTG safety recommends that adolescents and women of child bearing age planning to get pregnant and including those who are pregnant should avoid using DTG and instead take ATV treatment based on medicines that have adequate efficacy and safety.
Currently in the country there are no patients using DTG as first line treatment, the national Antiretroviral therapy guidelines recommend use of the medicine as part of its third line treatment.The current total number of patients on third line is about 200 of which 108 are women.
In view of these recent developments, the ministry of health has reported that it will continue working closely with WHO, PEPFAR and other partners to understand the current limited data and consider any new data as it comes.
“Ministry will defer the transition to DTG for women living with HIV of child bearing age who intend to fall pregnant, these women will continue to take efavirenz-based regimens as a safe and effective first line regimen until further data is available,” added MoHCC.