Infectious Disease

Dolutegravir-based ART that is superior to the standard of care for children living with HIV

March 26, 2021

2 min read

Source / information

Source:

Turkova A et al. Abstract 174. Presented at: Conference on Retroviruses and Opportunistic Infections; 6-10 March 2021 (virtual meeting).

Disclosure:
Turkova does not report any relevant financial information.

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Dolutegravir-based ART with two nucleoside reverse transcriptase inhibitors was superior to the standard of care in children with HIV enrolled in the international ODYSSEY study, researchers at CROI reported.

Anna Turkova

“ODYSSEY is the first randomized controlled trial comparing dolutegravir-based ART with standard childcare.” Anna Turkova, a pediatric advisor at Great Ormond Street Hospital for Children in London, said Healio. “It is strong evidence for policy makers and policymakers that dolutegravir-based ART is better than standard of care for children starting first- or second-line ART and should therefore be the preferred option in treatment programs. “

Turkova and colleagues included 707 children, ages 2 to 18, from Uganda, Zimbabwe, South Africa, Thailand, and Europe who weighed at least 14 kg and who randomly provided them with dolutegravir (n = 350) or standard of care (n = 357) .

Among them, 311 children started initial treatment, including 92% in the standard group who received efavirenz combined with two NRTIs: ABC / 3TC in 78% of children, TDF / XTC in 20%, or ZDV / 3TC in the remaining 2 %. The other 396 children entered second-line care, including 72% in the standard arm who received lopinavir / ritonavir and 25% who received atazanavir / ritonavir.

According to the study, 14% (n = 48) of children in the dolutegravir group had treatment failure after 96 weeks compared to 22% (n = 75) in the standard-of-care group, a difference of -7, 7% (95) corresponds to% CI, -13.2 to -2.3). There were 40 virologic failures in the dolutegravir group and 67 failures in the standard-of-care group.

According to the researchers, 65 serious adverse events were reported in 35 children in the dolutegravir group and 46 serious adverse events in 42 children in the standard-of-care group, including two deaths in the dolutegravir group and three in the standard-of -Care group -care group. In addition, 73 children in the dolutegravir group reported at least 119 grade 3 adverse events, and 88 children in the standard-of-care group reported 135 adverse events.

“We had a similar number of participants with major and major adverse events in the dolutegravir and standard care arms. However, we had a lower number of adverse events of all degrees of severity that resulted in a change in treatment with dolutegravir compared to standard treatment. This means that dolutegravir was tolerated better than standard of care, ”said Turkova. “Children randomly assigned to receive dolutegravir also had better lipid outcomes, which may mean a lower risk of cardiovascular disease over the long term.”

Turkova found that dolutegravir can quickly suppress HIV viral loads when part of an ART regimen. Since 2018, WHO has recommended dolutegravir-based ART as the preferred treatment for adults and children. That recommendation was conditional and based on low level of evidence, but the results of her analysis provide stronger evidence for it, she said.

“It has a high threshold for resistance mutations, which means it is more difficult for HIV to develop resistance to dolutegravir and make treatment ineffective,” Turkova said. “It comes in small film-coated or dispersible tablets and is tasty. Therefore, it is easy to take, which is very important for young children, who often cannot swallow large tablets. “

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Conference on Retroviruses and Opportunistic Infections (CROI)

Conference on Retroviruses and Opportunistic Infections (CROI)

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