Open AccessPhase 2 Open-Label Study of Long-Term Safety, Tolerability, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive Adolescents Living with HIV-1
Author(s) -
Johan Lombaard,
Francis Ssali,
Thanyawee Puthanakit,
Jan Fourie,
Simon Vanveggel,
Cornelia Linthicum,
Veerle Van Eygen,
Rodica Van SolingenRistea
Publication year - 2022
Publication title -
antimicrobial agents and chemotherapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.07
H-Index - 259
eISSN - 1070-6283
pISSN - 0066-4804
DOI - 10.1128/aac.00916-21
Subject(s) - rilpivirine , medicine , tolerability , adverse effect , viral load , efavirenz , dolutegravir , emtricitabine , human immunodeficiency virus (hiv) , pill , reverse transcriptase inhibitor , antiretroviral therapy , virology , pharmacology
This phase 2 study investigated long-term safety and efficacy of rilpivirine (RPV [Edurant]) plus two investigator-selected nucleos(t)ide reverse transcriptase inhibitors (NRTIs) in HIV-1-infected antiviral therapy-naive adolescents. Participants (≥12 to <18 years of age) were treated with RPV at 25 mg once daily (q.d.) plus 2 NRTIs for participants who entered the treatment extension period for up to 240 weeks, with visits every 3 months. Long-term safety (analysis of adverse events [AEs] and laboratory results), efficacy (virologic response and outcome for patients with viral loads of <50 and <400 by time to loss of virologic response [TLOVR] and FDA Snapshot methods, as well as CD4+ cell count), and adherence (by pill count) for up to 240 weeks are presented.