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New Breakthrough In HIV/AIDS Drugs For Children

Release time:2022/1/26 17:29:59
Author:Huateng Pharma

The antiretroviral drug Dolutegravir is not only convenient to take (only needs to be taken orally once a day) compared w…

Currently, there are about 1.8 million children and adolescents under the age of 15 living with HIV worldwide, and for this group of people, their treatment options are very limited. Especially for pediatric patients, if the therapeutic drug has a poor taste and is inconvenient to take, it will greatly reduce the compliance of long-term treatment.



The results of a global trial called ODYSSEY led by researchers at University College London (UCL) showed that the antiretroviral drug Dolutegravir is not only convenient to take (only needs to be taken orally once a day) compared with previous standard therapy, and was able to suppress HIV more effectively in children and adolescents (under 18 years) and reduce the probability of treatment failure by about 40%. The results of the study were recently published in the prestigious medical journal, The New England Journal of Medicine (NEJM).

"This study provides strong evidence for the widespread use of Dolutegravir in children and adolescents with HIV worldwide, and provides the latest evidence for the WORLD Health Organization (WHO) recommendations for HIV treatment," said Professor Diana Gibb, principal investigator of the ODYSSEY trial and one of the paper's senior authors.  

Dolutegravir is an integrase inhibitor that blocks HIV replication by acting on the integrase enzyme. ODYSSEY is an open-label, randomized, non-inferiority trial designed to compare Dolutegravir based antiretroviral therapy with prior standard therapy in first-line (ODYSSEY A cohort) and second-line (ODYSSEY B Cohort) treatment in children and adolescents. The study included more than 700 patients from 29 clinical centers in Africa, Europe and Asia.  


Included patients were randomized to receive the Dolutegravir regimen or standard of care and were followed for at least two years. The primary endpoint of the study was the proportion of patients who failed antiviral therapy within 96 weeks.

The study's main results showed that 14% of patients treated with Dolutegravir had treatment failure (detectable levels of the virus in the blood or HIV-related health symptoms) over a 96-week period. About 22% of patients who received standard treatment failed.  In other words, durlutwivir, currently widely used for treatment in adults, reduces the chance of treatment failure in young HIV patients by approximately 40% compared to standard treatment.  

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▲The proportion of patients with treatment failure in the 48th, 96th and 144th weeks of the study (Image source: Reference [1])

Evidence from previous studies in adults with HIV suggests that Dolutegravir-based antiretroviral therapy may be associated with weight gain.

All of the young HIV patients enrolled in the current trial weighed 14 kg or more and the vast majority were 6 years and older, but durutrevir did not cause abnormal weight gain in patients who gained more than 1 kg or gained more than 1 cm over a 2-year period.  In general, patients in the Dolutegravir-treated group had a good lipid profile and therefore a lower risk of long-term cardiovascular disease. 

Dr. Anna Turkova, lead author of the study, said: "Only about half of young HIV patients worldwide are currently receiving treatment, and those who are not receiving treatment are at high risk for compromised immune systems and worsening health. As a once-daily antiretroviral drug, Dolutegravir is not only low cost, but can be given to infants and young children in small tablets or distributed in water, which is very important for improving treatment adherence."  

The paper emphasizes that previous research evidence shows that Dolutegravir has a high genetic barrier to drug resistance. That’s to say, HIV is relatively less likely to develop resistance to it over time. Results from the current ODYSSEY trial confirmed that children or young adults who received Dolutegravir based treatment had significantly lower rates of drug resistance.  

As a dynamic science company, Huateng Pharma is dedicated to providing PEG derivatives and pharmaceutical intermediates to customers worldwide. We supply intermediates of anti-HIV/AIDS drug dolutegravir, such as (R)-3-Aminobutan-1-ol (CAS No. 61477-40-5), R-3-Aminobutyric acid (CAS No. 3775-73-3) and 2,4-Difluorobenzylamine (CAS NO.:72235-52-0).




[1] Dolutegravir as First-or Second-Line Treatment for HIV-1 Infection in Children