New Breakthrough In HIVAIDS Drugs For Children

Huateng Pharma https://us.huatengsci.com

New Breakthrough In HIV/AIDS Drugs For

Children

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

Huateng Pharma https://us.huatengsci.com

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.

Huateng Pharma https://us.huatengsci.com

▲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.

Huateng Pharma https://us.huatengsci.com

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).

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