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EMA warns against use of ViiV Healthcare HIV drug due to risk of birth defects

The European Medicines Agency has cautioned against the usage of ViiV Healthcare Ltd.'s HIV medicine dolutegravir in certain women due to the risk of birth defects in babies born to mothers who became pregnant while taking the drug.

Dolutegravir is an integrase inhibitor, which blocks an enzyme called integrase that is required by the HIV virus to duplicate itself in the body.

EMA's Pharmacovigilance Risk Assessment Committee, which carried out the review, concluded that dolutegravir should not be prescribed to women seeking to become pregnant and prompted women to use contraception while taking the medicine.

The committee analyzed babies born to 11,558 HIV-infected women in Botswana, found that 0.9% of the babies, or 4 of 426, whose mothers became pregnant while taking dolutegravir had a neural tube defect, versus 0.1% of the babies, or 14 of 11,173, whose mothers took other HIV medicines.

The neural tube is the foundation of the spinal cord, brain and the bone and tissues that surround it. Neural tube defects occur when the neural tube fails to completely form; this formation takes place between zero and 28 days after conception.

Final results of the study are expected in about a year. The EMA said it will update the recommendations when it concludes its assessment.

In a response to the issue of birth defects found in the study, the World Health Organization noted that the preliminary data from the study in Botswana currently seems to suggest that the potential safety issue arises from a woman's exposure to the medicine at the time of conception, rather than during pregnancy.

The organization noted that dolutegravir has established efficacy, tolerability and a high genetic barrier to resistance.

The WHO's current guidelines released in 2016 cautioned that there was insufficient data for using the drug during pregnancy or breastfeeding and recommended Bristol-Myers Squibb Co.'s Sustiva, or efavirenz, in combination with tenofovir plus lamivudine or emtricitabine as the preferred option in pregnancy.

The organization has convened an expert guideline development group meeting on May 16 to May 18 to review all available data on the efficacy and safety data of dolutegravir, including the Botswana data, and will release updated guidance on the role of the drug in first- and second-line HIV treatment in the coming months.

In the meantime, the WHO has advised that pregnant women who are taking dolutegravir should not stop their antiretroviral therapy and should speak with their health provider for additional guidance. It also recommended that antiretroviral therapy for women of childbearing age, including pregnant women should be based on drugs for which adequate efficacy and safety data are available.

The WHO also advised that in cases where first-line antiretroviral therapies cannot be used in women of childbearing age, dolutegravir may be considered if consistent contraception can be assured.

Dolutegravir has been authorized since 2014 in the EU. It is marketed on its own as Tivicay and in combination with lamivudine and abacavir as Triumeq.

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline PLC and Pfizer Inc. GSK holds a majority stake in the company.