The international study will compare the World Health Organization's recommended regimen against 2 others.
Anthony Fauci, MD
The development of antiretroviral therapy (ART) for patients with HIV has changed the scope of treatment options. Years ago, patients received “nothing, or something,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), told MD Magazine.
But with effective drugs for HIV flooding the market, clinicians have the resources to consider the most effective, tolerable, and safe drug regimens for patients.
As a result, the National Institutes of Health (NIH) have launched an international study to consider the safety and efficacy of 3 different ART regimens for pregnant women with HIV. The comparison trials will also evaluate the regimens’ safety for their infants, and evaluate the recommended World Health Organization (WHO) first-line regimen among the therapy groups.
The study should have clinical impact on the estimated 1.5 million women with HIV who give birth, annually. Though previous studies have indicated ART’s suppression of prenatal virus transmission, this larger study will consider infected mothers’ viral loads at delivery, as well as the regimens’ effects on adverse pregnancy outcomes.
WHO’s recommended combination ART regimen — efavirenz (EFV), lamivudine (3TC) or emtricitabine (FTC), and tenofovir disproxil fumarate (TDF) — for pregnant women with HIV will be compared with regimens containing newcomer drug dolutegravir (DTG) and either tenofovir alternative alafenamide (TAF), or TDF.
It’s already been established that WHO’s recommended regimen is susceptible to causing intolerability or adverse events in pregnant women with HIV, Fauci said. EFV has caused neuropsychiatric symptoms such as suicidal thoughts in patients, as well as liver issues. TDF can has had an effect on both the patients and their infants before, causing kidney issues in adults, and loss of bone mineral density in both mother and child.
Fauci emphasized that pregnant women with HIV are a “special population of patients.”
“Since the trials that showed (these regimens) were receptive in women, it’s become very clear that there’s drugs now that are much more effective, prone to resistance, and safer in lack of toxicities,” Fauci said.
The study (IMPAACT 2010) is organized as a phase 3 clinical trial. Its goal is to enroll 639 women with HIV currently not on ART, who are also 14 to 28 weeks into pregnancy. Each patient will be randomly assigned to EFV/FTC, DTG/FTC/TAF, or DTG, FTC/TDF regimens. Following birth, infants will receive standard-of-care interventions for HIV prophylaxis.
Researchers will continue to analyze patients and infants for 50 weeks post-delivery, monitoring mothers’ viral loads and testing infants for HIV. There will also be consideration made to the individual therapies’ potential adverse effects: mothers’ liver and kidney function will be monitored, as well as their psychiatric state. Both infants and mothers will be tested for bone density.
Overall, the study is projected to last about 3 years. NIAID and the National Institute of Child Health and Human Development (NICHD) are providing funding to the clinical research sites, while Gilead Sciences, Mylan, and ViiV Healthcare are providing ART therapy.
For all the consideration being made to HIV therapy complexities, Fauci’s reasoning for the study was as simple as it could be.
“As a woman, pregnant or not, you’re going to want to make sure you don’t have a situation where a drug is fundamentally toxic,” Fauci said.
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