Antiretroviral Therapy in Children and Adolescents: A Look Into Modern Single Tablet Regimens

Abstract

Single tablet regimens (STRs) have simplified antiretroviral therapy (ART) over the years in the adult human immunodeficiency virus (HIV) population. However, there is still a prevalent need to simplify regimens in children and adolescents living with HIV. Finding the optimal regimen requires a multi-factorial approach due to their complex pharmacokinetic profiles throughout childhood and the challenges and limitations of medication non-adherence in the pediatric population. These challenges include pill size, available formulations, palatability, and caregiver health literacy, which can all affect the proper administration of medications. The complexity of this population implies the importance of customizing everyone's antiretroviral regimen so that the patient and family can successfully adhere to the therapy. The current recommendations for ART in the adult and pediatric populations are similar, yet the use of STRs are limited. The goal of this review was to assess current data on available STRs and determine their utility as ART in the pediatric population.

Assessment of swallowability and acceptability of scored darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets in HIV-1–infected children aged ≥6 to <12 years, using matching placebo tablets: A randomized study

“…6,7 Simplified ARV regimens, such as single-tablet regimens, have been shown to improve adherence in the pediatric population. 5,20 However, such regimens need to be acceptable to children for long-term daily dosing with respect to swallowability and palatability. 17,22,23 Therefore, assessing the acceptability of single-tablet regimens in the pediatric population is important to long-term adherence and outcomes in children living with HIV.…”

“…[1][2][3][4] The development of simplified antiretroviral (ARV) regimens, such as single-tablet regimens, that reduce pill burden is a high priority for pediatric populations living with HIV. 5 Pediatric guidelines recommend the use of simplified regimens, such as darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF), to optimize adherence, which is key to achieving and maintaining viral suppression and preventing medication resistance. 6,7 The D/C/F/TAF fixed-dose combination (FDC) was developed as a oncedaily, complete ARV therapy addressing the need for simplified protease inhibitor-based ARV regimens.…”

Could Anti-retroviral treatment affects the profile of hepatitis B vaccine specific antibody in vertically HIV-infected children?

“…Drug therapy and regimen characteristics can have a significant impact on the achievement of specific treatment goals. Advances in ART have made HIV a chronic disease that can be managed with lifelong drug therapy [2]. Controlling viral load, restoring immune function and preventing long-term complications are essential for successful HIV management, but some ARVs have been reported to be toxic.…”

Bioequivalence of a Pediatric Fixed‐Dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Compared With Coadministration of the Separate Agents in Healthy Adults: An Open‐Label, Randomized, Replicate Crossover Study

“…Compared with multitablet regimens, STRs have been shown to increase adherence, increase virologic suppression, and improve quality of life in adults living with HIV 7–10 . The development of simplified ART regimens, such as STRs, that reduce pill burden is also a high priority for pediatric populations living with HIV 11 …”

“…[7][8][9][10] The development of simplified ART regimens, such as STRs, that reduce pill burden is also a high priority for pediatric populations living with HIV. 11 To address the need for simplified ART regimens, a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablet, consisting of the protease inhibitor darunavir (DRV), the boosting agent cobicistat (COBI), and 2 nucleoside reverse transcriptase inhibitors, emtricitabine (FTC) and tenofovir alafenamide (TAF), was developed as a once-daily STR at doses of 800/150/200/10 mg for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults and adolescents weighing 40 kg or greater. [12][13][14][15][16] The efficacy, safety, and high genetic barrier to resistance of the D/C/F/TAF 800/150/200/10-mg FDC tablet were demonstrated in the international Phase 3 AMBER and EMERALD studies in treatment-naïve and treatment-experienced, virologically suppressed adults with HIV-1, respectively.…”