Assessment of lamivudine, zidovudine, lopinavir, and ritonavir plasma levels in HIV-positive pregnant women: Drug monitoring application to improve patient safety. Simultaneous therapeutic drug monitoring (TDM) of combination antiretroviral therapy (cART) is critical during pregnancy in order to improve clinical follow-up, monitor viral load, and patient adherence to treatment.A modified simple
Lamivudine/Zidovudine Teva 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union 18 November 2010 EMA/41752/2011 Committee for Medicinal Products for Human Use (CHMP) Assessment report Lamivudine / Zidovudine Teva International nonproprietary name: lamivudine / zidovudine Procedure No. EMEA/H/C/001236 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted. Table of contents 1. Background information on the procedure.............................................. 3 1.1. Submission of the dossier
Prevalence and dynamics of the K65R drug resistance mutation in HIV-1-infected infants exposed to maternal therapy with lamivudine, zidovudine and either nevirapine or nelfinavir in breast milk. K65R is a relatively rare drug resistance mutation (DRM) selected by the NRTIs tenofovir, didanosine, abacavir and stavudine and confers cross-resistance to all NRTIs except zidovudine. Selection by other NRTIs is uncommon. In this study we investigated the frequency of emergence of the K65R mutation and factors associated with it in HIV-1-infected infants exposed to low doses of maternal lamivudine, zidovudine and either nevirapine or nelfinavir ingested through breast milk, using specimens collected from the Kisumu Breastfeeding Study. Plasma specimens with viral load ≥1000 copies/mL collected
A randomized controlled trial of single-class maintenance therapy with abacavir/lamivudine/zidovudine after standard triple antiretroviral induction therapy: final 96-week results from the FREE study. The aim of the study was to test the antiviral efficacy of a triple nucleoside reverse transcriptase inhibitor (NRTI) regimen, with potential beneficial metabolic effects, as maintenance therapy baseline, 120 patients (baseline: median HIV-1 RNA 5.19 log10 copies/mL; median CD4 count 180 cells/μL) were randomized to receive abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) (n=61) or to continue the PI-based ART (n=59). For the proportions of patients (intention-to-treat; missing=failure) with HIV-1 RNA <400 copies/mL (PI group, 66%; ABC/3TC/ZDV group, 71%) and <50 copies/mL (PI group, 63%; ABC/3TC
Evaluation of steady-state pharmacokinetic interactions between ritonavir-boosted BILR 355, a non-nucleoside reverse transcriptase inhibitor, and lamivudine/zidovudine in healthy subjects. BILR 355 is a second generation non-nucleoside reverse transcriptase inhibitor. It has shown promising in vitro anti-HIV-1 activities and favourable human pharmacokinetic properties after co-administration
/8963), showing a decrease from 59.62% to 41.40% from 2016 to 2023. Factors such as being aged ≥50 years, male, Han nationality, lower education levels, occupations including workers, peasants and children, AIDS, pre-treatment CD4 T cell counts <200 cells/mm3, infection with CRF01_AE and CRF55_01B subtypes, and ART regimen lamivudine/zidovudine/nevirapine were associated with higher susceptibility
with cobicistat and clinically approved or investigational antiretroviral drugs was evaluated. The selected drugs were tenofovir, emtricitabine, abacavir, lamivudine, zidovudine, efavirenz, nevirapine, raltegravir, elvitegravir, atazanavir and darunavir. Overall, no significant changes were observed in the activity of any of the tested antiretroviral drugs in the presence of 5 μM cobicistat. Given that the use