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The FDA issued a security alert on May 18, saying that HIV-1-infected women treated with dolutegravir (DTG) have reported severe congenital neural tube defects in the brain and spine/spinal cord of their babies. An initial result of a prospective study being conducted in Botswana showed that patients who have received dolutegravir HIV-1-infected patients during pregnancy or early pregnancy have a higher risk of developing the above-mentioned defects.

Neural tube defect is a neonatal defect caused by the failure of normal development of the spinal cord, brain, and related organs in early embryo formation. In this observational study, women with dolutegravir during the second trimester have not reported neonatal neural tube defects. The FDA said it is investigating the safety of dolutegravir further.

The FDA recommends that patients do not stop abruptly without communicating with healthcare practitioners. Otherwise, HIV-1 infection may worsen. The specific recommendations are as follows:

If you are already pregnant, stopping the use of dolutegravir without an alternative drug will cause the HIV-1 viral load to rise and be transmitted to the fetus.

If dolutegravir is used during pregnancy or during the first 3 months of pregnancy, the fetus may have a higher risk of neural tube development defects. Pregnant women should communicate with healthcare practitioners using a treatment that does not contain dolutegravir.

If you are already pregnant or are pregnant, you should talk to your health care provider before using dolutegravir-containing drugs to see if alternative treatments are available.

Women of gestational age should take effective birth control measures before taking medications containing dolutegravir.

Before treatment with drugs containing dolutegravir, tests should be performed to see if they are pregnant.

Dolutegravir is an integrase chain transfer inhibitor (INSTI) that inhibits HIV-1 virus replication. It was first approved by the FDA in August 2013 and its time to market was close to five years. There are currently three FDA-approved drugs containing dolutegravir, including Tivicay (dolutegravir), Juluca (Juluca/ripiprin), and Triumeq (abacavir/dolutegravir).

Global AIDS drug market size (billion U.S. dollars) and corporate share

It’s a bad news for GSK undoubtedly, whose AIDS business is increasingly contributing to corporate revenue. With these three drugs, GSK is launching a powerful challenge to Gilead’s dominance of the AIDS drug market. Currently, the efficacy of AIDS drugs is facing a bottleneck. Safety is a topic that doctors and patients are most concerned about.

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