Original Research

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

Paula Munderi, Edwin Were, Anchalee Avihingsanon, Pascale A.M Mbida, Lerato Mohapi, Samba B. Moussa, Marjolein Jansen, Ceyhun Bicer, Perry Mohammed, Yvon van Delft
Southern African Journal of HIV Medicine | Vol 20, No 1 | a949 | DOI: https://doi.org/10.4102/sajhivmed.v20i1.949 | © 2019 Perry Mohammed, Paula Munderi, Edwin Were, Anchalee Avihingsanon, Pascale A.M Mbida, Lerato Mohapi, Samba B. Moussa, Marjolein Jansen, Ceyhun Bicer, Yvon van Delft | This work is licensed under CC Attribution 4.0
Submitted: 24 January 2019 | Published: 23 July 2019

About the author(s)

Paula Munderi, MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda
Edwin Were, Partners in Prevention, Eldoret, Kenya
Anchalee Avihingsanon, HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thailand; and, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Pascale A.M Mbida, Cabinet Medical IDOC, Douala, Cameroon
Lerato Mohapi, Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa
Samba B. Moussa, District Centre de Gaspard Kamara, Dakar, Senegal
Marjolein Jansen, Janssen-Cilag BV, Breda, the, Netherlands
Ceyhun Bicer, BICER Consulting & Research, Antwerp, Belgium
Perry Mohammed, Janssen Ltd, High Wycombe, United Kingdom
Yvon van Delft, Janssen-Cilag BV, Breda, the, Netherlands


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Abstract

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.


Keywords

LMIC; Single-Tablet-Regimen; Virologically suppressed adults; Treatment-emergent Resistance; SALIF

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