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February 15, 2022
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Study shows bNAbs may be viable treatment for children with HIV

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Broadly neutralizing monoclonal antibodies, or bNAbs, may be a viable treatment option for young children with HIV, according to study findings presented at the Conference on Retroviruses and Opportunistic Infections.

“Children who received early ART may be an ideal group for treatment with bNAbs,” Roger L. Shapiro, MD, MPH, an associate professor of medicine at Harvard Medical School, said while presenting the findings.

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Broadly neutralizing monoclonal antibodies may be a viable treatment for children with HIV. Source: Adobe Stock

“Long-term ART has adherence challenges and side effects, but a low viral reservoir and limited HIV diversity in these children may be associated with successful outcomes with bNAbs,” Shapiro said.

Roger Shapiro

Shapiro and colleagues evaluated the monthly IV dosing of two bNAbs — VRC01LS and 10-1074 — as a treatment alternative to ART among a cohort of 28 HIV-positive children in Botswana who began HIV treatment less than 7 days after birth. The children had a median age of 3.6 years upon enrollment.

“The study had three steps,” said Shapiro, who is also the faculty director of Harvard’s Botswana Clinical Fellowship Program. “The first step was ART plus dual bNAbs. In this step, the first six participants underwent an additional [pharmacokinetic] assessment of dual bNAb dosing, leading to 32 weeks of overlap with ART and dual bNAbs. All subsequent participants received 8 weeks of ART, plus dual bNAbs.”

Twenty-five children from the initial cohort were eligible for step two, during which “ART was held and treatment with dual VRC01LS and 10-1074 was continued for up to 24 weeks, and HIV RNA was checked every 1 to 2 weeks,” Shapiro explained.

Children entered the third stage if any value higher than 400 copies/mL was detected, or at 24 weeks, he said.

“In step 3, bNAbs were discontinued and ART was restarted, with IV bNAb infusions given every 4 weeks,” Shapiro said.

The researchers reported that 44% of children remained virally suppressed for 24 weeks while being treated with the bNAbs but not ART. “These children were categorized as successes,” Shapiro said, noting that the 95% CI was 24% to 65%.

In a press conference, Shapiro said the children’s caregivers were surveyed regarding the study, and that they preferred the bNAb treatment over ART.

“We were surprised by the surveys that we did that showed it was almost universally preferred to standard ART by the caregivers,” he said. “Giving children antiretrovirals every day is challenging. It's in syrup, usually, for younger kids, and they can be not the best tasting syrups and they can be difficult to get kids to take and the parents found this a welcome break from the ART. I'm not saying that it will always be the case for all parents, but in our study was really highly acceptable.”

He said the findings indicate that bNAbs may be a viable option for treatment that could “get better and better.”

“I think this is the first evidence that you can treat with a different strategy [from ART],” Shapiro said. “We know that [bNAbs are] going to get broader and more potent, and to have a different way of treating children for HIV is a real advantage.”