Efficacy of Rilpivirine-Based Regimens as Switch Therapy From Nevirapine-Based Regimens in Human Immunodeficiency Virus-Infected Patients With Virological Suppression: A Randomized Controlled Trial

Abstract

Background Nevirapine (NVP)-based antiretroviral therapy continues to be used in some human immunodeficiency virus (HIV)-infected patients. Rilpivirine (RPV) could be used as an alternative to NVP. We studied the efficacy of RPV-based regimens as switch therapy. Methods A randomized controlled noninferiority trial was conducted in HIV-infected patients who received NVP-based regimens and had undetectable plasma viral loads (VLs). Patients were randomized to a continuation arm (NVP was continued) or a switch arm (NVP was switched to RPV). Tenofovir disoproxil fumarate (TDF) plus lamivudine or emtricitabine were the backbone of the regimens. The primary endpoint was an HIV VL <40 copies/mL at week 48. Results A total of 106 patients were enrolled, 55 patients were in the continuation arm and 51 patients were in the switch arm. The mean (standard deviation) age was 49.1 (9.2) years and 51.9% were females. The median (interquartile range) baseline CD4 count was 561 (443–732) cells/mm 3 . At week 48, 52 patients (94.6%) in the continuation arm and 50 patients (98.0%) in the switch arm had an HIV VL <40 copies/mL, with an efficacy difference of 3.5% (95% confidence interval [CI], −13.0 to 5.6; P = .619). Decreases in total cholesterol and triglyceride were observed in the switch arm (−17.1 mg/dL, 95% CI = −29.7 to −4.4, P = .008 and −36.0 mg/dL, 95% CI = −71.0 to −1.1, P = .044, respectively). Conclusions Switching from NVP to RPV can maintain virological suppression and decrease total cholesterol and triglyceride at week 48. In patients virologically suppressed with NVP-based regimens, RPV-based regimens can be a switch option.

Efficacy and Safety of Rilpivirine-Based Antiretroviral Therapy in Treatment-Naïve and Treatment-Experienced HIV-1-Positive Patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

“…Any disagreements were resolved by consensus. Eighteen articles met the inclusion criteria and were included in the systematic review [3][4][5][6][7][8][9][10][11][12][13][14]28,[32][33][34][35][36] (Table 1). Four of these articles were presented in tables and were not included in the quantitative metaanalyses of the efficacy and safety outcomes.…”

“…Rilpivirine (RPV; TMC278; Edurant®) is a secondgeneration non-nucleoside reverse-transcriptase inhibitor (NNRTI) with activity against many viral strains resistant to previous NNRTIs and a moderatehigh genetic barrier to resistance development [1,2]. RPV efficacy and safety have been assessed in registrative randomized controlled clinical trials (RCTs) in HIV-positive treatment-naïve [3][4][5][6][7] and treatmentexperienced patients [8][9][10][11][12][13][14] with documented longterm efficacy and tolerability. Real-life data from observational studies [15][16][17][18][19][20][21] eventually confirmed these results.…”

“…were used when reporting results for lipid values, as the publication of the pooled analysis did not detail such quantitative information [36]) and the publications at 148 weeks of follow-up of the SWORD 1-2 trials [35] and at 192 weeks of the TMC278-C204 trial [6] (which were not used in the meta-analyses, as no other study had data for a comparable follow-up period). Thus, a total of 14 publications [5,[7][8][9][10][11][12][13][14]28,[32][33][34]36], which provided results on 12 distinct RCTs at 48 and/or 96 (± 8) weeks of follow-up, were included in the metaanalyses. The data were extracted from the selected articles in a standardized format by 2 independent reviewers.…”

“…Our primary efficacy endpoint was the proportion of participants with viral suppression (defined as HIV RNA levels < 50 copies/mL) at 48 and 96 (± 8) weeks of follow-up. One study that defined viral suppression as HIV RNA levels < 40 copies/mL was also considered [14]. The secondary efficacy endpoint was the change in CD4 cell counts from baseline at 48 and 96 (± 8) weeks of follow-up.…”

Use of rilpivirine in HIV-1-infected individuals in routine clinical practice from 2012 to 2017 in France

“…1,2,3 Others clinical trials have shown that the rilpivirine/emtricitabine/TDF combination can maintain virological suppression in antiretroviral (ARV)-experienced virologically-controlled PLHIV. [4][5][6][7][8] In recent trials, the dual therapy dolutegravir/rilpivirine was non-inferior to a current triple antiretroviral therapy (ART) regimen in ARV-experienced virologically-controlled PLHIV at week 48 and efficacy and safety were maintained at week 100. 9,10 It is important to obtain data from real-life settings to assess how rilpivirine is used in routine care and evaluate its virological efficacy, as a complement to data from clinical trials.…”