TY - JOUR
T1 - Observational cohort study of rilpivirine (RPV) utilization in Europe
AU - Cozzi-Lepri, Alessandro
AU - Peters, Lars
AU - Pelchen-Matthews, Annegret
AU - Neesgaard, Bastian
AU - De Wit, Stephane
AU - Johansen, Isik Somuncu
AU - Edwards, Simon
AU - Stephan, Christoph
AU - Adamis, Georgios
AU - Staub, Therese
AU - Zagalo, Alexandra
AU - Domingo, Pere
AU - Elbirt, Daniel
AU - Kusejko, Katharina
AU - Brännström, Johanna
AU - Paduta, Dzmitry
AU - Trofimova, Tatyana
AU - Szlavik, Janos
AU - Zilmer, Kai
AU - Losso, Marcello
AU - Van Eygen, Veerle
AU - Pai, Helen
AU - Lundgren, Jens
AU - Mocroft, Amanda
AU - EuroSIDA study group
AU - Gerstoft, Jan
N1 - © 2022. The Author(s).
PY - 2022/8/6
Y1 - 2022/8/6
N2 - INTRODUCTION: Data on safety and effectiveness of RPV from the real-world setting as well as comparisons with other NNRTIs such as efavirenz (EFV) remain scarce. METHODS: Participants of EuroSIDA were included if they had started a RPV- or an EFV-containing regimen over November 2011-December 2017. Statistical testing was conducted using non-parametric Mann-Whitney U test and Chi-square test. A logistic regression model was used to compare participants' characteristics by treatment group. Kaplan-Meier analysis was used to estimate the cumulative risk of virological failure (VF, two consecutive values > 50 copies/mL). RESULTS: 1,355 PLWH who started a RPV-based regimen (11% ART-naïve), as well as 333 initiating an EFV-containing regimen were included. Participants who started RPV differed from those starting EFV for demographics (age, geographical region) and immune-virological profiles (CD4 count, HIV RNA). The cumulative risk of VF for the RPV-based group was 4.5% (95% CI 3.3-5.7%) by 2 years from starting treatment (71 total VF events). Five out of 15 (33%) with resistance data available in the RPV group showed resistance-associated mutations vs. 3/13 (23%) among those in the EFV group. Discontinuations due to intolerance/toxicity were reported for 73 (15%) of RPV- vs. 45 (30%) of EFV-treated participants (p = 0.0001). The main difference was for toxicity of central nervous system (CNS, 3% vs. 22%, p < 0.001). CONCLUSION: Our estimates of VF > 50 copies/mL and resistance in participants treated with RPV were similar to those reported by other studies. RPV safety profile was favourable with less frequent discontinuation due to toxicity than EFV (especially for CNS).
AB - INTRODUCTION: Data on safety and effectiveness of RPV from the real-world setting as well as comparisons with other NNRTIs such as efavirenz (EFV) remain scarce. METHODS: Participants of EuroSIDA were included if they had started a RPV- or an EFV-containing regimen over November 2011-December 2017. Statistical testing was conducted using non-parametric Mann-Whitney U test and Chi-square test. A logistic regression model was used to compare participants' characteristics by treatment group. Kaplan-Meier analysis was used to estimate the cumulative risk of virological failure (VF, two consecutive values > 50 copies/mL). RESULTS: 1,355 PLWH who started a RPV-based regimen (11% ART-naïve), as well as 333 initiating an EFV-containing regimen were included. Participants who started RPV differed from those starting EFV for demographics (age, geographical region) and immune-virological profiles (CD4 count, HIV RNA). The cumulative risk of VF for the RPV-based group was 4.5% (95% CI 3.3-5.7%) by 2 years from starting treatment (71 total VF events). Five out of 15 (33%) with resistance data available in the RPV group showed resistance-associated mutations vs. 3/13 (23%) among those in the EFV group. Discontinuations due to intolerance/toxicity were reported for 73 (15%) of RPV- vs. 45 (30%) of EFV-treated participants (p = 0.0001). The main difference was for toxicity of central nervous system (CNS, 3% vs. 22%, p < 0.001). CONCLUSION: Our estimates of VF > 50 copies/mL and resistance in participants treated with RPV were similar to those reported by other studies. RPV safety profile was favourable with less frequent discontinuation due to toxicity than EFV (especially for CNS).
KW - Anti-HIV Agents/adverse effects
KW - HIV Infections/drug therapy
KW - HIV-1/genetics
KW - Humans
KW - Rilpivirine/therapeutic use
KW - Treatment Outcome
KW - Viral Load
KW - Europe
KW - Real-world effectiveness
KW - Eviplera™
KW - Edurant™
KW - Efavirenz
KW - Cohort Study
UR - http://www.scopus.com/inward/record.url?scp=85135598196&partnerID=8YFLogxK
U2 - 10.1186/s12981-022-00457-0
DO - 10.1186/s12981-022-00457-0
M3 - Journal article
C2 - 35933352
SN - 1742-6405
VL - 19
SP - 1
EP - 12
JO - AIDS Research and Therapy
JF - AIDS Research and Therapy
IS - 1
M1 - 38
ER -