Details

Autor(en) / Beteiligte

• LINDSEY, Jane C
• HUGHES, Michael D
• MOULTRIE, Harry
• KHADSE, Sandhya
• SCHIMANA, Werner
• BOBAT, Raziya
• ZIMMER, Bonnie
• PETZOLD, Elizabeth
• MOFENSON, Lynne M
• JEAN-PHILIPPE, Patrick
• PALUMBO, Paul
• VIOLARI, Avy
• ESHLEMAN, Susan H
• ABRAMS, Elaine J
• BWAKURA-DANGAREMBIZI, Mutsa
• BARLOW-MOSHA, Linda
• KAMTHUNZI, Portia
• SAMBO, Pauline M
• COTTON, Mark F

Titel

Predictors of Virologic and Clinical Response to Nevirapine versus Lopinavir/Ritonavir-based Antiretroviral Therapy in Young Children With and Without Prior Nevirapine Exposure for the Prevention of Mother-to-child HIV Transmission

Ist Teil von

• The Pediatric infectious disease journal, 2014-08, Vol.33 (8), p.846-854

Ort / Verlag

Hagerstown, MD: Lippincott Williams & Wilkins

Erscheinungsjahr

2014

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• In a randomized trial comparing nevirapine (NVP)-based versus lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) in HIV-infected children [primary endpoint discontinuation of study treatment for any reason or virologic failure by week 24] aged 2 months to 3 years, we assessed whether clinical, virologic, immunologic and safety outcomes varied by prior single-dose NVP exposure (PrNVP) for prevention of mother-to-child HIV transmission and other covariates. Efficacy was assessed by time to ART discontinuation or virologic failure, virologic failure/death and death; safety by time to ART discontinuation because of a protocol-defined toxicity and first ≥ grade 3 adverse event; immunology and growth by changes in CD4%, weight/height World Health Organization z-scores from entry to week 48. Cox proportional hazards and linear regression models were used to test whether treatment differences depended on PrNVP exposure and other covariates. Over a median follow up of 48 (PrNVP) and 72 (no PrNVP) weeks, there was no evidence of differential treatment effects by PrNVP exposure or any other covariates. LPV/r-based ART was superior to NVP-based ART for efficacy and safety outcomes; however, those on NVP had larger improvements in CD4%, weight and height z-scores. Lower pretreatment CD4% and higher HIV-1 RNA levels were associated with reduced efficacy, lower pretreatment CD4% with shorter time to ART discontinuation because of a protocol-defined toxicity, and no PrNVP with shorter time to first grade ≥ 3 adverse event. Differences between LPV/r and NVP ART in efficacy, safety, immunologic and growth outcomes did not depend on PrNVP exposure, prior breast-feeding, sex, HIV-1 subtype, age, pretreatment CD4%, HIV-1 RNA or World Health Organization disease stage. This finding should be considered when selecting an ART regimen for young children.