Page 265 - SAHCS HIVMed Journal Vol 20 No 1 2019

Southern African Journal of HIV Medicine
ISSN: (Online) 2078-6751, (Print) 1608-9693
Page 1 of 10 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

Authors: Background: In low- and middle-income countries (LMICs), a substantial unmet need for
Paula Munderi affordable single-tablet regimen (STR) options remains. Rilpivirine (RPV, TMC278) is
1
Edwin Were
2
Anchalee Avihingsanon formulated in a low-cost STR with tenofovir disoproxil fumarate (TDF) and emtricitabine
3,4
Pascale A.M. Mbida 5 (FTC).
Lerato Mohapi
6
Samba B. Moussa 7 Objectives: Switching at Low HIV-1 RNA into Fixed Dose Combinations (SALIF) compared
Marjolein Jansen RPV with efavirenz (EFV), both as STRs with TDF and FTC, in maintaining virologic
8
Ceyhun Bicer suppression.
9
Perry Mohammed
10
8
Yvon van Delft Methods: SALIF was a phase 3b, randomised, open-label, non-inferiority study in virologically
Affiliations: suppressed adults (HIV-1 RNA < 50 copies/mL) on non-nucleoside reverse transcriptase
1 MRC/UVRI Uganda Research inhibitor (NNRTI)-based first-line antiretroviral therapy (ART) in Cameroon, Kenya, Senegal,
Unit on AIDS, Entebbe, South Africa, Uganda and Thailand. Patients (N = 426), stratified by NNRTI use, were
Uganda randomised 1:1 to receive TDF/FTC/RPV (300/200/25 mg qd) or TDF/FTC/EFV (300/200/600
2 Partners in Prevention, mg qd). Primary endpoint was proportion of patients with virologic suppression (HIV-1 RNA
Eldoret, Kenya < 400 copies/mL) at week 48 (intent-to-treat, modified Food and Drug Administration
3 HIV Netherlands Australia Snapshot, 10% non-inferiority margin).
Thailand Research
Collaboration (HIV-NAT), Results: Patients received TDF/FTC/RPV (n = 213) or TDF/FTC/EFV (n = 211). At week 48,
Thailand 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
4 Faculty of Medicine,
Chulalongkorn University, non-inferiority of TDF/FTC/RPV. One patient in each arm experienced virologic failure
Bangkok, Thailand without treatment-emergent resistance. Twenty-seven patients discontinued prematurely
5 Cabinet Medical IDOC, (8.0% RPV vs. 4.7% EFV), the most frequent reasons being adverse events (3.3% vs. 0.5%,
Douala, Cameroon 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%).
6 Perinatal HIV Research Unit,
University of the Conclusion: In adults with suppressed viral load on first-line NNRTI-based ART in LMICs,
Witwatersrand,
Johannesburg, South Africa 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.
7 District Centre de Gaspard
Kamara, Dakar, Senegal Keywords: LMIC; Single-Tablet-Regimen; Virologically suppressed adults; Treatment-
emergent Resistance; SALIF.
8 Janssen-Cilag BV, Breda,
the Netherlands
Introduction
9 BICER Consulting &
Research, Antwerp, Belgium Current HIV treatment guidelines 1,2,3 recommend that antiretroviral therapy (ART), administered
as a single-tablet regimen (STR), can be initiated in all patients living with HIV, regardless of
10 Janssen Ltd, High Wycombe,
United Kingdom clinical stage and CD4+ cell count. In low- and middle-income countries (LMICs), there is a
substantial unmet need for affordable STR options. The WHO policy brief from July 2018 stated
4
that dolutegravir (DTG)-based regimens may be recommended as a preferred first-line regimen
for people living with HIV initiating ART, and the alternative first-line treatment regimen is
efavirenz (EFV)-based. These first-line recommended treatments may result in some patients
experiencing neuropsychiatric events or other tolerability issues, 5,6,7 while the use of nevirapine
8
(NVP) is associated with the risk of hepatotoxicity and skin reactions. Given that DTG is not
Read online: Corresponding author: Perry Mohammed, [email protected]
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Scan this QR Dates: Received: 24 Jan. 2019|Accepted: 23 Mar. 2019|Published: 23 July 2019
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