In Brief | Paediatrics & Neonatology | HIV
Researchers confirm dosing efficacy of pediatric HIV drug combination
Time to read: 01:33
Type of article: In Brief
MedED Catalogue Reference: MPIB005
Keywords: HIV, dolutegravir, dispersible table, paediatrics
Sources: The Lancet HIV
This article is a review of recent studies originally published The Lancet HIV: May 2022. It does not represent the original research, nor is it intended to replace the original research. Access the full Disclaimer Information.
There is a need for effective antiretroviral treatments for infants and young children with HIV-1, who often face challenges with adherence and limited treatment options. The WHO has recommended the HIV integrase inhibitor dolutegravir as a first-line treatment for HIV-1 since 2018. Its use has however been limited to adults and older children due to formulation issues.
A dispersible tablet formulation of dolutegravir was developed to address this issue; its effectiveness is the subject of the International Maternal Paediatric Adolescent AIDS Clinical Trial (IMPAACT) P1093, an ongoing multicentre, open-label, non-comparative study.
The outcomes for this study were identified as:
-
To determine which dose of dolutegravir achieved C24 and the AUC24 in these children.
-
Toxicity was the primary safety outcome identified as either grade 3 or 4 adverse events, termination of treatment due to adverse drug events or death.
-
The secondary outcomes measured included pharmacokinetic variables, tolerability, and clinical efficacy.
-
Virological success was defined as achieving a plasma HIV-1 RNA of less than 400 copies per mL. Other efficacy outcomes included the proportion achieving HIV-1 RNA of less than 50 copies per mL and the change from baseline in CD4 cell count and percentage.
.
The following was recorded:
-
73 participants (48% female, median age of 1 year & median weight of 8·5 kg) received the final proposed dose of dolutegravir. The dosage schedule can be found here
-
The selected dose within each age cohort (≥ two years to <6 years, ≥6 months to <2 years of age and ≥ four weeks to <6 months) achieved geometric mean trough (ng/mL) of 688, 1179, and 1446, and 24 h area-under-the-curve (h·mg/L) of 53, 74, and 65, respectively.
-
No grade 3 or worse adverse events were attributed to dolutegravir.
Based on these findings, the researchers conclude that using a single dose of dolutegravir dispersible tablets as first-line or second-line treatment for infants and children under six years living with HIV-1 is safe and effective.
Disclaimer
This article is compiled from a variety of resources researched and compiled by the contributor. It is in no way presented as an original work. Every effort has been made to correctly attribute quotes and content. Where possible all information has been independently verified. The Medical Education Network bears no responsibility for any inaccuracies which may occur from the use of third-party sources. If you have any queries regarding this article contact us
Fact-checking Policy
The Medical Education Network makes every effort to review and fact-check the articles used as source material in our summaries and original material. We have strict guidelines in relation to the publications we use as our source data, favouring peer-reviewed research wherever possible. Every effort is made to ensure that the information contained here is an accurate reflection of the original material. Should you find inaccuracies, out of date content or have any additional issues with our articles, please make use of the contact us form to notify us.
