▎ WuXi AppTec content team editor
There are currently about 1.8 million people living with HIV/AIDS in children and adolescents under the age of 15 worldwide, and their treatment options are limited for this group of people. Especially for pediatric patients, if the therapeutic drug tastes poor and it is inconvenient to take, it will greatly reduce the compliance with long-term treatment.
The results of a global trial called ODYSSEY, led by researchers at University College London (UCL) in the UK, showed that the antiretroviral drug dulutweil is not only convenient to take (only needs to be taken once a day) compared to previous standard therapies, but also more effective in suppressing HIV in children and adolescents (under 18 years of age) and reduces the probability of treatment failure by about 40%! The results of this study were recently published in the prestigious medical journal New England Journal of Medicine (NEJM).
Professor Diana Gibb, lead investigator of the ODYSSEY trial and one of the senior authors of the paper, said: "This study provides strong evidence for the widespread use of Trudeaux in children and adolescents with AIDS worldwide, as well as the latest evidence for the World Health Organization's (WHO) recommendations for the treatment of AIDS. ”
Screenshot source: NEJM
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 trumantweil-based antiretroviral therapy with previous standard therapies in children and adolescents in first-line (ODYSSEY A cohort) versus second-line (ODYSSEY B cohort). The study included more than 700 patients from 29 clinical medical centers in Africa, Europe and Asia.
Included patients were randomized to receive a truutvir regimen or standard therapy and followed up for at least two years. The primary endpoint of the study was the proportion of patients who failed antiviral therapy within 96 weeks.
The main findings of the study showed that over a 96-week period, 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 health symptoms) was 14% compared with about 22% of the patients who received the standard treatment regimen. That said, the Truutvir-based regimen, which is currently widely used in adult treatment, reduces the probability of treatment failure in young people with AIDS by about 40% compared to standard treatment regimens!
The proportion of patients who failed treatment at weeks 48, 96, and 144 of the study (Image source: Reference[1])
It is worth noting that evidence from previous studies in adult AIDS patients suggests that trumantvir-based antiretroviral therapy may be associated with weight gain.
The current trial included young AIDS patients weighing more than 14 kg and the vast majority of them aged 6 years and older, but evaluating patients who gained more than 1 kg of weight or grew taller than 1 cm within 2 years found that truttvir did not cause abnormal weight gain in this group of patients. Overall, patients in the duruterine treatment group had impressive lipid profile profiles and therefore a lower risk of long-term cardiovascular disease.
Dr Anna Turkova, lead author of the study, said: "Only about half of the young AIDS patients worldwide are currently being treated, and untreated patients are at high risk of immunodeficiency and deteriorating health. As an antiretroviral drug that can be taken once a day, dulutvir is not only less expensive, but can be given to infants and young children in small tablets or dispersed in water, which is very important for improving treatment adherence. ”
The paper highlights evidence from previous studies that Truttweil has a high resistance gene barrier. That said, over time, hiv is relatively less likely to become resistant to it. This is reaffirmed by the results of the current ODYSSEY trial, which states that the proportion of drug-resistant children or young AIDS patients receiving durutevir-based treatment is significantly lower.