January 08, 2020
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Outcomes similar among infants who start ART at 2 vs. 14 days

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Louise Kuhn, PhD, MPH
Louise Kuhn

For infants with HIV, early initiation of ART is crucial for viral suppression. However, results from a study published in E-Clinical Medicine showed that infants who started therapy at 2 days had similar outcomes as those who began ART up to 14 days after birth — suggesting that viral suppression can be achieved as long as therapy is initiated within 2 weeks of birth.

“Our results should be reassuring for clinicians that speed is not everything,” Louise Kuhn, PhD, MPH, professor of epidemiology at Columbia University’s Gertrude H. Sergievsky Center, told Healio. “Although undue delay should not be introduced, good outcomes of ART for neonates with HIV can be obtained if ART is started in the first 2 weeks of life.”

Kuhn and colleagues analyzed 73 HIV-infected infants from a single hospital in Johannesburg, South Africa, all of whom initiated ART with the first 14 days of birth. Of the infants, 46 initiated ART within less than 2 days of birth, whereas the remaining 27 infants initiated treatment between 2 and 14 days of birth.

The study was designed following the report of the so-called “Mississippi baby,” who started ART within 30 hours of birth and was able to maintain viral suppression without treatment for more than 2 years. Another report presented at the 2017 International AIDS Society conference showed that a South African child who was diagnosed with HIV as an infant and received early therapy had suppressed the virus for more than 8 years without treatment. Kuhn and colleagues initially considered enrolling infants in a clinical trial studying ART treatment interruption, but there was an insufficient number to attain a target population, they said.

Instead, the researchers delivered results on the effects of early ART.

Excluding three infants who died and nine who were lost to follow-up before 48 weeks of age, 75% attained a viral load of less than 50 copies/mL on ART. However, the researchers observed similar rates of achieving and sustaining viral suppression among infants who initiated ART within less than 2 days of birth (51%) and within 2 to 14 days of birth (54%).

CDC data show the earlier ART treatment is initiated in pregnant women, the more effective the medicine will be at preventing transmission to the infant. The agency estimates that 73 children aged 13 years or younger perinatally acquired HIV in the United States in 2017.

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Despite regional variations, the study’s results are likely applicable to a U.S. health care setting, according to Kuhn.

“The primary difference between the U.S. health care setting and the South Africa health care setting is the number of new HIV infections in neonates,” Kuhn said. “New HIV infections in neonates are very rare in the U.S. at the current time.”

A major limitation of the analysis was that the researchers were unable to confirm that the infants took the antiretrovirals, according to Kuhn, who suggested that research into long-acting formulations may be beneficial to parents of HIV-infected children.

“The most important factor is finding a way to help parents with the challenges of adhering to the antiretroviral regimen for their infants,” Kuhn said. “This can be very difficult for new parents.” – by Eamon Dreisbach

References:

CDC. HIV and pregnant women, infants, and children. https://www.cdc.gov/hiv/group/gender/pregnantwomen/index.html. Accessed January 7, 2020.

Kuhn L, et al. EClinicalMedicine. 2019;doi:10.1016/j.eclinm.2019.100241.

Violari A, et al. Viral and host characteristics of a child with perinatal HIV-1 following a prolonged period after ART cessation in the CHER trial. Presented at: IAS Conference on HIV Science; July 23-26, 2017; Paris.

Disclosures: Kuhn reports receiving grants from the NIH. Please see the study for all other authors’ relevant financial disclosures.