Abstract
BackgroundIn 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).ObjectivesSwitching 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.MethodsSALIF 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).ResultsPatients 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%).ConclusionIn 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.
Highlights
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 clinical stage and CD4+ cell count
Switching at Low HIV-1 RNA into Fixed Dose Combinations (SALIF) was a 48-week, multicentre, phase 3b, randomised, open-label study designed to demonstrate non-inferiority of RPV to EFV in maintaining HIV-1 RNA suppression among adult patients in low- and middle-income countries (LMICs) on firstline NNRTI-based ART with HIV-1 RNA < 50 copies/mL
Ethics committee approval was obtained at all participating centres in accordance with the principles of the 2008 Declaration of Helsinki
Summary
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 clinical stage and CD4+ cell count. The WHO policy brief from July 20184 stated 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 (NVP) is associated with the risk of hepatotoxicity and skin reactions.[8] Given that DTG is not http://www.sajhivmed.org.za. 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)
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