Dolutegravir-based ART superior to standard of care among children with HIV
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Dolutegravir-based ART with two nucleoside reverse transcriptase inhibitors was superior to standard of care among children with HIV enrolled in the international ODYSSEY trial, researchers reported at CROI.
“ODYSSEY is the first randomized controlled trial comparing dolutegravir-based ART to standard of care in children,” Anna Turkova, a pediatric consultant for Great Ormond Street Hospital for Children in London, told Healio. “It provides strong evidence for guidelines and policymakers that dolutegravir-based ART is better than standard of care for children starting first-line or second-line ART, and therefore, should be the preferred option in treatment programs.”
Turkova and colleagues enrolled 707 children aged 2 to 18 years from Uganda, Zimbabwe, South Africa, Thailand and Europe who weighed at least 14 kg and randomly assigned them to receive dolutegravir (n = 350) or standard of care (n = 357).
Among them, 311 children began first-line treatment, including 92% in the standard-of-care group who received efavirenz, which was 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 started second-line care, which included 72% in the standard-of-care arm who received lopinavir/ritonavir and 25% who received atazanavir/ritonavir.
According to the study, 14% (n = 48) of children in the dolutegravir group experienced treatment failure by 96 weeks compared with 22% (n = 75) in the standard-of-care group, a difference of –7.7% (95% CI, –13.2 to –2.3). There were 40 virological failures among the dolutegravir group and 67 failures in the standard-of-care group.
According to the researchers, there were 65 severe adverse events reported among 35 children in the dolutegravir group and 46 severe adverse events among 42 children in the standard-of-care group, including two deaths in the dolutegravir group and three in the standard-of-care group. Additionally, 73 children in the dolutegravir group reported at least a 119 grade 3 adverse events, and 88 children in the standard-of-care group reported 135 adverse events.
“We had similar numbers of participants with serious and severe adverse events in the dolutegravir and standard-of-care arms. However, we had lower number of adverse events of all severity leading to treatment change on dolutegravir compared to standard of care. This means dolutegravir was better tolerated than standard of care,” Turkova said. “Children randomized to dolutegravir also had better lipid results, which may mean lower risk of cardiovascular disease long-term.”
Turkova noted that dolutegravir is able to quickly suppress HIV viral load when it is part of an ART regimen. Since 2018, WHO has recommended dolutegravir-based ART as the preferred treatment for adults and children. This recommendation was conditional and based on a low certainty of evidence, but the results from their analysis provides stronger evidence for it, she said.
“It has a high threshold to resistance mutations, meaning that it is harder for HIV to develop resistance to dolutegravir and make treatment ineffective,” Turkova said. “It comes in small film-coated or dispersible tablets, and it is palatable. Therefore, it is easy to take, which is very important for young children, who often cannot swallow large tablets.”
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Turkova A, et al. Abstract 174. Presented at: Conference on Retroviruses and Opportunistic Infections; March 6-10, 2021 (virtual meeting).
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