Abstract
IntroductionDespite a significant reduction in mother‐to‐child transmission of HIV, an estimated 180,000 children were infected with HIV in 2017, and only 52% of children under 15 years of age living with HIV (CLHIV) are on life‐saving antiretroviral therapy (ART). Without effective treatment, half of CLHIV die before the age of two years and only one in five survives to five years of age.DiscussionOver the past four years, the United States Food and Drug Administration tentatively approved new formulations of lopinavir/ritonavir (LPV/r) in the form of oral pellets and oral granules. However, the slow uptake of the aforementioned formulations in the low‐ and middle‐income countries with the highest paediatric HIV burden is largely due to three challenges: limited manufacturing capacity; current unit cost of the pellets and granules; and slow uptake of these new formulations by policy makers and health care workers.ConclusionsSolutions to overcome these barriers include ensuring availability of an adequate supply of LPV/r oral pellets and oral granules, considering all programmatic and clinical factors when selecting paediatric ART formulations, and leveraging current resources to decrease paediatric HIV morbidity and mortality.
Highlights
Despite a significant reduction in mother-to-child transmission of HIV (MTCT), an estimated 180,000 children were infected with HIV in 2017, and only 52% (44% to 73%) of children under 15 years of age living with HIV (CLHIV) are on life-saving antiretroviral therapy (ART) [1]
The historical use of single-dose nevirapine in prevention of motherto-child transmission (PMTCT) programmes has led to drug resistance and treatment failure among children receiving NVP-based ART regimens
According to the memorandum issued in January 2019, the Antiretroviral Procurement Working Group has stated that LPV/r oral pellets and oral granules are clinically equivalent and the dosing frequency is equivalent; the majority of the implementation studies have been conducted in lopinavir/ritonavir pellets [22]
Summary
Despite a significant reduction in mother-to-child transmission of HIV (MTCT), an estimated 180,000 children were infected with HIV in 2017, and only 52% (44% to 73%) of children under 15 years of age living with HIV (CLHIV) are on life-saving antiretroviral therapy (ART) [1]. The historical use of single-dose nevirapine (sdNVP) in prevention of motherto-child transmission (PMTCT) programmes has led to drug resistance and treatment failure among children receiving NVP-based ART regimens. LPV/r, currently available as oral solution, heat-stable tablets, oral pellets and oral granules, can be used to construct a more robust ART regimen compared to a regimen containing NVP [14]. In May 2015, the United States Food and Drug Administration (US FDA) tentatively approved a new formulation of LPV/ r: oral pellets [18] This formulation (lopinavir 40 mg/ritonavir 10 mg; manufactured by Cipla Limited) is packaged in a capsule that can be opened and sprinkled over soft food or, in the case of a young infant, placed in expressed breast milk or infant formula [19,20]. According to the memorandum issued in January 2019, the Antiretroviral Procurement Working Group has stated that LPV/r oral pellets and oral granules are clinically equivalent and the dosing frequency is equivalent; the majority of the implementation studies have been conducted in lopinavir/ritonavir pellets [22].1
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