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New Study of Pregnant HIV-Positive Women to Shed Light on Antiretroviral Regimens

An ongoing study aims to confirm that newer ART regimens are as safe for pregnant women living with HIV as they are for their non-pregnant counterparts.

Roughly 1.5 million women worldwide who have HIV give birth every year. Antiretroviral therapy (ART) is extremely important for these mothers in order to ensure that they stay healthy and minimize the chance of passing on the virus to their babies.

The regimen currently recommended by the World Health Organization (WHO) for pregnant women living with HIV consists of efavirenz (EFV), tenofovir disoproxil fumarate (TDF), and either lamivudine (3TC) or emtricitabine (FTC); however, there are serious downsides to some of these medications. EFV may trigger anxiety and depression—including thoughts of suicide—along with liver injury. TDF can have an adverse effect on the kidneys as well as cause bone density loss, with concerns that the latter may even affect infants.

Because of these worries, scientists at the National Institutes of Health (NIH) are launching a study that will test the standard medication regimen against regimens that incorporate dolutegravir (DTG), a more recent addition to the HIV-drug lineup that’s gaining in popularity in the United States, and either TDF or tenofovir alafenamide (TAF). DTG can be taken only once daily, is at least as safe as other ART medications, and has a low incidence of resistance. TAF is similar to TDF in terms of effectiveness but seems to be less risky in terms of kidney and bone issues.

The study ultimately will enroll 639 women who are between 14 and 28 weeks pregnant and are not yet taking ART. They’ll be randomly assigned to take the standard EFV/FTC/TDF regimen or one of the newer regimens, consisting of DTG/FTC/TAF or DTG/FTC/TDF. Once born, the babies will also enroll in the study and be treated according to the standards of HIV care in each study locale. All participants will be followed for nearly a year after delivery, with the babies tested for HIV and the women screened for depression and provided with counseling on optimal feeding options and ART adherence. The women’s viral loads will be measured regularly, along with their liver and kidney function; mothers and babies alike will have bone density scans.

Several research sites in Zimbabwe already have begun treating women, while additional sites in Zimbabwe and the United States are currently enrolling participants. More sites in Botswana, Malawi, Tanzania, Uganda, South Africa, Brazil, India, Haiti, and the United States will open for enrollment within the next few months.

“One of the driving forces of the study is we want to give to mothers the optimal therapy that’s available to the [wider HIV-positive] community,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, a division of the NIH, told Contagion®. Describing the study results of DTG, Dr. Fauci was succinct: “Less toxicity, more powerful, dropped the viral load in a more sustained way, [and] less prone to resistance.”

Newer medication regimens incorporating DTG are now used successfully by non-pregnant women with HIV. Because there has been limited data available on the effects of different ART regimens on pregnant women with HIV, he explained, this study aims to ensure that pregnant women living with HIV are not given short shrift when it comes to treatment options for themselves and their babies.

Laurie Saloman, MS, is a health writer with more than 20 years of experience working for both consumer- and physician-focused publications. She is a graduate of Brandeis University and the Medill School of Journalism at Northwestern University. She lives in New Jersey with her family.