Pediatric HIV: new opportunities to treat children

Linden, Dimitri Van der; Callens, Steven; Brichard, Bénédicte; Colebunders, Robert

doi:10.1517/14656560903012377

Cited by 10 publications

(5 citation statements)

References 35 publications

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“…Despite many innovations, pediatric formulations are still very limited in comparison to the number of adult formulations [ 80 , 81 ]. Without adequate or convenient pediatric formulations, prescribers and caregivers resort to cutting, crushing, or substituting adult medications to meet the need for easier administration of medications for children [ 26 , 32 , 38 , 61 ].…”

Section: Future Of Pediatric Antiretroviral Therapymentioning

confidence: 99%

The Need for Pediatric Formulations to Treat Children with HIV

Schlatter

Deathe

Vreeman

2016

AIDS Research and Treatment

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Over 3.2 million children worldwide are infected with HIV, but only 24% of these children receive antiretroviral therapy (ART). ART adherence among children is a crucial part of managing human-immunodeficiency virus (HIV) infection and extending the life and health of infected children. Important causes of poor adherence are formulation- and regimen-specific properties, including poor palatability, large pill burden, short dosing intervals, and the complex storage and transportation of drugs. This review aims to summarize the various regimen- and formulation-based barriers to ART adherence among children to support the need for new and innovative pediatric formulations for antiretroviral therapy (ART). Detailing the arguments both for and against investing in the development of pediatric HIV medications, as well as highlighting recent advances in pediatric ART formulation research, provides a synopsis of the current data related to pediatric ART formulations and adherence.

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Section: Future Of Pediatric Antiretroviral Therapymentioning

confidence: 99%

The Need for Pediatric Formulations to Treat Children with HIV

Schlatter

Deathe

Vreeman

2016

AIDS Research and Treatment

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“…Even if children are able to swallow pills, certain PIs are available only as large pills [28,29]. At the time of PENPACT-1, no PIs were available as complete-regimen combinations for children, whereas single-tablet NNRTI regimens could facilitate adherence through administration of fewer pills [2,[30][31][32][33][34]. More recently, a novel four-in-one fixed-dose combination of abacavir, lamivudine, and LPV/r granule-filled capsules has been under study and submitted to the…”

Section: Discussionmentioning

confidence: 99%

“…Unfortunately, treatment disruptions may result in treatment failure, acquisition of resistance mutations, and loss of future treatment options-which are particularly consequential in children. Compared with adults, children have greater pharmacokinetic variability and fewer available licensed drugs [2,3]. Due to longer lifetime antiretroviral exposure, children have more potential for long-term toxicity [4,5].…”

Section: Introductionmentioning

confidence: 99%

Time to treatment disruption in children with HIV-1 randomized to initial antiretroviral therapy with protease inhibitors versus non-nucleoside reverse transcriptase inhibitors

et al. 2020

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Background Choice of initial antiretroviral therapy regimen may help children with HIV maintain optimal, continuous therapy. We assessed treatment-naïve children for differences in time to treatment disruption across randomly-assigned protease inhibitor versus non-nucleoside reverse transcriptase inhibitor-based initial antiretroviral therapy. Methods We performed a secondary analysis of a multicenter phase 2/3, randomized, open-label trial in Europe, North and South America from 2002 to 2009. Children aged 31 days to <18 years, who were living with HIV-1 and treatment-naive, were randomized to antiretroviral therapy with two nucleoside reverse transcriptase inhibitors plus a protease inhibitor or non-nucleoside reverse transcriptase inhibitor. Time to first documented treatment disruption to any component of antiretroviral therapy, derived from treatment records and adherence questionnaires, was analyzed using Kaplan-Meier estimators and Cox proportional hazards models. Results The modified intention-to-treat analysis included 263 participants. Seventy-two percent (n = 190) of participants experienced at least one treatment disruption during study. At 4 years, treatment disruption probabilities were 70% (protease inhibitor) vs. 63% (non-nucleoside reverse transcriptase inhibitor). The unadjusted hazard ratio (HR) for treatment disruptions comparing protease inhibitor vs. non-nucleoside reverse transcriptase inhibitor-based regimens was 1.19, 95% confidence interval [CI] 0.88–1.61 (adjusted HR 1.24, 95% CI 0.91–1.68). By study end, treatment disruption probabilities converged (protease inhibitor 81%, non-nucleoside reverse transcriptase inhibitor 84%) with unadjusted HR 1.11, 95% CI 0.84–1.48 (adjusted HR 1.13, 95% CI 0.84–1.50). Reported reasons for treatment disruptions suggested that participants on protease inhibitors experienced greater tolerability problems. Conclusions Children had similar time to treatment disruption for initial protease inhibitor and non-nucleoside reverse transcriptase inhibitor-based antiretroviral therapy, despite greater reported tolerability problems with protease inhibitor regimens. Initial pediatric antiretroviral therapy with either a protease inhibitor or non-nucleoside reverse transcriptase inhibitor may be acceptable for maintaining optimal, continuous therapy.

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“…Treatment of infants less than 6 months old with liquid formulations may be still a major problem. Data from the study of children treated with HIV antiretroviral (Children with HIV early antiretroviral) therapy showed a significant reduction (76%) in mortality among infants who received antiretroviral therapy within 3 months of their life as opposed to those who were deferred therapy [7]. It is therefore beneficial to treat the infants rather deferring them to attain certain age, with conveniently and accurately administrable dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Formulation and Evaluation of Fixed Dose Combination Suppositories Containing Stavudine, Lamivudine and Nevirapine for Pediatric Applications

et al. 2015

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Suppositories are the convenient way of administering drugs in infants. In view of the lack of suitable pediatric antiretroviral formulations in the market, suppositories containing fixed dose combination (FDC) of stavudine, lamivudine and nevirapine (SLN) were developed to allow administration of the correct weight-related dose in pediatric HIV patients as recommended by WHO. Suppositories containing 10 mg of stavudine, 40 mg of lamivudine and 70 mg of nevirapine were prepared by the fusion method using Witepsol H15 semi-synthetic suppository base. All the prepared suppositories were evaluated for various physical parameters like weight variation, melting point, drug content and hardness. The rate and extent of drug release was evaluated using USP apparatus I and samples were analyzed by a validated UV-multicomponent method. The use of surfactants significantly increased the drug release from formulations manufactured with Witepsol H 15 fatty base. The development of pediatric fixed-dose combination formulations represent a new era and mark an important milestone for children living with HIV/AIDS.

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Pediatric HIV: new opportunities to treat children

Cited by 10 publications

References 35 publications

The Need for Pediatric Formulations to Treat Children with HIV

The Need for Pediatric Formulations to Treat Children with HIV

Time to treatment disruption in children with HIV-1 randomized to initial antiretroviral therapy with protease inhibitors versus non-nucleoside reverse transcriptase inhibitors

Formulation and Evaluation of Fixed Dose Combination Suppositories Containing Stavudine, Lamivudine and Nevirapine for Pediatric Applications

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