A Randomized Switch From Nevirapine-Based Antiretroviral Therapy to Single Tablet Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in Virologically Suppressed Human Immunodeficiency Virus-1-Infected Rwandans

Collins, Sean E; Grant, Philip; Uwinkindi, François; Talbot, Annie; Seruyange, Eric; Slamowitz, Deborah; Mugeni, Adeline; Remera, Eric; Niyonsenga, Simon Pierre; Nyirimigabo, Josbert; Uwizihiwe, Jean Paul; Dongier, Pierre; Ribakare, Muhayimpundu; Mazarati, Jean-Baptiste; Zolopa, Andrew; Nsanzimana, Sabin

doi:10.1093/ofid/ofw141

Cited by 3 publications

(7 citation statements)

References 24 publications

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“…However, the switching strategies were different between that study and our study. The NRTI backbones before switching to TDF/FTC/RPV in the Rwandan study included TDF (63%), azidothymidine (35%), and abacavir (1%) combined with 3TC [11]. In our study, 70% used TDF + 3TC and 30% used TDF/FTC as backbones.…”

Section: Discussionmentioning

confidence: 99%

“…Other than efficacy, the switch to RPV-based regimens in our study demonstrated a beneficial effect on total cholesterol and triglyceride. The switch trial in Rwanda also showed a trend toward a reduction in total cholesterol and HDL-C in the RPV switch arm compared with the NVP continuation arm, but no significant differences were detected in other fasting lipid measurements at week 24 [11]. A prospective, open-label, controlled trial in the Netherlands showed significant decreases in total cholesterol, HDL-C, and LDL-C over 24 weeks after switching from NVP to RPV [20].…”

Section: Discussionmentioning

confidence: 99%

“…Although the switch to RPV in treatment-experienced patients did not show higher virological failure [8, 11, 21], this switching strategy had some concerns on pharmacokinetics. Rilpivirine should always be taken with a meal to enhance its bioavailability.…”

Section: Discussionmentioning

confidence: 99%

“…The sample size was calculated from the proportional response rate from the previous trial [11] using n4Studies program, version 1.4.0 [15]. A population of 53 in each group was required to establish the noninferiority of the switching group compared with the continuing group and allowing for a dropout rate of approximately 10% at 0.9 power and a 0.05 significance level.…”

Section: Methodsmentioning

confidence: 99%

“…A small, prospective, single-arm study of switching from tenofovir disoproxil fumarate (TDF)/FTC + NVP to a TDF/FTC/RPV single-tablet regimen in virologically suppressed, HIV-1-infected subjects demonstrated that all 32 patients remained virologically suppressed at weeks 12 and 24 [10]. A randomized controlled study in Rwandans revealed that a switch from NVP plus any 2 NRTIs to coformulated TDF/FTC/RPV was virologic effective, with few adverse events at week 24 [11].…”

mentioning

confidence: 99%

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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

Petchkum

Sungkanuparph

Kiertiburanakul

et al. 2019

Open Forum Infectious Diseases

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

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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

Petchkum

Sungkanuparph

Kiertiburanakul

et al. 2019

Open Forum Infectious Diseases

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Predictors of Virological Failure Among People Living with HIV Switching from an Effective First-Line Antiretroviral Regimen

Magnasco

Pincino

Pasculli

et al. 2022

AIDS Research and Human Retroviruses

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Aim of this study was to assess the predictors of virological failure (VF) among patients living with HIV (PLWHIV) switching from an effective first-line antiretroviral therapy (ART) regimen, and to evaluate the emergence of resistance-associated mutations. All adult patients enrolled in the Antiviral Response Cohort Analysis cohort who started ART after 2010, with at least 6 months of virological suppression (VS) before ART switch and with an available genotypic resistance test (GRT) at baseline were included. Thirty-two patients out of the 607 PLWHIV included (5.3%) experienced VF after a median of 11 months from ART switch. Younger age (adjusted Hazard Ratio [aHR] 0.96, 95% confidence interval [CI] 0.92-0.99, p = .023), being male who have sex with male (aHR 0.15, 95% CI 0.03-0.69, p = .014), and longer time from VS to ART switch (aHR 0.97, 95% CI 0.95-1.00, p = .021) resulted protective toward VF, while receiving a first-line regimen containing a backbone other than ABC/3TC or TXF/FTC (aHR 3.61, 95% CI 1.00-13.1, p = .050) and a boosted protease inhibitor as anchor drug (aHR 3.34, 95% CI 1.20-9.28, p = .021) were associated with higher risk of VF. GRT at the moment of VF was available only for 13 patients (40.6%). ART switch in patients with stable control of HIV infection is a safe practice, even if particular attention should be paid in certain cases of patients switching from regimens containing low-performance backbones or protease inhibitors.

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Switching at Low HIV-1 RNA into Fixed Dose Combinations: TDF/FTC/RPV is non-inferior to TDF/FTC/EFV in first-line suppressed patients living with HIV

Munderi

Were

Avihingsanon

et al. 2019

Southern African Journal of HIV Medicine

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Background In low- and middle-income countries (LMICs), a substantial unmet need for affordable single-tablet regimen (STR) options remains. Rilpivirine (RPV, TMC278) is formulated in a low-cost STR with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Objectives Switching at Low HIV-1 RNA into Fixed Dose Combinations (SALIF) compared RPV with efavirenz (EFV), both as STRs with TDF and FTC, in maintaining virologic suppression. Methods SALIF was a phase 3b, randomised, open-label, non-inferiority study in virologically suppressed adults (HIV-1 RNA < 50 copies/mL) on non-nucleoside reverse transcriptase inhibitor (NNRTI)-based first-line antiretroviral therapy (ART) in Cameroon, Kenya, Senegal, South Africa, Uganda and Thailand. Patients ( N = 426), stratified by NNRTI use, were randomised 1:1 to receive TDF/FTC/RPV (300/200/25 mg qd) or TDF/FTC/EFV (300/200/600 mg qd). Primary endpoint was proportion of patients with virologic suppression (HIV-1 RNA < 400 copies/mL) at week 48 (intent-to-treat, modified Food and Drug Administration Snapshot, 10% non-inferiority margin). Results Patients received TDF/FTC/RPV ( n = 213) or TDF/FTC/EFV ( n = 211). At week 48, virologic suppression was maintained in 200/213 (93.9%) patients in the RPV arm and 203/211 (96.2%) in the EFV arm (difference –2.3%; 95% confidence interval: −6.4, +1.8), demonstrating non-inferiority of TDF/FTC/RPV. One patient in each arm experienced virologic failure without treatment-emergent resistance. Twenty-seven patients discontinued prematurely (8.0% RPV vs. 4.7% EFV), the most frequent reasons being adverse events (3.3% vs. 0.5%, respectively), site closure (1.9% vs. 0.5%), loss to follow-up (0.9% vs. 1.4%) and consent withdrawal (0.9% vs. 1.4%). Conclusion In adults with suppressed viral load on first-line NNRTI-based ART in LMICs, switching to an STR of TDF/FTC/RPV was non-inferior to TDF/FTC/EFV in maintaining high rates of viral suppression with a comparable tolerability profile.

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A Randomized Switch From Nevirapine-Based Antiretroviral Therapy to Single Tablet Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in Virologically Suppressed Human Immunodeficiency Virus-1-Infected Rwandans

Cited by 3 publications

References 24 publications

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

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

Predictors of Virological Failure Among People Living with HIV Switching from an Effective First-Line Antiretroviral Regimen

Switching at Low HIV-1 RNA into Fixed Dose Combinations: TDF/FTC/RPV is non-inferior to TDF/FTC/EFV in first-line suppressed patients living with HIV

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