The WHO has warned against the use of HIV drug Dolutegravir by women planning to get pregnant.
Studies in Botswana linked Dolutegravir (DTG) to serious birth defects on the brain and spinal cord.
DTG is a commonly used antiretroviral and was recommended as the third-line drug for patients who were not responding to the second-line ARV therapy.
In a statement, the World Health Organization urged women taking the DTG not to stop their therapy, but seek help from their health providers.
If other first-line ARVs cannot be used by women of childbearing age, the DTG may be considered where consistent contraception can be assured, it said.
In June last year, the Health ministry issued a circular that recommended the use of the DTG in alternative regimen for HIV-positive people who are intolerant to Efavirenz, people who inject drugs and are on ARV therapy, and new patients in the same category.
However, preliminary data from a recent independent study conducted in Botswana identified a potential safety issue with the DTG.
The team reported it to the WHO. It is related to birth defects (neural tube defects) in infants born to women taking DTG at the time of conception. The study found four cases of neural tube defects out of 426 women who became pregnant while taking the DTG.
The WHO yesterday said surveillance is going on among additional pregnant Botswana women who were exposed to the DTG at the time of conception.
“Their deliveries will be monitored closely over the next nine months (May this year to February next year). Results will be known thereafter. These data will provide more information about the safety of the DTG for women of childbearing age,” the statement reads.
The WHO recognised that the DTG has established efficacy, tolerability and a high genetic barrier to resistance.
It however added that ARV therapy for women of childbearing age, including pregnant women, should be based on drugs for which adequate efficacy and safety data are available. It cited the “efavirenz-based regimen — a safe and effective first-line regimen”.
The organisation is currently working closely with the Health ministry, researchers, pharmaceuticals and other agencies to investigate the preliminary findings.
“Regulatory authorities are also reviewing this matter. The WHO will update the data and information at a later date as more information becomes available,” the statement said.
The DTG or Tivicay is manufactured by UK pharmaceutical giant GlaxoSmithKline and was made available to patients through a partnership between the Health ministry and Geneva-based Unitaid. It was authorised in the US in 2013 and in the European Union in 2014.