Globally, an estimated 1.8 million children and adolescents under the age of 15 are infected with human immunodeficiency virus (HIV). However, to date, children infected with human immunodeficiency virus type 1 (HIV-1) have very limited options for access to effective antiretroviral therapy. Therefore, there is an urgent need for researchers to find effective treatments.
Recently, the results of a global trial called ODYSSEY, led by researchers at University College London (UCL), showed that the antiretroviral drug dulutvir is not only convenient to take (only once a day orally) compared to previous standard therapies, but also more effective in suppressing HIV in children and adolescents (under 18 years of age) and reducing the risk of treatment failure by about 40%. The findings were published in the prestigious medical journal The New England Journal of Medicine under the title "Dolutegravir as First- or Second-Line Treatment for HIV-1 Infectionin Children."
Research Results (Credit: The New England Journal of Medicine)
Truutvir is a integrase inhibitor that blocks HIV replication by acting on integrases. ODYSSEY is an open-label, randomized, non-inferiority trial that aims to compare the role of trudervir-based antiretroviral therapy with previous standard therapies in children and adolescents in first-line (ODYSSEY A cohort) versus second-line (ODYSSEY B cohort).
In the study, a total of 707 patients from 29 clinical medical centers in Africa, Europe and Asia were included. These patients were randomly assigned to duruterine regimens or standard therapies and followed up for at least two years.
Proportion of participants who failed treatment at 48, 96, and 144 weeks (Credit: The New England Journal of Medicine)
The primary endpoint of the study was the proportion of patients who failed antiviral therapy at 96 weeks, and other secondary endpoints included virology, immunology, and safety endpoints. According to the final findings, the proportion of patients who received the Durutvir regimen failed treatment (the presence of detectable levels of the virus in the blood or the development of HIV-related symptoms) within 96 weeks was 14%, compared with about 22% of patients who failed to receive the standard treatment regimen. The above data show that receiving the Truutvir regimen reduces the likelihood of treatment failure in adolescents and children infected with HIV by about 40%!
Previous studies have shown that Truotvir has a high genetic barrier to drug resistance, meaning that over time, the virus is less likely to become resistant to it. This has also been confirmed in ODYSSEY clinical trials, where much less resistance occurs in children and adolescents treated with durutervir.
In addition, it is worth mentioning that previous studies have shown that trutrutvir-based antiretroviral therapy may be associated with weight gain. The trial included young HIV patients weighing more than 14 kg and mostly over the age of 6, and patients who gained more than 1 kg or grew taller than 1 cm over 2 years were evaluated, and the researchers found that truntvir did not cause abnormal weight gain in these patients. It can be said that the patients in the durutvir group have a good blood lipid profile, which means that the risk of cardiovascular disease is lower in the long run.
Taken together, this study shows that in children and adolescents weighing at least 14 kg, truletvir-based antiretroviral therapy is superior to standard treatment regimens.
Written by | Muzijiu
Typography | Muzijiu
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Resources:
[1] Turkova A, White E, Mujuru HA, et al. ODYSSEY Trial Team. Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children. N Engl J Med. 2021 Dec 30;385(27):2531-2543.doi: 10.1056/NEJMoa2108793. PMID: 34965338.