TRIUMEQ-PD: The First Dispersible Single Tablet Regimen For Children With HIV

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Highlights:

• TRIUMEQ is a fixed dose combination of Abacavir, Dolutegravir and Lamivudine for the treatment of pediatric patients weighing 14 kg to <25 kg with HIV-1
• TRIUMEQ is the first dispersible single tablet regimen containing Dolutegravir for children living with HIV
• The label extension of TRIUMEQ tablet, has led to lowering the minimum weight that a child with HIV-1 can be prescribed this medicine from 40 kg to 25 kg

TRIUMEQ PD is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in children. TRIUMEQ PD contains the prescription medicines Abacavir, Dolutegravir, and Lamivudine. It is approved for use in children who weigh 22 lb (10 kg) to less than 55 lb (25 kg). It is currently advocated as a complete treatment regimen or with other HIV medicines in children.

HIV treatment in children has been a challenging issue as it requires the use of multiple drugs and formulations that do not always taste well, and are difficult to administer. There are currently more than two million children living with HIV (CLHIV) across the globe and despite making up only four percent of the worldwide HIV population, children account for 15 percent of AIDS-related deaths. There have been significant advances in HIV treatment and care over the past decade, but only 52% of children living with HIV (under 14 years old) have access to optimized pediatric drug formulations. Medications like TRIUMEQ-PD provide an innovative daily treatment regimen for children living with HIV (1^✔).

TRIUMEQ PD: The Clinical Data

A study published in The Lancet HIV evaluated the clinical data of this new dispersible formulation. IMPAACT 2019 was an international, open-label, non-comparative dose-confirmation study of Abacavir, Dolutegravir, and Lamivudine in children younger than 12 years. Dosing of these drugs was confirmed in children and the FDC formulations were found to be safe, efficacious and well tolerated through 24 weeks of treatment. The finding of the trial supports the global efforts to expand the availability of this formulation to children with HIV. ViiV Healthcare, primarily owned by GSK, along with Pfizer and Shionogi as shareholders has been granted the marketing authorization for TRIUMEQ by the European commission for this formulation (2^✔).

Antiretroviral therapy in children: Important Recommendations

Antiretroviral drugs are not an absolute cure for HIV, however they are the most important treatment option as they reduce the mortality and morbidity in children with HIV and help to improve quality of life for HIV-infected infants and children. The current standard treatment for uses three ARV medications (triple drug therapy) in order to suppress the replication of the virus in the body and to arrest the progression of HIV disease. It is important to actively support drug compliance in children in order to maximize the efficacy of the regimen. The current first-line treatment is cheaper, relatively less toxic, and more easily administered than second line treatment options.

‘A novel dispersible tablet formulation containing three drugs for the treatment of children with Human immunodeficiency virus type 1 (HIV-1). #HIVtreatment #HIVtreatmentinchildren’

Important considerations for ART regimens for children include:

1. The availability of a suitable formulation that can be taken by children in appropriate doses has a simple dosage schedule, is suitable to the taste and thus the potential for compliance in young children
2. Fixed-dose combinations (FDCs) are preferred to syrups and multiple drugs because they promote treatment adherence and reduce the cost of treatment
3. Adult tablets that require cutting up can result in under dosing or overdosing when given to children, and this may lead to an increased risk of resistance or toxicity (3^✔)

The focus for infants and children on ART has shifted in recent times to understand that the ARV treatment will be a program that they will be on for the rest of their lives. Recommendations for the care of those who are HIV-infected will change over time, but the challenges of providing this care will need reconsiderations as new challenges emerge. ART is a life-long therapy and drugs combinations like TRIUMEQ-PD offer a solution and a vision to make this possible in a comprehensive way.

References:

1. Global HIV statistics - (https:www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf)
2. Pharmacokinetics, safety, and tolerability of dispersible and immediate-release abacavir, dolutegravir, and lamivudine tablets in children with HIV (IMPAACT 2019): week 24 results of an open-label, multicentre, phase 1-2 dose-confirmation study - (https:www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(23)00107-8/fulltext)
3. Antiretroviral Therapy (ART) - (https:www.ncbi.nlm.nih.gov/books/NBK304141/)

Source: Medindia

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