Development and in vivo evaluation of child-friendly lopinavir/ritonavir pediatric granules utilizing novel in situ self-assembly nanoparticles

Pham, Kevin; Li, Diana; Guo, Shujie; Penzak, Scott R.; Dong, Xiaowei

doi:10.1016/j.jconrel.2016.02.001

Cited by 38 publications

(32 citation statements)

References 32 publications

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“…Combinations may also result in further pharmacokinetics challenges produced by their own interactions. The extensive research required to ensure the safety of new medications can deter researchers and investigators from studying new and innovative pediatric antiretroviral medications; however, many of the innovations currently being studied show promising results [ 58 – 61 ].…”

Section: Barriers To New Pediatric Formulationsmentioning

confidence: 99%

“…These modes include sachets that deliver liquid or gel ART all at once, sprinkles and nanoparticles that allow caregivers to mix medications with food or liquids, and dissolvable tablets that can be incorporated into fluids. Nanotechnologies have been used to administer insoluble LPV/r in sprinkles or sachet formulations and have shown stability and good bioavailability [ 58 ]. Two articles studied the effectiveness of novel sprinkle formulations of LPV/r and efavirenz (EFV) [ 66 , 69 ].…”

Section: Benefits Of Child-friendly Artmentioning

confidence: 99%

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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: Barriers To New Pediatric Formulationsmentioning

confidence: 99%

Section: Benefits Of Child-friendly Artmentioning

confidence: 99%

The Need for Pediatric Formulations to Treat Children with HIV

Schlatter

Deathe

Vreeman

2016

AIDS Research and Treatment

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“…Pediatric pellets are heat-stable and generally more acceptable than syrups, but palatability and administration problems persist and may increase over time [61][62][63]. Pediatric granules, especially in the four-in-one combination, may improve palatability and decrease pill burden [35,64]. Precision medicine related to taste-sensing genotypes may hold promise for prescribing according to individualized palatability [65].…”

Section: Plos Onementioning

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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“…The efficacy and side effects have not been determined. Lopinavir/Ritonavir is a drug used to treat human immunodeficiency virus (HIV) infection in children over 14 days of age when used in combination with other protocols (30)(31)(32). The efficiency dosage of Lopinavir/Ritonavir is 200 mg/50 mg/capsule, two capsules each time, two times/day with oral administration (21,27,29,33,34) (Table 2).…”

Section: Lopinavir/ritonavirmentioning

confidence: 99%

Potential Drugs for Treating COVID-19 Infection

et al. 2020

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: The novel Coronavirus Disease 2019 (COVID-19) appeared as an emerging respiratory disease in December 2019 in Wuhan, Hubei province, China, and then spread rapidly worldwide, being declared a pandemic on March 11, 2020. Researchers are attempting to discover specifically designed antiviral treatments for COVID-19. Several therapeutic agents such as Interferon-α, Lopinavir/Ritonavir, Ribavirin, Chloroquine, Chloroquine phosphate, Hydroxychloroquine, Arbidol, Favipiravir, Remdesivir, Darunavir, Imatinib, Teicoplanin, Azithromycin, COVID-19 convalescent plasma, other potential antiviral drugs, and Chinese herbal agents are now being clinically studied to examine both pharmaceutical efficacy and safety for COVID-19 treatment in several countries. Some favorable results from these studies have been obtained to date. This review article summarizes and reiterates drugs that are potentially efficient against COVID-19.

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Development and in vivo evaluation of child-friendly lopinavir/ritonavir pediatric granules utilizing novel in situ self-assembly nanoparticles

Cited by 38 publications

References 32 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

Potential Drugs for Treating COVID-19 Infection

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