August 17, 2022

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Clinical trials show Dolutegravir better suppresses HIV in children

Clinical trials show Dolutegravir better suppresses HIV in children



 

NEJM: Clinical trials show easy-to-take Dolutegravir better suppresses HIV in children.

 

A once-a-day Dolutegravir-based antiretroviral (ART) drug that is low-cost and easy to take in children, according to a global clinical trial led by researchers from University College London (UCL) in the United Kingdom , It is also more effective than standard therapy (ie, non-dlutevir-based ART drugs) at suppressing HIV.

 

They found that the Dolutegravir-based regimen, which is already widely used in adult patients, reduced the chance of treatment failure by about 40 percent in young infected people aged 3 to 18 years, compared with standard therapy.

 

The findings are published in the December 30, 2021, issue of the NEJM journal under the title “Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children.”

 

These findings are based on a random program called ODYSSEY controlled clinical trial, the clinical trials involving more than 700 children from Africa, Europe and Asia 29 clinical centers who were randomly given degree Lute Wei or standard anti-HIV drugs , and was followed up for at least two years.

 

The results of the clinical trial, sponsored by the Penta Foundation and funded by ViiV Healthcare, have led to new guidelines for the World Health Organization (WHO) recommending Dolutegravir-based therapy for children.

 

Professor Diana Gibb , co-corresponding author of the paper and principal investigator of the ODYSSEY clinical trial , said, “Our findings provide strong evidence for the global roll-out of Dolutegravir in children with HIV.

Due to the need for separate formulations and studies, Medical treatment of children often lags far behind that of adults.

With the evidence for the use of simplified doses of ODYSSEY, this treatment gap has been closed, and we hope that countries will rapidly expand access to treatment for children globally.”

 

Dr Anna Turkova, lead author of the paper and from the MRC Clinical Trials Unit at UCL, said: “About 1.8 million children have AIDS, but they have limited treatment options, and the medicines don’t taste good, requiring larger doses of twice a day. Pills that are difficult to swallow.

Dolutegravir comes in small tablets, usually once a day, which can be dispersed in water, which means it is easier for young children to take.

This is very important to encourage treatment acceptance and persistence for many years.

Sadly , only about half of HIV-infected children are currently on treatment, and those who do not face a high risk of immunocompromised and deteriorating health.”

 

 Clinical trials show Dolutegravir better suppresses HIV in childrenImage via NEJM, 2021, doi:10.1056/NEJMoa2108793.

 

In the new study, the authors found that 14 percent of children receiving Dolutegravir experienced treatment failure within two years, compared with 22 percent of children receiving standard care.

If HIV becomes measurable in the blood — that is, it is not completely suppressed — or if the child develops HIV-related ill health symptoms, then this is considered a treatment failure.

This failure may be due to not taking the drug, or it may be that the drug is not working.

 

Evidence from adults shows that Dolutegravir has a high genetic barrier to resistance, meaning the virus is less likely to develop resistance to it over time.

This was also confirmed in the ODYSSEY clinical trial , with much less resistance in children and adolescents treated with Dolutegravir.

 

Past research has suggested that Dolutegravir may be associated with weight gain in infected adults, but the authors say the new findings are reassuring for children, who took Dolutegravir within two years.

Gained 1kg and grew 1cm taller – all indicating better growth, not abnormal weight gain.

Children in the Dolutegravir-treated group had better lipid profiles, which meant a lower risk of cardiovascular disease in the long run.

 

The children in the clinical trial all weighed more than 14 kilograms, and most were 6 years and older.

The effectiveness of Dolutegravir was also studied in young children and infants weighing less than 14 kg, recruited as a separate trial group; results have not been published.

 

The clinical trial participants were recruited in Uganda, Zimbabwe, South Africa, Thailand, United Kingdom, Spain, Portugal and Germany. Most of the participants were in sub-Saharan Africa, where the majority of HIV-infected children are located.

 

Early findings from the ODYSSEY clinical trial suggest that adult-strength Dolutegravir tablets can be safely taken by children weighing 20kg or more, which informs WHO’s dosing guidelines and helps to gain access to the US and Europe in 2020 New license for it.

 

“Simplified dosing is key,” said Dr. Cissy Kityo of the Uganda Joint Clinical Research Centre. “Older children are able to take the same pills as adults, which gives the majority of HIV-infected children access to Dolutegravir.

It Significantly simplifies and reduces costs for low- and middle-income countries’ procurement of national health systems.”

 

Dolutegravir is an integrase inhibitor, i.e. inhibits HIV by inhibiting integrase, an enzyme necessary for HIV replication.

 

 

 

Reference:
Anna Turkova et al. Dolutegravir for first- and second-line HIV treatment in children. NEJM, 2021, doi:10.1056/NEJMoa2108793.

Clinical trials show Dolutegravir better suppresses HIV in children

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